SAVELLA (Milnacipran) 12.5mg, 25mg, 50mg, 100mg tablets by Forest and Cypress
COMPANIES: Forest and Cypress
PHARMACOLOGIC CLASS: Serotonin and norepinephrine reuptake inhibitor (SNRI)
ACTIVE INGREDIENT: Milnacipran HCl 12.5mg, 25mg, 50mg, 100mg; tabs; contain tartrazine.
PHARMACOLOGY: The mechanism of action of milnacipran, which is pharmacologically similar to certain antidepressants, in the management of fibromyalgia is unknown. It inhibits the synaptic reuptake of norepinephrine and, to a lesser extent, serotonin. It does not directly affect other neurotransmitters.
CLINICAL TRIALS: Two double-blind, placebo-controlled, multicenter studies conducted in adults demonstrated the efficacy of milnacipran in managing fibromyalgia. In the first study, patients were given milnacipran 100mg/day, milnacipran 200mg/day, or placebo for 6 months. More patients in the milnacipran treatment arms had at least a 30% reduction in pain from baseline and considered themselves globally improved than those given placebo. Treatment with 200mg/day of the study drug was not superior to treatment with 100mg/day. In a 3-month study, patients were given milnacipran 100mg or 200mg/day or placebo. This study also showed that treatment with the study drug was superior to that with placebo, and that the 200mg dose did not confer additional benefit over 100mg/day.
ADULTS: May take with food. Titrate dose. Day 1: 12.5mg once. Days 2–3: 12.5mg twice daily. Days 4–7: 25mg twice daily. After Day 7: 50mg twice daily (recommended dose); max 100mg twice daily. Severe renal impairment (CrCl 5–29mL/min): maintenance 25mg twice daily; max 50mg twice daily. Withdraw gradually.
CHILDREN: <17yrs: not recommended.
CONTRAINDICATIONS: Allow at least 14 days after MAOI discontinuance before starting milnacipran; allow at least 5 days after discontinuing milnacipran before starting an MAOI. Uncontrolled narrow-angle glaucoma.
PRECAUTIONS: Substantial alcohol abuse, chronic liver disease, ESRD: not recommended. Hypertension. Heart disease. Arrhythmias. Monitor BP and heart rate; reduce dose or discontinue if elevated BP persists. Controlled narrow-angle glaucoma. Seizure disorder. Suicidal ideation (monitor). Mania. Severe hepatic dysfunction. Discontinue if liver dysfunction develops. Volume depleted. GU obstruction. Aspirin allergy (tartrazine). Risk of bleeding. Reevaluate periodically. Write Rx for smallest practical amount. Pregnancy (Cat.C; see literature for effects on fetus). Labor & delivery, nursing mothers: not recommended.
INTERACTIONS: See Contraindications. Concomitant serotonin precursors (eg, tryptophan), serotonergics (eg, triptans, tramadol): not recommended. Avoid IV digoxin (postural hypotension, tachycardia). May potentiate anticoagulants (eg, aspirin, NSAIDs, Coumadin). May antagonize certain antihypertensives (eg. clonidine). Serotonin syndrome with SSRIs, SNRIs, lithium, tramadol, triptans (monitor). Caution with other CNS-active drugs or those that can increase BP. Arrhythmias, hypertension with epinephrine, norepinephrine.
ADVERSE REACTIONS: GI upset, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, palpitations, increased heart rate, dry mouth, hypertension; rare: GU effects in men; hyponatremia (esp. in elderly); serotonin syndrome; seizure.
HOW SUPPLIED: Tabs 12.5mg—60; 25mg, 50mg, 100mg—60; 180 Titration Pack (4 week supply)—1For more information call (800) 678-1605 or visit www.Savella.com.