CLOMID TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CLOMIPHENE CITRATE

Disponibbli minn:

SANOFI-AVENTIS CANADA INC

Kodiċi ATC:

G03GB02

INN (Isem Internazzjonali):

CLOMIFENE

Dożaġġ:

50MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

CLOMIPHENE CITRATE 50MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

50

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ESTROGEN AGONIST-ANTAGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0102713001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2020-07-15

Karatteristiċi tal-prodott

_Page 1 of 23_
PRODUCT MONOGRAPH
Pr
CLOMID
®
(clomiphene citrate USP)
50 mg Tablets
Ovulatory Agent
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
August 9, 2013
Submission Control No.: 165671
_Page 2 of 23_
PRODUCT MONOGRAPH
PR
CLOMID
®
(clomiphene citrate USP)
50 mg Tablets
Ovulatory agent.
ACTION AND CLINICAL PHARMACOLOGY
CLOMID (clomiphene citrate) is an orally-administered, non-steroidal
agent which may induce
ovulation in anovulatory women in appropriately selected cases.
1-16
The ovulatory response to
cyclic CLOMID therapy appears to be mediated through increased output
of pituitary
gonadotropins, which in turn stimulate the maturation and endocrine
activity of the ovarian
follicle and the subsequent development and function of the corpus
luteum. The role of the
pituitary is indicated by increased plasma levels of gonadotropins and
by the response of the
ovary, as manifested by increased plasma level of estradiol.
Antagonism of competitive
inhibition of endogenous estrogen may play a role in the action of
CLOMID on the
hypothalamus.
CLOMID IS A DRUG OF CONSIDERABLE PHARMACOLOGIC POTENCY. ITS
ADMINISTRATION SHOULD BE
PRECEDED BY CAREFUL EVALUATION AND SELECTION OF THE PATIENT, AND MUST
BE ACCOMPANIED BY
CLOSE ATTENTION TO THE TIMING OF THE DOSE. WITH CONSERVATIVE SELECTION
AND MANAGEMENT OF
THE PATIENT, CLOMID HAS BEEN DEMONSTRATED TO BE A USEFUL THERAPY FOR
THE ANOVULATORY
PATIENT.
Based on studies with 14C-labeled clomiphene, the drug is readily
absorbed orally in humans,
and is excreted principally in the feces. Cumulative excretion of the
14C-label averaged 51% of
the oral dose after 5 days in 6 subjects, with mean urinary excretion
of 8% and mean fecal
excretion of 42%; less than 1% per day was excreted in fecal and urine
samples collected from
31 to 53 days after 14C-labelled clomiphene administration. Since C-14
appeared in the feces
6 weeks after administration, available data suggested that the
remaining drug/metabolites were
being slowly excreted fr