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Savella Generic Name & Formulations
Legal Class
Rx
General Description
Milnacipran (as HCl) 12.5mg, 25mg, 50mg, 100mg; tabs.
Pharmacological Class
SNRI.
How Supplied
Tabs—60; Titration Pack (4 week supply)—1
Manufacturer
Generic Availability
NO
Savella Indications
Indications
Fibromyalgia.
Savella Dosage and Administration
Adult
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
<18yrs: not recommended.
Savella Contraindications
Contraindications
Concomitant MAOIs during or within 5 days of discontinuing milnacipran. During or within 14 days of discontinuing an MAOI. Concomitant linezolid or IV methylene blue. Uncontrolled narrow-angle glaucoma.
Savella Boxed Warnings
Boxed Warning
Suicidality and antidepressant drugs.
Savella Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor closely for clinical worsening or unusual changes in all patients. Monitor for serotonin syndrome; discontinue if occurs. Substantial alcohol abuse, chronic liver disease, end stage renal disease: not recommended. Hypertension. Heart disease. Arrhythmias. Monitor BP and HR prior to starting therapy and periodically thereafter; reduce dose or discontinue if elevation is sustained. Seizure disorder. Mania. Severe hepatic dysfunction. Discontinue if jaundice or liver dysfunction occurs. Moderate renal impairment. Volume depleted. Hyponatremia (esp. in elderly). History of dysuria. GU obstruction. Sexual dysfunction. Risk of bleeding. Controlled narrow-angle glaucoma. Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Pregnancy (Cat.C; see full labeling for effects on fetus). Nursing mothers.
Savella Pharmacokinetics
Elimination
Renal. Half-life: 6–8 hours.
Savella Interactions
Interactions
See Contraindications. Avoid IV digoxin (postural hypotension, tachycardia). Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Increased risk of bleeding with concomitant aspirin, NSAIDs, or others that affect coagulation. May antagonize certain antihypertensives (eg, clonidine). Caution with other CNS-active drugs. Arrhythmias, hypertension with epinephrine, norepinephrine.
Savella Adverse Reactions
Adverse Reactions
Nausea, vomiting, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, palpitations, increased heart rate, dry mouth, hypertension; rare: GU effects in men.
Savella Clinical Trials
See Literature
Savella Note
Not Applicable
Savella Patient Counseling
See Literature
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