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Sacubitril + valsartan
ساکوبیتریل + والسارتان
❤️ Cardiovascular SystemAngiotensin receptor–neprilysin inhibitor (ARNI)
🤰 Pregnancy:Dangerous / avoid🤱 Breastfeeding:Dangerous / avoid👶 Children:Use with caution👴 Older adults:No specific problem stated 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA207620ATC C09DX04
Market / country: 🇺🇸 USA
Entresto (US)
🧮 Dose calculator
Heart failure · Regimen source: FDA Entresto · 2.2
- • Amounts are sacubitril + valsartan combined (49/51 = 100 mg). Double the dose after 2–4 weeks. At least 36 h apart from an ACE inhibitor. FDA Entresto · 2.2FDA Entresto · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ History of angioedema with ACEi or ARB; concomitant ACE inhibitor (36 h washout); aliskiren in diabetes; hypersensitivity. FDA Entresto · 4
Warnings
- • Boxed warning: fetal toxicity — stop as soon as pregnancy is detected. FDA Entresto · Boxed Warning
Formulations
- Sacubitril 24 mg / valsartan 26 mg tablet — tablet 🇺🇸 USA FDA Entresto · 3
- Sacubitril 49 mg / valsartan 51 mg tablet — tablet 🇺🇸 USA FDA Entresto · 3
- Sacubitril 97 mg / valsartan 103 mg tablet — tablet 🇺🇸 USA FDA Entresto · 3
- 4 mg/mL oral suspension (prepared from 49/51 mg tablets; combined) — suspension 🇺🇸 USA FDA Entresto · 2.4
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Entresto · 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) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Entresto · 8.2
“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.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Entresto · 8.4
“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.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Entresto · 8.5
“No overall differences in safety or effectiveness of ENTRESTO have been observed between patients 65 years of age and older and younger adult patients in either study.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA207620
- DailyMed (FDA label)FDA Entresto
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDC09DX04
- Darooyab (Iran)Sacubitril-Valsartan
🇮🇷 Registered in Iran Darooyab · G-4847/Sacubitril-Valsartan
Dosage forms with Iranian generic codes, per Darooyab.
- 51005 · SACUBITRIL/VALSARTAN 49/51MG TAB · قرص ساکوبیتریل / والسارتان ۴۹ / ۵۱ میلیگرم
- 50702 · SACUBITRIL/VALSARTAN 24/26MG TAB · قرص ساکوبیتریل / والسارتان ۲۴ / ۲۶ میلیگرم
- 52234 · SACUBITRIL/VALSARTAN 103/97MG TAB · قرص ساکوبیتریل / والسارتان ۱۰۳ / ۹۷ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Entresto · 3FDA Entresto · 2.4FDA Entresto · 2.2FDA Entresto · 2.1FDA Entresto · 2.3, Table 1FDA Entresto · 4FDA Entresto · Boxed WarningFDA Entresto · 8.2FDA Entresto · 8.4FDA Entresto · 8.5FDA Entresto · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4847/Sacubitril-Valsartan
- Clinical review⚠ Unverified