Ovuclon (Clomiphene Citrate)

Therapeutic Group: Gynaecological Fertility and Ovulation Stimulant

Each tablet contains Clomiphene citrate BP 50 mg.

Clomiphene citrate (Ovuclon) is the first non-steroidal preparation {a mixture of 2 geometric isomers-Cis [Zuclomiphene] and Trans [Enclomiphene] that in many patients induces ovulation, which has failed previously. Clomiphene citrate stimulates the increased secretion of both gonadotropins (FSH and LH) from pituitary, which induce maturation of the ovarian follicle, ovulation and subsequent normal function of the corpus luteum. It does not interfere with the other functions of pituitary and thyroid and has no progesteronic or androgenic effect. Clomiphene citrate is taken orally and readily absorbed from gastro intestinal tract. Its biological half-life in plasma is 5-7 days. It is partially metabolized in the liver and through the bile is excreted in the faeces. A part is reabsorbed and enters into enterohepatic recirculation-pool.

- Clomiphene citrate is chiefly indicated for the treatment of ovulatory failure in female patients who wish to become pregnant. This therapy will not be successful unless the patient though unovulatory, is capable of ovulation and her partner is fertile. - Polycystic ovary syndrome. - Menorrhagia caused by hyperplastic endometrium. - Amenorrhea with galactorrhea syndrome. - Psychogenic amenorrhea syndrome. - Secondary amenorrhea of unknown cause. - Amenorrhea during post oral contraceptive period.

For the treatment of ovulatory failure: 50 mg (1 tab) daily for 5 days, starting within about 5 days of onset of menstruation (or may be from the 1st day of menstruation). If this dose induces ovulation there is no need to increase the dose in the following courses. If this dose induces ovulation but not pregnancy, stimulation with Clomiphene citrate is to be continued up to 6 stimulative courses. If the1st course does not induce ovulation, 2nd dose of Clomiphene citrate is100 mg (2 tab at a time) daily for 5 days is recommended. Minimum 3 and maximum 6 simulative courses should constitute an adequate therapeutic trial. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy and the next course should be delayed until correct diagnosis has been determined. The modern studies reveal that ultrasonographic monitoring for ovulation is most preferable. For other indications: The recommended dose for other gynaecological problems is 50 mg (1 tab) for 5 days, starting from the 5th day of menstruation or according to the physicians recommendation, but never more than 6 cycles in total.

Clomiphene citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued. There is a minimal chance of multiple pregnancies, about which the patient should be warned.

Clomiphene citrate should be used with caution in the following conditions: longer maintenance therapy, with alcoholic drinks and antidepressants.

Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium.

Pregnancy: Not recommended in pregnancy. Nursing mother: In some cases Clomiphene citrate may reduce lactation, if it is administered to a woman during lactating period. So it should be avoided during lactational period. Drug Interaction No drug interaction has been reported during the administration of Clomiphene citrate.

No such effects of acute over dosage of Clomiphene citrate have been reported. However, in case of over dosage, a few sign symptoms of nausea, vomiting, vasomotor flushes, scotoma, and ovarian enlargement with pelvic or abdominal pain may occur. In the event of over dosage appropriate supportive measures should be employed. Storage Ovuclon tablet should be stored below 25o C and protected from light and moisture.

Each box contains 3 blister strips of 10 tablets. Each box contains 2 blister strips of 10 tablets.