Covista 50 tablet: Each coated tablet contains Sacubitril Valsartan Sodium Complex equivalent to Sacubitril INN 24 mg and Valsartan USP 26 mg.
Covista 100 tablet: Each coated tablet contains Sacubitril Valsartan Sodium Complex equivalent to Sacubitril INN 49 mg and Valsartan USP 51 mg.
Covista 200 tablet: Each coated tablet contains Sacubitril Valsartan Sodium Complex equivalent to Sacubitril INN 97 mg and Valsartan USP 103 mg.
Covista is a combination of a neprilysin inhibitor, sacubitril and an practical angiotensin receptor blocker,valsartan. Covista ® inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril and blocks the angiotensin II type-1 (AT1) receptor via valsartan. Valsartan also inhibits angiotensin II-dependent aldosterone release.
Route of administration: Covista ® should be taken in oral route.
Adult heart failure : The recommended starting dose is 100 mg twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 200 mg twice daily, as tolerated by the patient.
Pediatric heart failure: Recommended dose for pediatric patients aged one year and older:
Pediatric patients at least 40 kg, less than 50 kg: Starting 24/26 mg, Second 49/51 mg, Final 72/78 mg‡ twice daily
Pediatric patients at least 50 kg: Starting 49/51 mg, Second 72/78 mg‡, Final 97/103 mg twice daily
‡Doses of 72/78 mg can be achieved using three 24/26 mg tablets.
Dose adjustment for patients not taking an ACE inhibitor or ARB or previously taking low doses of these agents: In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) and for patients previously taking low doses of these agents, start this drug at half the usually recommended starting dose. After initiation, increase the dose every 2 to 4 weeks in adults and every 2 weeks in pediatric patients to follow the recommended dose escalation thereafter.
Renal and hepatic impairment In adults and pediatric patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) and with moderate hepatic impairment (Child-Pugh B classification), start at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter. Use in patients with severe hepatic impairment is not recommended.
Concomitant ACE inhibitors increase angioedema risk (strict 36-hour washout required); potassium-sparing diuretics increase hyperkalemia risk; lithium levels increase.
This combination is contraindicated in patients with known hypersensitivity to sacubitril and valsartan or any other components of this product. It is also contraindicated in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy
Common: Hypotension, hyperkalemia, cough, dizziness.
Overdose
Limited data are available with regard to overdose. In cases of overdose hypotension can occur. Symptomatic treatment should be provided. It is unlikely to be removed by hemodialysis because of high protein binding.
Category D (Contraindicated in 2nd/3rd trimesters). Causes fetal oligohydramnios, renal failure, and death; discontinue immediately when pregnancy is detected. Lactation: Excretion in human milk unknown; breastfeeding not recommended.
Store below 30°C in a cool, dry place. Protect from moisture and light. Keep out of reach of children.