Product Overview
† commercial product
Medroxyprogesterone Tablets represent a synthetic progestin formulation available in 5 mg and 10 mg dosage strengths, designed to address various reproductive health conditions through hormonal regulation.[1]
This pharmaceutical preparation contains medroxyprogesterone as its active ingredient, functioning as a synthetic analog of naturally occurring progesterone that may provide therapeutic benefits for women experiencing specific gynecological conditions.[2]
The formulation is commonly utilized in clinical practice for the management of secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance, and prevention of endometrial hyperplasia in postmenopausal women receiving estrogen therapy.[3]
Healthcare providers may prescribe these tablets as part of comprehensive treatment strategies for various conditions related to reproductive endocrinology, though individual patient responses may vary significantly.[4]
The medication works through its interaction with progesterone receptors in target tissues, potentially influencing menstrual cycle regulation and endometrial development.[5]
Medroxyprogesterone tablets should be administered according to specific indication-based dosing protocols under appropriate medical supervision.[48]
For secondary amenorrhea treatment, typical dosing may involve 5 to 10 mg daily for 5 to 10 consecutive days, with treatment potentially initiated at any time during the cycle.[49]
Abnormal uterine bleeding may be managed with 5 to 10 mg daily for 5 to 10 days, typically beginning on the 16th or 21st day of the menstrual cycle.[50]
Endometrial hyperplasia prevention in postmenopausal women receiving estrogen therapy might utilize 5 to 10 mg daily for 12 to 14 consecutive days per month.[51]
Tablets may be administered with or without food, and patients should maintain consistent timing of daily doses.[52]
Withdrawal bleeding typically occurs within 3 to 7 days after treatment completion.[53]
Dosing should be individualized based on patient response, medical history, and concurrent medications.[54]
Healthcare providers should monitor patients regularly and adjust treatment regimens as clinically indicated.[55]
Patients should be counseled on proper administration techniques and importance of adherence to prescribed dosing schedules.[56]
Medroxyprogesterone exerts its therapeutic effects primarily through binding to progesterone receptors located in the hypothalamus, female reproductive tract, and pituitary gland.[6]
Upon receptor binding, the compound may induce conformational changes that could lead to inhibition of gonadotropin-releasing hormone secretion, potentially affecting the hypothalamic-pituitary-gonadal axis.[7]
This mechanism might result in decreased frequency of gonadotropin-releasing hormone release, which could subsequently blunt the midcycle luteinizing hormone surge and potentially prevent follicular maturation and ovulation.[8]
The compound may transform proliferative endometrium to secretory endometrium, potentially making implantation more difficult and altering the endometrial environment.[9]
Additionally, medroxyprogesterone could increase cervical mucus viscosity, potentially impeding sperm migration into the uterine cavity.[10] In postmenopausal women, the medication might counteract estrogen-induced endometrial proliferation, potentially reducing the risk of endometrial hyperplasia.[11]
The compound is metabolized primarily through cytochrome P450 3A4-mediated pathways, with plasma protein binding approximately 88% to albumin.[12]
Medroxyprogesterone tablets are contraindicated in several clinical situations that may present significant safety risks to patients.[13]
Pregnancy represents an absolute contraindication, as the medication may potentially cause birth defects or other adverse fetal outcomes.[14]
Patients with known or suspected breast cancer, uterine cancer, or other hormone-dependent malignancies should not receive this medication due to potential tumor stimulation.[15]
Undiagnosed abnormal vaginal bleeding constitutes a contraindication until proper evaluation excludes malignancy.[16]
Active or history of arterial or venous thromboembolic disorders, including deep vein thrombosis, pulmonary embolism, stroke, or myocardial infarction, represents significant contraindications due to potential thrombotic risks.[17]
Severe hepatic impairment or active liver disease precludes use of this medication.[18]
Known hypersensitivity to medroxyprogesterone or any component of the formulation represents an absolute contraindication.[19]
Patients should undergo comprehensive medical evaluation before therapy initiation to identify potential contraindications and assess individual risk-benefit profiles.[20]
Medroxyprogesterone metabolism occurs primarily through cytochrome P450 3A4 enzymatic pathways, making it susceptible to clinically significant drug interactions with CYP3A4 inducers and inhibitors.[21]
