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Averomilan

CNS
Product

AVEROMILAN film coated tablets

Active

Milnacipran Hydrochloride 50 mg

Category
CNS
Indication

Averomilan is indicated for the management of fibromyalgia. Averomilan is not approved for use in pediatric patients.

Dose

Averomilan is given orally with or without food. Taking Averomilan with food may improve the tolerability of the drug.

Recommended Dosing

The recommended dose of Averomilan is 100 mg/day (50 mg twice daily).

Based on efficacy and tolerability dosing may be titrated according to the following schedule:

Day 1: 12.5 mg once

Days 2-3: 25 mg/day (12.5 mg twice daily)

Days 4-7: 50 mg/day (25 mg twice daily)

After Day 7: 100 mg/day (50 mg twice daily)

Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).

Doses above 200 mg/day have not been studied.

Averomilan should be tapered and not abruptly discontinued after extended use.

Patients with Renal Insufficiency

No dosage adjustment is necessary in patients with mild renal impairment. Averomilan should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).

Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).

Averomilan is not recommended for patients with end-stage renal disease.

Patients with Hepatic Insufficiency

No dosage adjustment is necessary for patients with hepatic impairment. As with any drug, caution should be exercised in patients with severe hepatic impairment.