Prometrium

Critical Warnings And Restrictions In Canada

Basic Prometrium Information

• INN (International Nonproprietary Name): Progesterone.
• Brand Names Available In Canada (English): Prometrium — capsules 100 mg and 200 mg (blister packs).
• ATC Code: G03DA04.
• Forms & Dosages: Soft capsules 100 mg and 200 mg in blister packs of 30/90; vaginal capsules/softgels 100 mg and 200 mg noted in international listings.
• Manufacturers In Canada (English): AbbVie (manufacturer of Prometrium).
• Registration Status In Canada (English): Prometrium listed for US/Canada markets in international product data; prescription-only status is specified.
• OTC / Rx Classification: Prescription only (Rx).
• Standard Dosages Per Indication: Secondary amenorrhea — 400 mg orally once daily at bedtime for 10 days; endometrial protection with estrogen — 200 mg orally once daily at bedtime for 12 days of a 28-day cycle.
• Dosage Adjustments: Not indicated in children; elderly — monitor for increased sensitivity; contraindicated in severe hepatic dysfunction; use with caution in renal impairment.
• Typical Treatment Duration And Regimens: Secondary amenorrhea — 10-day course repeated as prescribed; HRT — 12 days per 28-day cycle with estrogen.
• Missed Dose: Take as soon as remembered unless close to next dose; do not double up.
• Overdose: May cause nausea, vomiting, withdrawal bleeding and sedation; seek medical advice and supportive care.
• Storage/Transport Guidelines: Store below 25°C (77°F); protect from moisture and light; do not refrigerate or freeze; keep in original packaging.
• Absolute Contraindications: Severe liver dysfunction; known or suspected breast or other hormone-dependent cancer; undiagnosed abnormal vaginal bleeding; current or history of thrombosis (DVT, PE, stroke, MI); allergy to peanuts (capsules may contain peanut oil); pregnancy for certain indications.

Prometrium (micronized progesterone capsules 100 mg and 200 mg marketed by AbbVie) is prescription-only across Canada and must be used in line with Health Canada and product monograph guidance.

Absolute contraindications include severe hepatic dysfunction, known or suspected breast or hormone-dependent cancer, unexplained vaginal bleeding, active or history of thromboembolic events, and peanut allergy because the capsules may contain peanut oil.

Baseline checks should include liver function where indicated, clotting and thrombosis risk assessment, and recent breast/cancer screening history before prescribing.

• Contraindications Checklist: severe liver disease; breast or hormone-dependent cancer; undiagnosed vaginal bleeding; active or past thromboembolic disease; peanut allergy; pregnancy for some indications.
• Prescriber Safety Steps: verify contraindications, check baseline liver tests if history of liver disease, assess thrombosis risk and smoking status, confirm breast cancer screening history, document allergy to peanuts, perform pregnancy test if clinically indicated.

High-Risk Groups (Elderly, Pregnant, Indigenous Health Considerations)

Elderly patients may show increased sensitivity to sedative effects and a higher fall risk when taking progesterone capsules.

Pregnant people: some indications list pregnancy as a contraindication; confirm indication-specific guidance before use.

Indigenous patients may face access barriers and higher prevalence of comorbidities; culturally safe counselling and coordination with Indigenous health services and primary care is recommended.

Coordinate care with provincial programs and local primary care to ensure culturally appropriate follow-up and monitoring.

Interaction With Activities (Driving, Machinery, Workplace Safety Under Canadian Law)

Drowsiness and dizziness are reported with micronized progesterone and can affect driving or operating machinery.

Advise patients to avoid driving or hazardous tasks until they know how the medication affects them and to follow employer and occupational health rules.

Document workplace safety advice in the pharmacy record when applicable.

Q&A — “Can I Drive After Taking It In Canada?”

Short answer: Avoid driving or operating heavy machinery until you know how Prometrium affects you; drowsiness and dizziness are reported.

Follow employer or occupational health guidance and provincial road-safety rules if your job involves driving or heavy machinery.

Usage Basics For Canadians

• INN (International Nonproprietary Name): Progesterone.
• Brand Names Available In Canada (English): Prometrium — softgel capsules 100 mg and 200 mg in blister packs.
• ATC Code: G03DA04.
• Forms & Dosages: oral soft capsules 100 mg and 200 mg; vaginal use of oral capsules is referenced in other jurisdictions but is off-label in Canada.

Prometrium is prescription-only under Health Canada; patients should consult their prescriber or pharmacist for the correct Drug Identification Number (DIN) and provincial coverage details.

