Generic Prometrium ( Progesterone )

Buy Generic Prometrium (Progesterone) without prescription in Canada

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Prometrium (micronized progesterone) is a bio‑identical hormone replacement, chemically identical to the progesterone produced by the ovaries. It is used to restore hormonal balance in women who have low or absent progesterone, particularly for the treatment of menopausal symptoms when combined with estrogen, to protect the uterine lining from overgrowth in postmenopausal women receiving hormone therapy, and to regulate the menstrual cycle in women with secondary amenorrhoea. Unlike synthetic progestins, micronized progesterone has a molecular structure identical to endogenous progesterone, which may offer a more favourable safety profile with respect to breast cancer risk and thromboembolic events.

Usual adult dose: For postmenopausal women with an intact uterus using estrogen therapy, the recommended dose is 200 mg taken orally once daily at bedtime for the last 12 to 14 days of each estrogen cycle. For secondary amenorrhoea, the usual dose is 400 mg once daily at bedtime for 10 days. The 100 mg capsule may be used for women who require a lower dose due to side effects, or in combination with a second 100 mg capsule to achieve the 200 mg dose. Prometrium should be taken at bedtime because it can cause drowsiness and dizziness. It must be taken with food to enhance absorption.

Dosage form: Oral capsules: 100 mg and 200 mg of micronized progesterone. The capsules are typically oval, opaque, and light yellow (100 mg) or pale orange (200 mg), containing the hormone suspended in peanut oil.

Onset of action: For menstrual regulation, withdrawal bleeding usually begins 3 to 7 days after the last dose of a 10‑day course. For endometrial protection, the effect is exerted during each monthly progestin phase. Symptomatic relief of menopausal symptoms (in combination with estrogen) is gradual over weeks to months.

Duration of action: The plasma half‑life of progesterone is approximately 5 to 10 minutes when given intravenously, but oral micronized progesterone is absorbed more slowly and has a longer apparent half‑life of about 16 to 18 hours, supporting once‑daily dosing at bedtime. Steady‑state levels are achieved after 3 to 5 days of daily administration.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Prometrium. Alcohol may worsen the drowsiness and dizziness caused by progesterone, and heavy drinking can increase the risk of liver stress. Alcohol intake should be minimised, particularly before taking the medication at bedtime.

Most common side effects: Drowsiness, dizziness, headache, breast tenderness, bloating, nausea, and mood changes. These effects are most pronounced when starting therapy and often diminish with continued use. Because Prometrium contains peanut oil, it is contraindicated in patients with peanut allergy. Rare but serious risks include venous thromboembolism (blood clots), particularly when used in combination with estrogen, and an increased risk of breast cancer with long‑term combined hormone therapy.

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General Information about Prometrium (Progesterone)

• INN (International Nonproprietary Name): Progesterone (micronized).
• Brand names available in Canada: Prometrium® (Merck Canada Inc.) is the original brand‑name product. Generic versions of micronized progesterone capsules are also available from various manufacturers, including APO‑Progesterone (Apotex Inc.), TEVA‑Progesterone (Teva Canada Limited), and others.
• ATC code: G03DA04 (progestogens, pregn‑4‑ene derivatives).
• Dosage forms and strengths: Oral capsules: 100 mg and 200 mg of micronized progesterone. The capsules contain peanut oil as a carrier and must not be used in patients with peanut allergy.
• Manufacturers in Canada: Merck Canada Inc. (Prometrium), Apotex Inc., Teva Canada Limited, and other generic pharmaceutical companies.
• Registration status in Canada: Approved by Health Canada. Marketed. DINs: 02214526 (Prometrium 100 mg), 02216607 (Prometrium 200 mg). First approved in Canada in the mid‑1990s.
• 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

