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Misoprostol

Generic Misoprostol ( Misoprostol )

Misoprostol is a synthetic prostaglandin used to prevent stomach ulcers and manage various reproductive conditions. It helps protect the stomach lining and induces uterine contractions when medically needed. The drug must be used under medical supervision, especially in pregnancy-related treatments. Common side effects include abdominal cramps and diarrhea.
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Buy cheap Generic Misoprostol (Misoprostol) without dr prescription at Canadian Pharmacy


Misoprostol (100 mcg, 200 mcg): Comprehensive Patient Information for Canada

Basic Product Information

Generic Name (INN) Misoprostol
Canadian Brand Names / Trade Names Cytotec (brand name, cancelled post-market since 2005); generic misoprostol tablets are available from AA Pharma Inc. (DIN 02244023 for 200 mcg) and Jamp Pharma Corporation (Jamp Misoprostol 200 mcg). Mifegymiso is a combination product containing mifepristone and misoprostol for medical abortion.
ATC Code A02BB01
Available Dosage Forms and Strengths Tablets: 100 mcg and 200 mcg. Each 200 mcg tablet contains 200 mcg of misoprostol. Commercially available tablet strengths in Canada are 100 mcg and 200 mcg.
Manufacturers AA Pharma Inc. (Misoprostol 100 mcg and 200 mcg tablets); Jamp Pharma Corporation (Jamp Misoprostol 200 mcg); Linepharma International Inc. (Mifegymiso combination product). The brand-name Cytotec was manufactured by Pfizer Canada ULC and was cancelled post-market on 2005-08-05.
Prescription Status Prescription only in Canada. Misoprostol is classified as a Schedule I drug, meaning it can only be sold or dispensed legally with a prescription from a licensed healthcare provider.

Mechanism of Action

In simple terms: Misoprostol is a synthetic prostaglandin that helps protect the stomach lining from damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. It works by reducing the amount of acid produced in the stomach and by increasing the production of mucus and bicarbonate, which form a protective barrier against irritation. Misoprostol also causes the uterus to contract and softens the cervix, which is why it is used in obstetric and gynecological settings.

For specialists: Misoprostol is a synthetic prostaglandin E1 (PGE1) analog. It inhibits both basal and stimulated gastric acid secretion (histamine, pentagastrin, food, and coffee) and reduces nocturnal gastric acid secretion. The antisecretory effect of misoprostol is mediated by a direct effect on parietal cells. Misoprostol has no or negligible effect on gastrin secretion. Prophylactic treatment with misoprostol at a dose of 0.2 mg provides protection against acetylsalicylic acid-induced lesions in the gastric mucosa. Mucosal damage induced by necrotizing agents is reduced with misoprostol treatment. A mucosal protective effect has been observed in humans, manifested as reduced gastric and fecal blood loss after acetylsalicylic acid when misoprostol was given at doses of 25–50 mcg, doses that exert only a negligible antisecretory effect. The mechanism behind misoprostol's mucosal protection is multifactorial. Misoprostol stimulates normal physiological mechanisms in the gastroduodenal mucosa. Among other effects, it increases the production of protective gastric mucus (both in the adherent layer and in gastric juice) and the secretion of bicarbonate in the duodenum. In the uterus, misoprostol binds to myometrial prostaglandin receptors, stimulating uterine contractions and cervical ripening.

Pharmacokinetics

  • Absorption: Misoprostol is rapidly and almost completely absorbed after oral administration. It undergoes rapid metabolism to its active metabolite, misoprostol acid. Maximum plasma concentration of misoprostol acid is reached within 30 minutes. Food does not alter the bioavailability of misoprostol acid but reduces the maximum plasma concentration due to a slower absorption rate.
  • Metabolism: Misoprostol undergoes rapid and extensive metabolism. Misoprostol acid is further metabolized by beta-oxidation on the alpha side chain, omega oxidation of the beta-side chain, and reduction to prostaglandin F analogs. Misoprostol was not found to affect hepatic drug metabolism in rat studies.
  • Elimination: The plasma half-life is 20–40 minutes. Misoprostol and misoprostol acid are excreted as biologically inactive metabolites mainly via the kidneys (73%) but also via feces (15%). Approximately 56% of a given dose is eliminated in urine within 8 hours. No accumulation of misoprostol acid was found in multiple-dose studies, and plasma steady-state was achieved within 2 days. The protein binding of misoprostol acid is less than 90% and is concentration-independent at therapeutic doses.
  • Onset of Action: For gastric protection, the antisecretory effect begins within 30 minutes of oral administration. For uterine effects, contractions typically begin within 20 to 30 minutes after oral or buccal administration.
  • Duration of Action: The antisecretory effect lasts for approximately 3 hours. Uterine contractions may persist for several hours depending on the dose and route of administration.

