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SAVELLA (MILNACIPRAN): DOSAGE AND ADMINISTRATION
Savella (Milnacipran HCl) is given orally with or without food.
Taking Savella (Milnacipran Hydrochloride) with food may improve the tolerability of the drug.
The recommended dose of this medicine is 100 mg per 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 per day (12.5 mg twice daily)
Days 4-7: 50 mg per day (25 mg twice daily)
After Day 7: 100 mg per day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg per day (100 mg twice daily).
Doses above 200 mg per day have not been studied.
Milnacipran (Savella) 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.
Milnacipran HCl (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 per day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg per day (50 mg twice daily).
Milnacipran Hydrochloride (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.
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 (Milnacipran) should be tapered and not abruptly discontinued after extended use.
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 (Milnacipran HCl). In addition, at least 5 days should be allowed after stopping this drug before starting a MAOI.
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