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PROVIGIL
Overview
What is PROVIGIL?
PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is CHNOS and the molecular weight is 273.35.
The chemical structure is:
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.
What does PROVIGIL look like?
What are the available doses of PROVIGIL?
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What should I talk to my health care provider before I take PROVIGIL?
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How should I use PROVIGIL?
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSAHS and SWSD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSAHS, or SWSD should periodically reevaluate long-term usefulness for the individual patient.
The recommended dose of PROVIGIL is 200 mg given once a day.
For patients with narcolepsy and OSAHS, PROVIGIL should be taken as a single dose in the morning.
For patients with SWSD, PROVIGIL 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 and ).
What interacts with PROVIGIL?
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What are the warnings of PROVIGIL?
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What are the precautions of PROVIGIL?
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What are the side effects of PROVIGIL?
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What should I look out for while using PROVIGIL?
PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil, armodafinil or its inactive ingredients.
What might happen if I take too much PROVIGIL?
How should I store and handle PROVIGIL?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 PROVIGIL (modafinil) Tablets100 mg:NDC 54868-4492-1 - Bottles of 10NDC 54868-4492-0 - Bottles of 30200 mg:NDC 54868-4897-1 - Bottles of 10NDC 54868-4897-0 - Bottles of 30Store at 20° - 25° C (68° - 77° F). Manufactured for:Cephalon, Inc.Frazer, PA 19355U.S. Patent Nos. RE37,516 / 4,927,855© Cephalon, Inc., 2008. All rights reservedMarch 2008PROV-011Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents like amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of sympathomimetic amines.
Modafinil has weak to negligible interactions with receptors for norepinephrine, serotonin, dopamine, GABA, adenosine, histamine-3, melatonin, and benzodiazepines. Modafinil also does not inhibit the activities of MAO-B or phosphodiesterases II-V.
Modafinil-induced wakefulness can be attenuated by the α-adrenergic receptor antagonist prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to α-adrenergic agonists, such as the rat vas deferens preparation.
Modafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, modafinil binds to the dopamine transporter and inhibits dopamine reuptake. This activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals. In genetically engineered mice lacking the dopamine transporter (DAT), modafinil lacked wake-promoting activity, suggesting that this activity was DAT-dependent. However, the wake-promoting effects of modafinil, unlike those of amphetamine, were not antagonized by the dopamine receptor antagonist haloperidol in rats. In addition, alpha-methyl-p-tyrosine, a dopamine synthesis inhibitor, blocks the action of amphetamine, but does not block locomotor activity induced by modafinil.
In the cat, equal wakefulness-promoting doses of methylphenidate and amphetamine increased neuronal activation throughout the brain. Modafinil at an equivalent wakefulness-promoting dose selectively and prominently increased neuronal activation in more discrete regions of the brain. The relationship of this finding in cats to the effects of modafinil in humans is unknown.
In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans. Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. Modafinil was also partially discriminated as stimulant-like.
The optical enantiomers of modafinil have similar pharmacological actions in animals. Two major metabolites of modafinil, modafinil acid and modafinil sulfone, do not appear to contribute to the CNS-activating properties of modafinil.
Non-Clinical Toxicology
PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil, armodafinil or its inactive ingredients.CNS Active Drugs
Methylphenidate
In a single-dose study in healthy volunteers, simultaneous administration of modafinil (200 mg) with methylphenidate (40 mg) did not cause any significant alterations in the pharmacokinetics of either drug. However, the absorption of PROVIGIL may be delayed by approximately one hour when coadministered with methylphenidate.
In a multiple-dose, steady-state study in healthy volunteers, modafinil was administered once daily at 200 mg/day for 7 days followed by 400 mg/day for 21 days. Administration of methylphenidate (20 mg/day) during days 22-28 of modafinil treatment 8 hours after the daily dose of modafinil did not cause any significant alterations in the pharmacokinetics of modafinil.
Dextroamphetamine
In a single dose study in healthy volunteers, simultaneous administration of modafinil (200 mg) with dextroamphetamine (10 mg) did not cause any significant alterations in the pharmacokinetics of either drug. However, the absorption of PROVIGIL may be delayed by approximately one hour when coadministered with dextroamphetamine.
In a multiple-dose, steady-state study in healthy volunteers, modafinil was administered once daily at 200 mg/day for 7 days followed by 400 mg/day for 21 days. Administration of dextroamphetamine (20 mg/day) during days 22-28 of modafinil treatment 7 hours after the daily dose of modafinil did not cause any significant alterations in the pharmacokinetics of modafinil.
Clomipramine
The coadministration of a single dose of clomipramine (50 mg) on the first of three days of treatment with modafinil (200 mg/day) in healthy volunteers did not show an effect on the pharmacokinetics of either drug. However, one incident of increased levels of clomipramine and its active metabolite desmethylclomipramine has been reported in a patient with narcolepsy during treatment with modafinil.
Triazolam
In the drug interaction study between PROVIGIL and ethinyl estradiol (EE), on the same days as those for the plasma sampling for EE pharmacokinetics, a single dose of triazolam (0.125 mg) was also administered. Mean C and AUC of triazolam were decreased by 42% and 59%, respectively, and its elimination half-life was decreased by approximately an hour after the modafinil treatment.
