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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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