Some minor drug interactions may not be clinically relevant in all patients. You may report side effects to FDA at 1-800-FDA-1088.This Medication Guide summarizes the most important information about omeprazole delayed-release capsules. This information does not take the place of talking with your doctor about your medical condition or your treatment.Omeprazole delayed-release capsules can have other serious side effects. It comes in different strengths of 10mg, 20 mg, and 40 mg tablets or capsule and oral suspension of 2.5 mg or 10 mg. Omeprazole is sold under the following brand names: Prilosec; Prilosec OTC The primary efficacy end point of the study was clinically important upper GI bleeding (defined as bright red blood that did not clear after tube adjustment and 5-10 minutes of lavage or positive test for occult blood in gastric aspirate [''coffee ground material''] for 8 consecutive hours on days 1 and 2, or for 2-4 hours on days 3-14 that did not clear with 100 mL of lavage). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. Also, the manufacturer states that antacids, antacid/alginic acid combinations, histamine HOmeprazole usually is administered once daily in the morning; however, administering the drug in divided doses (e.g., every 12 hours) has been reported to improve efficacy in patients receiving more than 80 mg daily.The manufacturer states that omeprazole dosage adjustments based on age are not necessary in geriatric patients. Published observational studies suggest that PPI therapy like omeprazole may be associated with an increased risk of Although most of the reported cases occurred in patients receiving high doses of methotrexate, toxicity also has been reported in patients receiving low dosages of methotrexate (e.g., 15 mg per week) concomitantly with a proton-pump inhibitor. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of omeprazole sulfone. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (about 3.4 times a human dose of 40 mg/day, based on body surface area) for one year, and then followed for an additional year without the drug. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes) and always be stirred just before drinking and rinsed down with half a glass of water. Physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis).Effects on maternal bone were observed in pregnant and lactating rats in the pre- and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from administration of omeprazole in dosages of 13.8-138 mg/kg daily (about 5.6-56 times the human dosage of 20 mg daily based on body surface area) to parents.There are no adequate and controlled studies using omeprazole in pregnant women. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate.The capsule shells contains: D&C Red No. In dosages ranging from 20 mg every other day to 360 mg daily, omeprazole can maintain basal acid secretion below 5 or 10 mEq/hour in patients who have or have not undergone gastric surgery, respectively. The bioavailability of omeprazole increases slightly upon repeated administration of omeprazole delayed-release capsules.The plasma concentrations of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of omeprazole. To further evaluate this safety issue, FDA intends to analyze data obtained from several large, long-term, placebo-controlled trials of bisphosphonates in women at risk for osteoporosis-related fractures to assess risk of fractures based on use or nonuse of proton-pump inhibitors.The mechanism by which proton-pump inhibitors may increase risk of fractures has not been elucidated, but it has been suggested that the mechanism may involve decreased insoluble calcium absorption secondary to increased gastric pH. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.Avoid concomitant use with omeprazole.
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