Prometrium contains micronized progesterone, which is chemically identical to the natural progesterone produced by the corpus luteum in the ovary, the placenta, and the adrenal cortex. It acts by binding to progesterone receptors in target tissues, including the endometrium, breast, brain, and bone. In the estrogen‑primed endometrium, progesterone induces secretory transformation, which stabilises the lining and promotes orderly shedding during the withdrawal phase. This action prevents the endometrial hyperplasia and increased risk of endometrial cancer that would otherwise occur with unopposed estrogen therapy. Progesterone also has central nervous system effects: it acts on GABA_A receptors in the brain, producing mild sedative and anxiolytic effects, which can improve sleep quality but also cause daytime drowsiness. In the breast, progesterone promotes lobuloalveolar development and may influence cell proliferation; the role of progesterone in breast cancer risk is complex and differs from that of synthetic progestins. Because Prometrium is micronized—reduced to very small particle size—it is better absorbed from the gastrointestinal tract than non‑micronized progesterone. Oral administration results in peak plasma levels of progesterone within 2 to 4 hours. The drug is extensively metabolised in the liver, primarily to pregnanediols and their conjugates, which are excreted in the urine. The elimination half‑life of oral micronized progesterone is approximately 16 to 18 hours, allowing once‑daily dosing. Taking the capsule with food significantly increases bioavailability.

Indications

• Endometrial protection: For use in combination with estrogen therapy in postmenopausal women with an intact uterus to prevent estrogen‑induced endometrial hyperplasia and reduce the risk of endometrial carcinoma.
• Secondary amenorrhoea: For the induction of withdrawal bleeding in women with secondary amenorrhoea who have adequate endogenous estrogen (positive progestin challenge test).
• Off‑label uses: Prometrium is also used off‑label as part of menopausal hormone therapy to relieve vasomotor symptoms (hot flushes) when estrogen alone is insufficient or not tolerated, for luteal phase support in assisted reproductive technology (ART) cycles, for the prevention of preterm birth in high‑risk pregnancies, and for the management of premenstrual syndrome (PMS). The 100 mg and 200 mg doses are the standard strengths for these indications.
• Not indicated for use in children, premenopausal women without a documented progesterone deficiency, or in men.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Prometrium is not indicated for use during pregnancy, except under specialist supervision for specific indications such as luteal phase support in ART or prevention of preterm birth. There are no known risks of fetal harm when used at physiological doses in early pregnancy, but routine use is not recommended. If pregnancy occurs during therapy for other indications, the drug should be discontinued.
• Breastfeeding: Progesterone 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 Prometrium should be made in consultation with a physician.
• Paediatrics (< menarche): Safety and efficacy have not been established in children before menarche. Prometrium is not indicated for paediatric use.
• Elderly: In postmenopausal women using combined hormone therapy, the risks of venous thromboembolism, stroke, breast cancer, and probable dementia are increased. Hormone therapy should be used at the lowest effective doses for the shortest possible duration. Prometrium alone is not indicated in elderly women outside of combination with estrogen.
• Venous thromboembolism (VTE): Combined hormone therapy containing estrogen and progesterone 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. Micronized progesterone may be associated with a lower VTE risk than some synthetic progestins, but the overall combined HRT still elevates risk.
• Breast cancer: Long‑term use of combined hormone therapy has been associated with an increased risk of breast cancer. The risk increases with duration of use. Observational studies suggest that micronized progesterone may have a more favourable breast safety profile than synthetic progestins, but this is not definitively established. All women should undergo regular breast examinations and mammography.
• Stroke and cardiovascular disease: Combined hormone therapy increases the risk of ischaemic stroke. It should not be used for the prevention of cardiovascular disease. Women with pre‑existing cardiovascular disease should use hormone therapy with extreme caution.
• Liver disease: Prometrium 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.
• Peanut allergy: Prometrium capsules contain peanut oil. It is absolutely contraindicated in patients with known peanut allergy. Patients with soy or other legume allergies should also exercise caution and consult an allergist before use.
• Depression: Progesterone 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.
• Drowsiness and dizziness: Prometrium can cause significant drowsiness, dizziness, and sedation, particularly within 1 to 3 hours of dosing. It should be taken at bedtime. Patients should not drive or operate heavy machinery for at least 4 to 6 hours after taking a dose.
• Allergy: Do not take Prometrium if you have a known hypersensitivity to progesterone, peanut oil, or any excipient in the capsule.

