Savella
INDICATIONS
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients [see Use In Specific Populations].
DOSAGE AND ADMINISTRATION
Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
Recommended Dosing
The recommended dose of Savella 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.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella and WARNINGS AND PRECAUTIONS]
Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment.
Savella 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).
Savella 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.
Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see WARNINGS AND PRECAUTIONS].
Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see CONTRAINDICATIONS].
HOW SUPPLIED
Dosage Forms And Strengths
Film-coated, immediate-release tablets in four strengths: 12.5 mg, 25 mg, 50 mg, and 100 mg of milnacipran hydrochloride.
12.5 mg tablets are round, blue, “F” on one
side, “L” on the reverse;
25 mg tablets are round, white, “FL” on one
side, “25” on the reverse;
50 mg tablets are oval, white, “FL” on one
side, “50” on the reverse;
100 mg tablets are oval, pink, “FL” on one
side, “100” on the reverse [see DESCRIPTION and Storage and Handling].
Storage And Handling
12.5-mg tablets:
Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse
Bottles of 60: NDC 0456-1512-60
10X10 Unit Dose: NDC 0456-1512-63
25-mg tablets:
White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse
Bottles of 60: NDC 0456-1525-60
10X10 Unit Dose: NDC 0456-1525-63
50-mg tablets:
White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse
Bottles of 60: NDC 0456-1550-60
10X10 Unit Dose: NDC 0456-1550-63
100-mg tablets:
Pink, oval-shaped, film-coated tablets, debossed with “FL” on one side and “100” on the reverse
Bottles of 60: NDC 0456-1510-60
10X10 Unit Dose: NDC 0456-1510-63
Titration Pack:
4-Week Titration Pack: NDC 0456-1500-55
Blister package containing 55 tablets: 5 x 12.5-mg
tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets.
Storage
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature].
Revised: October 2012. Manufactured for: Forest Pharmaceuticals, Inc. Manufactured by: Forest Laboratories, Inc., Licensed from Pierre Fabre Medicament and Cypress Bioscience, Inc.
Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Savella Information
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