Sacubitril INN & Valsartan USP
Composition: Savatril-50: Each film coated tablet contains Sacubitril INN 24 mg & Valsartan USP 26 mg.
Indications:Sacubitril
/ Valsartan combination is indicated to reduce the risk of cardiovascular death
and hospitalization for heart failure in adult patients with chronicheart
failure and reduced left ventricular ejection fraction. For the treatment of
symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric
patients aged one year and older. It reduces NT-proBNP and is expected to
improve cardiovascular outcome.
Dosage and administration:
|
Indication |
Titration Step Dose (Twice Daily) |
||
|
Starting |
second |
Final |
|
|
Adult Heart Failure |
49/51 mg |
97/103 mg |
|
|
Pediatric Heart Failure at least 40 kg, less than 50kg |
24/26 mg |
49/51 mg |
72/78 mg (Three 24/26 mg Tablet) |
|
Pediatric Heart Failure at least 50kg |
49/51 mg |
72/78 mg (Three 24/26 mg Tablet) |
97/103 mg |
Adjust adult dose every 2 to 4 weeks and pediatric doses every
2weeks to the target maintainance dose, as tolerated by the patient. Reduce
the starting dose to 50 mg twice-daily for:
patients not currently taking an angiotensin-converting enzyme inhibitor (ACE)
or an angiotensin II receptor blocker (ARB) or previously taking a low dose of
these agents, patients with severe renal impairment and with moderate hepatic
impairment. Or, as directed by the registered physician.
Precautions: Most common adverse reactions include angioedema, hypotension, hyperkalemia, cough, dizziness, and renal failure.
Pregnancy and Lactation: Sacubitril/valsartan can cause fetal harm when
administered to a pregnant woman. Because of the potential for serious adverse
reactions in breastfed infants breastfeeding is not recommended during
treatment with sacubitril/valsartan.
Packing: Savatril-50 : Each box contains 1 x 10's tablets in a blister pack.
