Generic Provera ( Medroxyprogesterone Acetate )

Provera
Provera improves condition of women whose menstrual periods have stopped or in case of an abnormal bleeding of uterus due to hormone imbalance.
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Buy Generic Provera (Medroxyprogesterone Acetate) without prescription in Canada

In our Canadian pharmacy, you can buy Provera (Medroxyprogesterone Acetate) without a prescription, with delivery across Canada within 5‑14 days. Discreet and anonymous packaging.

Provera (medroxyprogesterone acetate) is a synthetic progestin, a man‑made version of the natural female hormone progesterone. It is used to treat a variety of menstrual disorders, including irregular or missed periods (secondary amenorrhoea), abnormal uterine bleeding caused by hormonal imbalance, and, in combination with estrogen, to protect the uterine lining from overgrowth in postmenopausal women receiving hormone replacement therapy. It works by acting on the lining of the uterus, inducing a stable secretory endometrium and promoting a predictable withdrawal bleed when the medication is stopped.

Usual adult dose: For secondary amenorrhoea, the recommended dose is 5 mg to 10 mg taken orally once daily for 5 to 10 days. For abnormal uterine bleeding due to hormonal imbalance, the usual dose is 5 mg to 10 mg daily for 5 to 10 days, beginning on the 16th day of the cycle and continuing to the 25th day. When combined with estrogen therapy for endometrial protection in postmenopausal women with a uterus, the recommended dose is 5 mg or 10 mg daily for the last 12 to 14 days of each estrogen cycle. The specific strength and duration are individualised based on the condition being treated and the patient’s response. The 5 mg tablet may be used when lower progestin exposure is desired; the 10 mg tablet provides stronger endometrial support.

Dosage form: Oral tablets: 5 mg and 10 mg of medroxyprogesterone acetate. The 5 mg tablet is typically white, round, and scored; the 10 mg tablet is white, round, and scored.

Onset of action: When used for menstrual regulation, withdrawal bleeding usually begins 3 to 7 days after the last dose of a 5‑ to 10‑day course. When used for endometrial protection, the effect is exerted during each month’s progestin phase.

Duration of action: The plasma half‑life of medroxyprogesterone acetate is approximately 30 hours. The biological effect on the endometrium is transient; withdrawal bleeding occurs after discontinuation. For continuous protection, the progestin must be taken in each cycle as prescribed.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Provera. Heavy alcohol intake can increase the risk of liver stress and may worsen side effects such as dizziness and mood changes. Moderate consumption is generally considered acceptable.

Most common side effects: Breast tenderness, breakthrough uterine bleeding or spotting (especially in the first few months), weight changes, mood disturbances (depression, irritability), headache, nausea, bloating, and fatigue. More serious but rare risks include blood clots (venous thromboembolism), particularly when used in combination with estrogen, and an increased risk of breast cancer with long‑term combined hormone therapy. The 10 mg dose may be associated with more pronounced progestin‑related side effects than the 5 mg dose.

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General Information about Provera (Medroxyprogesterone Acetate)

  • INN (International Nonproprietary Name): Medroxyprogesterone Acetate
  • Brand names available in Canada: Provera® (Pfizer Canada Inc.) is the original brand‑name product. Generic versions are widely available and include APO‑Medroxyprogesterone (Apotex Inc.), TEVA‑Medroxyprogesterone (Teva Canada Limited), Sandoz Medroxyprogesterone (Sandoz Canada Inc.), PMS‑Medroxyprogesterone (Pharmascience Inc.), and many others. Medroxyprogesterone acetate is also the active ingredient in the contraceptive injection Depo‑Provera® (150 mg/mL for intramuscular use).
  • ATC code: G03DA02 (progestogens, pregn‑4‑ene derivatives).
  • Dosage forms and strengths: Oral tablets: 2.5 mg, 5 mg, and 10 mg of medroxyprogesterone acetate. The 5 mg and 10 mg tablets are the most commonly prescribed strengths for menstrual disorders and endometrial protection.
  • Manufacturers in Canada: Pfizer Canada Inc. (Provera), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., and other generic pharmaceutical companies.
  • Registration status in Canada: Approved by Health Canada. Marketed. DINs: 00030741 (Provera 5 mg), 00030768 (Provera 10 mg), and numerous generic DINs. First approved in Canada in the 1960s.
  • OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act. A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