Driving and alcohol

Prometrium can cause pronounced drowsiness, dizziness, and sedation. Patients must not drive, operate heavy machinery, or engage in hazardous activities for at least 4 to 6 hours after taking a dose. The medication is best taken at bedtime to minimise the impact of these side effects. Alcohol consumption should be avoided or strictly limited because it can intensify the sedative effects of progesterone, increasing the risk of profound drowsiness and impairment.

Dosage Instructions

• Endometrial protection with estrogen therapy: 200 mg taken orally once daily at bedtime for the last 12 to 14 days of each estrogen cycle. This regimen effectively transforms the proliferative endometrium into a secretory one and prevents endometrial hyperplasia. The 200 mg capsule may be taken as a single capsule or two 100 mg capsules.
• Secondary amenorrhoea: 400 mg taken orally once daily at bedtime for 10 days. Withdrawal bleeding usually begins 3 to 7 days after the last dose. The dose can be administered as four 100 mg capsules or two 200 mg capsules.
• Luteal phase support (off‑label, specialist use): 100 mg to 200 mg two to three times daily, or 200 mg to 400 mg once daily at bedtime, beginning after ovulation and continuing until placental autonomy, under the guidance of a fertility specialist.
• Administration: The capsule(s) should be swallowed whole with a glass of water. They must be taken with food to improve absorption; taking Prometrium on an empty stomach significantly reduces bioavailability. Because of the sedative effects, dosing should be at bedtime. Do not crush, chew, or open the capsules.
• Missed dose: If a dose is missed, take it as soon as remembered on the same day, with food. If it is close to the time of the next scheduled dose, skip the missed dose and resume the regular 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 or endometrial protection.
• Duration of therapy: For menstrual regulation, therapy is typically cyclic and limited to a few months. For endometrial protection with HRT, treatment may be long‑term, with periodic reassessment of risks and benefits (every 6‑12 months). The lowest effective dose for the shortest possible duration should be used.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Drowsiness, dizziness, and fatigue (occur within 1–3 hours of dosing and affect a substantial proportion of patients). Breakthrough bleeding or spotting, particularly during the first months of use.
• Common side effects (1–10%): Breast tenderness or enlargement, bloating, nausea, vomiting, headache, mood swings, depression, and abdominal cramps. Weight gain may occur. These effects are more common with higher doses (e.g., 400 mg for amenorrhoea) and often diminish with continued use or dose reduction.
• 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 therapy. Ischaemic stroke. Gallbladder disease. Cholestatic jaundice. Anaphylactic reactions in patients with peanut allergy (due to the peanut oil excipient).
• Contraindications: Known or suspected pregnancy (except for specific indications under specialist care); 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; known peanut allergy (due to peanut oil content); hypersensitivity to progesterone or any excipient. Not indicated for use in children.

Drug Interactions

• Enzyme‑inducing drugs (reduce progesterone efficacy): Rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, topiramate, griseofulvin, and St. John’s wort can increase the hepatic metabolism of progesterone and reduce its therapeutic effect, potentially leading to breakthrough bleeding and reduced endometrial protection. Alternative or additional contraceptive/protective measures may be required.
• CYP3A4 inhibitors (increase progesterone exposure): Ketoconazole, itraconazole, clarithromycin, ritonavir, and grapefruit juice may increase progesterone levels and side effects. Monitoring for excessive sedation is recommended.
• Bromocriptine: Progesterone may reduce the efficacy of bromocriptine in the treatment of hyperprolactinaemia. If concomitant use is necessary, prolactin levels should be monitored.
• Cyclosporine: Progesterone may inhibit the metabolism of cyclosporine, increasing its serum levels and toxicity. Cyclosporine levels should be monitored.
• Alcohol and other CNS depressants: Alcohol, benzodiazepines, opioids, and other sedating drugs will have additive sedative effects with Prometrium, increasing the risk of profound drowsiness and impaired coordination. Alcohol should be avoided around the time of dosing.
• Food: Prometrium must be taken with food to ensure adequate absorption. A high‑fat meal significantly increases bioavailability.

