PROTA INJ
Manufacturer Details
SAMARTH PHARMA
Compositions:
Protamine sulphate 50mg per 5ml injection,
Strength
|
Rate
|
Packing Style
|
50mg/5ml
|
47.95
|
5ml injection
|
List of Related Indications:
- Antidote to coumarin anticoagu
- Heparin overdosage
List Of Drugs:
- Protamine sulphate - @ Heparin antagonist
Indication Type Description:
Pharmacology/ Pharmacokinetics
Indication:
Treatment of heparin over dosage
Adverse Reaction:
Sudden fall in blood pressure, bradycardia, transitory flushing and feeling of warmth, dyspenea, nausea, vomiting, lassitude, pulmonary edema, back pain in conscious patients undergoing such procedures as cardiac catheterization anaphylaxis may occur in severe respiratory distress, circulatory collapse, capillary leaks and non cardiogenic pulmonary edema, acute pulmonsary hypertension, circulatory collapse
Contra-Indications:
Hypersentivity to the drug
Special precautions:
Recurrent bleeding- Hyperheparinemia or bleeding has occured in some patients 30 minutes to 18 hours after cardiac surgery ( under cardiopulmonary bypass ) in spite of complete neutralization of heparin by adequate dose of protamine at the end of the operation.
Observe patients closely, after cardiac surgery. Too rapid admininstration- can cause severe hypotensive and anphylactoid reactions. Have facilities available to treat shock.
Pulmonary edema- High protein , non-cardiogenic pulmonary edema associated with use of protamine has occured on cardiopulmonary bypass who are undrgoing cardiovascular surgery. The etiologic role of protamine in the pathogenisis of this conditionnis uncertain, and multiple fasctors have been present in most cases.
Hypersenitivity- Patients with a history of allergy to fish develop hypersensitivity reactions, although to date no relationship has been established between allergic reactions to protamine and fish allergy.
Pregnancy- Adminster to pregnant women only if clearly needed
Lactation- Not known whether thids drug is excreted in breast milk. Administer caution to nursing mother.
Children- Safety and efficacy in children have not been established.
Dosages/ Overdosage Etc:
Treatment of heparin over dosageĀ
Dosage
Protamine Sulfate 1mg neutralize approx. 90 USP units of heparin activity derived from lung tissue or about 115USP units derived from intestinal mucosa. Protamine sulfate injection is for use without further dilution, if further dilution is desired use Dextrose % in water or normal saline
Overdosage- Symptoms- Overdose of protamine sulfate may cause bleeding Treatment- In managing overdosage consider the possibility of multiple drug ovedoses, interaction among drugs and unusual drug kinetics. Replace blood loss with blood transfusion or fresh frozen plasma. If patient is hypotensive consider fluids,ephinephrine, dobutamine or dopamine.
Patient Information:
Rapid admin. of protamine is more likely to result in bradycardia, dyspnea, a sensation of warmth, flushing and severe hy[otension. Hypertension has also occured.
Pharmacology/ Pharmacokinetics:
Pharmacology- Protamine are strongly basic simple proteins of low molecular weight , rich in arginine, Theyt occur in sperm of salmon and certsain fish species. Given alone, protamine sulphate has an anticouglant efffect. however, when given with hepatin ( strongly acidic ) a stable resulting in loss of antocougulant activites of both the drugs
Pharmacokinetics- Protamine salt has a rapid onset of action which persists approx. 2 hours. Heparin is neutralized within 2 minutes of IV injection. The metabolic fate of heparin -protamine complex is unknown, but one theory is that protamine sulfate comlex may be partially metabolised or may be cleaved by fubrinolysin , thus freeing heparin.
Pregnancy and lactation:
Pregnancy- Adminster to pregnant women only if clearly needed Lactation- Not known whether this drug is excreted in breast milk. Administer caution to nursing mother. Children- Safety and efficacy in children have not been established.