Auro-Modafinil

Auro-Modafinil Uses, Dosage, Side Effects, Food Interaction and all others data.

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

Trade Name Auro-Modafinil
Availability Prescription only
Generic Armodafinil
Armodafinil Other Names Armodafinil, Armodafinilo, Armodafinilum
Related Drugs Adderall, methylphenidate, Concerta, modafinil, Ritalin, dextroamphetamine, Provigil, Nuvigil, Sunosi, solriamfetol
Type
Formula C15H15NO2S
Weight Average: 273.35
Monoisotopic: 273.082349901
Protein binding

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

Groups Approved, Investigational
Therapeutic Class CNS stimulant drugs
Manufacturer
Available Country Canada, United States
Last Updated: September 19, 2023 at 7:00 am
Auro-Modafinil
Auro-Modafinil

Uses

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

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

How Auro-Modafinil works

Nuvigil (armodafinil) is a single-isomer of modafini. The exact mechanism of action is unknown. Auro-Modafinil belongs to a class of drugs known as eugeroics, which are stimulants that provide long-lasting mental arousal. Pharmacologically, armodafinil does not bind to or inhibit several receptors and enzymes potentially relevant for sleep/wake regulation. Auro-Modafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, both armodafinil and modafinil bind to the dopamine transporter and inhibit dopamine reuptake. [Medilexicon]

Dosage

Auro-Modafinil 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 Auro-Modafinil 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, Auro-Modafinil 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 Auro-Modafinil 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 Auro-Modafinil 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 Auro-Modafinil 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 Auro-Modafinil which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Auro-Modafinil.

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

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

Caution should be used when concomitantly administering MAO inhibitors and Auro-Modafinil.

Food Interaction

  • Avoid alcohol.
  • Exercise caution with grapefruit products. Auro-Modafinil is partially metabolized by CYP3A4, and grapefruit is a CYP3A4 inhibitor.
  • Exercise caution with St. John's Wort. Auro-Modafinil 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.

[Minor] Administration with food may delay the absorption of modafinil (the racemate) and armodafinil (the R-enantiomer) without significantly affecting their overall bioavailability.

According to the product labeling, modafinil's absorption may be delayed by approximately one hour if taken with food.

Similarly, the time to reach peak plasma concentration (Tmax) of armodafinil may be delayed by approximately 2 to 4 hours in the fed state.

Volume of Distribution

Apparent volume of distribution: 42L.

Elimination Route

Tmax is 2 hours when fasted and can be delayed approximately 2-4 hours by food, potentially affecting the onset of action.

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 Auro-Modafinil in pregnant women. Auro-Modafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether Auro-Modafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Auro-Modafinil is administered to a nursing woman.

Contraindication

Contraindicated in patients with known hypersensitivity to Auro-Modafinil or any of theexcipients of this product.

Special Warning

Patients with hepatic impairment: In patients with severe hepatic impairment, Auro-Modafinil 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 Auro-Modafinil clinical studies. Symptoms of Auro-Modafinil 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 Auro-Modafinil 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 Auro-Modafinil which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Auro-Modafinil. Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Auro-Modafinil which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Auro-Modafinil. More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Auro-Modafinil is co-administered with Warfarin. Caution should be used when concomitantly administering MAO inhibitors and Auro-Modafinil.

Storage Condition

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

Innovators Monograph

You find simplified version here Auro-Modafinil

Auro-Modafinil contains Armodafinil see full prescribing information from innovator Auro-Modafinil Monograph, Auro-Modafinil MSDS, Auro-Modafinil FDA label

*** Taking medicines without doctor's advice can cause long-term problems.
Share