Profertil

PROFERTIL^®
tablets
Clomiphene Citrate USP

Composition
Each tablet contains:
Clomiphene Citrate USP ........................ 50 mg

Pharmacology
PROFERTIL^® is chemically designated as 2- (p-(2-chloro-1, 2-diphenylvinyl) phenoxy) triethylamine dihydrogen citrate. PROFERTIL^® is an agent with a relative specific action on systems affecting the reproductive organs both in men and women. It has been proved in experimental animals that PROFERTIL^® (Clomiphene Citrate) possesses both estrogenic and antiestrogenic effects. Clinical experiments with PROFERTIL^® (Clomiphene Citrate) showed that it is an effective inducer of ovulation in women and spermatogenesis in men (1). The proposed mechanism of induction of ovulation by PROFERTIL^® is that it increases the plasma FSH (2) and LH (3) levels by preventing the inhibition of their secretion by estrogen or androgen. There is no clinical evidence that PROFERTIL^® possesses any progestational or androgenic effects. It is beneficial therefore in the treatment of infertility due to lack of ovulation in women and oligospermia in men. PROFERTIL^® is readily absorbed through the gastro-intestinal tract; it is slowly excreted by the liver into the biliary tract and is involved in the enterohepatic circulation.
The biological half life of PROFERTIL^® (Clomiphene Citrate) ranges from 5 to 7 days.

Indications
PROFERTIL^® is indicated for the treatment of infertility in women with amenorrhoeae. Stein-Leventhal syndrome. or functional uterine bleeding. in which lack of ovulation represents the problem. It is also indicated to stimulate sperm production in male infertility associated with oligospermia.

Contraindications
PROFERTIL^® should not be administered to patients with hepatic insufficiency, pregnancy, and ovarial cysts. It should also not be given to patients with organic disorders of the pituitary. ovary or other reproductive organs.

Adverse reactions
Excessive enlargement of the ovaries and ovarial cysts formation represent the common features encountered when doses of 100 to 200 mg daily are given for 2 to 3 weeks. But these untoward effects can be minimized by decreasing the dose to 50 mg daily without significantly altering the effectiveness of therapy.
The other side effects such as hot flashes, gastro-intestinal complaints, skin rashes may sometimes occur in sensitive individuals. Blurred vision, headache, and insomnia have also been reported in some cases.

Precautions
Accurate obstetrical and gynecological examinations should be exercised in selecting the proper candidates for PROFERTIL^® therapy. Patients should be warned of the possibility of multiple pregnancy. They should also be warned about the possibility of blurred vision and should be told to stop the drug and report immediately to their physicians if any visual symptoms occur.

Dosage
The recommended dosage of PROFERTIL^® in the treatment of anovulatory infertility is 1 tablet daily for 5 days starting on the 5th day of menstrual cycle or any time in case of amenorrhoeae.
Ovulation usually occurs, within 6 to 10 days after the last dosage of PROFERTIL^®. If ovulation does not occur. further courses of 1 tablet twice daily for 5 days may be given. If pregnancy fails to occur after 6 courses of treatment, further courses are unlikely to be successful. In cases of oligospermia the recommended dosage of PROFERTIL^® is 1 tablet daily for 40 to 90 days. The increase of sperm-count may be detected within 4 to 5 weeks after the start of therapy (4, 5, 6).

Presentation
Box of 1 strip x 10 tablets in strip: Reg. No. DKL 8511603410A1

References
1. Shirai, E. et al., Fertility and Sterility, 1972, 5, 331.
2. Jacobson, A., Obsted. Gynec., 1968, 102 - 284.
3. Jacobson. A. et al., Amer. J. Obsted Gynec., 1968, 101, 1025.
4. Halim. A. et al., Proc. Roy. Soe. Med., 1973, 66, 373.
5. Schellen, TMCM and Beck, JHMM: Fertility and Sterility, 1974, 25, 407.
6. Jungck, E.C. et al., Fertility and Sterility. 1964, 15, 40.

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