Generic Misoprostol ( Misoprostol )

Buy Generic Misoprostol (Misoprostol) without prescription in Canada

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

Misoprostol is a synthetic prostaglandin E1 analogue used primarily to prevent gastric ulcers caused by nonsteroidal anti‑inflammatory drugs (NSAIDs) in patients at high risk, and it is also used in combination with mifepristone for the medical termination of intrauterine pregnancy. It works by binding to prostaglandin receptors in the stomach, where it increases bicarbonate and mucus secretion and maintains mucosal blood flow, protecting the lining from acid damage, and in the uterus, it stimulates myometrial contractions and softens the cervix, leading to expulsion of the pregnancy.

Usual adult dose: For NSAID‑induced gastric ulcer prevention, the recommended dose is 200 mcg taken orally four times daily, with meals and at bedtime. If the 200 mcg dose is not tolerated, a reduced dose of 100 mcg four times daily may be used. For medical abortion (in combination with mifepristone), 800 mcg (four 200 mcg tablets) is administered buccally or vaginally 24 to 48 hours after mifepristone, according to a standardised protocol under medical supervision. For cervical ripening and induction of labour, doses of 25 mcg to 100 mcg are used vaginally, starting with 25 mcg, although this is an off‑label use that must be managed in a hospital setting.

Dosage form: Oral tablets: 100 mcg and 200 mcg. The tablets are typically white, round, and scored.

Onset of action: For gastric mucosal protection, the effect begins within minutes of absorption. For uterine effects, contractions usually start 30 minutes to a few hours after administration and may last several hours.

Duration of action: The gastric antisecretory effect lasts for several hours, supporting four‑times‑daily dosing. The plasma half‑life of misoprostol acid is approximately 20 to 40 minutes, but the biological effects on the uterus persist for several hours.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Misoprostol. Alcohol can irritate the gastric mucosa and increase the risk of bleeding, counteracting the protective effect of the medication. For medical abortion, alcohol should be avoided, as it may worsen bleeding and increase the risk of side effects.

Most common side effects: Diarrhoea (up to 14%), abdominal pain, nausea, flatulence, and headache. Diarrhoea is the most frequent side effect and is dose‑related; it is usually mild to moderate and self‑limiting but may be severe enough to require discontinuation. In women using the medication for pregnancy termination, uterine cramping and vaginal bleeding are expected. Rare but serious side effects include uterine rupture (particularly in later pregnancy or with a prior uterine scar), severe hypotension, and anaphylaxis.

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General Information about Misoprostol

• INN (International Nonproprietary Name): Misoprostol
• Brand names available in Canada: Cytotec® (Pfizer Canada Inc.) is the original brand‑name product. Generic versions are widely available and include APO‑Misoprostol (Apotex Inc.), TEVA‑Misoprostol (Teva Canada Limited), Sandoz Misoprostol (Sandoz Canada Inc.), PMS‑Misoprostol (Pharmascience Inc.), and other manufacturer‑branded generics.
• ATC code: A02BB01 (misoprostol; other antiulcer drugs).
• Dosage forms and strengths: Oral tablets: 100 mcg and 200 mcg of misoprostol. The tablets are white, round, and scored.
• Manufacturers in Canada: Pfizer Canada Inc. (Cytotec), 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: 00872508 (Cytotec 200 mcg), among others. The 100 mcg tablet is also approved and available.
• 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

Misoprostol is a synthetic analogue of prostaglandin E1 (alprostadil). In the gastrointestinal tract, it binds to prostaglandin EP3 receptors on parietal cells, inhibiting basal and stimulated gastric acid secretion. It also promotes the secretion of bicarbonate and mucus by the gastric epithelium and maintains submucosal blood flow, thereby enhancing the natural defence mechanisms of the mucosa against injury from NSAIDs, alcohol, and other irritants. In the uterus and cervix, misoprostol acts as a potent utero‑tonic and cervical‑ripening agent by stimulating myometrial smooth‑muscle contractions and degrading collagen in the cervix, leading to softening and dilation. These dual effects make it useful for both gastric protection and reproductive health indications. After oral administration, misoprostol is rapidly de‑esterified to its active metabolite, misoprostol acid. Peak plasma levels are reached in about 12 minutes, and the elimination half‑life is approximately 20 to 40 minutes. The drug is excreted primarily in the urine as inactive metabolites. Food and antacids decrease the rate of absorption but not the overall extent, and taking the drug with meals reduces the incidence of diarrhoea.

