Indications |
Oral Peptic ulcer Adult: 20 mg daily as a single dose or 40 mg daily in severe cases. Treatment duration: Duodenal ulcers: 4 wk; gastric ulcers: 8 wk. Maintenance: 10-20 mg once daily. Hepatic impairment: Dose reduction may be necessary. Oral NSAID-associated ulceration Adult: 20 mg daily. Same dose may also be used for prophylaxis of ulceration in patients who require continued NSAID therapy. Hepatic impairment: Dose reduction may be necessary. Oral H.pylori infection Adult: Dose varies with regimen. As triple therapy: 20 mg bid or 40 mg once daily; requires combination therapy with antibiotics. Therapy is given for 1 wk. Omeprazole may be continued for another 4-8 wk on its own. Hepatic impairment: Dose reduction may be necesary. Oral Gastro-oesophageal reflux disease Adult: 20 mg once daily for 4 wk, may continue for another 4-8 wk if necessary. Maintenance: 10 mg daily. Child: Neonate, 1 mth-2 yr: 700 mcg/kg/day, may increase up to 3 mg/kg/day, or 20 mg daily. >2 yr: <20 kg: 10 mg once daily; ≥20 kg: 20 mg daily. Doses may be doubled if necessary. Hepatic impairment: Dose reduction may be necessary. Oral Zollinger-Ellison syndrome Adult: Initially, 60 mg once daily, adjust according to response. Maintenance: 20-120 mg daily. Doses >80 mg are administered usually in 2 divided doses. Hepatic impairment: Dose reduction may be necessary. Oral Prophylaxis of acid aspiration during general anaesthesia Adult: Initially, 40 mg given the evening before surgery and another 40 mg 2-6 hr before the procedure. Hepatic impairment: Dose reduction may be necessary. Oral Acid-related dyspepsia Adult: 10 or 20 mg daily for 2-4 wk. Hepatic impairment: Dose reduction may be necessary. Oral Erosive oesophagitis Adult: 20 mg/day for 4-8 wk. Maintenance of healing: 20 mg/day for up to 12 mth of total therapy (including treatment period). Hepatic impairment: Dose reduction may be necessary. Intravenous Reflux oesophagitis Adult: By infusion over 20-30 minutes or slow inj over 5 minutes: 40 mg once daily until oral admin is possible. Hepatic impairment: Dose adjustment is required; a daily dose of 10-20 mg may be sufficient. Intravenous Gastric and duodenal ulcers Adult: By infusion over 20-30 minutes or slow inj over 5 minutes: 40 mg once daily until oral admin is possible. Hepatic impairment: Dose adjustment is required; a daily dose of 10-20 mg may be sufficient. Intravenous Prophylaxis of acid aspiration during general anaesthesia Adult: 40 mg, to be given and completed 1 hr before the surgery. May be given via inj over 5 minutes or infusion over 20-30 minutes. Hepatic impairment: Dose adjustment is required; a daily dose of 10-20 mg may be sufficient. Reconstitution: The solution for IV inj is obtained by adding to the vial 10 ml of the solvent provided. (No other solvent should be used). The solution should be given over a period of at least 2.5 min at a max rate of 4 ml/minute; use within 4 hr of reconstitution. The solution for IV infusion is obtained by dissolving 1 vial in 100 ml saline for infusion or 100 ml 5% dextrose for infusion. The solution should be used within 12 hr when dissolved in saline and within 6 hr when dissolved in 5% dextrose. After reconstitution, start the infusion immediately. The constituted solution should not be mixed or co-administered in the same infusion set with any other drug. Infusion should be given over a period of ≥20-30 minutes. |
Warnings / Precautions |
Exclude malignancy, prolonged use, hepatic impairment. Pregnancy, lactation, children <1 yr. Elderly and Asians (increased bioavailability). |
Adverse Reactions |
Diarrhoea, nausea, fatigue, constipation, vomiting, flatulence, acid regurgitation, taste perversion, arthralgia, myalgia, urticaria, dry mouth, dizziness, headache, paraesthesia, abdominal pain, skin rashes, weakness, back pain, upper respiratory infection, cough. Potentially Fatal: Anaphylaxis. |
Overdose Reactions |
Confusion, drowsiness, blurred vision, tachycardia, nausea, flushing, diaphoresis, headache, and dry mouth. Treatment is supportive; not dialysable. |
Drug Interactions |
Decreases absorption of itraconazole, ketoconazole, dasatinib, oral iron salts. Decreases levels of nelfinavir. Increases levels of benzodiazepines (e.g. diazepam, midazolam, triazolam), HMG-CoA reductase inhibitor, CYP2C19 substrates (e.g. citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline), and CYP2C9 substrates (e.g. bosentan, dapsone, fluoxetine, glimepiride, glipizide, losartan, montelukast, nateglinide, paclitaxel, phenytoin, warfarin, and zafirlukast). Decreased levels/effects with CYP2C19 inducers (e.g. aminoglutethimide, carbamazepine, phenytoin, and rifampin). Decreases excretion of methotrexate. Enhances the adverse/toxic effect of cilostazol. May alter the concentrations/effects of clozapine. Avoid concurrent use with clopidogrel. See Below for More omeprazole Drug Interactions |
Lab Interactions |
False negative results in the urea breath test. |
Food Interactions |
Absorption may be delayed. St John's wort decreases omeprazole levels. Avoid ethanol (may cause gastric mucosal irritation). |
Mechanism of Actions |
Omeprazole suppresses gastric acid secretion by specific inhibition of the enzyme system hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) present on the secretory surface of the gastric parietal cell. Onset: Antisecretory: approx 1 hr; peak effect:0.5-3.5 hr. Duration: 72 hr. Absorption: Rapid but variable (oral); dose-dependent. Bioavailability: Oral: approx 30-40%. Distribution: Protein-binding: 95%. Metabolism: Extensively hepatic; converted to hydroxyomeprazole and omeprazole sulfone. Excretion: Via urine (77%) and bile. Elimination half-life: 0.5-3 hr. |
Administration |
Cap: Should be taken with food. (Take immediately before a meal.) MUPS tab: May be taken with or without food. Powd for oral susp: Should be taken on an empty stomach. (Take on an empty stomach at least 1 hr before a meal.) |
Storage Conditions |
Intravenous: Store at 15-30 °C. Protect from light. Oral: Store at 15-30 °C. Protect from light. |
ATC Classification |
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD). |
Storage |
Intravenous: Store at 15-30 °C. Protect from light. Oral: Store at 15-30 °C. Protect from light. |
Available As |
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Omeprazole
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Drug - Drug Interactions of Omeprazole
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