Uses in Daily Life and Best Practice Advice

Misoprostol is used in Canada for the prevention and treatment of NSAID-induced gastroduodenal damage and for obstetric and gynecological indications. Your physician will determine the appropriate use and dose based on your specific medical situation.

  • Typical Uses: Treatment and primary prevention of gastroduodenal damage caused by NSAIDs; healing of duodenal ulcers; medical termination of intrauterine pregnancy (as part of the Mifegymiso combination regimen); cervical ripening and induction of labor (in hospital settings); and prevention of postpartum hemorrhage (off-label).
  • Administration: Tablets are taken orally with food. Misoprostol can also be administered by vaginal, buccal, or sublingual routes for obstetric indications, but these routes are not approved for all indications in Canada.
  • Monitoring: If symptoms do not improve or if they worsen, consult your physician. For NSAID-induced ulcer prevention, the need for continued therapy should be reassessed periodically.
  • Do Not Exceed Recommended Dose: Do not take more than the prescribed dose. The usual adult dose for ulcer prevention is 200 mcg four times daily.

Morning vs. Evening Dosing

For ulcer prevention and treatment, misoprostol is typically taken four times daily with meals and at bedtime. There is no specific clinical recommendation for morning versus evening dosing beyond the meal-related timing. For obstetric indications, the timing and route of administration are determined by your healthcare provider based on the clinical situation.

  • Four Times Daily: The standard dosing for ulcer prevention is 200 mcg four times daily, taken with food and at bedtime.
  • Consistency: Take misoprostol at the same times each day to ensure consistent effects.
  • Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
  • Obstetric Use: For labor induction or medical abortion, dosing is determined by your healthcare provider based on the clinical protocol.

Administration With or Without Food

Misoprostol should be taken with food to reduce the incidence of gastrointestinal side effects, particularly diarrhea and abdominal pain. Taking each dose immediately after a meal or with food or milk will help prevent gastrointestinal disturbances that may occur in the first few days of therapy. Food also decreases the peak concentration of misoprostol acid but does not significantly affect the overall extent of absorption.

  • Take the tablet with a meal or snack.
  • Swallow the tablet whole. Do not crush or chew unless directed by your pharmacist.
  • For buccal administration (placing the tablet between the cheek and gum), follow the instructions provided by your healthcare provider.
  • For vaginal administration, follow the specific instructions provided by your healthcare provider.
  • Do not take misoprostol with antacids containing magnesium, as these may worsen diarrhea.

Interaction Warnings

Interaction Advice
Antacids containing Magnesium Magnesium-containing antacids may worsen misoprostol-induced diarrhea. Avoid concomitant use or use with caution.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Misoprostol is used concomitantly with NSAIDs for the prevention of NSAID-induced ulcers. The combination is intentional in this setting. Starting misoprostol with the prescribed NSAID improves its effectiveness.
Oxytocin and Other Uterotonic Drugs Concomitant use with oxytocin or other uterotonic agents may increase uterine tone and the risk of uterine rupture. Use with caution in obstetric settings.
Phenylbutazone Should be used with caution when given with misoprostol.
Alcohol Avoid excessive alcohol consumption as it may increase the risk of gastrointestinal irritation and ulcer formation.

Indications for Misoprostol

Condition Status
Treatment and primary prevention of gastroduodenal damage caused by NSAIDs Approved (Health Canada)
Healing of duodenal ulcers Approved (Health Canada)
Medical termination of intrauterine pregnancy (as part of Mifegymiso) Approved (Health Canada) for up to 63 days gestation
Cervical ripening and induction of labor Off-label / Hospital use only
Prevention of postpartum hemorrhage Off-label / Hospital use only

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.

