Generic Omeprazole

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Omeprazole is a proton pump inhibitor used to treat conditions caused by too much acid in the stomach, including gastroesophageal reflux disease, stomach and duodenal ulcers, and Zollinger-Ellison syndrome. It works by blocking the tiny pumps in the stomach lining that produce acid.
The usual dose ranges from 10 mg to 40 mg once daily, depending on what is being treated. Duodenal ulcers typically need 20 mg daily for 2 to 4 weeks, while reflux esophagitis often requires 20 mg to 40 mg daily for 4 to 8 weeks.
The administration form is delayed-release capsules and tablets in 10 mg and 20 mg strengths, with 40 mg available as a tablet in some generic formulations. The capsules must be swallowed whole.
The medication starts reducing acid within an hour of the first dose, but the full healing effect on ulcers and inflamed tissue takes days to weeks to develop.
Alcohol does not interact directly with omeprazole, but drinking can irritate the stomach lining and make reflux symptoms worse. Cutting back is sensible while you are treating an acid-related condition.
The most common side effects are headache, diarrhea, abdominal pain, and nausea.
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Common Use Omeprazole

Omeprazole belongs to a class of drugs called proton pump inhibitors. It works by irreversibly blocking the hydrogen-potassium ATPase enzyme, often called the proton pump, which is the final step in acid production in the stomach's parietal cells. By shutting down this pump, omeprazole reduces both the amount of acid produced and the total volume of gastric juice. This gives damaged tissue in the esophagus and stomach a chance to heal. Omeprazole is approved in Canada for duodenal ulcers, gastric ulcers, NSAID-associated ulcers, reflux esophagitis, symptomatic reflux disease, and Zollinger-Ellison syndrome. It is also used as part of combination therapy to eradicate Helicobacter pylori. For occasional heartburn, a 20 mg dose sold in a 14-day package can be obtained without a prescription, but the prescription-strength product is intended for diagnosed conditions.

Basic Omeprazole Information

• INN (International Nonproprietary Name): Omeprazole
• Brand names available in Canada: Losec®; generics including Apo-Omeprazole, Teva-Omeprazole, Sandoz Omeprazole, PMS-Omeprazole, Jamp-Omeprazole DR, Mylan-Omeprazole, and others
• ATC Code: A02BC01
• Forms and dosages: Delayed-release capsules – 10 mg and 20 mg. Delayed-release tablets – 10 mg, 20 mg, and 40 mg (omeprazole magnesium).
• Manufacturers in Canada: AstraZeneca Canada Inc. (Losec), Apotex Inc. (Apo-Omeprazole), Teva Canada Limited (Teva-Omeprazole), Sandoz Canada Inc. (Sandoz Omeprazole), Pharmascience Inc. (PMS-Omeprazole), Jamp Pharma Corporation (Jamp-Omeprazole DR), Mylan Pharmaceuticals ULC (Mylan-Omeprazole), Pro Doc Limitée (Omeprazole)
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 02245058 (Apo-Omeprazole 20 mg), 02295415 (Teva-Omeprazole 20 mg), 02296438 and 02296446 (Sandoz Omeprazole 10 mg and 20 mg), 02339927 (Omeprazole, Pro Doc), and 02420198 (Jamp-Omeprazole DR 20 mg). The original Losec DIN 02119579 is also listed.
• OTC / Rx classification: Prescription only (Rx) for the 10 mg and 40 mg strengths and for long-term use. A 20 mg strength is available without a prescription in a 14-day package for frequent heartburn, but the prescription product is not sold over-the-counter in Canadian pharmacies.

Dosage & Direction

Take omeprazole once daily, usually in the morning before breakfast. Swallow the capsule or tablet whole with water. Do not chew, crush, or split it, because the delayed-release coating protects the drug from stomach acid and releases it later in the intestine. If you have trouble swallowing capsules, ask your pharmacist about the tablet form, which some people find easier. The dose depends on the condition. Duodenal ulcers are usually treated with 20 mg daily for 2 to 4 weeks. Gastric ulcers, reflux esophagitis, and NSAID-associated ulcers typically need 20 mg daily for 4 to 8 weeks. For reflux disease without esophagitis, 10 mg to 20 mg daily may be enough. Zollinger-Ellison syndrome often requires higher doses, sometimes starting at 60 mg daily. For H. pylori eradication, omeprazole 20 mg is taken twice daily alongside two antibiotics for 7 to 14 days. If you have severe liver problems, your doctor may start you on a lower dose, usually 10 mg daily. Do not stop the medication early just because you feel better. Ulcers and inflamed tissue need the full course to heal properly.

