Modafinil
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Questions & Answers
Side Effects & Adverse Reactions
Skin Cancer / Skin Aging Alert:
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.
- On damaged or broken skin
- Keep out of eyes. Rinse with water to remove.
- Rash occurs.
If product is swallowed, get medical help or contact a Poison Control Center right away.
- On damaged or broken skin
- Rash occurs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- Helps prevent sunburn
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Modafinil Manufacturers
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Cima Labs Inc
![Modafinil Tablet [Cima Labs Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Modafinil | Laboratoires Clarins S.a.
Apply liberally 15 minutes before sun exposure Apply to all skin exposed to the sun Children under 6 months: Ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating.
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Stat Rx Usa Llc
Modafinil | Stat Rx Usa Llc
The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General Considerations
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Mylan Institutional Inc.
Modafinil | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
HypertensionThe initial dose of atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.
Atenolol tablets may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin and alpha-methyldopa.
Angina PectorisThe initial dose of atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.
Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 mg to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.
Acute Myocardial InfarctionIn patients with definite or suspected acute myocardial infarction, treatment with atenolol I.V. injection should be initiated as soon as possible after the patient’s arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. Atenolol I.V. injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate and electrocardiogram. Dilutions of atenolol I.V. injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.
In patients who tolerate the full intravenous dose (10 mg), atenolol tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, atenolol tablets can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol tablets should be discontinued. (See full prescribing information prior to initiating therapy with atenolol tablets.)
Data from other beta-blocker trials suggest that if there is any question concerning the use of I.V. beta-blocker or clinical estimate that there is a contraindication, the I.V. beta-blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets 50 mg twice daily or 100 mg once a day for at least 7 days (if the I.V. dosing is excluded).
Although the demonstration of efficacy of atenolol is based entirely on data from the first 7 postinfarction days, data from other beta-blocker trials suggest that treatment with beta blockers that are effective in the postinfarction setting may be continued for 1 to 3 years if there are no contraindications.
Atenolol tablets are an additional treatment to standard coronary care unit therapy.
Elderly Patients or Patients with Renal ImpairmentAtenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.
No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73 m2. Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.
The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:
Creatinine
Clearance
(mL/min/1.73m2) Atenolol
Elimination
Half-Life
(hrs) Maximum
Dosage15 to 35
16 to 27
50 mg daily
< 15
> 27
25 mg daily
Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of atenolol: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose ("trough" blood pressure) to ensure that the treatment effect is present for a full 24 hours.
Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.
Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.
Cessation of Therapy in Patients with Angina PectorisIf withdrawal of atenolol tablets therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.
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Qualitest Pharmaceuticals
Modafinil | Qualitest Pharmaceuticals
The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General Considerations
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS). -
Dispensing Solutions, Inc.
Modafinil | Dispensing Solutions, Inc.
The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General Considerations
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Bryant Ranch Prepack
Modafinil | Bryant Ranch Prepack
The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General ConsiderationsDosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Par Pharmaceutical Inc.
Modafinil | Avpak
Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.
Oxybutynin chloride extended-release tablets may be administered with or without food.
Adults: The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.
Pediatric patients aged 6 years of age and older: The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).
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Apotex Corp.
Modafinil | Apotex Corp.
The recommended dose of modafinil tablets is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil tablets should be taken as a single dose in the morning.
For patients with SWD, modafinil tablets should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General ConsiderationsDosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Orchidpharma Inc
Modafinil | Orchidpharma Inc
2.1 Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA)The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
2.2 Dosage in Shift Work Disorder (SWD)The recommended dosage of modafinil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
2.3 Dosage Modifications in Patients with Severe Hepatic ImpairmentIn patients with severe hepatic impairment, the dosage of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.4 Use in Geriatric PatientsConsideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
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Avkare, Inc.
Modafinil | L.n.k. International, Inc.
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years : do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage -
Golden State Medical Supply, Inc.
Modafinil | Golden State Medical Supply, Inc.
The recommended dose of modafinil tablets is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil tablets should be taken as a single dose in the morning.
For patients with SWD, modafinil tablets should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General ConsiderationsDosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (SeeCLINICAL PHARMACOLOGY and PRECAUTIONS).
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Mylan Pharmaceuticals Inc.
Modafinil | Mylan Pharmaceuticals Inc.
2.1 Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA)The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
2.2 Dosage in Shift Work Disorder (SWD)The recommended dosage of modafinil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
2.3 Dosage Modifications in Patients with Severe Hepatic ImpairmentIn patients with severe hepatic impairment, the dosage of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.4 Use in Geriatric PatientsConsideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
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American Health Packaging
Modafinil | American Health Packaging
The recommended dose of modafinil tablets is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil tablets should be taken as a single dose in the morning.
For patients with SWD, modafinil tablets should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (see CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General Considerations
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (see PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil tablets and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil tablets and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (see CLINICAL PHARMACOLOGY and PRECAUTIONS). -
Ingenus Phamaceuticals, Llc
Modafinil | Laboratoires Clarins S.a.
• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly
use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses.
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating. -
Aurobindo Pharma Limited
Modafinil | Walgreen Co.
do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: do not use -
Aphena Pharma Solutions – Tennessee, Llc
Modafinil | Aphena Pharma Solutions - Tennessee, Llc
The recommended dose of modafinil tablets is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil tablets should be taken as a single dose in the morning.
For patients with SWD, modafinil tablets should be taken approximately one hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (see CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General ConsiderationsDosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (see PRECAUTIONS: Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Aphena Pharma Solutions – Tennessee, Llc
Modafinil | Aphena Pharma Solutions - Tennessee, Llc
The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General Considerations
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
-
Actavis Pharma, Inc.
Modafinil | Actavis Pharma, Inc.
The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General ConsiderationsDosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
-
Hikma Pharmaceutical
Modafinil | Hikma Pharmaceutical
The recommended dose of modafinil tablets is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil tablets should be taken as a single dose in the morning.
For patients with SWD, modafinil tablets should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
General ConsiderationsDosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See PRECAUTIONS, Drug Interactions).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil tablets and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one half of that recommended for patients with normal hepatic function (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
In elderly patients, elimination of modafinil tablets and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
![Modafinil Tablet [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eba3a655-074b-46b3-88cf-3e6b2c0c8b15&name=ModafinilC-IV200mgLabel42549.jpg)
![Modafinil Tablet [Mylan Institutional Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=404b246f-1d29-4a3a-a735-8bf4543984c7&name=atenolol-50mg-2.jpg)
![Modafinil Tablet [Qualitest Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2cc86071-bc4b-446c-9b65-37b1ff43770f&name=100-30.jpg)
![Modafinil Tablet [Dispensing Solutions, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ca740635-df30-46af-9202-55af9204f381&name=NDC68258-7981-03------CEPHALON.jpg)
![Modafinil Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=299a585f-fed1-49f2-8750-657b1c5e0c70&name=49981.jpg)
![Modafinil Tablet [Par Pharmaceutical Inc.]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Modafinil Tablet [Orchidpharma Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=01f6690c-1410-42ad-8eb3-e7df32eab3ba&name=modafinil-tablets-figure-2.jpg)
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