Dosing According to Clinical Indication

Indication Adults Route Duration
Prevention of NSAID-induced gastroduodenal damage 200 mcg four times daily with food and at bedtime Oral As long as NSAID therapy continues
Treatment of duodenal ulcer 200 mcg four times daily with food and at bedtime Oral 4 to 8 weeks
Treatment of gastric ulcer 100 mcg four times daily with food and at bedtime Oral 4 to 8 weeks
Medical termination of pregnancy (Mifegymiso regimen) 800 mcg (four 200 mcg tablets) 24 to 48 hours after mifepristone 200 mg Buccal Single dose
Labor induction (hospital use only) 20 to 25 mcg every 3 to 6 hours, titrated to effect, maximum 50 mcg Vaginal or oral As directed by physician; maximum 4 to 5 doses over 24 hours
Maximum daily dose (ulcer indications) 800 mcg per day (four 200 mcg doses) Oral As directed by physician

Doses should always be adjusted according to the advice of your physician and depending on your health condition. Misoprostol is contraindicated in pregnancy when used for ulcer indications because it can cause uterine contractions and may lead to abortion. For obstetric indications, dosing is determined by clinical protocols and healthcare provider supervision. Commercially available tablet strengths of 100 mcg and 200 mcg require careful dilution and preparation for labor induction to avoid dosing errors.

Side Effects and Safety Profile

Common (>10%) Occasional (1–10%) Rare / Serious (<1%) Warnings
  • Diarrhea (up to 40%)
  • Abdominal pain (up to 20%)
  • Nausea
  • Flatulence
  • Headache
  • Dyspepsia (indigestion)
  • Vomiting
  • Constipation
  • Dizziness
  • Vaginal bleeding (with obstetric use)
  • Fever/chills
  • Weakness
  • Uterine rupture — reported with misoprostol use in pregnancy, particularly with high doses or in women with prior uterine surgery. Carries a 13% uterine rupture risk in women with prior cesarean delivery and is absolutely contraindicated in these patients.
  • Uterine hyperstimulation — excessive uterine contractions (more than 5 contractions per 10 minutes or contractions lasting more than 2 minutes) can occur with labor induction.
  • Severe allergic reactions — anaphylaxis, angioedema.
  • Heavy vaginal bleeding — with obstetric use.
  • Fetal death and teratogenicity — misoprostol can cause abortion, premature birth, or birth defects if used during pregnancy.
  • Pelvic infections (endometritis, salpingitis) and vaginal haemorrhages — reported with medical abortion; rare cases of fatalities have been reported.
  • Do not use for ulcer prevention or treatment during pregnancy; misoprostol can cause uterine contractions and may lead to abortion.
  • Women of childbearing potential should use effective contraception while taking misoprostol for ulcer indications. If pregnancy is suspected, discontinue use and consult a physician immediately.
  • Diarrhea is the most common side effect and is dose-related. It often resolves within a few days of continued therapy. Patients should continue taking misoprostol if these symptoms develop; they usually disappear within a few days.
  • Seek immediate medical attention if you experience signs of a severe allergic reaction, heavy vaginal bleeding, or severe abdominal pain.
  • Use with caution in patients with inflammatory bowel disease or conditions that predispose to diarrhea.
  • For obstetric use, misoprostol should be administered only under close medical supervision in a hospital setting with continuous electronic fetal monitoring and uterine activity monitoring.
  • Never use misoprostol in women with prior cesarean delivery or uterine surgery for labor induction—this carries a 13% uterine rupture risk and is absolutely contraindicated.
  • Additional absolute contraindications for labor induction include classical cesarean scar or any full-thickness uterine incision, active cardiovascular disease, placenta previa or vasa previa, advanced liver failure, and known prostaglandin hypersensitivity.

Guidelines for Correct Use

  • Take misoprostol exactly as prescribed by your physician. Do not change your dose without medical advice.
  • Take each dose immediately after a meal or with food or milk. This will help prevent gastrointestinal disturbances (loose stools, diarrhea, and abdominal cramping) that may occur in the first few days of therapy.
  • Continue to take misoprostol if you develop these symptoms. Do not be alarmed. This is part of the effect of the medicine which your body is adjusting to. These symptoms will usually disappear within a few days.
  • Do not use misoprostol for ulcer prevention or treatment if you are pregnant or planning to become pregnant.
  • Women of childbearing potential should use effective contraception while taking misoprostol for ulcer indications.
  • If you suspect you are pregnant, stop taking misoprostol and contact your physician immediately.
  • For obstetric indications, follow the specific instructions provided by your healthcare provider regarding the route of administration and timing.
  • Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking misoprostol.
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
  • Store at room temperature in a dry place. Keep out of reach of children.

