Adult Dosing
Management of fibromyalgia
- Recommended dose: 50 mg PO bid
- Based on efficacy and tolerability, titrate the dose according to following schedule
- Day 1: 12.5 mg PO qd
- Days 2-3: 12.5 mg PO bid
- Days 4-7: 25 mg PO bid
- After Day 7: 50 mg PO bid, may increase to 100 mg PO bid if required/tolerated
- Max dose: 200 mg/day
Note: Taper dose gradually while discontinuing after extended use.
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Mild renal impairment: No dose adjustments
- Moderate renal impairment: Use with caution
- Severe renal impairment (5-29 mL/min): Reduce the maintenance dose by 50%
- End-stage renal disease: Contraindicated
Hepatic Dose Adjustment
- Mild-moderate hepatic impairment: No dose adjustments
- Severe hepatic impairment: Caution advised
See Supplemental Patient Information
- Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. Closely monitor all patients for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of therapy and at times of dose modifications. [US Black Box Warning]
- In case of worsening depressive symptoms or emergent suicidality, gradually taper the dose if discontinuation of the drug is required
- As per study, risk of suicidality with antidepressants did not increase when compared to placebo in adults >24yrs and reduced in adults aged 65 yrs and older [US Black Box Warning]
- Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions presented as changes in mental status, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms have been reported with SNRIs alone or with concomitant use of serotonergic drugs or drugs which impair metabolism of serotonin (e.g., MAOIs), antipsychotics, or other dopamine antagonists. Closely monitor the patients for signs and symptoms of serotonin syndrome or NMS-like reactions
- Concomitant use with MAOIs and serotonin precursors such as tryptophan is contraindicated
- Exercise caution when used concomitantly with triptan (5-HT receptor agonist), especially during treatment initiation and dose increases
- Increase in blood pressure has been associated with SNRIs. Use cautiously with drugs that increase BP. Monitor blood pressure prior to initiation and during therapy. Discontinue the drug if there is sustained increase in BP
- Increase in heart rate has been reported with the use of SNRIs. Monitor heart rate prior to initiation of therapy and during therapy. Treat preexisting tachyarrhythmias and other cardiovascular disease prior to therapy
- Increase in ALT, AST, liver enzymes levels has been reported. Discontinue therapy if patients develop jaundice or other evidence of liver dysfunction
- Contraindicated in patients with substantial alcohol use or evidence of chronic liver disease
- Slowly taper the dose if discontinuation of drug is needed as abrupt discontinuation may cause withdrawal symptoms
- Hyponatremia may occur in patients treated with SNRIs and SSRIs, including milnacipran. In many cases, this hyponatremia is due to SIADH. Elderly patients and those taking diuretics or who are otherwise volume-depleted may be at greater risk. Discontinue the drug in patients with symptomatic hyponatremia
- Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may increase the risk of bleeding events
- SNRIs including milnacipran may affect urethral resistance and micturition. Use cautiously in patients with a history of dysuria, especially male patients with prostatic hypertrophy, prostatitis, and other lower urinary tract obstructive disorders
- Use cautiously in controlled narrow-angle glaucoma, but is contraindicated in uncontrolled narrow-angle glaucoma
Cautions: Use cautiously in
- Severe hepatic impairment
- Moderate to severe renal impairment
- History of mania or hypomania
- History of seizure disorder
- Dehydration
- Obstructive uropathy
- Pregnancy 3rd trimester
Supplemental Patient Information
- Advise patients to refrain from driving automobiles or operating heavy machinery, as the drug may diminish mental and physical abilities necessary to perform such tasks
- Advise patients to avoid consumption of alcohol during therapy
- Instruct patients to promptly report their physician if they become pregnant or plan to become pregnant during therapy
- Caution patients about the risk of serotonin syndrome with concomitant use of milnacipran and triptans, tramadol, or other serotonergic agents
Pregnancy Category:C
Breastfeeding: Use not recommended as the effect of milnacipran in nursing mothers has not been studied. An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 08 January 2011). As per manufacturer's data, milnacipran is secreted in animal milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made regarding discontinuation of nursing or the drug, analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Savella 12.5 MG TABS [Bottle] (FOREST)
60 mg = $145.79
180 mg = $406.07 - Savella 50 MG TABS [Bottle] (FOREST)
60 mg = $144.24
180 mg = $408.71 - Savella Titration Pack 12.5 & 25 & 50 MG MISC [Disp Pack] (FOREST)
55 mg = $133.92
165 mg = $377.97 - Savella 100 MG TABS [Bottle] (FOREST)
100 mg = $239.98
300 mg = $701
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