Strong CYP3A4 inducers, including rifampin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort, may significantly decrease medroxyprogesterone plasma concentrations, potentially reducing therapeutic efficacy.[22]
Moderate CYP3A4 inducers such as bosentan, efavirenz, and modafinil may also decrease medication effectiveness.[23]
CYP3A4 inhibitors, including ketoconazole, itraconazole, clarithromycin, and grapefruit juice, might increase medroxyprogesterone concentrations, potentially enhancing adverse effects.[24]
HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors may cause significant bidirectional changes in progestin plasma levels, requiring careful monitoring.[25]
Anticonvulsants including topiramate, oxcarbazepine, and griseofulvin may reduce contraceptive efficacy when used for contraceptive purposes.[26]
Patients receiving concurrent medications should be monitored for potential interactions, and healthcare providers may need to consider alternative therapies or additional contraceptive measures when appropriate.[27]
Medroxyprogesterone tablets may cause various adverse effects that range from common to rare but serious complications.[28]
Menstrual irregularities represent the most frequently reported adverse effects, including breakthrough bleeding, spotting, amenorrhea, and changes in menstrual flow patterns.[29]
Weight gain occurs commonly, with studies reporting average increases of approximately 3.23 kg over extended treatment periods.[30]
Nervous system effects may include headache, dizziness, nervousness, depression, and mood changes.[31]
Breast-related symptoms such as tenderness, pain, or discharge may occur in some patients.[32]
Gastrointestinal side effects might include nausea, abdominal pain, and bloating.[33]
Serious but less common adverse effects may include thromboembolic events such as deep vein thrombosis, pulmonary embolism, stroke, or myocardial infarction.[34]
Allergic reactions ranging from skin rash to severe anaphylaxis have been reported rarely.[35]
Long-term use may potentially be associated with decreased bone mineral density and increased fracture risk.[36]
Visual disturbances, including changes in vision or contact lens tolerance, may occasionally occur.[37]
Patients should be counseled about potential adverse effects and advised to report any concerning symptoms promptly.[38]
Medroxyprogesterone tablets are contraindicated during pregnancy and carry significant reproductive safety considerations.[39]
The medication has been assigned pregnancy category X by regulatory authorities, indicating that studies have demonstrated fetal abnormalities and that risks clearly outweigh any potential benefits.[40]
Animal studies and human data suggest potential teratogenic effects, including possible masculinization of female fetuses.[41]
Women of reproductive potential should undergo pregnancy testing before treatment initiation and utilize reliable contraceptive methods during therapy.[42]
If pregnancy occurs during treatment, medication should be discontinued immediately and patients counseled about potential risks.[43]
Inadvertent exposure during early pregnancy may be associated with increased risk of certain birth defects, though epidemiological data remains limited.[44]
Healthcare providers should carefully assess pregnancy risk in all women of childbearing age before prescribing this medication.[45]
The medication may affect fertility and ovulation patterns, potentially delaying return of normal menstrual function after discontinuation.[46]
Patients planning pregnancy should discuss appropriate timing for medication discontinuation with their healthcare providers.[47]
Medroxyprogesterone tablets require proper storage conditions to maintain pharmaceutical integrity and therapeutic efficacy.[57]
The medication should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F), with brief excursions permitted to 15°C to 30°C (59°F to 86°F) during transportation.[58]
Tablets should be maintained in original containers away from excessive moisture, heat, and direct light exposure.[59]
Storage areas should remain dry and cool, avoiding locations such as bathrooms or areas near heating sources.[60]
The medication should be kept out of reach of children and pets to prevent accidental ingestion.[61]
Expired or unused medication should be disposed of properly through appropriate pharmaceutical disposal programs rather than household waste.[62]
Tablets should be inspected before administration for any signs of deterioration, discoloration, or physical damage.[63]
Healthcare facilities should maintain appropriate inventory management systems to ensure proper rotation and prevent dispensing of expired products.[64]
Temperature monitoring may be necessary in certain storage environments to ensure compliance with stability requirements.[65]
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- Westhoff C. Depot-medroxyprogesterone acetate injection (Depo-Provera): a highly effective contraceptive option with proven long-term safety. Contraception. 2003;68(2):75-87.
