Drug Catalog - Product Detail
ARMODAFINIL 250MG TB 30CT CIV
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65862-0807-30 | AUROBINDO PHARMA | 30 | 250MG | NA |
PACKAGE FILES
Generic Name
ARMODAFINIL
Substance Name
ARMODAFINIL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA206069
Description
11 DESCRIPTION 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 C 15 H 15 NO 2 S 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 methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 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. Bottles of 30 NDC 65862-805-30 Bottles of 60 NDC 65862-805-60 Bottles of 500 NDC 65862-805-05 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. Bottles of 30 NDC 65862-806-30 Bottles of 60 NDC 65862-806-60 Bottles of 500 NDC 65862-806-05 Armodafinil Tablets, 200 mg are white to off-white rounded, rectangular uncoated tablets debossed with ‘10’ on one side and ‘N’ on the other side. Bottles of 30 NDC 65862-998-30 Armodafinil Tablets, 250 mg are white to off-white, oval shaped uncoated tablets debossed with ‘K’ on one side and ‘60’ on the other side. Bottles of 30 NDC 65862-807-30 Bottles of 60 NDC 65862-807-60 Bottles of 500 NDC 65862-807-05 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE 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. 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). ( 1 ) Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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. (2.1) SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift. (2.2) Hepatic Impairment: reduced dose in patients with severe hepatic impairment. (2.3 , 12.3) Geriatric Patients: consider lower dose. (2.4 , 12.3) 2.1 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 (12.3) and Clinical Studies (14.1 , 14.2) ] . 2.2 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. 2.3 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 (8.6) and Clinical Pharmacology (12.3) ]. 2.4 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 (8.5) ].