Ovuclon(Clomiphene)
Therapeutic Group: Gynaecological
Presentation
Ovuclon 50 tablet: Each tablet contains Clomiphene citrate BP 50 mg.
Ovuclon 100 tablet: Each tablet contains Clomiphene citrate BP 100 mg.
Description
Clomiphene citrate (Ovuclon) is the first non-steroidal preparation (a mixture of 2 geometric isomers-Cis [Zuclomiphene] & Trans [Enclomiphene]) that in many patients induces ovulation, which has failed previously. Clomiphene citrate stimulates the increased secretion of both gonadotropins (FSH & LH) from pituitary, which induce maturation of the ovarian follicle, ovulation & subsequent normal function of the corpus luteum. It does not interfere with the other functions of pituitary & thyroid & has no progesteronic or androgenic effect. Clomiphene citrate is taken orally & readily absorbed from gastro intestinal tract. Its biological half-life in plasma is 5-7 days. It is partially metabolized in the liver & through the bile is excreted in the faeces. A part is reabsorbed & enters into enterohepatic recirculation-pool.
Indications
- 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 & 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.
Dosage & Administration
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 & 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 & 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 physician\\\\\\\\\\\\\\\'s recommendation, but never more than 6 cycles in total.
Side Effects
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 & 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.
Precautions
Clomiphene citrate should be used with caution in the following conditions: longer maintenance therapy, with alcoholic drinks & antidepressants.
Use in Pregnancy & Lactation
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.
Over Dose
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 25 °C and protected from light & moisture.
Commercial Pack
Ovuclon 50 tablet: Each box contains 3 blister strips of 10 tablets.
Ovuclon 100 tablet: Each box contains 2 blister strips of 10 tablets.