CLOMBOLIC - Clomifene citrate 50mg

Category:- Hormones | Type:- Tablet

COMPOSITION

Each Tablet Contains: Clomifene Citrate BP 50 mg

PHARMACOLOGICAL CLASSIFICATION

Ovulation controlling agents.

PHARMACOLOGICAL ACTION

Clomifene acts as a competitive inhibitor at oestogen receptors, blocking their activation by endogenous oestrogen. By Clomifene competing with oestrogen for binding sites at the hypothalamic level, the gonadotropins, follicle stimulating hormone (FSH) and luteinising hormone secretion, is increased, which results in the maturation of the ovarian follicle and thus the development and function of the corpus luteum.

INDICATIONS

Treatment of anovulatory infertility and that due to polycystic ovaries.

CONTRA-INDICATIONS

Pregnancy, liver disease, history of liver dysfunction, pituitary failure, endometrial carcinoma or ovarian cysts (other than polycystic ovary), undiagnosed ,abnormal uterine bleeding. Hypersensitivity to Clomifene or any of the ingredients of this formulation.

WARNINGS

Prolonged courses of treatment are not recommended. Basal body temperature must be monitored throughout all treatment cycles and the patient should be carefully monitored to determine whether ovulation occurs. If the basal temperature, following Clomifene administration is biphasic and is not followed by menses, the patient should be examined carefully and should undergo a pregnancy test. This is to avoid inadvertent treatment with Clomifene during early pregnancy. The patient should be warned of the possibility of multiple births, particularly if higher doses are used.

DOSAGE AND DIRECTIONS FOR USE

During the first course - 50 mg (1 tablet daily) for 5 days, beginning on day 5 of the cycle, or any day if there is amenorrhoea. Should ovulation appear not to have occurred, after the first course of therapy a second course of 100 mg daily (as a single dose) may be administered for 5 days. If pregnancy does not occur after 6 courses, further courses are unlikely to be successful.

SIDE-EFFECTS AND SPECIALPRECAUTIONS

Side effects are dose related. Common side effects include vasomotor flushes, abdominal or pelvic discomfort or pain, ovarian enlargement, cyst formation and visual blurring. The normal variation of ovarian size may be exaggerated, even at normal dosage. There have been rare reports of massive ovarian enlargement and rupture of a lutein cyst with resulting haemoperitoneum. Visual side effects have been described as blurring or spots and flashes (scintillating scotomata). Ophthalmologically definable scotomata and retinal cell function changes have been reported. The administration of Clomifene citrate tablets should be discontinued if visual symptoms occur and a thorough ophthalmological evaluation should be made. No further courses of Clomifene citrate tablets should be administered. Less frequent side effects include nausea and vomiting, increased nervous tension, depression, fatigue, dizziness or light headedness, insomnia, vertigo, headache, mastalgia, menorrhagia, intermenstrual spotting, weight gain, skin reactions such as allergic rashes and urticaria, increased urinary frequency and moderate reversible alopecia. The formation of Hydatidiform mole has been associated with Clomifene citrate tablets administration. Some abnormalities of liver function may occur. It is very important to select and evaluate each patient and to pay careful attention to dosage instructions, contraindications and side effects. Before starting treatment patients should be thoroughly examined to exclude liver disease, pituitary or ovarian failure and neoplasms of the endometrium. The cause of infertility and any abnormal bleeding should be investigated. The patient must be instructed to report any abdominal or pelvic pain as this may indicate the presence or enlargement of ovarian cysts. Since the ovaries are stimulated by the administration of Clomifene, abnormal ovarian enlargement may occur. Patients suffering from polycystic ovary disease should receive the lowest dose of Clomifene, in order to prevent any further enlargement or cyst formation. If enlargement of the ovaries occur, administration of Clomifene should be discontinued. Should conception occur, during a cycle in which Clomifene is administered, there is the possibility of increased incidence of multiple pregnancy. Both patients and their husbands should be advised of this possibility.

KNOWN SYMPTOMS OFOVERDOSAGE AND PARTICULARS OFITS TREATMENT

See “Side effects and Special Precautions”. Treatment is symptomatic and supportive.

PRESENTATION 5x10 tablets in a blister packed in carton along with package insert

STORAGE INSTRUCTION

Store below 30°C in a dry place. Protect from light.

KEEP OUT OF REACH OF CHILDREN

Manufactured by : COOPER PHARMA LIMITED