Medication Summary
Provera Provera
Generic: Medroxyprogesterone
Drug class: Progestin
Dosage form: Tablet
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
What should I know before taking it?
PROVERA is contraindicated in women with any of the following conditions: 1.Undiagnosed abnormal genital bleeding. 2.Known, suspected, or history of breast cancer. 3.Known or suspected estrogen- or progesterone-dependent neoplasia. 4.Active DVT, PE, or a history of these conditions 5.Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. 6.Known anaphylactic reaction or angioedema to PROVERA. 7.Known liver impairment or disease. 8.Known or suspected pregnancy.
What important warnings are listed?
See BOXED WARNINGS. What is the most important information I should know about PROVERA (a progestin hormone)? • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). • Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older. •You and your healthcare provider should talk regularly about whether you still need treatment with PROVERA.
How is this medication usually taken?
Physicians are advised to discuss the Patient Information leaflet with women for whom they prescribe PROVERA. There may be an increased risk of minor birth defects in children whose mothers are exposed to progestins during the first trimester of pregnancy. The possible risk to the male baby is hypospadias, a condition in which the opening of the penis is on the underside rather than the tip of the penis. This condition occurs naturally in approximately 5 to 8 per 1000 male births. The risk may be increased with exposure to PROVERA. Enlargement of the clitoris and fusion of the labia may occur in female babies. However, a clear association between hypospadias, clitoral enlargement and labial.
What side effects are listed?
See BOXED WARNINGS , WARNINGS , and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions have been reported in women taking PROVERA tablets, without concomitant estrogens treatment:
What interactions are listed?
Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted. Inducers and/or inhibitors of CYP3A4 may affect the metabolism of MPA.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a586be28-96af-4fed-a13f-9b94fd4c7405
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.