CLOMIPHENE CITRATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

DIRECTRX

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION an

Produkt oppsummering:

Clomiphene citrate tablets, USP, 50 mg are round, off-white, debossed “Par 701” with bisect on one side and plain on the other. They are supplied in cartons of 10 (NDC 49884-701-54) and cartons of 30 (NDC 49884-701-55). Storage - Store at controlled room temperature 15°-30°C (59°-86°F). Protect from heat, light, and excessive humidity, and store in closed containers. Manufactured by: PAR PHARMACEUTICAL Chestnut Ridge, N Y 10977 Revised: 06/2016

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOMIPHENE CITRATE- CLOMIPHENE CITRATE TABLET
DIRECTRX
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CLOMIPHENE CITRATE
Clomiphene citrate tablets, USP is an orally administered,
nonsteroidal, ovulatory stimulant designated
chemically as 2-[p-(2chloro-1,2-diphenylvinyl)phenoxy] triethylamine
citrate (1:1). It has the molecular
formula of C26H28CINO • C6H8O7 and a molecular weight of 598.10. It
is represented structurally
as:
[This is the structural formula]
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 off-white debossed tablet contains 50 mg clomiphene citrate USP.
The tablet also contains the
following inactive ingredients: corn starch, lactose monohydrate,
magnesium stearate, pregelatinized
corn starch, and sucrose.
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 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 ovulation, plasma
progesterone and estradio