Ovulet 50mg 10pcs

Indication

Ovulation induction, Female infertility, Polycystic ovary syndrome, Amenorrhea-galactorrhea syndrome, Psychogenic amenorrhea

Administration

May be taken with or without food.

Adult Dose

Oral Anovulatory infertility Adult: 50 mg daily for 5 days starting on the 5th day of menstrual cycle or at any time if there is amenorrhoea. If ovulation does not occur, a 2nd course of 100 mg for 5 days may be used commencing as early as 30 days after the previous therapy. Further treatment may not be recommended if pregnancy has not occurred after a total of 6 treatment cycles.

Contraindication

Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium, hypersensitivity; abnormal bleeding; lactation; uncontrolled thyroid or adrenal dysfunction, patient with an organic intracranial lesions such as pituitary tumor.

Mode of Action

Clomifene inhibits the negative feedback mechanisms of oestrogens in the hypothalamus and pituitary which stimulates the secretion of pituitary gonadotrophic hormones resulting in stimulation of ovulation.

Precaution

Clomiphene citrate should be used with caution in the following conditions: longer maintenance therapy, with alcoholic drinks & antidepressants. Polycystic ovaries, evaluate presence of ovarian cyst before each cycle treatment. Uterine fibroids; visual disturbances may develop which will impair ability to drive or operate machinery. There is a minimal chance of multiple pregnancies, about which the patient should be warned. Lactation: It is not known whether clomiphene is excreted in human milk. Use with caution in nursing women. In some patients, clomiphene may reduce lactation.

Side Effect

>10% Ovarian enlargement (14%),Vasomotor flushing (10%) 1-10% Abdominal discomfort (6%),Blurred vision (1.5%),Breast discomfort (2%),Nausea/vomiting (2%)

Pregnancy Category Note

Pregnancy Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs; patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle; the next course of therapy should be delayed until these conditions have been excluded Available human data from epidemiologic studies do not show apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly Lactation It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if drug is administered to a nursing woman; in some patients, therapy may reduce lactation