Medroxyprogesterone acetate (MPA) is a synthetic progestin that acts on the endometrium by binding to progesterone receptors in the nuclei of endometrial cells. In an estrogen‑primed endometrium, it transforms the proliferative lining into a secretory one, which is then shed in an orderly fashion upon withdrawal. This provides predictable menstrual bleeding and prevents the endometrial hyperplasia and increased risk of endometrial cancer that can result from unopposed estrogen stimulation. MPA also suppresses the hypothalamic‑pituitary‑ovarian axis at sufficient doses, inhibiting the mid‑cycle luteinizing hormone (LH) surge and preventing ovulation. It has weak androgenic and glucocorticoid activity and does not have significant estrogenic effects. After oral administration, MPA is well absorbed, with peak plasma concentrations reached within 2–4 hours. The drug is highly protein‑bound (90–95%) and is metabolised extensively in the liver, primarily via hydroxylation, with subsequent conjugation and excretion in the urine. The elimination half‑life is approximately 30 hours, supporting once‑daily dosing.

Indications

  • Secondary amenorrhoea: For the induction of withdrawal bleeding in women with secondary amenorrhoea who have adequate endogenous estrogen (positive progestin challenge test).
  • Abnormal uterine bleeding: For the treatment of dysfunctional (anovulatory) uterine bleeding due to hormonal imbalance, in the absence of organic pathology such as fibroids or uterine cancer.
  • Endometrial protection: As part of combined hormone replacement therapy (HRT) in postmenopausal women with an intact uterus, to reduce the risk of estrogen‑induced endometrial hyperplasia and carcinoma.
  • Off‑label uses: Provera is sometimes used off‑label for the treatment of endometriosis, premenstrual syndrome (PMS), and as part of protocols for fertility treatment. The 5 mg and 10 mg tablets are the standard strengths for these gynaecological indications. Provera is not indicated for contraception; the injectable form (Depo‑Provera) is used for that purpose.

Important Warnings and Precautions

At‑risk groups

  • Pregnancy: Provera is contraindicated during pregnancy. Progestins may cause fetal harm, including genital abnormalities, when administered to pregnant women. A pregnancy test should be performed before initiating therapy for menstrual disorders. If pregnancy occurs, the medication must be discontinued immediately.
  • Breastfeeding: Medroxyprogesterone acetate is excreted in human breast milk in small amounts. No adverse effects on the nursing infant have been consistently demonstrated, but caution should be exercised. The decision to breastfeed while taking Provera should be made in consultation with a physician.
  • Paediatrics (< menarche): Safety and efficacy have not been established in children before menarche. Provera is not indicated for paediatric use outside of specialist gynaecological care.
  • Elderly: In postmenopausal women using combined HRT, the risks of venous thromboembolism, stroke, breast cancer, and probable dementia are increased. HRT should be used at the lowest effective doses for the shortest possible duration. Provera alone is not indicated in elderly women except as part of cyclical HRT.
  • Venous thromboembolism (VTE): Combined HRT containing estrogen and a progestin increases the risk of deep vein thrombosis and pulmonary embolism. The risk is highest in the first year of use and in women with a personal or family history of VTE, thrombophilia, obesity, or prolonged immobilisation. Provera alone (without estrogen) is not significantly associated with VTE risk.
  • Cardiovascular disease: Combined HRT increases the risk of stroke and coronary heart disease in older postmenopausal women. It should not be used for the prevention of cardiovascular disease.
  • Breast cancer: Long‑term use of combined HRT has been associated with an increased risk of breast cancer. The risk increases with duration of use and decreases after discontinuation. All women should undergo regular breast examinations and mammography.
  • Liver disease: Provera is contraindicated in patients with active liver disease, severe hepatic impairment, or a history of cholestatic jaundice. Use with caution in mild to moderate hepatic impairment; liver function tests should be monitored.
  • Depression: Progestins can cause or exacerbate depression. Women with a history of depression should be monitored closely, and the medication should be discontinued if severe depression recurs.
  • Fluid retention: Progesterone analogues can cause fluid retention. Use with caution in patients with conditions that could be aggravated by fluid retention, such as cardiac or renal insufficiency.
  • Allergy: Do not take Provera if you have a known hypersensitivity to medroxyprogesterone acetate or any excipient in the tablet.