Some provinces require bilingual labelling and clear allergen labelling; check packaging for peanut oil warnings.

• Patient Instructions: take at bedtime to use sedative effects; if a dose is missed, take when remembered unless it is close to the next dose; do not double dose.
• Pharmacy Role: verify indication and allergies, check for interactions, advise proper storage (store below 25°C, protect from moisture and light), and counsel on dosing and missed-dose rules.

Reference: consult the Health Canada monograph and provincial formularies to verify the DIN and official labelling information before dispensing.

Canadian Dosing Guide

Typical Health Canada–aligned regimens reflected in international product information are used by prescribers in Canada.

For secondary amenorrhea the standard regimen is 400 mg orally at bedtime once daily for 10 days, repeated as prescribed.

For endometrial protection with estrogen in HRT, a common regimen is 200 mg orally at bedtime for 12 days of a 28-day cycle.

Adjustments: avoid in severe hepatic dysfunction and use with caution in renal impairment.

Comorbidity notes: monitor glucose and weight in diabetes, review thrombosis history for cardiovascular risk, and screen for mood changes in psychiatric history.

• Monitoring Checklist: liver function if history of hepatic disease, blood pressure, mood screening at initiation and follow-up, review of bleeding pattern at 1–3 months.

Q&A — “What If I Miss A Dose Under My Provincial Drug Plan?”

Short answer: Clinical missed-dose advice is the same regardless of plan: take the missed dose when remembered unless it is close to the next scheduled dose; do not double up.

If coverage limits or delays risk running out, contact your pharmacist and the provincial drug plan (e.g., ODB, PharmaCare, RAMQ) before the medication is exhausted to arrange renewals or prior authorizations.

Interaction Chart (Canadian Context)

Prometrium (micronized progesterone) has clinically relevant interactions that affect sedation and systemic hormone levels.

Central nervous system depressants can increase sedation risk, hepatic enzyme inducers may lower progesterone levels, and anticoagulant metabolism can be affected.

• Pharmacy Action: verify all prescription, OTC and herbal products (especially St. John’s wort), review smoking status, and counsel on alcohol safety.
• High-Alert Interactions: check INR if anticoagulated and monitor mood when combined with antidepressants or antipsychotics.

Always consult provincial drug interaction databases and electronic health records for the most current interaction information.

User Reports And Trends In Canada

Patients report a range of experiences with micronized progesterone, from clear symptom relief to bothersome side effects.

Common themes include improved menstrual regulation, breast tenderness, drowsiness, and mixed feedback on mood effects compared with synthetic progestins.

• Top Patient-Reported Outcomes: symptom relief for amenorrhea, variable drowsiness/fatigue, breast tenderness, and concern about peanut-allergen labelling.

Community pharmacy feedback notes adherence issues with bedtime dosing and confusion between micronized progesterone and synthetic progestins.

Encourage reporting adverse events to Canada Vigilance and document real-world outcomes in primary care records, especially for Indigenous and rural patients to improve representation.

Access And Purchase Options

Prometrium is supplied to Canadian pharmacies by manufacturers such as AbbVie and is available by prescription through national chains and independents, though stock and generics vary by region.

National chains carrying Prometrium commonly include Shoppers Drug Mart, Rexall, London Drugs, Jean Coutu, and independent pharmacies depending on local stock.

• Patient Checklist To Obtain Medication: get a valid prescription with indication and DIN; call pharmacy to confirm stock and brand; check provincial coverage and prior authorization requirements; confirm allergen content (peanut oil); request blister packaging and pharmacist counselling.

Practical note: In our online pharmacy, prometrium is available without a prescription, with discreet delivery to Canada (English) in 5-14 days.

Mechanism And Pharmacology

Prometrium contains micronized progesterone, a natural steroid hormone that supports the luteal phase and stabilizes the endometrium.

Micronization improves oral bioavailability so that progesterone in soft capsules achieves systemic exposure when taken orally.

• ATC Code: G03DA04.
• Micronized: small particle formulation to improve absorption.
• Luteal Support: supports endometrial changes following ovulation.
• Endometrial Protection: counters estrogen-driven endometrial proliferation in HRT.

Pharmacokinetics: the drug undergoes hepatic metabolism, so bedtime dosing is commonly used to leverage mild sedative effects and steady exposure; avoid use in severe hepatic dysfunction.