Indications

• Prevention of NSAID‑induced gastric ulcers: Misoprostol is indicated for the prevention of gastric and duodenal ulcers caused by nonsteroidal anti‑inflammatory drugs (NSAIDs) in patients at high risk of developing these complications, including the elderly, patients with a history of peptic ulcer disease, and those with concomitant debilitating illnesses. It is particularly useful when NSAID therapy must be continued.
• Medical termination of intrauterine pregnancy: In combination with mifepristone, misoprostol is approved by Health Canada for the medical termination of pregnancy up to 9 weeks (63 days) of gestation. The fixed‑dose combination product Mifegymiso® contains mifepristone 200 mg and misoprostol 800 mcg (four 200 mcg tablets) for buccal or vaginal use. Generic misoprostol is also used off‑label for this indication under medical supervision.
• Off‑label uses: Cervical ripening and induction of labour, treatment of incomplete abortion and miscarriage, prevention and treatment of postpartum hemorrhage (particularly where oxytocin is not available), and pre‑operative cervical dilatation before surgical abortion or hysteroscopy. These uses are not formally approved by Health Canada but are supported by clinical guidelines and are widely practised in hospital settings.
• Misoprostol is not indicated for use in children, except under specialist paediatric gastroenterology or gynaecology care.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Misoprostol is absolutely contraindicated in women who are pregnant or who may become pregnant when used for the prevention of NSAID‑induced ulcers, because it can cause abortion, premature birth, or birth defects (including Möbius syndrome and limb defects). Women of childbearing potential must have a negative pregnancy test before starting therapy for ulcer prevention, must use effective contraception, and must be counselled about the abortifacient risk. For medical abortion, misoprostol is specifically intended to terminate pregnancy and must only be administered under medical supervision after confirmation of intrauterine pregnancy and gestational age.
• Breastfeeding: Misoprostol is rapidly metabolised to misoprostol acid, which is excreted in breast milk in small amounts. There are no reports of adverse effects in nursing infants, but caution should be exercised. In the setting of medical abortion, breastfeeding women should be counselled that small amounts of misoprostol acid may appear in breast milk, and the decision to breastfeed should be made in consultation with a healthcare provider.
• Paediatrics (< 18 years): Safety and efficacy have not been established in children for most indications. Use in paediatric patients is reserved for specialist settings, such as treatment of severe NSAID‑induced gastroduodenal ulceration in juvenile idiopathic arthritis.
• Elderly: No dose adjustment is required based on age alone. However, elderly patients may be at higher risk of dehydration and electrolyte imbalances from diarrhoea. Adequate hydration should be maintained.
• Inflammatory bowel disease: Misoprostol may exacerbate symptoms in patients with Crohn’s disease or ulcerative colitis. It should be used with caution, and the patient should be monitored for worsening diarrhoea or abdominal pain.
• Renal impairment: No dosage adjustment is required. However, patients with severe renal impairment may have reduced clearance of the active metabolite, and the risk of diarrhoea and fluid loss should be considered.
• Hepatic impairment: Misoprostol is metabolised in the liver, but no specific dose adjustment is recommended in mild to moderate hepatic impairment. Patients with severe hepatic disease should be monitored for potential accumulation.
• Uterine rupture: Uterine rupture, a life‑threatening obstetric emergency, has been reported with the use of misoprostol, particularly during induction of labour in the third trimester or in women with a prior uterine scar (e.g., previous caesarean section or myomectomy). Misoprostol should be used for cervical ripening and labour induction only in a hospital setting with immediate access to emergency obstetric services. It should not be used in women with a history of classical caesarean incision, multiple prior uterine surgeries, or other significant risk factors for rupture.
• Cardiovascular effects: Rare cases of severe hypotension, myocardial infarction, and coronary vasospasm have been associated with misoprostol. Caution is advised in patients with cardiovascular disease, particularly when high doses are used.
• Allergy: Do not take Misoprostol if you have a known hypersensitivity to misoprostol, other prostaglandins, or any excipient in the formulation.

Driving and alcohol

Misoprostol may cause dizziness and drowsiness. Patients should be cautious when driving, operating machinery, or performing activities that require mental alertness until they know how the medication affects them. Alcohol consumption should be limited during treatment. Alcohol can irritate the gastric mucosa and may increase the risk of gastrointestinal bleeding, opposing the protective effect of the drug. For medical abortion, alcohol should be avoided, as it may increase the risk of heavy bleeding and impair recovery.

