Neoresotyl
Neoresotyl Uses, Dosage, Side Effects, Food Interaction and all others data.
Neoresotyl is a preparation of Neoresotyl which is an indirect dopamine receptor agonist. Neoresotyl is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Neoresotyl binds to the dopamine transporter and inhibits dopamine reuptake. As a result, Neoresotyl increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.
Trade Name | Neoresotyl |
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 | |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Neoresotyl is used to improve wakefulness in adult patients with Obstructive sleep apnea (OSA). Narcolepsy Shift work disorder (SWD).
Neoresotyl is also used to associated treatment for these conditions: Narcolepsy, Shift-work related sleep disturbance, Somnolence
How Neoresotyl works
Nuvigil (armodafinil) is a single-isomer of modafini. The exact mechanism of action is unknown. Neoresotyl 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. Neoresotyl 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
Neoresotyl 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 Neoresotyl 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, Neoresotyl 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 Neoresotyl 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 Neoresotyl 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 Neoresotyl 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 Neoresotyl which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Neoresotyl.
Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Neoresotyl which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Neoresotyl.
More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Neoresotyl is co-administered with Warfarin.
Caution should be used when concomitantly administering MAO inhibitors and Neoresotyl.
Food Interaction
- Avoid alcohol.
- Exercise caution with grapefruit products. Neoresotyl is partially metabolized by CYP3A4, and grapefruit is a CYP3A4 inhibitor.
- Exercise caution with St. John's Wort. Neoresotyl 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.
Neoresotyl Drug Interaction
Minor: aripiprazole, aripiprazole, amphetamine / dextroamphetamine, amphetamine / dextroamphetamineUnknown: duloxetine, duloxetine, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, pregabalin, pregabalin, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, bupropion, bupropion, cetirizine, cetirizine
Neoresotyl Disease Interaction
Moderate: alcoholism, cardiovascular dysfunction, liver dysfunction, psychiatric complications, bipolar disorders, psychotic disorders
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 Neoresotyl in pregnant women. Neoresotyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether Neoresotyl or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neoresotyl is administered to a nursing woman.
Contraindication
Contraindicated in patients with known hypersensitivity to Neoresotyl or any of theexcipients of this product.
Special Warning
Patients with hepatic impairment: In patients with severe hepatic impairment, Neoresotyl 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 Neoresotyl clinical studies. Symptoms of Neoresotyl 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 Neoresotyl 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 Neoresotyl which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Neoresotyl. Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Neoresotyl which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Neoresotyl. More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Neoresotyl is co-administered with Warfarin. Caution should be used when concomitantly administering MAO inhibitors and Neoresotyl.
Storage Condition
Store in a cool (below 25°C) and dry place protected from light.
Innovators Monograph
You find simplified version here Neoresotyl
Neoresotyl contains Armodafinil see full prescribing information from innovator Neoresotyl Monograph, Neoresotyl MSDS, Neoresotyl FDA label