Armodafinil (Armodafinil)

Trade Name : Armodafinil

Sandoz Inc

TABLET

Strength 50 mg/1

ARMODAFINIL

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Armodafinil (Armodafinil) which is also known as Armodafinil and Manufactured by Sandoz Inc. It is available in strength of 50 mg/1 per ml. Read more

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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). ()
Limitations of Use
In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

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. (, )

Tablets: 50 mg, 150 mg, 200 mg, and 250 mg. ()

Armodafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients .
Armodafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ()

No data

Serious Rash, including Stevens-Johnson Syndrome: discontinue armodafinil at the first sign of rash, unless the rash is clearly not drug-related. ()
DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue armodafinil. ()
Angioedema and Anaphylaxis Reactions: if suspected, discontinue armodafinil. ()
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. ()
Psychiatric Symptoms: use particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing armodafinil if psychiatric symptoms develop. ()
Known Cardiovascular Disease: consider increased monitoring. ()

The following serious adverse reactions are described below and elsewhere in the labeling:
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279
u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Most common adverse reactions (u22655%): headache, nausea, dizziness, and insomnia. ()

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 .
The effectiveness of steroidal contraceptives may be reduced when used with armodafinil and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with armodafinil and for one month after discontinuation of armodafinil treatment.
Blood levels of cyclosporine may be reduced when used with armodafinil. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with armodafinil.
Effects of Armodafinil on CYP2C19 Substrates
Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by armodafinil via inhibition of metabolic enzymes, with resultant higher systemic exposure. Dose reduction of these drugs may be required when these drugs are used concomitantly with armodafinil.
Warfarin
More frequent monitoring of prothrombin times/INR should be considered whenever armodafinil is coadministered with warfarin .
Monoamine Oxidase (MAO) Inhibitors
Caution should be used when concomitantly administering MAO inhibitors and armodafinil.

Steroidal contraceptives (e.g., ethinyl estradiol): use alternative or concomitant methods of contraception while taking armodafinil and for one month after discontinuation of armodafinil treatment. ()
Cyclosporine: blood concentrations of cyclosporine may be reduced. ()
CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam: exposure of these medications may be increased. ()

Pregnancy: based on animal data, may cause fetal harm. ()

No data

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 an armodafinil overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

Armodafinil tablets are a wakefulnessu2011promoting 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 2u2011[(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.

No data

Carcinogenesis
In a mouse carcinogenicity study, armodafinil (R-modafinil) was administered at oral doses of up to 300 mg/kg/day in males and 100 mg/kg/day in females for approximately two years, no tumorigenic effects were observed.
In a rat carcinogenicity study modafinil (a mixture of R- and S-modafinil) was administered at oral doses of up to 60 mg/kg/day for two years; no tumorigenic effects were observed.
At the highest doses studied in mouse and rat, the plasma armodafinil exposures (AUC) were less than that in humans at the MRHD of armodafinil (250 mg/day).
Mutagenesis
Armodafinil was negative in an in vitro bacterial reverse mutation assay and in an in vitro chromosomal aberration assay in human lymphocytes.
Modafinil was negative in a series of in vitro (i.e., bacterial reverse mutation, mouse lymphoma tk, chromosomal aberration in human lymphocytes, cell transformation in BALB/3T3 mouse embryo cells) or in vivo (mouse bone marrow micronucleus) assays.
Impairment of Fertility
A fertility and early embryonic development (to implantation) study was not conducted with armodafinil alone.
Oral administration of modafinil (doses of up to 480 mg/kg/day) to male and female rats prior to and throughout mating, and continuing in females through day 7 of gestation produced an increase in the time to mate at the highest dose; no effects were observed on other fertility or reproductive parameters. The no-effect dose of 240 mg/kg/day was associated with a plasma armodafinil AUC less than that in humans at the MRHD of armodafinil.

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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 .
DRESS/Multi-organ Hypersensitivity
Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately .
Angioedema and Anaphylactic Reactions
Advise patients of life-threatening symptoms suggesting anaphylaxis or angioedema (such as hives, difficulty in swallowing or breathing, hoarseness, or swelling of the face, eyes, lips, or tongue) that can occur with armodafinil. Instruct them to discontinue armodafinil and immediately report these symptoms to their healthcare provider .
Wakefulness
Advise patients that treatment with armodafinil will not eliminate their abnormal tendency to fall asleep. Advise patients that they should not alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with armodafinil has been shown to produce levels of wakefulness that permit such activities. Advise patients that armodafinil is not a replacement for sleep.
Continuing Previously Prescribed Treatments
Inform patients that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).
Psychiatric Symptoms
Advise patients to stop taking armodafinil and contact their physician right away if they experience, depression, anxiety, or signs of psychosis or mania.
Pregnancy
Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to armodafinil during pregnancy .
Females of Reproductive Potential
Caution females regarding the potential increased risk of pregnancy when using hormonal contraceptives (including depot or implantable contraceptives) with armodafinil and advise females who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with armodafinil and for one month after discontinuation of armodafinil.
Concomitant Medication
Advise patients to inform their physician if they are taking, or plan to take, any prescription or overu2011theu2011counter drugs, because of the potential for interactions between armodafinil and other drugs.
Alcohol
Advise patients that the use of armodafinil in combination with alcohol has not been studied. Advise patients that it is prudent to avoid alcohol while taking armodafinil.
The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
Distributed by Sandoz Inc.Princeton, NJ 08540
Rev. December 2018

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This Medication Guide has been approved by the U.S. Food and Drug Administration.n
Rev. October 2018
The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
Distributed by Sandoz Inc.Princeton, NJ 08540

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Armodafinil (Armodafinil)

Trade Name : Armodafinil

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Armodafinil (Armodafinil)

Trade Name : Armodafinil

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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