Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.Generic Nucynta (Tapentadol)

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing, weak pulse, slow heartbeat;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• seizure (convulsions);
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex; or
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol side effects may include:

• constipation, mild nausea, stomach pain;
• headache, tired feeling; or
• mild drowsiness or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Tapentadol dosing information

Usual Adult Dose for Pain:

Immediate release:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Extended release:
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)

Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.

Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• high blood pressure, heart disease, or prior heart attack;
• mental illness or psychosis; or
• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor’s instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

Overdose Symptoms?

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

Armodafinil side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• skin sores or blistering;
• mouth sores, trouble swallowing;
• chest pain, uneven heart beats; or
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects may include:

• headache, dizziness;
• nausea; or
• sleep problems (insomnia).

Armodafinil dosing information

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:

-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day dose.
-In OSA, this drug is not a treatment for the underlying obstruction.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

What other drugs will affect armodafinil?
Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.