Armoda Tablet

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

Uses

Armoda is used to improve wakefulness in adult patients with Obstructive sleep apnea (OSA). Narcolepsy Shift work disorder (SWD).

Armoda is also used to associated treatment for these conditions: Narcolepsy, Shift-work related sleep disturbance, Somnolence

Trade Name Armoda
Generic Armodafinil
Other Names Armodafinil, Armodafinilo, Armodafinilum
Weight 150mg, 250mg
Type Tablet
Formula C15H15NO2S
Weight Average: 273.35
Monoisotopic: 273.082349901
Protein binding

Specific data unavailable. Similar to modafinil: approximately 60%, primarily to albumin.

Therapeutic Class CNS stimulant drugs
Manufacturer ACI Limited
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:16 am

Dosage

Armoda dosage

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 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. Patients with hepatic impairment: In patients with severe hepatic impairment, Armoda 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.

Side Effects

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

Precaution

Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Armoda 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 to patients with known cardiovascular disease.

Interaction

The clearance of drugs that are substrates for CYP3A4 or CYP3A5 (e.g., steroidal contraceptives, Cyclosporine, Midazolam and Triazolam) may be increased by Armoda which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armoda.

Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Armoda which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armoda.

More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Armoda is co-administered with Warfarin.

Caution should be used when concomitantly administering MAO inhibitors and Armoda.

Food Interaction

  • Avoid alcohol.
  • Exercise caution with grapefruit products. Armoda is partially metabolized by CYP3A4, and grapefruit is a CYP3A4 inhibitor.
  • Exercise caution with St. John's Wort. Armoda is partially metabolized by CYP3A4, and St. John's Wort is a CYP3A4 inducer.
  • Take with or without food. Taking armodafinil with food can delay the Tmax by 2-4 hours.

Volume of Distribution

Apparent volume of distribution: 42L.

Half Life

Terminal half-life is approximately 15 hours.

Clearance

The oral clearance of armodafinil is approximately 33 mL/min.

Pregnancy & Breastfeeding use

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

Contraindication

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

Special Warning

Patients with hepatic impairment: In patients with severe hepatic impairment, Armoda 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.

Acute Overdose

There were no overdoses reported in the Armoda clinical studies. Symptoms of Armoda 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 overdose. However, if overdose occurs, it should be managed with primary supportive care.

Interaction with other Medicine

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

Storage Condition

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

Armoda contains Armodafinil see full prescribing information from innovator Monograph