Meprate®

Medroxyprogesterone Acetate tablets U.S.P.
 

COMPOSITION

  • MEPRATE : Each uncoated scored tablet contains Medroxyprogesterone Acetate I.P. 10mg (chemical name)
  • MEPRATE -2.5 : Each uncoated scored tablet contains Medroxyprogesterone acetate I.P. 2.5mg (chemical name)

INDICATIONS
MEPRATE is a synthetic progestogen structurally related to natural progesterone with actions and uses similar to all other progestogens in general use. It is used prior to the treatment of secondary amenorrhoea and for abnormal uterine bleeding not due to organic pathology in suitable doses. The dose is individualized as advised by the physician. MEPRATE is also indicated for mild and moderate endometriosis in dosage ranging from 10mg to 30mg by mouth. MEPRATE is indicated also for re-programming the menstrual cycle as per the physician’s requirement. As a corollary, it can also be used for postponement of menses as per individual requirement. MEPRATE can also be used to induce menstrual bleeding in a woman of reproductive age, if she has secondary amenorrhoea, in the dosage to be determined by the physician. MEPRATE may also be used in the palliative treatment of some hormone dependent malignant neoplasms. It is also used occasionally for breast carcinoma in doses to be determined by the physician. In endometrial, renal and prostatic carcinoma, the recommended dose ranges from 100 mg - 500 mg by mouth. MEPRATE-2.5 can be a valuable adjuvant in women on Hormone Replacement Therapy (estrogen replacement therapy) who have intact uterus, for protection against endometrial hyperplasia.

DOSAGE AND ADMINISTRATION
Medroxyprogesterone is absorbed from intestinal tract, it is hydroxylated in the liver and has been shown to be kind to the digestive system. Hence, by and large, it is tolerated very well however, as a precautionary measure, it should be taken after food, and as per the advice of the physician.

  • MEPRATE
    To induce withdrawal bleeding in a case of secondary amenorrhoea, the dose of 5-10 days usually suffices. In any condition where optimal secretory transformation of the endometrium is desired, provided the endometrium has been adequately primed by either exogenous or endogenous estrogen, the dosage needed is 1-mg/day for 10 days. Therapy may be started any day so long as the woman is amenorrhoeic. Withdrawal bleeding usually occurs anytime from 3-7 dyas after the last dose of MEPRATE. In dysfunctional uterine bleeding, a dosage range of 5-10 mg/day for 5-10 days may be suitable. Therapy may be started on day 16 or day 21 of the menstrual cycle. If the patient of dysfunctional uterine bleeding is anaemic, the withdrawal bleeding or the menstrual period is not desirable, MEPRATE may be continued till the haemoglobin count comes-up and the patient is regarded no more anaemic. The length of therapy in such a case can be individually determined by the physician.
  • MEPRATE-2.5 is administered in a dose of one-two tablets per day either in a continuous combined regime along with estrogen administration or in a cyclical manner with estrogens. In latter case estrogen may be administered from day one to day 25 of the cycle and MEPRATE-2.5 in a dose of one to two tablets may be added from days 16 to 25 of the cycle.

CONTRA-INDICATIONS & WARNING
As with all progestogens (or Progestins) hypersensitivity reactions may occur. Thrombophlebitis, thromboembolic disorders, cerebral haemorrhage, have been occasionally reported. Patients with the history of these conditions may not be given progestogens. Impaired liver function or disease, breast carcinoma, undiagnosed vaginal bleeding, missed abortion, are some of the other contra-indications.

Synthetic progestogens are usually not advisable for administration during pregnancy. Hence, even while a woman is on synthetic progestogen for treatment of any condition, and if pregnancy is detected, the progestogen must be withdrawn at the discretion of the physician. This is because of the finding of potential harm to the foetus when given during the first 4 months of pregnancy.

Several studies have reported the association between intrauterine pregnancy exposure to progestational drugs in first trimester of pregnancy and genital abnormalities in the foetus, both male and female. Medication must be discontinued if there is a sudden partial or complete loss of vision, onset of proptosis, diplopia, or migraine. The therapy may also be discontinued if papilloedema or retinal vascular lesions occur. Use during pregnancy is not recommended. MEPRATE does not adversely affect lactation and may on the contrary increase milk production and duration of lactation if given during puerperium. Patients with diabetic history receiving progestational therapy must receive careful attention. Urine sugar must be monitored carefully and any abnormality must be reported to the physician.

PRECAUTIONS
As with other progestogens, physical examination of breasts and pelvic organs prior to treatment is suggested. In case of irregular vaginal bleeding, non-functional cause must be considered prior to treatment. In other words, the functional cause of vaginal bleeding must be established prior to treatment with progestogens.

Fluid retention may occur on prolonged therapy, therefore, prevalence of such conditions as epilepsy, migraine, asthma, cardiac or renal dysfunction need to be given due credence. Patients with history of psychic depression need to be observed while on synthetic progestogens for aggravation of the symptoms.

Photosensitisation may occur. Hence, protective measures should be suggested to the patient with known sensitivity, such as use of sunscreens or protective clothing.

DRUG INTERACTIONS
Some drugs like Aminoglutethimide may increase the hepatic metabolism of MEPRATE, possibly decreasing its therapeutic effect.

Laboratory test results of hepatic function, coagulation tests, thyroid, dynamic tests with Metyrapone and endocrine functions may be affected both by progestogens and estrogens.

A decrease in glucose tolerance has been observed in a small number of patients receiving estrogen and progestin combination.

Determination of pregnanediol may be altered by the use of progestins.

ADVERSE REACTIONS
Breakthrough bleeding, vaginal spotting, change in menstrual flow, amenorrhoea, changes in cervical erosion, and cervical secretion, breast tenderness, oedema, changes in weight, mental depression, gastrointestinal disturbance, acne, changes in libido, alterations in liver function test have been reported with all synthetic progestogens, Hypersensitivity reactions like pruritus, urticaria, generalized rash, alopecia, have also been occasionally reported.

STORAGE
MEPRATE and MEPRATE-2.5 must be stored in a cool, dry and dark place.

PRESENTATION
MEPRATE and MEPRATE-2.5 are packed in boxes containing 10 blister packs, each containing 10 tablets.

   

 
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