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In the medical fields across the world there are some mandatory
norms set by the Food and Drugs Administration – FDA that are
required to be obeyed and strictly followed by all the
manufacturers, traders and concerned people worldwide. Of course
such FDA agencies are set by the local governmental authorities in
their respective countries and provinces who take care of the
necessary regulations. It is mandatory to seek the formal approval
of any drug or medicine before launching in the market for public
use.
Capoten was put by Bristol-Myers Squibb & Company Inc., for
necessary approval by the U.S. FDA. Capoten along with its generic
drug Captopril was awarded FDA approval in June, 1981. The drug went
generic in the United States since February of 1996 and manufacturer
of Capoten, Bristol-Myers Squibb & Co Inc., lost their exclusivity
on the drug. They do enjoy their brand Capoten.
Capoten is categorized as specific competitive inhibitor of
Angiotensin Converting Enzyme–ACE Inhibitor. This enzyme is
responsible for conversion of angiotensin-I to angiotensin-II.
Captopril is white to off-white crystalline powder and may have
slight sulfurous odor, soluble in water, methanol, and ethanol. It
is sparingly soluble in chloroform and ethyl acetate. Capoten has
been approved for 12.5mg, 25mg, 50mg and 100mg as scored tablets for
oral dosage with its inactive ingredients like microcrystalline
cellulose, corn starch, lactose and stearic acid.
Capoten’s mechanism of action is not yet completely clarified. Its
efficacy in hypertension and heart failure is basically supposed due
to suppression of the rennin-angiotensin-aldosterone system. Anyway,
there is no reliable connection between rennin levels and response
to this drug.
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