Driving and alcohol

Provera is not known to impair the ability to drive or operate machinery. However, some patients may experience dizziness, fatigue, or mood changes. Alcohol consumption should be limited, as heavy drinking can worsen mood disturbances and increase the risk of liver stress. Moderate alcohol intake is generally acceptable.

Dosage Instructions

  • Secondary amenorrhoea: 5 mg to 10 mg taken orally once daily for 5 to 10 days. Withdrawal bleeding usually occurs 3 to 7 days after the last dose. A positive response (bleeding) confirms adequate endogenous estrogen production. The treatment course may be repeated monthly as needed.
  • Abnormal uterine bleeding: 5 mg to 10 mg once daily for 5 to 10 days, typically starting on the assumed or calculated 16th day of the menstrual cycle and continuing through to the 25th day. Withdrawal bleeding occurs within 3 to 7 days after stopping the drug. Treatment may be repeated for several cycles until bleeding is regulated.
  • Endometrial protection with estrogen therapy: In postmenopausal women with an intact uterus, a progestin must be added to estrogen therapy. The recommended regimen is 5 mg or 10 mg of Provera once daily for the last 12 to 14 days of each estrogen cycle. A cyclic regimen (e.g., estrogen days 1–25, with Provera added days 12–25) or a continuous combined regimen may be used. The lowest effective dose should be used.
  • Administration: Swallow the tablet whole with a glass of water. It may be taken with or without food. To minimise stomach upset, taking it with a meal or at bedtime may be helpful. The tablets are scored and may be split if a half‑dose is prescribed (e.g., 2.5 mg).
  • Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next scheduled dose, skip the missed dose and resume the regular daily schedule. Do not double the dose. If you miss more than one day, contact your doctor for guidance, as this may alter the expected bleeding pattern.
  • Duration of therapy: For menstrual disorders, therapy is typically cyclical and limited to a few months until the cycle is regulated. For endometrial protection with HRT, treatment may be long‑term, with periodic reassessment of risks and benefits.

Side Effects and Contraindications

  • Very common side effects (≥ 10%): Breakthrough bleeding or spotting (especially in the first months), breast tenderness, and changes in menstrual flow.
  • Common side effects (1–10%): Weight gain or loss, bloating, nausea, headache, dizziness, depression, mood swings, fatigue, acne, and alopecia (hair loss).
  • Less common but serious side effects: Venous thromboembolism (deep vein thrombosis, pulmonary embolism), particularly when combined with estrogen therapy. Increased risk of breast cancer with long‑term combined HRT. Ischaemic stroke. Gallbladder disease. Cholestatic jaundice. Anaphylactic and anaphylactoid reactions have been reported rarely.
  • Contraindications: Known or suspected pregnancy; active or past history of venous thromboembolism; active or recent arterial thromboembolic disease (e.g., myocardial infarction, stroke); known, suspected, or history of breast cancer; severe liver disease or cholestatic jaundice; undiagnosed abnormal vaginal bleeding; and hypersensitivity to medroxyprogesterone acetate or any excipient. Not indicated for contraception (oral form).

Drug Interactions

  • Enzyme‑inducing drugs (reduce progestin efficacy): Rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, topiramate, griseofulvin, and St. John’s wort can increase the hepatic metabolism of progestins and reduce their therapeutic effect, potentially leading to breakthrough bleeding and reduced endometrial protection. Alternative or additional contraceptive/protective measures may be required.
  • Protease inhibitors and NNRTIs: Some HIV medications (e.g., ritonavir, nelfinavir, nevirapine, efavirenz) can alter progestin metabolism; the clinical significance is uncertain but caution is advised.
  • Cyclosporine: Progestins may inhibit the metabolism of cyclosporine, increasing its serum levels and toxicity. Cyclosporine levels should be monitored.
  • Laboratory tests: Medroxyprogesterone may affect the results of certain endocrine and liver function tests. Inform the laboratory that you are taking this medication.
  • Food and alcohol: No significant food interactions. Alcohol should be limited to moderate amounts to avoid additive liver effects.