• Natural Progesterone Vs Synthetic Progestins: natural progesterone may have different mood and vascular risk profiles compared with medroxyprogesterone or dydrogesterone.

Prescribers should consult the product monograph for in-depth pharmacology and interaction details.

Indications And Off-Label Uses In Canada

Approved and typical indications drawn from product labelling and international sources include endometrial protection in postmenopausal HRT and induction of withdrawal bleeding in secondary amenorrhea.

Off-label uses are sometimes considered by Canadian clinicians with informed consent, for example luteal-phase support in IVF or vaginal administration of oral capsules in select clinics; such use should follow evidence-based protocols.

Key Clinical Findings

Recent reports and product information indicate micronized progesterone is effective for endometrial protection in HRT and for inducing withdrawal bleeding in secondary amenorrhea.

• Top Clinical Outcomes: efficacy in endometrial protection, induction of withdrawal bleeding, common tolerability issues include drowsiness and breast tenderness, and important safety monitoring for thromboembolism and liver dysfunction.

Research Gaps: more Canadian real-world evidence is needed, especially for Indigenous and rural populations and head-to-head HRT comparisons.

Alternatives Matrix

• Pros And Cons Checklist For Selecting Agent: check contraindications, allergy risk (peanut oil), cost and provincial coverage, preferred route, psychiatric history and thrombosis risk.

Involve the pharmacist for DIN verification and generic interchange decisions and confirm formulary listings in the relevant province.

Common Questions From Canadian Patients

• Is This Natural Progesterone? Yes — Prometrium contains micronized progesterone derived to match natural progesterone.
• Will It Make Me Gain Weight? Weight changes are reported but variable and not guaranteed.
• Is It Safe Long Term? Long-term use requires periodic review, monitoring for thrombotic risk, liver issues and routine cancer screening.
• Can I Use It While Breastfeeding? Discuss with your prescriber; benefits and risks should be reviewed.
• What About Peanut Allergy? The capsule excipient may contain peanut oil — check the label and avoid if there is a true peanut allergy.

When To Call Emergency: chest pain, sudden shortness of breath, sudden severe leg swelling, sudden severe headache or jaundice require urgent care.

• Home Monitoring Checklist: watch for mood changes, excessive drowsiness, unexpected bleeding, signs of thrombosis, or severe abdominal pain.
• Overdose Advice: contact poison control or emergency services; supportive care is typical; signs can include sedation, nausea, vomiting, and withdrawal bleeding.

Coverage And Purchase Comparison Table

1. Get a prescription that includes indication and, if available, DIN.
2. Call the chosen pharmacy to confirm stock and brand availability.
3. Check provincial coverage and begin prior-authorization processes if required.
4. Ask the pharmacist to confirm allergen content, storage instructions, and bedtime dosing.
5. Arrange follow-up with prescriber for monitoring and refill planning.

Registration And Regulation

Prometrium and other micronized progesterone products require Health Canada marketing authorization and a Drug Identification Number (DIN) to be dispensed in Canada.

Prescription-only labelling, allergen disclosure (including peanut oil where applicable), bilingual label rules in some jurisdictions, and storage directions are part of regulatory labelling requirements.

• Key Regulatory Terms: DIN (Drug Identification Number), monograph, Canada Vigilance, Notice Of Compliance (NOC).

Pharmacy responsibilities include retaining prescription records, verifying the DIN before dispensing, and following provincial rules for returns and disposal.

Adverse events should be reported to Canada Vigilance and manufacturers are responsible for post-market surveillance and product monographs.

Storage And Handling

Store Prometrium in the original packaging below 25°C (77°F) and protect it from moisture and light.

Do not refrigerate or freeze the capsules.

• Patient Checklist: keep in original blister, store away from children and pets, avoid extreme temperatures, bring prescription when travelling, and ask the pharmacist about expiry and partial-use guidance.

Guidelines For Proper Use

Prescribers and pharmacists should document the indication, counsel on sedative risk and peanut allergy, and provide a clear dosing schedule—bedtime dosing is common.

• When To Call: severe chest pain, sudden breathlessness, sudden leg swelling, severe abdominal pain, or jaundice.
• Routine Monitoring Timeline: review at 3–6 months for bleeding pattern, mood changes, blood pressure and liver function as indicated.
• Pharmacist Counselling Points: missed dose instructions, overdose actions, interaction review, and safe-driving advice.

Ensure informed consent for off-label uses, culturally safe care for Indigenous patients, and shared decision-making documented in the medical record.

Delivery Across Canada (English)