Provula

Provula

clomifene

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Clomiphene citrate.
Action
Pharmacology: Clomiphene citrate possesses both estrogenic and anti-estrogenic effects, however, the exact mechanism of action in the induction of ovulation on anovulatory women has not been determined. It stimulates the release of gonadotropin pituitary, follicle-stimulating hormone (FSH) and luteinising hormone (LH), which cause the development and maturation of ovarian follicle, ovulation and development and functionalisation of the corpus luteum.
The release of gonadotropin may result from direct stimulation of the hypothalamic-pituitary axis or because of the diminution of oestrogen inhibition effect to hypothalamic-pituitary axis by competing with endogenous oestrogen from uterus, pituitary or hypothalamus. Clomiphene citrate may also directly influence the biosynthesis of ovarian hormones.
Clomiphene citrate has no progestational, androgenic or antiandrogenic effects and it does not interfere with pituitary-adrenal or pituitary-thyroid functions.
Indications/Uses
Infertility in women. Oligospermia (clomiphene is used to increase spermatogenesis).
Dosage/Direction for Use
Infertility in Women: One tab daily for 5 days, starting on the 5th day of menstrual cycle or any time in case of amenorrhoea. Ovulation usually occurs within 5-14 days after the last dosage. If ovulation does not occur, doses can be increased to 1 tab twice daily for 5 days, starting at least 30 days after 1st treatment. If ovulation still fails to occur, diagnosis should be re-analysed.
Oligospermia: One tab daily for 40-90 days.
Contraindications
Patients with liver disease or history of liver dysfunction; clinical evaluation of liver function should be performed before treatment. Patients with abnormal uterus haemorrhage due to unknown cases. Endometrial carcinoma and ovarian cysts. Pregnancy. Uncontrolled thyroid or adrenal dysfunction.
Patients with ovarian cyst should not use clomiphene citrate, since it may cause enlargement of the ovaries.
Special Precautions
Caution should be exercised in patients known to be hypersensitive to gonadotropin pituitary eg, patients with polycystic syndromes.
Patients should always be monitored for signs of ovarian hyperstimulation (eg, pelvic pain) during administration of clomiphene.
If ovary enlargement or cyst formation has occurred, therapy should be discontinued until the size of the ovary returns to normal; then doses or duration of continuing therapy should be reduced.
If sight disturbances have occurred during clomiphene therapy, treatment should be discontinued and complete ophthalmologic examination should be performed.
Effects on the Ability to Drive or Operate Machinery: Caution should be taken if the job of the patients need a high degree of alertness or high level of mental and physical conditions (eg, machinery operator, driver), especially if working under various lighting since clomiphene citrate may cause sight disturbances, dizziness or lightheadedness.
Adverse Reactions
At recommended dosage, adverse reactions have occurred rarely, except in patients with polycystic ovary syndromes where it may cause excessive responses.
In high doses (≥100 mg daily) or if the treatment is extended, adverse reactions have often occurred.
The most common adverse reactions are enlargement of the ovaries or ovarian cyst formation and vasomotor disturbances eg, hot flushes. Other adverse effects are abdominal/pelvic discomfort, sight disturbances eg, blurred vision, diplopia, scotomata, phosphenes, photophobia; nausea/vomiting; increase in frequency and volume of urine; increased appetite and body weight; various dermatological conditions including urticaria, rash or allergic dermatitis; breast tenderness; headache, nervousness, insomnia, dizziness, lightheadedness, depression, fatigue and hair loss.
These adverse reactions usually diminish or disappear if treatment is discontinued.
Drug Interactions
No drug interactions have been reported.
ATC Classification
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
Presentation/Packing
Tab 50 mg x 30's.
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