MYLAN-CAPTOPRIL TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CAPTOPRIL

Tilgængelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

C09AA01

INN (International Name):

CAPTOPRIL

Dosering:

100MG

Lægemiddelform:

TABLET

Sammensætning:

CAPTOPRIL 100MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0114954003; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2017-01-09

Produktets egenskaber

PRODUCT MONOGRAPH
MYLAN-CAPTOPRIL
(CAPTOPRIL, USP)
TABLETS, USP
12.5, 25, 50 AND 100 MG
ANGIOTENSIN-CONVERTING ENZYME INHIBITOR
Mylan Pharmaceuticals ULC
DATE OF PREPARATION:
85 Advance Road
July 15, 2009
Etobicoke, Ontario
DATE OF REVISION:
M8Z 2S6
Control#: 131234
1
PRODUCT MONOGRAPH
MYLAN-CAPTOPRIL
(CAPTOPRIL, USP)
TABLETS, USP
12.5, 25, 50 AND 100 MG
THERAPEUTIC CLASSIFICATION
Angiotensin-Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
MYLAN-CAPTOPRIL (captopril) is an angiotensin-converting enzyme
inhibitor, which is used
in the treatment of hypertension and heart failure.
The mechanism of action of captopril has not yet been fully
elucidated. It appears to lower blood
pressure and be an adjunct in the therapy of congestive heart failure
primarily through
suppression of the renin-angiotensin-aldosterone system; however,
there is no consistent
correlation between renin levels and response to the drug. Renin, an
enzyme synthesized by the
kidneys, is released into the circulation where it acts on a plasma
globulin substrate to produce
angiotensin I, a relatively inactive decapeptide. Angiotensin I is
then converted by angiotensin-
converting enzyme (ACE) to angiotensin II, a potent endogenous
vasoconstrictor substance.
2
Angiotensin II also stimulates aldosterone secretion from the adrenal
cortex, thereby contributing
to sodium and fluid retention.
Captopril prevents the conversion of angiotensin I to angiotensin II
by inhibition of ACE, a
peptidyldipeptide carboxy hydrolase.
ACE is identical to "bradykininase" and captopril may also interfere
with the degradation of the
vasopressor peptide, bradykinin. However, the effectiveness of
captopril in therapeutic doses
appears to be unrelated to potentiation of the actions of bradykinin.
Increased concentrations of
bradykinin or prostaglandin E
2
may also have a role in the therapeutic effect of captopril,
especially in low-renin hypertension.
Inhibition of ACE results in decreased plasma angiotensin II and
increased plasma renin activity
(PRA), the lat