Armodafinil

Armodafinil tablets are 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 tablets are 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 tablets for excessive sleepiness. …

• The recommended dosage of armodafinil tablets for each indication is as follows: OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning
• SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift
• Hepatic Impairment: reduced dose in patients with severe hepatic impairment
• Geriatric Patients: consider lower dose
• Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy The recommended dosage of armodafinil tablets 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 [see Clinical Pharmacology and Clinical Studies ]
• Dosage in Shift Work Disorder (SWD) The recommended dosage of armodafinil tablets for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift
• Dosage Modification in Patients with Severe Hepatic Impairment In patients with severe hepatic impairment, the dosage of armodafinil tablets should be reduced [see Use in Specific Populations and Clinical Pharmacology ]
• Use in Geriatric Patients Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations ]

Armodafinil Tablets, 50 mg are white to off-white, round shaped uncoated tablets debossed with ‘K’ on one side and ‘58’ on the other side. Armodafinil Tablets, 150 mg are white to off-white, oval shaped uncoated tablets debossed with ‘K’ on one side and ‘59’ on the other side. …

• Safety and effectiveness
• In pediatric patients have not been established
• Serious rash has been seen
• In pediatric patients receiving modafinil [see Warnings and Precautions ]

In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ].

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Serious Dermatologic Reactions Advise patients and caregivers about the risk of potentially fatal serious skin reactions
• Educate patients about the signs and symptoms that may signal a serious skin reaction
• Instruct patients to discontinue armodafinil and consult with their healthcare provider immediately if a skin reaction such as rash, mouth sores, blisters, or peeling skin occurs during treatment with armodafinil [see Warnings and Precautions ]. …

• Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ]
• Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil

Effects of Armodafinil on CYP3A4/5 Substrates The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by armodafinil via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with armodafinil [see Clinical Pharmacology (12.3) ] . The effectiveness of steroidal contraceptives may be reduced when used with armodafinil and for one month after discontinuation of therapy. …

Serious Rash, including Stevens-Johnson Syndrome: discontinue armodafinil at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue armodafinil. ( 5.2 ) Angioedema and Anaphylaxis Reactions: if suspected, discontinue armodafinil. ( 5.3 ) Persistent Sleepiness: assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity. ( 5.4 ) Psychiatric Symptoms: use particular caution in treating patients with a history of psychosis, depression, or mania. …

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Dermatologic Reactions [see Warnings and Precautions (5.1) ] Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.2) ] Angioedema and Anaphylaxis Reactions [see Warnings and Precautions (5.3) ] Persistent Sleepiness [see Warnings and Precautions (5.4) ] Psychiatric Symptoms [see Warnings and Precautions (5.5) ] Effects on Ability to Drive and Use Machinery [see Warnings and Precautions (5.6) ] Cardiovascular Events [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥5%): headache, nausea, dizziness, and insomn …

8.1 Pregnancy Risk Summary Limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. Intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and modafinil. …

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. …

9.1 Controlled Substance Armodafinil is a Schedule IV controlled substance. 9.2 Abuse Abuse of armodafinil has been reported in patients treated with armodafinil. Patterns of abuse have included euphoric mood and use of increasingly large doses or recurrent use of armodafinil for a desired effect. Drug diversion has also been noted. …

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.