- Practice bulletin no. 136: management of abnormal uterine bleeding associated with ovulatory dysfunction. Obstet Gynecol. 2013;122(1):176-185.
- Tamauchi S, Kajiyama H, Utsumi F, et al. Efficacy of medroxyprogesterone acetate treatment and retreatment for atypical endometrial hyperplasia and endometrial cancer. J Obstet Gynaecol Res. 2018;44(1):151-156.
- Barra F, Scala C, Ferrero S. Current understanding on pharmacokinetics, clinical efficacy and safety of progestins for treating pain associated to endometriosis. Expert Opin Drug Metab Toxicol. 2018;14(4):399-415.
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- Munro MG, Mainor N, Basu R, et al. Oral medroxyprogesterone acetate and combination oral contraceptives for acute uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2006;108(4):924-929.
- The American College of Obstetricians and Gynecologists Committee Opinion no. 631. Endometrial intraepithelial neoplasia. Obstet Gynecol. 2015;125(5):1272-1278.
- De Rocco S, Buca D, Oronzii L, et al. Reproductive and pregnancy outcomes of fertility-sparing treatments for early-stage endometrial cancer or atypical hyperplasia: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2022;273:90-97.
- Stuenkel CA, Davis SR, Gompel A, et al. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011.
- Stockdale AD, Rostom AY. Clinical significance of differences in bioavailability of medroxyprogesterone acetate preparations. Clin Pharmacokinet. 1989;16(3):129-133.
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- Medroxyprogesterone Use During Pregnancy. Drugs.com. Available at: https://www.drugs.com/pregnancy/medroxyprogesterone.html
- Li CI, Beaber EF, Tang MT, et al. Effect of depo-medroxyprogesterone acetate on breast cancer risk among women 20 to 44 years of age. Cancer Res. 2012;72(8):2028-2035.
- Cobin RH, Goodman NF. American Association of Clinical Endocrinologists and American College of Endocrinology Position Statement on Menopause-2017 Update. Endocr Pract. 2017;23(7):869-880.
- The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-753.
- LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases; 2020.
- Lestishock L, Pariseau C, Rooholamini S, et al. Anaphylaxis from depot medroxyprogesterone acetate in an adolescent girl. Obstet Gynecol. 2011;118(2 Pt 2):443-445.
- Tepper NK, Krashin JW, Curtis KM, et al. Update to CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Revised Recommendations for the Use of Hormonal Contraception Among Women at High Risk for HIV Infection. MMWR Morb Mortal Wkly Rep. 2017;66(37):990-994.
- Mimura N, Kobayashi K, Nakamura Y, et al. Metabolism of medroxyprogesterone acetate (MPA) via CYP enzymes in vitro and effect of MPA on bleeding time in female rats in dependence on CYP activity in vivo. Life Sci. 2003;73(25):3201-3212.
- Wiesinger H, Klein S, Rottmann A, et al. The Effects of Weak and Strong CYP3A Induction by Rifampicin on the Pharmacokinetics of Five Progestins and Ethinylestradiol Compared to Midazolam. Clin Pharmacol Ther. 2020;108(4):798-807.
- DEPO-SUBQ PROVERA 104 Drug Interactions. Pfizer Medical Information. Available at: https://www.pfizermedicalinformation.com/depo-subq-provera-104/drug-interactions
- PREMPRO AND PREMPHASE Drug Interactions. Pfizer Medical Information. Available at: https://www.pfizermedicalinformation.com/prempro-and-premphase/drug-interactions
- Tseng A, Hills-Nieminen C. Drug interactions between antiretrovirals and hormonal contraceptives. Expert Opin Drug Metab Toxicol. 2013;9(5):559-572.
- Doose DR, Wang SS, Padmanabhan M, et al. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia. 2003;44(4):540-549.
