CLOMIPHENE CITRATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
15-01-2018

Aktiv ingrediens:

CLOMIPHENE CITRATE (UNII: 1B8447E7YI) (CLOMIPHENE - UNII:1HRS458QU2)

Tilgjengelig fra:

Teva Pharmaceuticals USA Inc

INN (International Name):

CLOMIPHENE CITRATE

Sammensetning:

CLOMIPHENE CITRATE 50 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

                                CLOMIPHENE CITRATE- CLOMIPHENE CITRATE TABLET
TEVA PHARMACEUTICALS USA INC
----------
CLOMIPHENE CITRATE TABLETS, USP
DESCRIPTION
ClomiPHENE citrate is an orally administered, nonsteroidal, ovulatory
stimulant designated chemically
as 2-[p-(2-chloro-1,2-diphenylvinyl) phenoxy] triethylamine citrate
(1:1). It has a molecular formula of
C
H CINO ·C H O and a molecular weight of 598.09. It is represented
structurally as:
ClomiPHENE citrate is a white to pale yellow, essentially odorless,
crystalline powder. It is freely
soluble in methanol; soluble in ethanol; slightly soluble in acetone,
water, and chloroform; and insoluble
in ether.
ClomiPHENE citrate is a mixture of two geometric isomers [cis
(zuclomiPHENE) and trans
(enclomiPHENE)] containing between 30% and 50% of the cis-isomer.
Each white scored tablet contains 50 mg clomiPHENE citrate USP. The
tablet also contains the
following inactive ingredients: lactose, microcrystalline cellulose,
starch, colloidal silicon dioxide,
magnesium stearate and sodium starch glycolate.
CLINICAL PHARMACOLOGY
ACTION
ClomiPHENE citrate is a drug of considerable pharmacologic potency.
With careful selection and
proper management of the patient, clomiPHENE citrate has been
demonstrated to be a useful therapy for
the anovulatory patient desiring pregnancy.
ClomiPHENE citrate is capable of interacting with
estrogen-receptor-containing tissues, including the
hypothalamus, pituitary, ovary, endometrium, vagina, and cervix. It
may compete with estrogen for
estrogen-receptor-binding sites and may delay replenishment of
intracellular estrogen receptors.
ClomiPHENE citrate initiates a series of endocrine events culminating
in a preovulatory gonadotropin
surge and subsequent follicular rupture. The first endocrine event in
response to a course of
clomiPHENE citrate therapy is an increase in the release of pituitary
gonadotropins. This initiates
steroidogenesis and folliculogenesis, resulting in growth of the
ovarian follicle and an increase in the
circulating level of estradiol. Following 
                                
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