Dosage Instructions

• Prevention of NSAID‑induced gastric ulcers: The recommended dose is 200 mcg taken orally four times daily, with meals and at bedtime. If the 200 mcg dose is not tolerated, the dose may be reduced to 100 mcg four times daily with meals. The last dose of the day should be taken at bedtime. Doses should be individualised based on tolerability; diarrhoea is the most common dose‑limiting side effect. The 100 mcg tablet allows flexible adjustment.
• Medical abortion (in combination with mifepristone): Under medical supervision, 800 mcg misoprostol (four 200 mcg tablets) is administered buccally (placed in the cheek pouches for 30 minutes, then swallowing any remnants) or vaginally 24 to 48 hours after a single oral dose of mifepristone 200 mg. The patient must be monitored for several hours after misoprostol administration and provided with follow‑up care to confirm complete abortion. This regimen is highly effective for pregnancies up to 9 weeks (63 days) of gestation.
• Cervical ripening and induction of labour (off‑label, hospital use): 25 mcg administered vaginally every 4 to 6 hours, with continuous fetal and uterine monitoring. Higher doses (50 mcg to 100 mcg) may be used in selected settings, but the risk of uterine hyperstimulation increases.
• Administration: For oral use, the tablet should be swallowed whole with a full glass of water and taken with food to reduce gastrointestinal side effects. For buccal administration, tablets are placed in the buccal pouches (between the cheek and gum) and held for 30 minutes before swallowing any remaining particles. The tablets should not be crushed or chewed. For vaginal administration, tablets are moistened with water and inserted high into the posterior fornix.
• Missed dose: For ulcer prevention, if a dose is missed, take it as soon as remembered 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.
• Duration of therapy: For chronic NSAID users at high risk of ulcers, therapy may be continued as long as NSAIDs are required. Periodic reassessment is recommended.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Diarrhoea (up to 14%), abdominal pain (7%), and nausea (3%). Diarrhoea is usually mild to moderate, begins within the first few days of therapy, and often resolves spontaneously within a week. It is dose‑related and may be managed by taking misoprostol with meals and avoiding magnesium‑containing antacids.
• Common side effects (1‑10%): Flatulence, headache, dyspepsia, vomiting, constipation, and dizziness. In women using misoprostol for abortion or labour induction, uterine cramping, vaginal bleeding, chills, and fever are expected pharmacologic effects.
• Serious adverse reactions: Uterine rupture (may be fatal), particularly with unsupervised use in the second or third trimester or in women with a prior uterine scar. Severe hypotension, myocardial infarction, and coronary vasospasm have been reported rarely. Anaphylactic reactions, including angioedema and bronchospasm, may occur. Uterine hyperstimulation can lead to fetal distress and adverse neonatal outcomes.
• Contraindications: Known hypersensitivity to misoprostol, other prostaglandins, or any excipient in the tablet. Pregnancy (when used for ulcer prevention or any indication other than medical abortion under supervision). For medical abortion, contraindications include confirmed or suspected ectopic pregnancy, an intrauterine contraceptive device (IUD) in place, chronic adrenal failure, known coagulopathy or anticoagulant therapy, and inherited porphyria. Misoprostol should not be used for cervical ripening or labour induction in women with a prior classical caesarean section, multiple uterine scars, or active genital herpes infection.

Drug Interactions

• Nonsteroidal anti‑inflammatory drugs (NSAIDs): Misoprostol is specifically prescribed to counteract the gastrointestinal toxicity of NSAIDs. There is no pharmacokinetic interaction, and the clinical benefit is additive. Misoprostol does not reduce the analgesic or anti‑inflammatory efficacy of NSAIDs.
• Antacids: Magnesium‑containing antacids may worsen misoprostol‑induced diarrhoea. If antacids are required, aluminium‑based antacids are preferred, and they should be taken at least one hour apart from misoprostol.
• Food: Taking misoprostol with food reduces the peak plasma concentration but does not alter the overall bioavailability. More importantly, food reduces the incidence of diarrhoea and abdominal pain, so administration with meals is recommended.
• Other drugs: No clinically significant interactions with drugs metabolised by the cytochrome P450 enzyme system have been identified. Misoprostol does not affect the pharmacokinetics of aspirin, indomethacin, diazepam, or propranolol.
• Alcohol: Alcohol may increase gastric irritation and the risk of bleeding; therefore, consumption should be limited. In the context of medical abortion, alcohol should be avoided to minimise the risk of excessive bleeding and to ensure safe recovery.

