CLOMIPHENE CITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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). Store tablets at controlled room temperature 15° to 30°C (59° to 86°F). Protect from heat, light, and excessive humidity, and store in closed containers. Rx Only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg. Lic. No.: TN00002121 OS701-01-74-01 Issued: 05/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOMIPHENE CITRATE- CLOMIPHENE CITRATE TABLET
PAR PHARMACEUTICAL, INC.
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CLOMIPHENE CITRATE TABLETS
DESCRIPTION
Clomiphene Citrate Tablets, USP is an orally administered,
nonsteroidal, ovulatory
stimulant designated chemically as
2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy]
triethylamine citrate (1:1). It has the molecular formula of C
H
CINO • C H O and a
molecular weight of 598.10. 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 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.
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 therapy is an
increase in the release of pituitary gonadotropins. This initiates
steroidogenesis and
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folliculogenesis, resulting in growth of the ovarian follicle and an
increase in the
circulating level of estradiol. Following ovulatio