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Berdazimer gel

ژل بردازیمر (مولوسکوم)

⚠ Unverified

🧴 DermatologicalsTopical nitric oxide releaser

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list 🇺🇸 FDA approved (NDA) NDA217424 ATC D06BB13

Market / country: 🇺🇸 USA

Zelsuvmi (US)

🧮 Dose calculator

Disease / regimen

Molluscum contagiosum · Regimen source: FDA Zelsuvmi · 2

⛔ Mix equal amounts of tube A and B per the dosing guide and immediately apply a thin layer to each lesion, once daily for up to 12 weeks. Not for eye, mouth or vagina. FDA Zelsuvmi · 2

🛡️ Safety & information

Warnings

• Application site reactions including allergic contact dermatitis. FDA Zelsuvmi · 5.1

Formulations

Berdazimer 10.3% gel (two tubes, mixed before use) — gel 🇺🇸 USA FDA Zelsuvmi · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Zelsuvmi · 8.1
“Risk Summary There are no available data on ZELSUVMI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zelsuvmi · 8.2
“Risk Summary There are no data on the presence of berdazimer or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Zelsuvmi · 8.4
“The safety and effectiveness of ZELSUVMI for the topical treatment of MC have been established in pediatric patients 1 year of age and older.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Zelsuvmi · 8.5
“Of the total number of ZELSUVMI-treated subjects in clinical studies for MC, none were 65 to 74 years of age, and one was 75 years of age and older [see Clinical Studies (14) ] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA217424
DailyMed (FDA label)FDA Zelsuvmi
MedlinePlus (NIH)❌ None
WHO ATC/DDDD06BB13
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Zelsuvmi · 3 FDA Zelsuvmi · 2 FDA Zelsuvmi · 5.1 FDA Zelsuvmi · SPL approval / marketing category FDA Zelsuvmi · 8.1 FDA Zelsuvmi · 8.2 FDA Zelsuvmi · 8.4 FDA Zelsuvmi · 8.5
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)✅ Present
Darooyab · search
Clinical review⚠ Unverified