Practical Advice

• Administration: For ulcer prevention, always take the tablet with a full glass of water and with food (i.e., with breakfast, lunch, dinner, and a bedtime snack). Consistent use is essential to maintain gastric protection. For medical abortion, follow the exact instructions provided by the healthcare team: place the four 200 mcg tablets in the cheek pouches and hold for 30 minutes, then swallow. Do not use any other route without specific direction. For vaginal administration, wash hands before insertion. The scored tablet can be split if a lower dose is prescribed.
• Monitoring: For chronic NSAID users, no routine laboratory monitoring is required. Patients should be advised to report severe or persistent diarrhoea, as this may lead to dehydration and necessitate dose reduction or discontinuation. Women using misoprostol for abortion must attend a follow‑up visit to confirm complete expulsion of the pregnancy. For labour induction, continuous electronic fetal monitoring is mandatory.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed and out of the reach and sight of children. Misoprostol is a potent abortifacient; ensure that women of childbearing potential are aware of the risks of handling or taking this medication.
• Lifestyle: If you are taking misoprostol for ulcer prevention, it is important to continue your NSAID therapy as prescribed; do not stop the NSAID without consulting your doctor. To minimise diarrhoea, eat smaller, more frequent meals, stay well hydrated, and avoid spicy or fatty foods. Do not take magnesium‑containing antacids (e.g., Maalox, Mylanta) unless specifically directed. If you are a woman of childbearing potential, you must use reliable contraception (non‑hormonal methods preferred) while taking misoprostol for gastric protection, and you must have a negative pregnancy test before starting.
• Missed dose: Take the missed dose with food as soon as you remember. If it is close to the time of your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose.
• When to seek medical review: Stop taking misoprostol and contact your doctor immediately if you experience: severe or bloody diarrhoea, severe abdominal pain, fainting, severe dizziness, signs of a serious allergic reaction (hives, swelling of the face or throat, difficulty breathing), or, in the setting of abortion, signs of incomplete abortion or infection (fever, chills, foul‑smelling discharge, prolonged heavy bleeding, severe pelvic pain). If you become pregnant while taking misoprostol for ulcer prevention, discontinue the drug immediately and inform your doctor.
• 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

• Proton pump inhibitors (PPIs): Omeprazole (Losec®), pantoprazole (Pantoloc®), lansoprazole (Prevacid®), esomeprazole (Nexium®), and rabeprazole (Pariet®) are the most effective agents for the prevention and treatment of NSAID‑induced ulcers. They act by directly inhibiting the gastric H⁺/K⁺‑ATPase pump. PPIs are generally preferred over misoprostol due to their once‑daily dosing, superior tolerability, and efficacy. However, misoprostol uniquely offers both gastric protection and the preservation of the gastric mucosal barrier, making it an option when PPIs are not tolerated or are contraindicated.
• H2‑receptor antagonists: Famotidine (Pepcid®) and ranitidine (Zantac®) are less effective than PPIs but may be used for mild or moderate NSAID‑related dyspepsia prophylaxis. They reduce gastric acid secretion but do not enhance mucosal defence mechanisms.
• For medical abortion: The combination of mifepristone and misoprostol is standard. In settings where mifepristone is not available, misoprostol alone may be used, but the efficacy is lower. Surgical aspiration (manual or electric vacuum aspiration) is an alternative for women who cannot or prefer not to use medical abortion, or for those beyond the recommended gestational age for medical methods.
• For cervical ripening and labour induction: Dinoprostone (prostaglandin E2) preparations, such as Cervidil® (vaginal insert) and Prepidil® (endocervical gel), are approved alternatives. Mechanical methods, such as the Foley balloon catheter, are also effective and do not cause uterine hyperstimulation. Oxytocin may be used once the cervix is ripe.
• Non‑pharmacological approaches: For NSAID‑related gastric risk, whenever possible, reduce or discontinue the NSAID, switch to a COX‑2‑selective inhibitor (e.g., celecoxib), or use non‑pharmacological pain management strategies such as physiotherapy, exercise, and weight loss.

Clinical Efficacy

The efficacy of misoprostol for the prevention of NSAID‑induced gastric ulcers was established in several randomised, double‑blind, placebo‑controlled trials. In high‑risk patients taking chronic NSAIDs, misoprostol 200 mcg four times daily reduced the incidence of gastric ulcer by approximately 75‑80% compared with placebo, and it also significantly reduced the rate of duodenal ulcer. For medical abortion, the combination of mifepristone 200 mg followed by misoprostol 800 mcg buccally or vaginally results in complete abortion rates of 95‑98% for pregnancies up to 9 weeks. Misoprostol alone, although less effective than the combination, achieves complete abortion in approximately 80‑85% of cases when an appropriate regimen is used. For cervical ripening, misoprostol is more effective than placebo and at least as effective as dinoprostone, with a shorter induction‑to‑delivery interval, but with a slightly higher risk of uterine hyperstimulation. Its low cost, stability at room temperature, and multiple routes of administration (oral, buccal, vaginal, rectal) make it an essential medicine globally, listed on the World Health Organization Model List of Essential Medicines for both gastroenterological and obstetric indications.

Important:

Misoprostol is a prescription medication that should be used only under the supervision of a qualified healthcare professional. When used for the prevention of gastric ulcers, it must never be taken by women who are pregnant or may become pregnant, as it can cause miscarriage, premature birth, and severe birth defects. Women of childbearing potential must have a negative pregnancy test before starting therapy, use effective contraception, and be fully informed of the risks. For medical abortion, misoprostol must only be used under direct medical supervision with appropriate follow‑up to confirm complete abortion and manage potential complications, including severe bleeding and infection. Do not use misoprostol without medical guidance for any pregnancy‑related purpose. If you experience severe or persistent diarrhoea, severe abdominal pain, fainting, or signs of an allergic reaction, stop taking the medication and seek medical attention immediately. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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