Prosulf

Prosulf10mg/ml

Type:10 Ampouless

Generic Name:Protamine Sulfate

Manufacturer:Radiant Pharmaceuticals Ltd.

Price:0.00

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Indication

Heparin Neutralization, Dalteparin or Tinzaparin Overdose, Enoxaparin Overdose

Administration

IV Preparation Reconstitute with 5 mL sterile water Resulting solution equals 10 mg/mL IV Administration Inject without further dilution over 1-3 min; maximum of 50 mg in any 10 min period For IV use only Administer slow IVP (50 mg over 10 min) Rapid IV infusion causes hypotension

Adult Dose

Heparin Neutralization 1-1.5 mg per 100 USP units of heparin; not to exceed 50 mg Monitor APTT 5-15 min after dose then in 2-8 hr In accidental overdoses of heparin, consider t1/2 heparin 60-90 min In setting without bleeding complications, consider observation, rather than reversal of anticoagulation with protamine (avoids ADR's) Complex of protamine and heparin may degrade over time requiring further doses Dalteparin or Tinzaparin Overdose 1 mg protamine for 100 units dalteparin or tinzaparin; if PTT prolonged 4hr after protamine overdose administer 0.5 mg per 100 units of dalteparin or tinzaparin Enoxaparin Overdose 1 mg per mg enoxaparin (if enoxaparin overdose given within 8 hr); if >8 hr of overdose or bleeding continues after 4 hr after first dose, give 0.5 mg protamine per mg enoxaparin Time Elapsed Since Heparin Dose Dose of protamine (mg) to neutralize 100 units of heparin <1/2 hr: 1-1.5 mg/100 units of heparin 30-120 min: 0.5-0.75 mg/100 units of heparin >2 hr: 0.25-0.375 mg/100 units of heparin

Contraindication

Hypersensitivity

Mode of Action

Protamine sulfate is prepared from the sperm or mature testes of salmon or related species and is composed of arginine, proline, serine and valine. It combines w/ strongly acidic heparin to form a stable complex, neutralising the anticoagulant activity of both drugs.

Precaution

Patient at risk of developing hypersensitivity to protamine (e.g. previous history of procedures such as coronary angioplasty or cardiopulmonary bypass surgery where protamine is frequently used, diabetics using protamine insulin, allergy to fish, vasectomised or infertile males who may have antibodies to protamine). Pregnancy and lactation. Protamine sulfate can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension

Side Effect

Frequency Not Defined Anaphylaxis Hypotension N/V Decreased O2 consumption Flushing Pulmonary hypertension Uncontrollable bleeding Circulatory collapse Pulmonary edema

Alternative brand of Prosulf