Monoamine Oxidase (MAO) Inhibitors
Interaction studies with monoamine oxidase inhibitors have not been performed. Therefore, caution should be used when concomitantly administering MAO inhibitors and modafinil.
Other Drugs
Warfarin
There were no significant changes in the pharmacokinetic profiles of R- and S-warfarin in healthy subjects given a single dose of racemic warfarin (5 mg) following chronic administration of modafinil (200 mg/day for 7 days followed by 400 mg/day for 27 days) relative to the profiles in subjects given placebo. However, more frequent monitoring of prothrombin times/INR is advisable whenever PROVIGIL is coadministered with warfarin (See )
Ethinyl Estradiol
Administration of modafinil to female volunteers once daily at 200 mg/day for 7 days followed by 400 mg/day for 21 days resulted in a mean 11% decrease in C and 18% decrease in AUC of ethinyl estradiol (EE; 0.035 mg; administered orally with norgestimate). There was no apparent change in the elimination rate of ethinyl estradiol.
Cyclosporine
One case of an interaction between modafinil and cyclosporine, a substrate of CYP3A4, has been reported in a 41 year old woman who had undergone an organ transplant. After one month of administration of 200 mg/day of modafinil, cyclosporine blood levels were decreased by 50%. The interaction was postulated to be due to the increased metabolism of cyclosporine, since no other factor expected to affect the disposition of the drug had changed. Dosage adjustment for cyclosporine may be needed.
Potential Interactions with Drugs That Inhibit, Induce, or are Metabolized by Cytochrome P-450 Isoenzymes and Other Hepatic Enzymes
In in vitro studies using primary human hepatocyte cultures, modafinil was shown to slightly induce CYP1A2, CYP2B6 and CYP3A4 in a concentration-dependent manner. Although induction results based on in vitro experiments are not necessarily predictive of response in vivo, caution needs to be exercised when PROVIGIL is coadministered with drugs that depend on these three enzymes for their clearance. Specifically, lower blood levels of such drugs could result (See Other Drugs, above).
The exposure of human hepatocytes to modafinil in vitro produced an apparent concentration-related suppression of expression of CYP2C9 activity suggesting that there is a potential for a metabolic interaction between modafinil and the substrates of this enzyme (e.g., S-warfarin and phenytoin). In a subsequent clinical study in healthy volunteers, chronic modafinil treatment did not show a significant effect on the single-dose pharmacokinetics of warfarin when compared to placebo (see ).
In vitro studies using human liver microsomes showed that modafinil reversibly inhibited CYP2C19 at pharmacologically relevant concentrations of modafinil. CYP2C19 is also reversibly inhibited, with similar potency, by a circulating metabolite, modafinil sulfone. Although the maximum plasma concentrations of modafinil sulfone are much lower than those of parent modafinil, the combined effect of both compounds could produce sustained partial inhibition of the enzyme. 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 PROVIGIL and may require dosage reduction and monitoring for toxicity.
Tricyclic antidepressants
CYP2C19 also provides an ancillary pathway for the metabolism of certain tricyclic antidepressants (e.g., clomipramine and desipramine) that are primarily metabolized by CYP2D6. In tricyclic-treated patients deficient in CYP2D6 (i.e., those who are poor metabolizers of debrisoquine; 7-10% of the Caucasian population; similar or lower in other populations), the amount of metabolism by CYP2C19 may be substantially increased. PROVIGIL may cause elevation of the levels of the tricyclics in this subset of patients. Physicians should be aware that a reduction in the dose of tricyclic agents might be needed in these patients.
In addition, due to the partial involvement of CYP3A4 in the metabolic elimination of modafinil, coadministration of potent inducers of CYP3A4 (e.g., carbamazepine, phenobarbital, rifampin) or inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole) could alter the plasma levels of modafinil.
PROVIGIL should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of either narcolepsy, OSAHS, and/or SWSD has been made in accordance with ICSD or DSM diagnostic criteria (See ). Such an evaluation usually consists of a complete history and physical examination, and it may be supplemented with testing in a laboratory setting. Some patients may have more than one sleep disorder contributing to their excessive sleepiness (e.g., OSAHS and SWSD coincident in the same patient).
Modafinil has been evaluated for safety in over 3500 patients, of whom more than 2000 patients with excessive sleepiness associated with primary disorders of sleep and wakefulness were given at least one dose of modafinil. In clinical trials, modafinil has been found to be generally well tolerated and most adverse experiences were mild to moderate.
The most commonly observed adverse events (≥5%) associated with the use of PROVIGIL more frequently than placebo-treated patients in the placebo-controlled clinical studies in primary disorders of sleep and wakefulness were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse event profile was similar across these studies.
In the placebo-controlled clinical trials, 74 of the 934 patients (8%) who received PROVIGIL discontinued due to an adverse experience compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for PROVIGIL than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain and nervousness (each <1%). In a Canadian clinical trial, a 35 year old obese narcoleptic male with a prior history of syncopal episodes experienced a 9-second episode of asystole after 27 days of modafinil treatment (300 mg/day in divided doses).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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