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Description
BIO-HMG™ is a Menotropins U.S.P., containing hormonal substance of F.S.H. and L.H. in a ratio of about 1:1.
Composition:
Each ampoule of sterile freeze-dried product contains:
Menotropins U.S.P. equivalent to the activity of
Follicle Stimulating Hormone (F.S.H.) 75 I.U. / 150 I.U.
Luteinizing Hormone (L.H.) 75 I.U. / 150 I.U.
Mannitol I.P. 12 mg
Potassium Dihydrogen Orthophosphate B.P. 0.46 mg
Dipotassium Hydrogen Orthophosphate B.P. 0.36 mg
Each 1 ml ampoule of diluent contains:
Sodium Chloride I.P. 0.9% w/v
Water for injection I.P. q.s.
Clinical Pharmacology
BIO-HMG™ (Menotropins) stimulates the growth and maturation of follicles in women and also induces an increase of the oestrogen levels and a proliferation of the endometrium. In men it stimulates the spermatogenesis by acting on the production of the androgen binding protein in the seminiferous tubules of the sertoli cells.
Indication
In Women: BIO-HMG™ (Menotropins) is indicated for the induction of ovulation in the amenorrhoeic patient or anovulatory woman with regular or irregular cycles.
In Men: BIO-HMG™ (Menotropins) is indicated for the stimulation of spermatogenesis in men who have primary or secondary hypogonadotrophic hypogonadism.
Dosage and Administration
BIO-HMG™ (Menotropins) is given as an Intramuscular injection only. The injection solution should be reconstituted with the diluent provided immediately prior to use.
IN WOMEN
Individually customized doses of BIO-HMG™ (Menotropins) are given several days to meet the main objective to develop a single mature Graafian follicle and then followed by treatment with Chorionic Gonadotrophin to release the ovum. The development of Graafian follicle is judged by the concentration of oestrogen measured either in blood or urine. Sonography or Clinical assessment of the response, pelvic examination and cervical mucus studies should be carried out in the patient. Treatment with BIO-HMG™ (Menotropins) should continue until the desired/adequate oestrogen level is achieved. The total oestrogen value of less than either 180 nmol/24h (50mg/24h) for total urinary oestrogens or 1100 pmol/l (300 pg/ml) for plasma 17ß-oestradiol are still inadequate and the follicular development may be not be mature enough in such cases. On the other hand if the levels are higher than either 514 nmol/24h (140 mg/24h) for total urinary oestrogens or 3000 pmol/l (800 pg/ml) for plasma 17 ß -oestradiol, there is an increased risk of ovarian hyperstimulation and treatment with Chorionic gonadotrophin in such case should be immediately withheld. The optimal time for Chorionic Gonadotrophin administration is the day on which the urinary oestrogen peaks or the day after the plasma 17 ß -oestradiol peaks.
The stimulated follicles will not liberate ova spontaneously in the anovulatory patient. The rupture of Follicular has to be achieved by injecting Chorionic Gonadotrophin, which stimulates the normal surge of luteinizing hormones at ovulation. The patient who wishes to conceive is recommended to have coitus on the day when Chorionic gonadotrophin is given and on the following day.
The dose of BIO-HMG™ (Menotropins) required to evoke the desired response is critical and varies both from patient to patient and in the same patient at different times. Monitoring by means of hormone assay is therefore very essential.
Recommended Dosage Schedules:
In Women
1. Alternate day therapy: Three customized equal dose of BIO-HMG™ (Menotropins) are given on alternate days in the first half of proliferative phase of the menstrual cycle. In a menstruating woman the initial injection of BIO-HMG™. (Menotropins) should be given on day 7, 8 or 9 of the cycle. A single dose of Chorionic gonadotrophin 10,000 I.U. is given one week after the first injection of BIO-HMG™(Menotropins), provided the clinical and biochemical response are adequate and not excessive.
2. Daily therapy: Daily injection of BIO-HMG™ (Menotropins) is given until an adequate response is achieved. The dosage of BIO-HMG™ (Menotropins) is judged on the basis of daily oestrogen determinations. In the absence of adequate response the dosage of BIO-HMG™ (Menotropins) may be increased or treatment abandoned. A single injection of 10,000 IU Chorionic gonadotrophin is administered 24-48 hours after the last dose of BIO-HMG™. Daily therapy is most commonly prescribed.
IN MEN
BIO-HMG™(Menotropins) 3 times a week in combination with Chorionic Gonadotrophin 2000 I.U. 2 times a week should be given for a minimum period of four months. If the patient does not respond with evidence of increased spermatogenesis at the end of four months treatment, the treatment may be continued with BIO-HMG™ (Menotropins) 3 times a week and Chorionic Gonadotrophin 2000 I.U. 2 times a week.
Contraindications & Warnings
IN WOMEN: Treatment with BIO-HMG™ (Menotropins) is precluded when a effective response cannot be obtained. The response could be due to ovarian dysgenesis, absentuterus, premature menopause, tubal occlusion and if detected appropriate corrective treatment should first be given for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia or pituitary tumour.
Adherence to the recommended dosage and monitoring schedules will minimize the possibility of ovarian hyperstimulation. Excessive oestrogenic responses to BIO-HMG™ (Menotropins) does not generally give rise to significant side effects unless Chorionic gonadotrophin is given to induce ovulation. Hormone assays can detect and excessive oestrogen response to BIO-HMG™ (Menotropins) and in which case treatment with Chorionic gonadotrophin should be withheld. The incidence of multiple births following Menotropins/Chorionic gonadotrophin therapy has been variously reported between 10% and 40%. However, the majority of multiple conceptions are twins.
Pregnancy wastage by abortion is higher than in a normal population but comparable with the rate in women with other fertility problems. The risks of congenital abnormalities are not increased by BIO-HMG™ (Menotropins).
IN MEN: Elevated adrogenous follicle stimulating hormone levels are indication on primary testicular failure and such patients do not respond to treatment with BIO-HMG™ (Menotropins) or Chorionic Gonadotrophin.
Side Effects
In WOMEN: In rare cases local reaction at the injection site, fever and arthralgies have been observed.
In MEN: A combined treatment with Menotropins and Chorionic Gonadotrophin may cause gynecomastia.
Storage
Store below 20oC. Protect from Light.
The reconstituted solution must be used immediately after reconstitution.
Presentation
BIO-HMG™ 75 I.U: Box containing 1 ampoule of H.M.G. 75 I.U. and 1ml ampoule of diluent.
BIO-HMG™ 150 I.U: Box containing 1 ampoule of H.M.G. 150 I.U. and 1ml ampoule of diluent. |
