Recommended Topic Related To:

Protamine

"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

Protamine Sulfate
Injection, USP

DRUG DESCRIPTION

Protamine Sulfate Injection, USP is a sterile, non-pyrogenic, isotonic solution of protamine sulfate in Water for Injection. It acts as a heparin antagonist. It is also a weak anticoagulant.

Protamines are simple protein principles obtained from the sperm of salmon and certain other species of fish. Protamine (protamines) s have low molecular weight, are rich in arginine, and are strongly basic.

Protamine sulfate (protamine (protamines) s) occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6 and 7. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex.

Each mL contains

Protamine sulfate 10 mg, sodium chloride 9 mg and Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment.

The preparation is preservative free.

Protamine sulfate is administered intravenously.

Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

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.


Women's Health

Find out what women really need.