Activase (Alteplase) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Activase

Heart Attack »

Heart attack facts

A heart attack results when a blood clot completely obstructs a coronary artery supplying blood to the heart muscle and heart muscle dies.
The blood clot that causes the heart attack usually forms at the site of rupture of an atherosclerotic, cholesterol plaque on the inner wall of a coronary artery.
The most common symptom of heart attack is chest pain.
The most common complications of a heart attack are heart failure and ventricular fibrillation.
The risk factors for atherosclerosis and heart attack include elevated cholesterol levels, increased blood pressure, tobacco use, diabetes, male gender, and a family history of heart attacks at an early age.
Heart attacks are diagnosed with electrocardiograms and measurement of cardiac enzymes in blood.
Early reopening of blocked coronary arteries reduces the amount of damage to the heart and im...

Read the Heart Attack article »

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ACTIVASE®
(alteplase)
A Recombinant Tissue Plasminogen Activator

DRUG DESCRIPTION

Activase® (Alteplase) is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. The manufacturing process involves the secretion of the enzyme alteplase into the culture medium by an established mammalian cell line (Chinese Hamster Ovary cells) into which the cDNA for alteplase has been genetically inserted. Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100 mg/L. However, the presence of the antibiotic is not detectable in the final product.

Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment.

Activase (alteplase) is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP.

Quantitative Composition of the Lyophilized Product
	100 mg Vial	50 mg Vial
Alteplase	100 mg (58 million IU)	50 mg (29 million IU)
L-Arginine	3.5 g	1.7 g
Phosphoric Acid	1 g	0.5 g
Polysorbate 80	≤ 11 mg	≤ 4 mg
Vacuum	No	Yes

Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units as tested against the WHO standard. The specific activity of Activase (alteplase) is 580,000 IU/mg.

Last reviewed on RxList: 5/9/2008
This monograph has been modified to include the generic and brand name in many instances.