Armoda250 mg

Armoda 250 mg is indicated to improve wakefulness in adult patients with- Obstructive sleep apnea (OSA) Narcolepsy Shift work disorder (SWD)

CNS stimulant drugs

Armoda 250 mg is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armoda 250 mg binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

Adults: Obstructive Sleep Apnea (OSA) & Narcolepsy: 150 mg to 250 mg as a single dose in the morning. Shift Work Disorder (SWD): 150 mg as a single dose approximately 1 hour prior to the start of work shift. Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.Elderly: In elderly patients, elimination of Armoda 250 mg 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.

Adults: Obstructive Sleep Apnea (OSA) & Narcolepsy: 150 mg to 250 mg as a single dose in the morning. Shift Work Disorder (SWD): 150 mg as a single dose approximately 1 hour prior to the start of work shift. Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.Elderly: In elderly patients, elimination of Armoda 250 mg 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.

The clearance of drugs that are substrates for CYP3A4 or CYP3A5 (e.g., steroidal contraceptives, Cyclosporine, Midazolam and Triazolam) may be increased by Armoda 250 mg which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armoda 250 mg.Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Armoda 250 mg which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armoda 250 mg.More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Armoda 250 mg is co-administered with Warfarin. Caution should be used when concomitantly administering MAO inhibitors and Armoda 250 mg.

Contraindicated in patients with known hypersensitivity to Armoda 250 mg or any of theexcipients of this product

The most common side effects of Armoda 250 mg are serious rash, including Stevens-Johnson syndrome, angioedema and anaphylaxis reactions, multi-organ hypersensitivity reactions, persistent sleepiness, psychiatric symptoms and some cardiovascular events.

Pregnancy: There are no adequate and well controlled studies of Armoda 250 mg in pregnant women. Armoda 250 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Lactation: It is not known whether Armoda 250 mg or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armoda 250 mg is administered to a nursing woman.

Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Armoda 250 mg therapy will not adversely affect their ability to engage in such activities. Caution should be taken in treating patients with a history of psychosis, depression or mania. Discontinuation of treatment should be considered if psychiatric symptoms develop. Increased monitoring of heart rate and blood pressure should be exercised. Caution should be exercised when prescribing Armoda 250 mg to patients with known cardiovascular disease.

There were no overdoses reported in the Armoda 250 mg clinical studies. Symptoms of Armoda 250 mg overdose are likely to be similar to those of Modafinil which included excitation or agitation, insomnia and slight or moderate elevations in hemodynamic parameters. There is no specific antidote for Armoda 250 mg overdose. However, if overdose occurs, it should be managed with primary supportive care.

Store in a cool (below 25°C) and dry place protected from light.

Patients with hepatic impairment: In patients with severe hepatic impairment, Armoda 250 mg should be administered at a reduced dose.Patients with renal impairment:There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.

CNS stimulant drugs

Armoda 250 mg is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armoda 250 mg binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

Pregnancy: There are no adequate and well controlled studies of Armoda 250 mg in pregnant women. Armoda 250 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Lactation: It is not known whether Armoda 250 mg or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armoda 250 mg is administered to a nursing woman.

Patients with hepatic impairment: In patients with severe hepatic impairment, Armoda 250 mg should be administered at a reduced dose.Patients with renal impairment:There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.