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ARMODAFINIL
Overview
What is ARMODAFINIL?
ARMODAFINIL is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is CHNOS and the molecular weight is 273.35.
The chemical structure is:
Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol.
ARMODAFINIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.
What does ARMODAFINIL look like?
What are the available doses of ARMODAFINIL?
Tablets: 200 mg. ()
What should I talk to my health care provider before I take ARMODAFINIL?
Pregnancy: based on animal data, may cause fetal harm.
How should I use ARMODAFINIL?
ARMODAFINIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Limitations of Use
In OSA, ARMODAFINIL is indicated to treat excessive sleepiness and not as treatment 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 ARMODAFINIL for excessive sleepiness.
The recommended dosage of ARMODAFINIL for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose .
What interacts with ARMODAFINIL?
Sorry No Records found
What are the warnings of ARMODAFINIL?
Sorry No Records found
What are the precautions of ARMODAFINIL?
Sorry No Records found
What are the side effects of ARMODAFINIL?
Sorry No records found
What should I look out for while using ARMODAFINIL?
ARMODAFINIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients .
What might happen if I take too much ARMODAFINIL?
Fatal overdoses involving modafinil alone or involving ARMODAFINIL or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying ARMODAFINIL or modafinil overdose, alone or in combination with other drugs, have included anxiety, dyspnea, insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
No specific antidote exists for the toxic effects of a ARMODAFINIL overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.
How should I store and handle ARMODAFINIL?
Sterile Bacitracin, USP is available in a vial (1's) containing 50,000 units (NDC 0009-0241-01) and as a pack of ten vials (10's) each containing 50,000 units (NDC 0009-0241-10).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The R- and S-enantiomers have similar pharmacological actions in animals.
Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines.
Modafinil-induced wakefulness can be attenuated by the α1-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.
Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake. For modafinil, 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 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.
Based on nonclinical studies, two major metabolites, acid and sulfone, of modafinil or armodafinil, do not appear to contribute to the CNS-activating properties of the parent compounds.
Non-Clinical Toxicology
ARMODAFINIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients .The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension.
Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
As the Lidocaine and Epinephrine Injections contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible heart block.
Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of ARMODAFINIL or modafinil (the racemic mixture of S- and R-enantiomers).
ARMODAFINIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.
In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction/ Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) . Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). The median time to rash that resulted in discontinuation was 13 days. No such cases were observed among 380 pediatric patients who received placebo.
Skin and mouth sores, blistering, and ulceration have been reported with modafinil and ARMODAFINIL in the postmarketing setting. Recurrence of signs and symptoms of serious dermatologic reactions following rechallenge has been reported in some cases.
Rare cases of serious or life-threatening rash, including SJS and toxic epidermal necrolysis (TEN), have been reported in adults and children in worldwide postmarketing experience with modafinil and ARMODAFINIL.
There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash associated with modafinil or ARMODAFINIL. In cases where the time to onset was reported, serious rash occurred 1 day to 2 months after initiation of treatment, but isolated cases of serious dermatologic reactions have been reported with symptoms beginning after prolonged treatment (e.g., 3 months).
Although benign rashes also occur with ARMODAFINIL, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, ARMODAFINIL should be discontinued at the first sign of rash, skin or mouth sores, or blistering or ulceration, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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