Branded Medicine

 
PROVULA

Tablet

 
:: COMPOSITIONS ::

Each tablet contains:

Clomiphene citrate 50 mg
 
:: PHARMACOLOGY ::

Clomiphene citrate has both estrogen and anti-estrogenic properties, however, the exact mechanism of action in the induction of ovulation on anovulatory women has not been determined. It stimulates the release of the gonadotropin pituitary, follicle-stimulating hormone (FSH), and luteinizing hormone (LH), which cause the development and maturation of ovarian follicle, ovulation and subsequent development and functionalization of the corpus luteum. Gonadotropin release may be caused by direct stimulation of the hypothalamic-pituitary axis or because of the reduction of estrogen inhibition effect to hypothalamic-pituitary axis by competing with the endogenous estrogen from uterus, pituitary or hypothalamus. Clomiphene citrate may also influence directly the biosynthesis of ovarian hormones. Clomiphene citrate has no progestational, androgenic, or anti-androgenic effects and it does not interfere with pituitary-adrenal or pituitary-thyroid function.

 
:: INDICATIONS ::
  • Infertility in women
  • Increase spermatogenesis in oligospermia patient
 
:: DOSAGE & ADMINISTRATION ::
  • Infertility in women
    1 tablet daily for 5 days, starting on the fifth day of menstrual cycle or anytime in amenorrhoeae case. Ovulation usually occurs within 5-14 days after last administration. If ovulation does not occur, dosage could be increased to 2 tablets daily for 5 days, starting at least 30 days after previous therapy. If ovulatory still fails to occur, diagnosis should be reanalyzed.
  • Oligospermia patient
    1 tablet 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 hemorrhage due to unknown case.
  • Endometrial carcinoma and ovarian cyst.
  • Pregnancy.
  • Uncontrolled thyroid or adrenal dysfunction.
 
:: ADVERSE REACTIONS ::

At recommended dosage, adverse reactions have occurred rarely, except in patients with polycystic ovary syndromes may cause excessive responses.

In high doses (100 mg or more daily) or prolonged therapy adverse reactions have often occurred.

The most common adverse reactions are ovaries enlargement or ovarian cyst formation, vasomotor disturbances e.g., hot flushes. Other adverse reactions are abdominal disturbances or pelvic discomfort, visual disturbances e.g., transient blurred vision, diplopia, scotomata, phosphenes, photophobia; nausea or vomiting increase in urinary frequency or volume; 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 effects are usually diminished or disappear if treatment is discontinued.

 
:: WARNINGS and PRECAUTIONS ::
  • Caution should be taken if the job of the patients need a high degree of alertness or high level of mental and physical condition (e.g., machinery operator, driver, especially if working under various lighting since clomiphene citrate may cause visual disturbances, dizziness or lightheadedness.
  • Clomiphene citrate should be used cautiously in patients known hypersensitive to gonadotropin pituitary e.g., patient with polycystic ovary syndrome.
  • Patient with ovarian cyst should not use clomiphene citrate, since it may cause enlargement of the ovaries.
  • Patients should always be monitored for signs of excessive ovarian stimulation (e.g., pelvic pain) during clomiphene therapy.
  • f ovary enlargement or cyst formation has occurred, therapy should be discontinued until the size of the ovary returns to normal, and the doses or duration of the continuing therapy should be reduced.
  • If any visual disturbances have occurred during clomiphene treatment, it should be discontinued and complete ophthalmologic evaluation should be performed.
 
:: PRESENTATION ::

Box, 3 strips @ 10 tablets

Reg. No.: DKL97050225010A1

STORE IN DRY PLACE, BELOW 30oC, PROTECT FROM LIGHT.

ON MEDICAL PRESCRIPTION ONLY

Manufactured by:

Dexa Medica