Provera Special Precautions



Full Prescribing Info
Special Precautions
Patients with a history of treatment for mental depression should be carefully monitored while receiving PROVERA therapy. Some patients may complain of premenstrual like depression while on PROVERA therapy.
Pathologists should be informed of the patients ingestion of PROVERA if endometrial or endocervical tissue is submitted for examination.
The following laboratory tests may be affected by the use of PROVERA: Gonadotropin levels, plasma progesterone levels, urinary pregnanediol levels, plasma testosterone levels (in the male), plasma estrogen levels (in the female), plasma cortisol levels, glucose tolerance test, metyrapone test and sex-hormone-binding-globulin.
Aminoglutethimide administered concomitantly with PROVERA may significantly depress the bioavailability of PROVERA.
A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination drugs. The mechanism of this decrease is obscure.
For this reason, diabetic patients should be carefully observed while receiving progestin therapy.
The pretreatment physical examination should include special reference to breast and pelvic organs, as well as papanicolaou smear.
Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation.
In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, non-functional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.
Effects on Ability to Drive and Use Machines: The effect of MPA on the ability to drive and use machinery has not been systematically evaluated.
100 mg: Before using PROVERA the general medical condition of the patient should be carefully evaluated.
This product should be used under the supervision of a specialist and the patients kept under regular surveillance.
Occasional uterine bleeding may occur in patient with high dose therapy.
Animal studies show that PROVERA possesses adrenocorticoid activity. This has also been reported in man, therefore patients receiving large doses continuously and for long period should be observed closely.
Treatment with progesterone in the premenopausal patient may mask the onset of the climacteric.
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