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Nitroglycerin 0.4% ointment (anal fissure)

پماد نیتروگلیسرین ۰٫۴٪ (شقاق مقعد)

⚠ Unverified

❤️ Cardiovascular SystemTopical nitrate

🤰 Pregnancy:Use with caution 👶 Children:Safety not established 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications ⚠️ 1 interactions 🇺🇸 FDA approved (NDA) NDA021359 ATC C05AE01

Market / country: 🇺🇸 USA

Rectiv (US)

🧮 Dose calculator

Disease / regimen

Anal fissure · Regimen source: FDA Rectiv · 2

⛔ With a covered finger, a 1-inch line as marked on the carton (375 mg ointment = 1.5 mg nitroglycerin) gently into the anal canal; every 12 h for up to 3 weeks. FDA Rectiv · 2

🛡️ Safety & information

Contraindications

⛔ PDE5 inhibitors (sildenafil, tadalafil, vardenafil); severe anaemia; raised intracranial pressure; nitrate hypersensitivity. FDA Rectiv · 4

Important interactions

• Sildenafil, tadalafil and vardenafil: severe hypotension — contraindicated. FDA Rectiv · 4

Formulations

0.4% ointment (1 inch = 1.5 mg nitroglycerin) — ointment 🇺🇸 USA FDA Rectiv · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Rectiv · 8.1
“Risk Summary There are no data on the use of nitroglycerin ointment intra-anally during pregnancy to determine a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
🤱 BreastfeedingNo data
The source for this drug has no section for this group.
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Rectiv · 8.4
“The safety and effectiveness of RECTIV in pediatric patients under 18 years of age have not been established.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Rectiv · 8.5
“Clinical studies of RECTIV did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA021359
DailyMed (FDA label)FDA Rectiv
MedlinePlus (NIH)❌ None
WHO ATC/DDDC05AE01
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 Rectiv · 3 FDA Rectiv · 2 FDA Rectiv · 4 FDA Rectiv · SPL approval / marketing category FDA Rectiv · 8.1 FDA Rectiv · 8.4 FDA Rectiv · 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