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GENERIC NAME: omeprazole, omeprazole/sodium bicarbonate

BRAND NAME: Prilosec, Zegerid DRUG CLASS AND MECHANISM: Omeprazole is in a class of drugs called proton pump inhibitors (PPI) that block the production of acid by the stomach. Other drugs in the class include lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esomeprazole (Nexium). Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome, which are all caused by stomach acid. Omeprazole, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Zegerid contains omeprazole and an antacid (sodium bicarbonate). The FDA approved omeprazole in September 1989. GENERIC AVAILABLE: Yes (Prilosec) PRESCRIPTION: Yes; No (Prilosec OTC, Zegerid OTC) PREPARATIONS: Capsules: 10, 20 and 40 mg. Tablets: 20 mg (Prilosec OTC). Powder for oral suspension: 20 and 40 mg STORAGE: Capsules should be stored at 15 to 30 C (59 to 86 F) and tablets at 20 to 25 C (68 to 77 F). They should be kept away from moisture and light. PRESCRIBED FOR: Omeprazole is used for treating acid-induced inflammation and ulcers of the stomach and duodenum; gastroesophageal reflux disease (GERD); erosive esophagitis, heartburn; prevention of upper gastrointestinal bleeding in critically ill patients; and ZollingerEllison Syndrome. It also is used in combination with antibiotics for eradicating H. pylori infection of the stomach. DOSING: For ulcers, GERD, erosive esophagitis and eradication of H. pylori the recommended dose for adults is 20-40 mg daily. Ulcer healing usually occurs within 4-8 weeks. H. pylori infections are treated for 10-28 days. The usual dose for prevention of upper gastrointestinal bleeding in critically ill patients is 40 mg daily for 14 days. Prilosec OTC is used for treating heartburn for up to two weeks, and the usual dose is 20 mg daily. For the management of Zollinger-Ellison Syndrome the starting dose for adults is 60 mg daily, and the dose is adjusted based on either the response of symptoms or the actual measurement of acid production. Doses greater than 80 mg should be divided. Doses up to 120 mg three times a day have been used in the treatment of Zollinger-Ellison Syndrome.

chewed or opened. Through unknown mechanisms. Omeprazole should not be used with clopidogrel. the . gastric proton pump) of the gastric parietal cell. The most common side effects are diarrhea. This may reduce the effectiveness of ketoconazole or increase digoxin toxicity. The dose of cilostazol should be reduced from 100 mg twice daily to 50 mg twice daily when given with omeprazole. weakness. SIDE EFFECTS: Omeprazole like other PPIs is well-tolerated. Therefore. abnormal heartbeat. being directly responsible for secreting H+ ions into the gastric lumen. Omeprazole reduces the activity of these enzymes and potentially can reduce the activity of clopidogrel. The proton pump is the terminal stage in gastric acid secretion. DRUG INTERACTIONS: Omeprazole potentially can increase the concentrations in blood of diazepam (Valium). swallowed whole and should not be crushed. warfarin (Coumadin). The absorption of certain drugs may be affected by stomach acidity. the dose of saquinavir may need to be reduced to avoid toxicity. muscle pain. Each packet of Zegerid powder for oral suspension contains 460 mg of sodium and each capsule contains 304 mg of sodium. and the doses of nelfinavir and atazanavir may need to be increased to maintain efficacy Clopidogrel (Plavix) is converted to its active form by enzymes in the liver. Accordingly. nausea. headaches. PREGNANCY: Use of omeprazole in pregnant women has not been adequately evaluated. MECHAnisms: Proton pump inhibitors act by irreversibly blocking the hydrogen/potassium adenosine triphosphatase enzyme system (the H+/K+ ATPase. or. Omeprazole should be used during pregnancy only if the benefits justify the unknown risks.For maximal efficacy. making it an ideal target for inhibiting acid secretion. more common. vomiting. omeprazole tablets should be taken before meals. and phenytoin (Dilantin) by decreasing the elimination of these drugs by the liver. Omeprazole increases the concentration of cilostazol (Pletal). and water retention occur infrequently. NURSING MOTHERS: Omeprazole is excreted in breast milk and potentially could cause adverse effects in the infant. drugs that are used for treating patients with infection caused by the human immunodeficiency virus (HIV). This should be taken into consideration in patients who need a sodium restricted diet. ("Irreversibility" refers to the effect on a single copy of the enzyme. leg cramps. omeprazole may increase blood levels of saquinavir and reduce blood levels of nelfinavir and atazanavir. rash and dizziness. omeprazole as well as other PPIs reduce the absorption and concentration in blood of ketoconazole (Nizoral) and increase the absorption and concentration in blood of digoxin (Lanoxin). Nervousness.

