Clomiphene citrate is a non-steroidal compound which are competitive antagonists against estrogen endogenous in endogenous receptors in the anterior pituitary and hypothalamus. Clomiphene citrate has a very weak estrogenic effects and moderate estrogenic anti-effects, which may affect reproductive organ system of female and male. Clomiphene citrate can stimulate ovulation and spermatogenesis by eliminating the influence the feedback of estrogen and androgen on gonadotropin secretion from adenohypophysis (release factor) and the hypothalamus, so that the secretion of the FSH hormone and LH increases without triggering the axis function of pituitary-adrenal and axis of the pituitary-thyroid gland. With the pharmacodynamic effect like that, Clomiphene citrate may induce ovulation in infertile women caused by anovulatory or amenorrhea also induces spermatogenesis in infertile men due to oligospermia.
Indications/Uses
Infertility in women caused by ovulation disorders. Infertility in men due to oligospermia.
Dosage/Direction for Use
Anovulatory infertility in women: 1 tablet daily for 5 days, starting on the fifth day of the menstrual cycle or at any time in the case of amenorrhea. Ovulation will occur usually in 6-10 days after the last dose. If ovulation does not occur, the dose can be increased to 100 mg daily (2 tab) given as a single daily dose for 5 days, starting as early as 30 days from the first administration. If the pregnancy fails, the patient should be re-diagnosed. Increased dosages of more than 100 mg daily or longer than 5 days of treatment are not recommended. Oligospermia: 1 tablet daily for 40-90 days. Increased sperm counts may be detected within 4-5 weeks after therapy begins.
Contraindications
Hypersensitivity to Clomiphene citrate and other drug components.
Liver insufficiency, pregnancy and ovarian cysts.
Patients with organic disorders in the pituitary, ovaries (abnormal uterine bleeding, ovarian endometriosis) or other reproductive organs: endometrial carcinoma.
Bilirubin metabolism disorder due to heredity.
Uncontrolled adrenal or thyroid dysfunction.
Inorganic intracranial lesions (pituitary tumors)
Special Precautions
Accurate obstetric and gynecological examination must be carried out before treatment with Clomiphene citrate.
The patient must be informed of the existence the possibility of multiple pregnancies.
Administration of Clomiphene citrate must be stopped if there is a visual impairment, for example blurred eyes, spots or flashes arise (in rare cases, scotomata can occur).
Infertile patients due to endocrine disorders must be treated first before Clomiphene administration and it is recommended to carry out semen analysis in infertile couples who are undergoing ovulation induction therapy.
Close evaluation including pelvic examination must be carried out before administration of Clomiphene.
To reduce the risk of ovarian enlargement during administration of this drug, the dose need to be reduced.
Ovarian hyperstimulation syndrome such as: abdominal pain, gastrointestinal disorders, ovarian enlargement, weight gain, dyspnea, oliguria may occur in patients who get Clomiphene citrate for ovulation induction therapy.
Long-term use may increase the risk of ovarian tumors.
Adverse Reactions
It is not recommended to use this drug more than 100 mg per day or use more than 5 days. Side effects that occur due to over dosage include: Ovarian and abdominal enlargement / pelvic discomfort, vasomotor symptoms (hot flushes).
Nausea, vomiting, breast pain and visual disturbances sometimes might occur.
Restlessness, insomnia, headache, dizziness, increased urine production, heavy menstruation, depression, fatigue, skin reactions (dermatitis, urticaria) have been reported to increase weight and temporary hair loss.
Seizures have been reported in several individuals.
Multiple pregnancy.
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