Valsartan (17 brand names, 4 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, CAPSULE, PELLETS, SOLUTION.
Routes of administration: ORAL.
Brand Names
- AMLODIPINE BESYLATE AND VALSARTAN
- AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
- BYVALSON
- DIOVAN
- DIOVAN HCT
- ENTRESTO
- ENTRESTO SPRINKLE
- EXFORGE
- EXFORGE HCT
- HYDROCHLOROTHIAZIDE; VALSARTAN
- PREXXARTAN
- SACUBITRIL AND VALSARTAN
- VALSARTAN
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- VALSARTAN; HYDROCHLOROTHIAZIDE
- VALTURNA
- VYDUO
Boxed Warning
When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1)
Contraindications
ENTRESTO is contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions (5.2)] with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions (7.1)] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions (7.1)]
Adverse Reactions
Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions (5.2)] Hypotension [see Warnings and Precautions (5.3)] Impaired Renal Function [see Warnings and Precautions (5.4)] Hyperkalemia [see Warnings and Precautions (5.5)]
Mechanism of Action
ENTRESTO contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. ENTRESTO 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. The cardiovascular and renal effects of ENTRESTO in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
Overdosage
Limited data are available with regard to overdosage in human subjects with ENTRESTO. In healthy volunteers, a single dose of ENTRESTO 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of ENTRESTO. Symptomatic treatment should be provided. ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.