Alternative Treatment Options

  • Proton Pump Inhibitors (PPIs) (e.g., omeprazole, pantoprazole, esomeprazole, lansoprazole): More effective than misoprostol for healing ulcers and are the preferred choice for most patients requiring gastroprotection with NSAIDs. PPIs are taken once daily and have a more favorable side effect profile.
  • H2 Receptor Antagonists (e.g., famotidine): An alternative for patients who cannot take PPIs. Famotidine is effective for preventing NSAID-induced duodenal ulcers but is less effective for gastric ulcers.
  • Sucralfate: Forms a protective barrier over ulcers and irritated tissue. Taken four times daily and requires dosing away from other medications.
  • Diclofenac/Misoprostol Combination (Arthrotec): A fixed-dose combination product containing an NSAID and misoprostol. Available in some markets but may not be available in Canada.
  • Acetaminophen: An alternative analgesic for patients who cannot take NSAIDs and therefore do not require gastroprotection.

Comparison: Misoprostol is effective for preventing NSAID-induced gastric ulcers but is associated with a high incidence of diarrhea and abdominal pain, which limits its tolerability. PPIs are generally preferred because they are more effective for healing ulcers and are better tolerated. Misoprostol is distinguished by its dual role as a gastroprotective agent and a uterotonic agent for obstetric indications. However, its use in pregnancy for ulcer indications is contraindicated. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

  • Registration: Misoprostol is authorized for sale in Canada by Health Canada as a prescription drug. The brand-name Cytotec (DIN 00632600) has been cancelled post-market since 2005-08-05. Generic misoprostol tablets are available from AA Pharma Inc. (DIN 02244023 for 200 mcg, 100 tablets) and Jamp Pharma Corporation (Jamp Misoprostol 200 mcg). Mifegymiso (mifepristone and misoprostol combination) has been approved by Health Canada since 2017. A generic mifepristone/misoprostol product, Jamp Mifepristone/Misoprostol, received approval in May 2026 (active ingredients: mifepristone 200 mg, misoprostol 200 mcg).
  • Prescription Status: Prescription only in Canada. Misoprostol is classified as a Schedule I drug under the Controlled Drugs and Substances Act, meaning it can only be sold or dispensed legally with a prescription from a licensed healthcare provider.
  • Coverage: Coverage varies by province, territory, and private insurance plan. For medical abortion, Mifegymiso is publicly funded in several provinces. All provinces and territories reimburse mifepristone and misoprostol for persons insured under a public health insurance plan. Mifegymiso is on all provincial drug formularies (though in some provinces private plans must be accessed first). For eligible Veterans, Jamp Misoprostol 200 mcg is listed as a Standard Benefit for Eligible Clients Canada Wide. Generic misoprostol for ulcer indications is generally covered by provincial drug plans under standard formulary criteria.
  • Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program.

Recent Research and Clinical Guidelines (2022–2026)

  • ISMP Canada issued a safety bulletin in 2025 regarding accurate dosing of misoprostol for induction of labor. The recommended starting oral dose is 20 to 25 mcg, titrated to effect, to a maximum dose of 50 mcg. Commercially available tablet strengths of 100 mcg and 200 mcg require careful dilution and preparation to avoid dosing errors. Health care providers have described challenges with the preparation of misoprostol doses, either when using partial tablets or preparing a solution.
  • A 2026 guideline for the management of misoprostol induction in Canada recommends 25 mcg misoprostol inserted into the posterior vaginal fornix every 3 to 6 hours, with a maximum of 4 to 5 doses over 24 hours, for term singleton pregnancies with intact cervix and no contraindications. Higher doses (50 mcg or more) are associated with increased uterine hyperstimulation and should be avoided. Continuous electronic fetal monitoring and uterine activity monitoring are mandatory after each misoprostol dose for at least 3 to 4 hours.
  • The Society of Obstetricians and Gynaecologists of Canada (SOGC) has released recommendations to improve early pregnancy loss management in Canada, calling for the medication management of pregnancy loss using mifepristone and misoprostol to be offered free of charge to women.
  • Decades of research show that medical abortion with mifepristone and misoprostol is safe, with serious complications occurring in less than 0.4% of patients.
  • Health Canada approved the Mifegymiso regimen with certain conditions, including administration for medical termination of pregnancy up to 63 days gestation. The SOGC 2016 guidelines recommend Mifegymiso as the first-line medication abortion method.
  • A drug shortage of misoprostol 200 mcg tablets from AA Pharma Inc. was reported in July 2026 due to a disruption in the manufacture of the drug, with an estimated end date of July 31, 2026. Another shortage was reported in January 2025 and resolved in February 2025.

