It is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia Savella is not approved for use in pediatric patients
Milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake in approximately 1:3 ratio respectively. These actions simultaneously works synergistically to treat both depression and fibromyalgia and also improve multiple fibromyalgia symptoms such as peripheral and central pain, depressiveness, sleep and quality
Administer it in two divided doses per day ? 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) ? Recommended dose is 100 mg/day (2.1). ? May be increased to 200 mg/day based on individual patient response . ? Dose should be adjusted in patients with severe renal impairment .
Milnacipran undergoes minimal CYP450 related metabolism, with the majority of the dose excreted unchanged in urine (55%), and has a low binding to plasma proteins (13%). In vitro and in vivo studies showed that Milnacipran is unlikely to be involved in clinically significant.
Use of monoamine oxidase inhibitors concomitantly or in close temporal proximity . ? Use in patients with uncontrolled narrow-angle glaucoma. ? Suicidality: Monitor for worsening of depressive symptoms and suicide risk . ? Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Serotonin syndrome or NMS-like reactions have been reported with SNRIs and SSRIs. Discontinue Savella and initiate supportive treatment . ? Elevated blood pressure and heart rate: Cases have been reported with Savella. Monitor blood pressure and heart rate prior to initiating treatment with Savella and periodically throughout treatment . ? Seizures: Cases have been reported with Savella therapy. Prescribe Savella with care in patients with a history of seizure disorder . ? Hepatotoxicity: More patients treated with Savella than with placebo experienced mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with Savella. Avoid concomitant use of Savella in patients with substantial alcohol use or chronic liver disease . ? Discontinuation: Withdrawal symptoms have been reported in patients when discontinuing treatment with Savella. A gradual dose reduction is recommended . ? Abnormal Bleeding: Savella may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of Savella and NSAIDs,aspirin,or other drugs that affect coagulation (5.9). ? Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events (5.11).
e nausea,headache,constipation,dizziness, insomnia,hot flush,hyperhidrosis,vomiting,palpitations,heart rate increased,dry mouth,and hypertension
Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Milnacipran therapy. Patients should be encouraged to enroll in the Milnacipran Pregnancy Registry if they become pregnant,preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy. Nursing: Advise patients to notify their physician if they are breast feeding
There is limited clinical experience with Savella overdose in humans. In clinical trials, cases of
acute ingestions up to 1000 mg, alone or in combination with other drugs, were reported with
none being fatal.
In postmarketing experience, fatal outcomes have been reported for acute overdoses primarily
involving multiple drugs but also with Savella only. The most common signs and symptoms
included increased blood pressure, cardio-respiratory arrest, changes in the level of
consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased
hepatic enzymes.
Store in a cool and dry place. Keep away from light and out of reach of children.
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