"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Protamine Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Protamine Sulfate (protamines) is indicated in the treatment of heparin (a drug used to treat and prevent blood clots) overdose. It is a heparin antagonist. It is also a weak anticoagulant. Common side effects include sudden fall in blood pressure, bradycardia, pulmonary hypertension, dyspnea, or flushing and a feeling of warmth. There have been reports of anaphylaxis that resulted in respiratory difficulty, systemic hypertension, nausea, vomiting and fatigue.
Protamine Sulfate is administered by a doctor and is given by very slow intravenous (IV) injection in doses not to exceed 50 mg in any 10-minute period. Protamine sulfate may interact with certain antibiotics, including several of the cephalosporins and penicillins. Tell your doctor all medications you are taking. Protamine sulfate should be given to a pregnant woman only if prescribed. It is not known whether this drug passes into breast milk. Consult a doctor before breast-feeding.
Our Protamine Sulfate (protamines) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Protamine FDA Prescribing Information: Side Effects
Intravenous injections of protamine (protamines) may cause a sudden fall in blood pressure, bradycardia, pulmonary hypertension, dyspnea, or transitory flushing and a feeling of warmth. There have been reports of anaphylaxis that resulted in respiratory embarrassment (see PRECAUTIONS).Other reported adverse reactions include systemic hypertension, nausea, vomiting and lassitude. Back pain has been reported rarely in conscious patients undergoing such procedures as cardiac catheterization. Because fatal reactions often resembling anaphylaxis have been reported after administration of protamine sulfate (protamine (protamines) s) , the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.
Read the entire FDA prescribing information for Protamine (Protamines)
Additional Protamine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.