Clome

Clome

COMPOSITION:

Each uncoated tablet of Clome contains:

Clomiphene Citrate ……………………. 50mg

DESCRIPTION:

Pharmaco-therapeutic class: Ovulation stimulant.

(Genito-Urinary system and sexual hormones).

The ovulatory response to cyclic Clome therapy appears to be mediated through increased output of pituitary gonadotropins, which in turn stimulates the maturation and endocrine activity of the ovarian follicle and the subsequent development and function of the corpus luteum.

After oral administration, the product is well absorbed, elimination is mainly in the faeces, the product and its metabolites being slowly eliminated via the entero-hepatic cycle.

INDICATION:

Treatment of ovulatory failure: treatment of sterility in subjects with normal blood prolactin levels, where anovulation (absence of ovulation) and dysovulation. inadequate ovulation: corpus luteum inadequate, short luteal phase, polycystic ovary syndrome is of a high functional origin.

Test for diagnostic and therapeutic purposes in certain amenorrheas (lack of menses) of hypothalamo-pituitary origin and in persistent amenorrhoea following oral contraception after having checked that plasma prolactin levels are normal.

DOSAGE:

Strictly follow the recommended dosage.

Treatment of ovulatory failure:

The recommended dose for the first course of Clome is 50 mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the course should be started on or about the fifth day of the cycle (i.e. 5 days after first day of menses). When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment. If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one. Increase of the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken. The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient, who does not exhibit evidence of ovulation. Long-term cyclic therapy is not recommended, i.e., beyond a total of about 6 cycles (including 3 ovulatory cycles).

Test for diagnostic and therapeutic purposes:

100 mg (2 tablets) daily for 5 consecutive days for a single cycle.

Special populations:

Special care with lower dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome.

Storage Conditions:

– Keep the medicine in a dry place at a temperature below 30 °C.

– Keep the medicine out of the reach of children.

– Protect the medicine from direct sunlight.

– Do not use Clome tablets after expire date.