Drug Interaction:
MAOI s- Concomittant serotonin precursors eg tryptophen, serotonergics eg triptans, tramadol not recomended
Avoid IV digoxin ( postural hypotension ) tachycardia
May potentiate anticoagulants eg asiprin, NSAIDs , coumarin
May antagonise certain antihypertensives eg clonidine Serotonin syndrome with SSRIs , SNRIs, lithium, tramadol, triptans ( monitor )
Caution with certain other CNS active drugs or those can increase BP. Arrhythmias, hypertension with epinephrine, norepinephrine
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
137. Milnacipran Hcl 25mg/50mg equivalent to 22-05-08
Milnacripran free base 21.77 or 43.55 mg tablet
For the treatment of adult patients with major
depressive disorder
Proprietary Name- Savella tablets
Established Name - Milnacipran Hcl
Applicant- Cypress Bioscience INC
Indication-
Management of Fibromyalgia
Approved by FDA on 14-1-2009 (Ref- FDA approved List- 2009)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Milnacipran 100mg 16-03-2010
Addtnl. Stgth
Same as approved
2.Milnacipran 25/50mg caps 15-04-2009
Addl.Indcn.
For the management of Fibromylagia
3.Milnacipran Hcl 12.5mg 06-02-2010
Addl.Stgth
same as approved
4.Milnacipran Hcl 25mg/50mg 22-05-2008
equiv.to Milnacipran Free base
21.77 or 43.55mg tablet
For the treatment of adult patients with major depressive disorder
Fibromyalgia
Adverse Reaction:
GI upset, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, palpitations, increased heart rate dry mouth, hypertension seratonin syndrome- (agitation, hallucinations, tschcardia, labile blood pressure hyperthermia, incordination, nausea, vomiting, diarrheoa )
Neuroleptic syndrome NMS like reactions.
Rarely- GU effects in men hyponatraemia ( esp in elderly ) seizures
Contra-Indications:
Allow at least 14 days after MAOI discontinuation before starting milnacipran Allow at least 5 days after discontinuing minacripran before starting MAOIs Uncontrolled narrow angle glaucoma, End stage renal disease Lactation
Special precautions-
substantial alcohol abuse, chronic liver disease .
Hypertension heart disease 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
Risk of bleeding reevaluate peridically labour and delivery- pregnancy - effects foetus
Dosages/ Overdosage Etc:
Dosage-
Day 1 12.5mg once Day 2-3 12.5mg twice Days 4 -7 25mg twice daily
After Day 7 50mg twice daily ( recommended dose )
Max 100mg twice daily Severe renal impairment - CrCl 5 - 29m/L
Maintenance - 25mg twice daily Max 50mg twice daily
Withdraw gradually
Children below 17 yrs not recommended
Pregnancy and lactation:
Oberve caution if use is required during pregnancy and lactation
Manufacturer Details