Valacyclovir
والاسیکلوویر
🦠 Antiinfectives For Systemic UseAntiviral (acyclovir prodrug)
Market / country: 🇺🇸 USA
Valtrex (US)
🧮 Dose calculator
Herpes labialis (cold sores) · Regimen source: FDA Valacyclovir · 2.1FDA Valacyclovir · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Clinically significant hypersensitivity (anaphylaxis, SCARs) to valacyclovir or acyclovir. FDA Valacyclovir · 4
Formulations
- 500 mg tablet — tablet 🇺🇸 USA FDA Valacyclovir 1 g · 3
- 1 g tablet (partially scored) — tablet 🇺🇸 USA FDA Valacyclovir 1 g · 3
- 50 mg/mL extemporaneous suspension (from 500 mg tablets) — suspension 🇺🇸 USA FDA Valacyclovir · 2.3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Valacyclovir · 8.1
“Risk Summary Clinical data over several decades with valacyclovir and its metabolite, acyclovir, in pregnant women, have not identified a drug associated risk of major birth defects.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Valacyclovir · 8.2
“Risk Summary Although there is no information on the presence of valacyclovir in human milk, its metabolite, acyclovir, is present in human milk following oral administration of valacyclovir.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Valacyclovir · 8.4
“The efficacy and safety of valacyclovir have not been established in pediatric patients: • aged less than 12 years with cold sores • aged less than 18 years with genital herpes • aged less than 18 years with herpes zoster • aged less than 2 years with chickenpox • for suppressive therapy following neonatal HSV …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Valacyclovir · 8.5
“Elderly patients are also more likely to have renal or CNS adverse events [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.2 , 5.3 ), Clinical Pharmacology ( 12.3 )].”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA203047
- DailyMed (FDA label)FDA ValacyclovirFDA Valacyclovir 1 g
- MedlinePlus (NIH)Valacyclovir
- WHO ATC/DDDJ05AB11
- Darooyab (Iran)Valaciclovir
🇮🇷 Registered in Iran Darooyab · G-1211/Valaciclovir
Dosage forms with Iranian generic codes, per Darooyab.
- 10064 · VALACICLOVIR 1000MG TAB · قرص والاسیکلوویر ۱۰۰۰ میلیگرم
- 16814 · VALACICLOVIR 250MG TAB · قرص والاسیکلوویر ۲۵۰ میلیگرم
- 09161 · VALACICLOVIR 500MG TAB · قرص والاسیکلوویر ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Valacyclovir 1 g · 3FDA Valacyclovir · 2.3FDA Valacyclovir · 2.1FDA Valacyclovir · 2.2FDA Valacyclovir · 4FDA Valacyclovir · 8.1FDA Valacyclovir · 8.2FDA Valacyclovir · 8.4FDA Valacyclovir · 8.5FDA Valacyclovir · 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-1211/Valaciclovir
- Clinical review⚠ Unverified