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Protamine sulfate

پروتامین سولفات

⚠ Unverified

🧪 VariousHeparin antagonist

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA089454 ATC V03AB14

Market / country: 🇺🇸 USA

Protamine (US)

🧮 Dose calculator

Disease / regimen

Heparin reversal / overdose · Regimen source: FDA Protamine · Dosage and Administration

⛔ Label: each mg neutralises at least 100 USP heparin units. Very slow IV over 10 min, no more than 50 mg per dose. Because heparin clears quickly, the dose falls with time (e.g. half the dose 30 min after heparin). Guide by coagulation tests. FDA Protamine · Dosage and Administration

🛡️ Safety & information

Contraindications

⛔ Previous intolerance to protamine. FDA Protamine · Contraindications

Warnings

• Rapid injection: severe hypotension and anaphylactoid reactions; shock treatment must be available. Rebound bleeding possible after cardiac surgery. FDA Protamine · Warnings

Formulations

10 mg/mL (50 mg/5 mL; 250 mg/25 mL) — injection 🇺🇸 USA FDA Protamine · How Supplied

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Protamine · Pregnancy
“Pregnancy Category C Animal reproduction studies have not been conducted with protamine sulfate.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Protamine · Nursing Mothers
“Because many drugs are excreted in human milk, caution should be exercised when protamine sulfate is administered to a nursing woman.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Protamine · Pediatric Use
“Safety and effectiveness in children have not been established.”
👴 Older adultsNo data
The source for this drug has no section for this group.
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)ANDA089454
DailyMed (FDA label)FDA Protamine
MedlinePlus (NIH)❌ None
WHO ATC/DDDV03AB14
Darooyab (Iran)Protamine

🇮🇷 Registered in Iran Darooyab · G-1976/Protamine

Dosage forms with Iranian generic codes, per Darooyab.

01073 · PROTAMINE SULFATE 1000UAH/ML 10ML VIAL · ویال پروتامین سولفات ۱۰۰۰ اواه / میلی‌لیتر ۱۰ میلی‌لیتر
01655 · PROTAMINE SULFATE 1000UAH/ML 5ML VIAL · ویال پروتامین سولفات ۱۰۰۰ اواه / میلی‌لیتر ۵ میلی‌لیتر
21774 · PROTAMINE50MG 5ML VIAL · ویال پروتامین ۵۰ میلی‌گرم ۵ میلی‌لیتر

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Protamine · How Supplied FDA Protamine · Dosage and Administration FDA Protamine · Contraindications FDA Protamine · Warnings FDA Protamine · Pregnancy FDA Protamine · Nursing Mothers FDA Protamine · Pediatric Use FDA Protamine · 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)✅ Present
Darooyab · G-1976/Protamine
Clinical review⚠ Unverified