Precautions

Long-term use of omeprazole, especially at higher doses, has been linked to several concerns. Prolonged acid suppression can reduce the absorption of vitamin B12, which may lead to deficiency over time, particularly in older adults and people with poor dietary intake. Low magnesium levels have been reported in patients taking proton pump inhibitors for three months or longer. Symptoms include muscle cramps, irregular heartbeat, and seizures. Your doctor may check your magnesium levels periodically if you are on long-term therapy. Omeprazole can increase the risk of bone fractures, especially hip, wrist, and spine fractures, in people who take it for a year or more at high doses. This risk is higher in older adults. If you have osteoporosis or are at risk for it, talk to your doctor about calcium and vitamin D intake. Acid suppression also allows bacteria that normally do not survive in the stomach to thrive, which raises the risk of infections such as Clostridium difficile diarrhea and community-acquired pneumonia. Omeprazole may also cause or worsen hypomagnesemia and hypokalemia. Tell your doctor if you have a history of low magnesium or potassium. Omeprazole is not recommended during pregnancy unless clearly needed. It passes into breast milk, so breastfeeding women should discuss the risks and benefits with their doctor. Safety and effectiveness in children under 18 years have not been established for most indications. If you have severe liver disease, the dose should be reduced, and your liver function should be monitored.

Contraindications

Do not take omeprazole if you are allergic to omeprazole, other substituted benzimidazoles such as esomeprazole or pantoprazole, or any of the inactive ingredients in the capsule or tablet. The medication must not be used together with rilpivirine, an HIV medication, because omeprazole reduces its absorption and can make it less effective. Do not take omeprazole with nelfinavir, another HIV drug, for the same reason. Omeprazole should not be used in patients with severe liver disease without dose adjustment. It is not recommended for children under 18 years of age except when specifically prescribed by a specialist. Do not take omeprazole if you are pregnant or breastfeeding unless your doctor has advised it. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

The most common side effects reported in clinical trials include headache, diarrhea, abdominal pain, nausea, and flatulence. These occur in roughly 1 to 10 percent of patients and are usually mild. Constipation, vomiting, and dry mouth are also reported. Some people experience drowsiness, dizziness, or a rash. These effects often settle after the first few weeks, but if they persist or bother you, tell your doctor. Serious side effects are uncommon but require medical attention. Low magnesium levels can cause muscle spasms, tremors, palpitations, and seizures. Low vitamin B12 levels can lead to fatigue, tingling in the hands and feet, and memory problems. Bone fractures may occur with long-term use. Clostridium difficile-associated diarrhea presents as watery diarrhea, fever, and stomach cramping and needs urgent medical evaluation. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely. Signs include rash, blisters, peeling skin, and sores in the mouth or eyes. Stop the medication and seek immediate help if these occur. Interstitial nephritis, a kidney inflammation, has also been linked to omeprazole. Symptoms include fever, rash, and decreased urination. If you notice any of these, contact your doctor right away.

Drug Interaction

Omeprazole is metabolized by the liver enzyme CYP2C19, and it also inhibits that enzyme. This means it can affect how other drugs are processed. The interaction with clopidogrel is the most clinically important. Clopidogrel is a prodrug that needs CYP2C19 to become active. Omeprazole blocks that enzyme and reduces clopidogrel's antiplatelet effect, which may increase the risk of heart attack and stroke in patients taking both drugs. If you take clopidogrel, do not start omeprazole without checking with your doctor. Pantoprazole is a better choice for many patients who need both a PPI and clopidogrel. Omeprazole also interacts with rilpivirine, nelfinavir, and saquinavir, all HIV medications, by reducing their absorption. Do not combine them. Methotrexate levels may increase when taken with omeprazole, especially at high doses, and your doctor may need to monitor you. Diazepam, phenytoin, and warfarin are metabolized by CYP2C19, and omeprazole can raise their levels. If you take warfarin, your INR should be monitored when starting or stopping omeprazole. Omeprazole reduces the absorption of drugs that need stomach acid, including ketoconazole, itraconazole, and atazanavir. It can also increase the absorption of digoxin. St. John's wort and rifampin can lower omeprazole levels by inducing CYP2C19 and CYP3A4. Tell your doctor and pharmacist about every medication you take, including over-the-counter products and supplements.

Missed Dose

If you forget a dose of omeprazole, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. Taking a double dose will not heal your ulcer faster and may increase side effects. If you miss several doses in a row, contact your doctor before restarting. Consistency matters for acid suppression because the drug needs to be present in your system regularly to keep acid production under control.

Overdose

Overdose with omeprazole is uncommon. Taking too much may cause drowsiness, blurred vision, rapid heartbeat, nausea, vomiting, and headache. Symptoms are usually mild and resolve without treatment. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent. Contact a poison control centre or go to an emergency department if you or someone else has taken more than the prescribed dose, especially if you have symptoms. Do not try to manage a suspected overdose at home.

Storage

Store omeprazole capsules and tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store the medication in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush medications down the toilet or pour them down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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