Entecavir
انتکاویر
🦠 Antiinfectives For Systemic UseNucleoside analogue (HBV)
Market / country: 🇺🇸 USA
Baraclude (US)
🧮 Dose calculator
Chronic hepatitis B · Regimen source: FDA Baraclude · 2.2
- • On an empty stomach (2 h after a meal and 2 h before the next). CrCl <50: reduce per label Table 2. FDA Baraclude · 2.1FDA Baraclude · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Boxed warning: severe hepatitis B flare after stopping; HIV resistance risk in untreated HIV co-infection; lactic acidosis and severe hepatomegaly with steatosis. FDA Baraclude · Boxed Warning
Formulations
- 0.5 mg tablet — tablet 🇺🇸 USA FDA Baraclude · 3
- 1 mg tablet — tablet 🇺🇸 USA FDA Baraclude · 3
- 0.05 mg/mL oral solution — solution 🇺🇸 USA FDA Baraclude · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Baraclude · 8.1
“Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Baraclude · 8.2
“When administered to lactating rats, entecavir was present in milk (see Data).”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Baraclude · 8.4
“BARACLUDE was evaluated in two clinical trials of pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Baraclude · 8.5
“Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.4) ].”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA021797
- DailyMed (FDA label)FDA Baraclude
- MedlinePlus (NIH)Entecavir
- WHO ATC/DDDJ05AF10
- Darooyab (Iran)Entecavir
🇮🇷 Registered in Iran Darooyab · G-4727/Entecavir
Dosage forms with Iranian generic codes, per Darooyab.
- 11471 · ENTECAVIR 0.5MG TAB · قرص انتکاویر ۰٫۵ میلیگرم
- 12741 · ENTECAVIR 1MG TAB · قرص انتکاویر ۱ میلیگرم
- 52677 · ENTECAVIR TABLET ORAL 0.5 mg · قرص انتکاویر ۰٫۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Baraclude · 3FDA Baraclude · 2.2FDA Baraclude · 2.1FDA Baraclude · 2.4FDA Baraclude · 2.3, Table 1FDA Baraclude · 2.3FDA Baraclude · Boxed WarningFDA Baraclude · 8.1FDA Baraclude · 8.2FDA Baraclude · 8.4FDA Baraclude · 8.5FDA Baraclude · 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-4727/Entecavir
- Clinical review⚠ Unverified