- Haas DW, Mngqibisa R, Francis J, et al. Pharmacogenetics of interaction between depot medroxyprogesterone acetate and efavirenz, rifampicin, and isoniazid during treatment of HIV and tuberculosis. Pharmacogenet Genomics. 2022;32(1):24-30.
- Bigrigg A, Evans M, Gbolade B, et al. Depo Provera. Position paper on clinical use, effectiveness and side effects. Br J Fam Plann. 1999;25(2):69-76.
- Mesics S. Depo-Provera. AWHONN Lifelines. 2002;6(2):93.
- ACOG Committee on Practice Bulletins-Gynecology. ACOG practice bulletin. No. 73: Use of hormonal contraception in women with coexisting medical conditions. Obstet Gynecol. 2006;107(6):1453-1472.
- Patel K, Cervantes JA, Keeling B, et al. A Fixed Drug Eruption to Medroxyprogesterone Acetate Injectable Suspension. Cutis. 2022;109(3):E12-E14.
- Medroxyprogesterone (Provera, Depo-Provera, and others). WebMD. Available at: https://www.webmd.com/drugs/2/drug-8674/medroxyprogesterone-oral/details
- Side effects of medroxyprogesterone tablets. NHS. Available at: https://www.nhs.uk/medicines/medroxyprogesterone-tablets/side-effects-of-medroxyprogesterone-tablets/
- Medroxyprogesterone. Memorial Sloan Kettering Cancer Center. Available at: https://www.mskcc.org/cancer-care/patient-education/medications/adult/medroxyprogesterone
- Medroxyprogesterone: Side Effects, Uses, Dosage, Interactions, Warnings. RxList. Available at: https://www.rxlist.com/medroxyprogesterone/generic-drug.htm
- Bahamondes L, Perrotti M, Castro S, et al. Forearm bone density in users of Depo-Provera as a contraceptive method. Fertil Steril. 1999;71(5):849-852.
- Medroxyprogesterone Tablets. Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/drugs/18932-medroxyprogesterone-tablets
- Medroxyprogesterone (oral route) – Side effects & dosage. Mayo Clinic. Available at: https://www.mayoclinic.org/drugs-supplements/medroxyprogesterone-oral-route/description/drg-20146771
- Depot Medroxyprogesterone Acetate (Depo Provera). MotherToBaby. Available at: https://mothertobaby.org/fact-sheets/depot-medroxyprogesterone/
- Understanding the new FDA pregnancy and lactation labeling rules. PMC. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC5412100/
- Conjugated estrogens / medroxyprogesterone Use During Pregnancy. Drugs.com. Available at: https://www.drugs.com/pregnancy/conjugated-estrogens-medroxyprogesterone.html
- Questions and Answers on the Pregnancy and Lactation Labeling Rule. FDA. Available at: https://www.fda.gov/drugs/labeling-information-drug-products/questions-and-answers-pregnancy-and-lactation-labeling-rule
- Estradiol / medroxyprogesterone (Lunelle) Use During Pregnancy. Drugs.com. Available at: https://www.drugs.com/pregnancy/estradiol-medroxyprogesterone.html
- Medroxyprogesterone Acetate – Drugs and Lactation Database (LactMed). NCBI Bookshelf. Available at: https://www.ncbi.nlm.nih.gov/books/NBK501287/
- Pregnancy and Lactation Labeling Resources. FDA. Available at: https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-resources
- A Semimechanistic Pharmacokinetic Model for Depot Medroxyprogesterone Acetate and Drug-Drug Interactions. PubMed. Available at: https://pubmed.ncbi.nlm.nih.gov/34151439/
- Pharmacokinetics of depot medroxyprogesterone acetate contraception. PubMed. Available at: https://pubmed.ncbi.nlm.nih.gov/8725700/
- Medroxyprogesterone Injection: Package Insert. Drugs.com. Available at: https://www.drugs.com/pro/medroxyprogesterone-injection.html
- DEPO-PROVERA CI Dosage and Administration. Pfizer Medical Information. Available at: https://www.pfizermedicalinformation.com/depo-provera
- PROVERA Storage and Handling. Pfizer Medical Information. Available at: https://www.pfizermedicalinformation.com/provera/storage-handling
- PREMPRO AND PREMPHASE Storage and Handling. Pfizer Medical Information. Available at: https://www.pfizermedicalinformation.com/en-us/prempro-and-premphase/storage-handling
- Medroxyprogesterone (oral route). Mayo Clinic. Available at: https://www.mayoclinic.org/drugs-supplements/medroxyprogesterone-oral-route/description/drg-20146771
- Medroxyprogesterone: MedlinePlus Drug Information. Available at: https://medlineplus.gov/druginfo/meds/a682470.html
- Halpern V, Combes SL, Dorflinger LJ, et al. Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm. Contraception. 2014;89(1):31-35.
