# Sacubitril+Valsartan ```text DRUG INFORMATION ADULT - The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - The target maintenance dose is 97 mg/103mg orally twice daily. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs [see Contraindications (4) and Drug Interactions (7.1)] . 2.2 Adult Heart Failure The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 CHILD - The safety and effectiveness of ENTRESTO have been established for the treatment of heart failure in pediatric patients 1 year to less than 18 years. Use of ENTRESTO was evaluated in a multinational, randomized, double-blind trial comparing ENTRESTO and enalapril in 375 patients aged 1 month to less than 18 years (ENTRESTO n = 187; Enalapril n = 188) (PANORAMA-HF) [see Clinical Studies (14.2)] . Source: US FDA label for sacubitril (ENTRESTO), section 'pediatric use', retrieved 2026-08-29 - The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103mg orally twice daily. ( 2.2 ) Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient. ( 2.2 ) For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - Exposure at the No-Observed-Adverse-Effect-Level (NOAEL) of 100 mg/kg/day was approximately 0.5-fold the AUC exposure to LBQ657 at the 3.1 mg/kg twice daily dose of ENTRESTO. Source: US FDA label for sacubitril (ENTRESTO), section 'pediatric use', retrieved 2026-08-29 RENAL IMPAIRMENT - ( 2.6 ) patients with severe renal impairment. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets [see Dosage and Administration (2.3, 2.4, 2.5)] . 2.7 Dose Adjustment for Severe Renal Impairment In adults and pediatric patients with severe renal impairment estimated glomerular filtration rate (eGFR less than 30 mL/min/1.73 m 2 ), start ENTRESTO at half the usually recommended starting dose. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - No starting dose adjustment is needed for mild or moderate renal impairment. 2.8 Dose Adjustment for Hepatic Impairment In adults and pediatric patients with moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half the usually recommended starting dose. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 HEPATIC IMPAIRMENT - ( 2.7 ) patients with moderate hepatic impairment. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - No starting dose adjustment is needed for mild or moderate renal impairment. 2.8 Dose Adjustment for Hepatic Impairment In adults and pediatric patients with moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half the usually recommended starting dose. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 - No starting dose adjustment is needed for mild hepatic impairment. Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and administration', retrieved 2026-08-29 PREGNANCY - Risk Summary ENTRESTO can cause fetal harm when administered to a pregnant woman. Source: US FDA label for sacubitril (ENTRESTO), section 'pregnancy', retrieved 2026-08-29 - Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death ( see Clinical Considerations ). Source: US FDA label for sacubitril (ENTRESTO), section 'pregnancy', retrieved 2026-08-29 - Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Source: US FDA label for sacubitril (ENTRESTO), section 'pregnancy', retrieved 2026-08-29 BREASTFEEDING - Lactation: Breastfeeding not recommended. Source: US FDA label for sacubitril (ENTRESTO), section 'use in specific populations', retrieved 2026-08-29 - Pre- and postnatal development studies in rats at sacubitril doses up to 750 mg/kg/day (2.2-fold the MRHD on the basis of LBQ657 AUC) and valsartan at doses up to 600 mg/kg/day (0.86-fold the MRHD on the basis of AUC) indicate that treatment with ENTRESTO during organogenesis, gestation and lactation may affect pup development and survival. Source: US FDA label for sacubitril (ENTRESTO), section 'use in specific populations', retrieved 2026-08-29 - Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO. Source: US FDA label for sacubitril (ENTRESTO), section 'use in specific populations', retrieved 2026-08-29 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)