Availability and Supply in Canada

Packaging Format Typical Price (CAD) Availability
Misoprostol 100 mcg tablet (AA Pharma), 100 tablets Price varies; check with pharmacy Available at pharmacies across Canada; prescription required
Misoprostol 200 mcg tablet (AA Pharma), 100 tablets Approximately $82.64 Available at pharmacies; prescription required. Subject to drug shortage reported in July 2026 (estimated end date July 31, 2026).
Jamp Misoprostol 200 mcg tablet, 100 tablets Price varies; check with pharmacy Available at pharmacies; prescription required. Listed as a Standard Benefit for Eligible Veterans Canada Wide.
Mifegymiso kit (mifepristone 200 mg + misoprostol 200 mcg x 4) Approximately $225–$300 per kit (publicly funded in some provinces) Available through pharmacies; prescription required; may require special ordering.

Prices and availability may vary by province, territory, and pharmacy. Some generic misoprostol products have been cancelled post-market, but AA Pharma and Jamp misoprostol remain marketed. Mifegymiso and generic mifepristone/misoprostol are available through a Canadian distribution program and may require the pharmacy to order the product. A drug shortage of AA Pharma misoprostol 200 mcg was reported in July 2026 with an estimated end date of July 31, 2026. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

  1. Is Cytotec (misoprostol) available in Canada?
    The brand-name Cytotec has been cancelled post-market in Canada since 2005. However, generic misoprostol tablets (100 mcg and 200 mcg) are available by prescription from manufacturers including AA Pharma Inc. and Jamp Pharma Corporation.
  2. What is misoprostol used for?
    Misoprostol is used to prevent and treat stomach and intestinal ulcers caused by NSAIDs (such as ibuprofen and naproxen). It is also used in combination with mifepristone (Mifegymiso) for medical termination of early pregnancy and, in hospital settings, for cervical ripening and labor induction.
  3. What is the difference between misoprostol 100 mcg and 200 mcg?
    The 200 mcg tablet is typically used for the prevention of NSAID-induced gastric ulcers, treatment of duodenal ulcers, and as part of the medical abortion regimen. The 100 mcg tablet is used for the treatment of gastric ulcers and is also used in hospital settings for labor induction, where lower doses are required. Your physician will determine the appropriate strength for your condition.
  4. Can I take misoprostol with food?
    Yes. Misoprostol should be taken with food to reduce the incidence of diarrhea and abdominal pain. Taking each dose immediately after a meal or with food or milk helps prevent gastrointestinal disturbances. Taking it with food also helps with absorption consistency.
  5. What should I do if I miss a dose of misoprostol?
    If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
  6. Can I take misoprostol if I am pregnant?
    No. Misoprostol is contraindicated during pregnancy for ulcer indications because it can cause uterine contractions and may lead to abortion, premature birth, or birth defects. Women of childbearing potential should use effective contraception while taking misoprostol for ulcer prevention or treatment. If you suspect you are pregnant, stop taking misoprostol and contact your physician immediately.
  7. What are the serious side effects of misoprostol?
    Serious side effects include uterine rupture (with obstetric use), uterine hyperstimulation, severe allergic reactions, heavy vaginal bleeding, and pelvic infections. Seek immediate medical attention if you experience these symptoms.
  8. Is misoprostol covered by Canadian health insurance?
    Coverage varies by province and territory. For ulcer indications, generic misoprostol is generally covered by provincial drug plans. For medical abortion, Mifegymiso is publicly funded in several provinces, and all provinces and territories reimburse mifepristone and misoprostol for persons insured under a public health insurance plan. For eligible Veterans, Jamp Misoprostol 200 mcg is listed as a Standard Benefit. Check with your provincial drug plan and private insurance provider for coverage details.
  9. What is Mifegymiso?
    Mifegymiso is a combination product containing mifepristone 200 mg and misoprostol 200 mcg tablets. It is approved in Canada for medical termination of intrauterine pregnancy up to 63 days gestation. The regimen involves taking mifepristone orally, followed by misoprostol buccally 24 to 48 hours later. Medical abortion with this combination is safe, with serious complications occurring in less than 0.4% of patients.
  10. Are there alternatives to misoprostol for ulcer prevention?
    Yes. Proton pump inhibitors (PPIs) such as omeprazole, pantoprazole, and esomeprazole are generally preferred over misoprostol for preventing NSAID-induced ulcers because they are more effective, better tolerated, and taken once daily. H2 receptor antagonists such as famotidine are another alternative. Your physician will determine the best option for your specific condition.

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