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milnacipran
Savella Pharmaceutical company:
Forest Pharmaceuticals, Inc.
www.savella.com

Pharmacologic classification: selective serotonin norepinephrine reuptake inhibitor
Therapeutic classification:
antidepressant
Pregnancy risk category:
C


AVAILABLE FORMS
Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg

INDICATIONS AND DOSAGES
Fibromyalgia—
Adults: Initially, 12.5 mg P.O. once daily. Increase dose to 12.5 mg b.i.d. on days 2 and 3, followed by 25 mg b.i.d. on days 4 to 7. Increase to 50 mg b.i.d. by day 7.
ADJUST-A-DOSE: For patients with a creatinine clearance of 5 to 29, give 25 mg b.i.d. May increase dose to 50 mg b.i.d. if needed and tolerated.

CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients hypersensitive to the drug or its ingredients, in patients taking MAO inhibitors, and in those with uncontrolled narrow-angle glaucoma. Avoid use in patients with end-stage renal disease.
   Use cautiously in patients with a history of mania, seizures, severe hepatic impairment, or dysuria; in patients who drink substantial amounts of alcohol; and in patients with hypertension or controlled angle-closure glaucoma.

INTERACTIONS
Drug-drug. Lithium and other serotonergic drugs: May cause serotonin syndrome (diarrhea, dysreflexia, fever, hallucinations, loss of coordination, nausea, tachycardia). Avoid use together.
Epinephrine, norepinephrine: May cause paroxysmal hypertension and arrhythmias. Avoid use together.
Digoxin: May cause orthostatic hypotension and tachycardia. Avoid use together.
Clonidine: May inhibit effects of clonidine. Use together cautiously.
Clomipramine: May cause euphoria and orthostatic hypotension when switching from clomipramine to milnacipran. Monitor patient closely.
MAO inhibitors: May cause hyperthermia, rigidity, myoclonus, autonomic instability, rapid fluctuations of vital signs, agitation, delirium, and coma. Avoid use within 2 weeks after MAO inhibitor therapy; wait at least 5 days after stopping milnacipran before starting an MAO inhibitor.
Drug-lifestyle. Alcohol use: May enhance CNS depression. Discourage use together.

ADVERSE REACTIONS
CNS: anxiety, depression, dizziness, dysgeusia, fall, fatigue, fever, headache, hypoesthesia, irritability, insomnia, migraine, paresthesia, seizures, stress, somnolence, tension headache, tremor.
CV: chest discomfort, chest pain, flushing, hypertension, palpitations, peripheral edema, tachycardia.
EENT: blurred vision.
GI: abdominal distension, abdominal pain, constipation, decreased appetite, diarrhea, dry mouth, flatulence, GERD, dyspepsia, nausea, vomiting.
GU: cystitis or urinary tract infection in men and women; dysuria, ejaculation disorder, ejaculation failure, erectile dysfunction, decreased libido, prostatitis, scrotal pain, testicular pain, testicular swelling, urethral pain, urinary hesitation, urinary retention, and urine flow decrease in men.
Metabolic: hypercholesteremia, weight loss.
Respiratory: dyspnea, upper respiratory tract infection.
Skin: hyperhidrosis, pruritis, rash.
Other: chills, contusion, hot flush, night sweats.

Reactions may be common, uncommon, life-threatening, or
COMMON AND LIFE-THREATENING.

     
   

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