is decreased by concomitant food intake.[7][8] The elimination half-life of proton pump inhibitors ranges from 0. particularly of vitamin B12 and of calcium. The inactive form is neutrally charged (lipophilic) and readily crosses cell membranes into intracellular compartments (like the parietal cell canaliculus) that have acidic environments. has been discontinued in 2007. results in a class of drugs that are significantly more effective than H2 antagonists and reduce gastric acid secretion by up to 99%. In an acid environment. It has been reported that these pharmacokinetic effects. which can be exacerbated by stomach acid. Adverse effects In general.[6] [edit] Pharmacokinetics In general. however the effect of a single dose on acid secretion usually persists up to 2–3 days. In addition. however.) Targeting the terminal step in acid production. the absorption of lansoprazole and esomeprazole is decreased and delayed by food. lack of stomach acid is also called hypochlorhydria. the absorption of proton pump inhibitors is unaffected by co-administration with food. however. however. or HCl. However. The range and occurrence of adverse effects are similar for all of the proton pump inhibitors.[5] The development of soraprazan. and the incidence of short-term adverse effects is relatively uncommon. have no significant impact on efficacy. as the enzymes are naturally destroyed and replaced with new copies. as well as the irreversible nature of the inhibition. proton pump inhibitors are well tolerated. The proton pump inhibitors are given in an inactive form. Soraprazan and revaprazan block H+ secretion much more quickly than classical PPIs (within a half-hour). deactivating it.effect on the overall human digestive system is reversible. though they have been reported more frequently with omeprazole. clinical experience. the inactive drug is protonated and rearranges into its active form. [edit] Potassium-competitive acid blockers (P-CABs) Potassium-competitive inhibitors are experimental drugs that reversibly block the potassium binding site of the proton pump.5–2 hours. This may be due to its longer availability and. and reduces the pain from indigestion and heartburn. As described above. hence. The lack of the acid in the stomach will aid in the healing of duodenal ulcers. the lack of sufficient hydrochloric acid. Hydrochloric acid is required for the digestion of proteins and for the absorption of nutrients. the active form will covalently and irreversibly bind to the gastric proton pump. . This is because of accumulation of the drug in parietal cell canaliculi and the irreversible nature of proton pump inhibition. The rate of omeprazole absorption.

it has been suggested that patients at higher risk of pneumonia should be prescribed proton pump inhibitors only at lower doses and only when necessary.Common adverse effects include: headache. This new information is based upon FDA review of several long-term studies that reported an increased risk of fractures of the hip. of about 100 mcg of B12 with the PPI.7 with once daily use and 2. Those taking smaller doses for 1 to 4 years were 1. is associated with an increased risk of community-acquired pneumonia.[13] Long-term use of proton pump inhibitors has been less studied. using H2-receptor antagonists and proton pump inhibitors. anxiety. fatigue.6 times more likely to break a hip.[19] The FDA is revising both the prescription and the over-the-counter (OTC) labels for PPIs to include the possible increased risk of fractures. the reduction of vitamin B12 (by raising homocysteine) may increase bone fragility. and acute interstitial nephritis. itch.[12] The risk can be minimized by judicious short term prescriptions.[14][15][16] Theories as to the cause of the increase are the possibility that the reduction of stomach acid reduces the amount of calcium dissolved in the stomach or that PPIs may interfere with the breakdown and rebuilding of bone by interfering with the acid production of osteoclasts.[11] PPIs have been shown to raise risk of Clostridium difficile infection by 1. Stevens Johnson syndrome.000 people 50 or older.[9] Infrequent adverse effects include rash.6 times more likely to break a hip.[9] Rarely PPI cause ‘idiosyncratic’ reactions such as erythema multiforme. It is suspected that acid suppression results in insufficient elimination of pathogenic organisms. But. or by the co-packaging. those taking high doses of PPIs for longer than one year have been found to be 2. in a study of 135.2 to 1. . nausea. and depression. diarrhea. The risk of a fracture increased with the length of time taking PPIs. [17] Also.4 with more than once daily use.[10] It has been observed that gastric acid suppression. Decreased vitamin B12 absorption may occur with long-term use. wrist. Therefore. an effect that may be offset by the consumption. flatulence. Some studies found a greater risk for these fractures from higher doses of PPI or use for one year or more. and spine with PPI use. constipation. Most studies evaluated individuals aged 50 or older and the increased risk of fractures was primarily in this group.[18] A 2009 report in Gastroenterology suggests that PPIs may cause dependency by increasing gastric symptoms if they are discontinued. but a PPI treatment should not be added to the antiplatelet dual therapy without formal indication. pancreatitis. A recent study has also suggested that proton pump inhibitors significantly decreased the effect of clopidogrel on platelets as tested by VASP phosphorylation. abdominal pain. and dizziness. The clinical impact of these results must be assessed by further investigations.