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Savella

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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 a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with Savella. Conversely, at least 5 days should be allowed after stopping Savella before starting a MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use of Savella with other MAOIs such as Linezolid or Methylene Blue

Do not start Savella in a patient being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving Savella therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Savella should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Savella may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Savella is unclear. The clinician should nevertheless be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].

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
10 x 10 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
10 x 10 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
10 x 10 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
10 x 10 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].

Manufactured for: Forest Pharmaceuticals, Inc. Manufactured by: Forest Laboratories, Inc. Revised: October 2013

Last reviewed on RxList: 11/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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