Practical Advice

• Administration: Take Prometrium exactly as prescribed, with food, at bedtime. Swallow the capsule(s) whole with a full glass of water. Do not take the medication during the day if you need to drive or remain alert, as it will cause significant drowsiness. If you are taking Prometrium cyclically (e.g., 12 days per month), mark your calendar to remember the start and stop dates.
• Monitoring: All women should have a complete medical history and physical examination, including a breast examination and blood pressure measurement, before starting therapy and at regular intervals during treatment. Mammography should be performed according to age‑appropriate screening guidelines. Any unexplained vaginal bleeding requires prompt investigation. Liver function tests should be monitored in patients with pre‑existing liver disease.
• 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. Avoid driving for at least 6 hours after taking your dose. Do not smoke, particularly if over 35, as it greatly increases cardiovascular risk when using combined hormone therapy. If you are scheduled for surgery or prolonged immobilisation, inform your doctor; you may need to stop Prometrium temporarily. Report any sudden severe headache, vision changes, leg pain or swelling, or chest pain immediately.
• Missed dose: If you miss a dose, take it with food as soon as you remember on the same day, but only if you are going to bed shortly afterward. If it is the next morning, skip the missed dose and resume your regular schedule that evening. Do not take a double 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. Seek emergency care for signs of anaphylaxis (hives, difficulty breathing, swelling of the face or throat), particularly if you have a peanut allergy.
• 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

• Synthetic progestins (e.g., medroxyprogesterone acetate — Provera®): A widely used synthetic progestin for endometrial protection and menstrual regulation. It is less sedating than micronized progesterone but is associated with a slightly higher risk of breast cancer and thromboembolic events when used in combined HRT. It is available in 2.5 mg, 5 mg, and 10 mg tablets.
• Norethindrone acetate (Aygestin®): Another synthetic progestin with similar indications. It has a different side‑effect profile and is also used in combined oral contraceptives.
• Levonorgestrel‑releasing intrauterine system (Mirena®, Kyleena®): Delivers progestin directly to the uterine lining, minimising systemic exposure and side effects. It is highly effective for endometrial protection during HRT and for heavy menstrual bleeding.
• Combined oral contraceptives: For menstrual regulation in premenopausal women, low‑dose combined pills provide predictable withdrawal bleeding and effective contraception.
• Non‑hormonal alternatives: For menopausal symptoms, non‑hormonal options include selective serotonin reuptake inhibitors (SSRIs), gabapentin, and lifestyle modifications. For endometrial protection, raloxifene (Evista®) is a SERM that protects bone without stimulating the endometrium but does not relieve vasomotor symptoms.

Clinical Efficacy

Micronized progesterone has been shown in randomised controlled trials to effectively protect the endometrium from estrogen‑induced hyperplasia when used cyclically for 12–14 days per month at doses of 200 mg/day. In the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial, micronized progesterone was associated with a more favourable lipoprotein profile than medroxyprogesterone acetate, and endometrial hyperplasia rates were comparable between the two progestin regimens. For secondary amenorrhoea, a 10‑day course of progesterone 400 mg daily induces withdrawal bleeding in over 90% of women with adequate endogenous estrogen. Observational studies suggest that micronized progesterone may be associated with a lower risk of breast cancer and venous thromboembolism than synthetic progestins when used in combined menopausal hormone therapy, although this evidence is not definitive and long‑term randomised data are limited. Micronized progesterone is included in the Canadian Menopause Society guidelines as an option for endometrial protection in postmenopausal women using estrogen therapy, particularly for those who experience side effects on synthetic progestins or who prefer a bio‑identical hormone.

Important:

Prometrium (micronized progesterone) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It can cause significant drowsiness and dizziness; do not drive or operate heavy machinery for at least 6 hours after taking a dose. This product contains peanut oil and is absolutely contraindicated in patients with peanut allergy. When used as part of combined hormone replacement therapy, 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, stroke, or liver problems, or signs of a severe allergic reaction. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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