Active Pharmaceutical Ingredients: Clomifen Citrate Bp 50mg CLOMITAB® acts as weak estrogen and as anti-estrogen because of its antagonism to the uterotropic effect of estradiol mono benzoate, but it is not used for this action in cases of breast cancer.
In women: when sterility is due to ovarian failure (functional), ovarian dysfunction, polycystic ovary syndrome, lactational amenorrhea, psychogenic amenorrhea and some cases of secondary amenorrhea of unknown origin or post contraceptive amenorrhea.
In men: sterility in men due to oligospermia and poor sperm motility.
DosageIn women: the first course of CLOMITAB® consist of 1 tablet daily for 5 days starting on the 5th day of the menstrual cycle or at any time if there is amenorrhea. If ovulation but no pregnancy occur, this may be repeated for a total (maximum) 6 cycles. If the ovulation does not occur after first cycle dosage may be increased to 2 tablets for 5 days. This dosage may be repeated up to maximum of 3 cycles if ovulation does not occur and up to maximum of 6 cycles if ovulation occurs but no pregnancy.
In men: 1/2 to 1 tablet for 6 months
Contraindications: pregnancy, liver insufficiency, abnormal vaginal bleeding (uterine tumor, ovarian cyst)
CLOMITAB® shall only be administered under medical supervision after careful selection of patients for CLOMITAB® (clomifen citrate) therapy. Complete pelvic examination is essential prior to start of treatment and should be repeated before such subsequent course. Incidence of multiple pregnancy is increased when conception take place during CLOMITAB therapy
Side effects are usually dose related, being more prominent and frequent at high doses. They uncommonly interfere with treatment at recommended doses. They include hot flushes, which are not usually severe and disappear after discontinuation of treatment. Abdominal symptoms are usually related to ovulatory or premenstured phenomena or ovarial enlargement. Multiple births and formation of multiple cysts in the ovaries is due to hyperstimulation of ovaries. It has not been resolved whether incidence of abortion, premature deliveries or congenital malformation is altered with CLOMITAB®.
Selection of patient for the therapy
Patients should be carefully selected for CLOMITAB therapy.
- Through pelvic examination prior to treatment and before start of subsequent courses
- Endometerial biopsy to be carried out before the start of CLOMITAB therapy in bleeding cases.