- Berlin FS. The paraphilias and Depo-Provera: some medical, ethical and legal considerations. Bull Am Acad Psychiatry Law. 1989;17(3):233-239.
- De Ceulaer K, Gruber C, Hayes R, et al. Medroxyprogesterone acetate and homozygous sickle-cell disease. Lancet. 1982;2(8292):229-231.
- DEPO-PROVERA CI Storage and Handling. Pfizer Medical Information. Available at: https://www.pfizermedicalinformation.com/en-us/depo-provera/storage-handling
- DEPO-SUBQ PROVERA 104 Storage and Handling. Pfizer Medical Information. Available at: https://www.pfizermedical.com/depo-subq-provera-104/storage-handling
- Medroxyprogesterone Tablets Storage Information. Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/drugs/18932-medroxyprogesterone-tablets
- Medroxyprogesterone storage guidelines. WebMD. Available at: https://www.webmd.com/drugs/2/drug-8674/medroxyprogesterone-oral/details
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- Temperature monitoring requirements. USP controlled room temperature specifications.
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- Venitz J, Zack J, Gillies H, et al. Clinical pharmacokinetics and drug-drug interactions of endothelin receptor antagonists in pulmonary arterial hypertension. J Clin Pharmacol. 2012;52(12):1784-1805.
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What is the typical duration of treatment with medroxyprogesterone tablets?
Treatment duration varies significantly based on indication, with some conditions requiring only 5-10 days of therapy while others may need cyclical monthly administration.[66]
When should I expect menstrual bleeding after completing treatment?
Withdrawal bleeding typically occurs within 3 to 7 days after discontinuing medroxyprogesterone therapy, though individual timing may vary.[67]
Can medroxyprogesterone tablets be used for contraception?
While medroxyprogesterone affects ovulation, oral tablets are not primarily indicated for contraceptive purposes, and patients should consult healthcare providers about appropriate contraceptive options.[68]
What should I do if I miss a dose?
Missed doses should be taken as soon as remembered, but patients should not double doses and should consult healthcare providers for specific guidance.[69]
Are there any dietary restrictions while taking this medication?
No specific dietary restrictions apply, though patients should avoid excessive alcohol consumption and maintain consistent timing with meals.[70]
How long does it take to see therapeutic effects?
Response timing varies by indication, with some effects potentially observable within days while others may require completing full treatment cycles.[71]
Can I take other medications simultaneously?
Many medications may be used concurrently, but patients should inform healthcare providers about all medications, including over-the-counter products and supplements.[72]
What monitoring is required during treatment?
Regular medical follow-up may include physical examinations, blood pressure monitoring, and assessment for adverse effects depending on individual risk factors.[73]
Is weight gain inevitable with this medication?
While weight gain represents a common side effect, individual responses vary and lifestyle modifications may help minimize this effect.[74]
When should I contact my healthcare provider?
Patients should seek immediate medical attention for signs of blood clots, severe headaches, vision changes, or any concerning symptoms.[75]
Disclaimer:
This product information is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider before starting, stopping, or modifying any medication regimen. The information presented herein does not constitute medical advice and should not be used as a substitute for consultation with a licensed healthcare professional. Individual patient responses to medications may vary significantly, and treatment decisions should always be made in consultation with appropriate medical supervision. This document does not imply endorsement, recommendation, or guarantee of safety or efficacy for any particular use. Healthcare providers should refer to current prescribing information and clinical guidelines when making treatment decisions.
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