Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
From the U.S. FDA-approved label for Protamine sulfate. Full label: DailyMed.
Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
From the U.S. FDA-approved label for Protamine sulfate. Full label: DailyMed.
Each mg of protamine sulfate, calculated on the dried basis, neutralizes not less than 100 USP Heparin Units. Protamine sulfate injection should be given by very slow intravenous injection over a 10-minute period in doses not to exceed 50 mg (see WARNINGS ). Protamine sulfate is intended for injection without further dilution; however, if further dilution is desired, D5-W or normal saline may be used.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.
Excerpt from the U.S. FDA-approved label. Talk to a pharmacist or doctor before use.
Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 30 minutes to 18 hours after cardiac surgery (under cardiopulmonary bypass) in spite of complete neutralization of heparin by adequate doses of protamine sulfate at the end of the operation. It is important to keep the patient under close observation after cardiac surgery. Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The intravenous administration of protamine sulfate may cause a sudden fall in blood pressure and bradycardia. Other reactions include transitory flushing and feeling of warmth, dyspnea, nausea, vomiting and lassitude.
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
6 products from 4 makers in the NepalDoc medicine catalog use this generic:
| Brand | Composition | Maker | Pack |
|---|---|---|---|
| Hepadot Injection | Protamine sulfate (NA) | Biological E Ltd | vial of 5 ml Injection |
| Neutrahep 10mg Injection | Protamine sulfate (10mg) | Gland Pharma Limited | vial of 5 ml Injection |
| Newtain 50mg Injection | Protamine sulfate (50mg/5ml) | Chandra Bhagat Pharma Pvt Ltd | vial of 5 injections |
| Prota 10mg Injection | Protamine sulfate (10mg) | Samarth Life Sciences Pvt Ltd | vial of 5 ml Injection |
| Prota 50mg Injection | Protamine sulfate (50mg) | Samarth Life Sciences Pvt Ltd | vial of 5 ml Injection |
| Protamine Sulphate 10mg Injection | Protamine sulfate (10mg) | Biological E Ltd | vial of 5 ml Injection |
Brand list from the NepalDoc medicine catalog. Availability varies by pharmacy — call ahead to confirm stock.
Store at 20° to 25°C (68° to 77°F).
Storage information from the U.S. FDA-approved label.
This page is information only and is not medical advice. Medicine details come from the sources listed above and may change — always confirm the medicine, strength and dose with a pharmacist or doctor before use. NLEM listing does not guarantee that a medicine is in stock at any pharmacy.