Practical Advice

  • Administration: Take the tablet at approximately the same time each day during your prescribed treatment days. If you are using cyclic therapy, mark your calendar to remember start and stop dates. Swallow the tablet whole; the scored tablet can be broken if a lower dose is prescribed. Taking it with food may reduce nausea.
  • Monitoring: Before starting therapy, a complete medical history and physical examination, including blood pressure and breast examination, should be performed. Any unexplained vaginal bleeding must be investigated before starting Provera. During long‑term use, periodic re‑evaluation (every 6‑12 months) is recommended. Women on combined HRT should have regular mammography and be alert for signs of thromboembolic events.
  • Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed. Keep out of the reach and sight of children.
  • Lifestyle: Maintain a healthy diet and regular exercise to help manage weight gain and fluid retention. Report any sudden severe headache, vision changes, leg pain or swelling, or chest pain immediately. Do not smoke, particularly if over 35, as it greatly increases cardiovascular risk. If you are scheduled for surgery or prolonged immobilisation, inform your doctor; you may need to stop Provera temporarily.
  • Missed dose: If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose and continue as scheduled. Do not double the dose.
  • When to seek medical review: Contact your doctor immediately if you experience: signs of a blood clot (leg pain/swelling, sudden chest pain, coughing up blood, shortness of breath); signs of a stroke (sudden severe headache, confusion, weakness on one side of the body, vision changes); signs of liver problems (jaundice, dark urine, right upper abdominal pain); a new breast lump; or severe depression.
  • Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

  • Micronised progesterone (Prometrium®): A bio‑identical progesterone derived from plant sources, available as an oral capsule. It has a better safety profile regarding breast cancer and thromboembolic risk compared with synthetic progestins, but may cause more sedation and dizziness. It is used for menstrual regulation and as part of HRT for endometrial protection.
  • Norethindrone acetate (Aygestin®): Another synthetic progestin used for similar indications: amenorrhoea, abnormal uterine bleeding, endometriosis, and endometrial protection. Norethindrone is also a component of many combined oral contraceptives.
  • Levonorgestrel‑releasing intrauterine system (Mirena®, Kyleena®): Provides long‑acting local progestin delivery directly to the endometrium, used for heavy menstrual bleeding and endometrial protection during HRT. It largely avoids systemic progestin side effects.
  • Combined oral contraceptives: For menstrual regulation in premenopausal women, combined estrogen‑progestin contraceptives are often used to establish regular withdrawal bleeding.
  • Non‑hormonal alternatives: For heavy menstrual bleeding, non‑steroidal anti‑inflammatory drugs (e.g., ibuprofen, naproxen) and tranexamic acid (Cyklokapron®) can be used. For endometrial protection in postmenopausal women, raloxifene (Evista®) is a SERM that protects bone and reduces breast cancer risk without stimulating the endometrium, but it is not indicated for women with a uterus and significant vasomotor symptoms.

Clinical Efficacy

Medroxyprogesterone acetate has been used clinically for decades for the management of various menstrual disorders and for endometrial protection. In secondary amenorrhoea, a 5‑ to 10‑day course of MPA 5 mg or 10 mg induces withdrawal bleeding in over 90% of women with adequate endogenous estrogen, confirming a functional hypothalamic‑pituitary‑ovarian axis. For abnormal uterine bleeding, cyclic progestin therapy reduces bleeding episodes and restores menstrual regularity in the majority of patients without organic uterine pathology. In combined HRT, the addition of MPA 5 mg or 10 mg for 12–14 days per cycle reduces the risk of estrogen‑induced endometrial hyperplasia from approximately 30% to less than 1%, comparable to the effect of natural progesterone. The Postmenopausal Estrogen/Progestin Interventions (PEPI) trial and the Women’s Health Initiative (WHI) confirmed the endometrial safety of combined estrogen‑progestin therapy, and also identified the increased risks of breast cancer and thromboembolic events with long‑term combined HRT. The 5 mg dose is generally sufficient for endometrial protection; the 10 mg dose may be used when breakthrough bleeding occurs on the lower dose. Medroxyprogesterone is included on the World Health Organization Model List of Essential Medicines for its role in reproductive health.

Important:

Provera (medroxyprogesterone acetate) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It is not to be used during pregnancy or as a primary contraceptive (in oral form). When used as part of hormone replacement therapy in postmenopausal women, it is associated with an increased risk of breast cancer, stroke, and venous thromboembolism (blood clots). The lowest effective dose should be used for the shortest possible duration. Seek immediate medical attention if you develop symptoms of a blood clot (leg pain/swelling, sudden chest pain, difficulty breathing), stroke (sudden severe headache, confusion, weakness), or liver problems (jaundice, dark urine, abdominal pain). Report any unexplained vaginal bleeding, new breast lumps, or severe depression promptly. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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