Trade Names:Prilosec- Capsules, delayed-release 10 mg- Capsules, delayed-release 20 mg- Capsules, delayed-release 40 mg
Trade Names:Prilosec- Suspension, delayed-release, oral 2.5 mg- Suspension, delayed-release, oral 10 mg
Trade Names:Prilosec OTC- Tablets, delayed-release 20 mgApo-Omeprazole (Canada)Losec (Canada)Losec MUPS (Canada)
Suppresses gastric acid secretion by blocking acid (proton) pump within gastric parietal cell.
Absorption is rapid. T max is 0.5 to 3.5 h. Bioavailability is 30% to 40% and increases upon repeat administration.
95% is protein bound.
Extensive in the liver by the CYP enzyme system.
Little is unchanged drug in the urine. Approximately 77% is eliminated as 6 metabolites; the remainder is eliminated in the feces. The half-life is 0.5 to 1 h. Total body Cl is 500 to 600 mL/min.
Up to 72 h.
There is slight increase in bioavailability in patients with chronic renal function impairment. No dose adjustment necessary.Hepatic Function Impairment
In patients with chronic hepatic disease, bioavailability is increased, plasma half-life is increased to 3 h, and plasma Cl is decreased. Consider dose adjustment.Elderly
The elimination rate is decreased. Bioavailability is increased. No dosage adjustment is necessary.Race
AUC is increased approximately 4-fold in Asian patients. Consider dose adjustment.
Short-term treatment of active duodenal ulcer; in combination with clarithromycin and amoxicillin to eradicate Helicobacter pylori ; in combination with clarithromycin to eradicate H. pylori ; short-term treatment of active benign gastric ulcer; treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD); short-term treatment of erosive esophagitis that has been diagnosed by endoscopy; maintenance of healing of erosive esophagitis; long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis).Nonprescription
Treatment of frequent heartburn that occurs 2 or more times a week.
As alternate-day therapy in maintaining ulcer or GERD remission rates during long-term treatment after healing during a short course of therapy; treatment of GERD-related laryngitis symptoms in patients who have not responded to antireflux measures alone; treatment of GERD-related laryngitis; treatment of GERD in infants and children; in combination with antibiotics (eg, amoxicillin, clarithromycin) for eradication of H. pylori in children; to improve enzyme absorption in cystic fibrosis patients with intestinal malabsorption.
PO 20 mg/day for 4 to 8 wk.GERD and Maintenance of Healing of Erosive EsophagitisChildren 1 yr of age and older
PO Weighing 5 to less than 10 kg, the dosage is 5 mg daily.
Weighing 10 kg to less than 20 kg, the dosage is 10 mg daily.
Weighing 20 kg or more, the dosage is 20 mg daily.GERD Without Esophageal LesionsAdults
PO 20 mg daily for up to 4 weeks.GERD with Erosive EsophagitisAdults
PO 20 mg/day for 4 to 8 wk. For maintenance treatment, give 20 mg/day.Pathologic Hypersecretory ConditionsAdults
PO For initial dosage, give 60 mg/day. Dosages up to 120 mg 3 times daily have been given. Divide daily doses of more than 80 mg.H. pyloriAdults (triple therapy)
PO Omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1,000 mg each given 2 times daily for 10 days; continue omeprazole 20 mg/day for an additional 18 days if an ulcer is present at start of therapy.Adults (dual therapy)
PO Omeprazole 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days; continue omeprazole 20 mg/day for an additional 14 days if an ulcer is present at start of therapy.Gastric UlcerAdults
PO 40 mg once daily for 4 to 8 wk.Heartburn (OTC)Adults
PO 1 tablet (20 mg) daily for 14 days. The 14-day course may be repeated every 4 mo.
Store packets for delayed-release oral suspension at 59° to 86°F. Store capsules at controlled room temperature (59° to 86°F). Protect capsules from light and moisture.
Plasma concentrations may be reduced by omeprazole, decreasing the efficacy. Coadministration with omeprazole is not recommended.Benzodiazepines (eg, diazepam)
Cl of benzodiazepines may be decreased.Cilostazol, tacrolimus
Plasma levels may be increased by omeprazole, increasing the therapeutic effects and adverse reactions.Clarithromycin
Omeprazole and clarithromycin plasma concentrations may be elevated.Cyclosporine
Coadministration of omeprazole has been reported to result in increased, decreased, and unaltered cyclosporine concentrations. Measure cyclosporine concentrations frequently when starting or stopping omeprazole.Drugs depending on gastric pH for bioavailability (eg, ampicillin, cyanocobalamin, digoxin, erlotinib, itraconazole, ketoconazole, indinavir, iron salts)
Absorption of these drugs may be affected.Ginkgo biloba, St. John's wort
Omeprazole plasma concentrations may be reduced, decreasing the therapeutic effect.Phenytoin
Decreased plasma Cl and increased phenytoin half-life.Saquinavir
Plasma concentrations may be elevated by omeprazole, increasing the risk of adverse reactions. Consider saquinavir dose reduction.Serotonin reuptake inhibitors (eg, escitalopram)
Plasma concentrations may be elevated by omeprazole. If an interaction is suspected, the dose of the serotonin reuptake inhibitor may need to be adjusted when starting or stopping omeprazole.Voriconazole
Omeprazole plasma concentrations may be elevated, which may necessitate dosage adjustments in patients with Zollinger-Ellison syndrome.Warfarin
Increased INR and PT, which may lead to abnormal bleeding and increase the risk of death.
None well documented.
Angina, bradycardia, chest pain, elevated BP, palpitations, peripheral edema, tachycardia (postmarketing).
Headache (7%); dizziness (2%); asthenia (1%); abnormal dreams, aggression, agitation, anxiety, apathy, confusion, depression, fatigue, hallucinations, insomnia, malaise, nervousness, paresthesia, sleep disturbances, somnolence, tremors, vertigo (postmarketing).
Rash (2%); alopecia, dry skin, erythema multiforme, hyperhidrosis, photosensitivity, petechiae, pruritus, purpura, skin inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria (postmarketing).
Anterior ischemic optic neuropathy, blurred vision, double vision, dry eye syndrome, ocular irritation, optic atrophy, optic neuritis, pharyngeal pain, taste perversion, tinnitus (postmarketing).
Abdominal pain (5%); diarrhea, nausea (4%); flatulence, vomiting (3%); acid regurgitation, constipation (2%); abdominal swelling, anorexia, dry mouth, esophageal candidiasis, fecal discoloration, gastric fundic gland polyps, gastroduodenal carcinoids, irritable colon, mucosal atrophy of the tongue, pancreatitis, stomatitis (postmarketing).
Elevated serum creatinine, glucosuria, gynecomastia, hematuria, interstitial nephritis, microscopic pyuria, proteinuria, testicular pain, urinary frequency, UTI (postmarketing).
Cholestatic disease, elevated LFTs (alkaline phosphatase, bilirubin, ALT, AST, gamma-glutamyl-transferase), hepatic encephalopathy, hepatic failure (some fatal), hepatocellular disease, jaundice, liver necrosis, mixed hepatitis (postmarketing).
Agranulocytosis, anemia, hemolytic anemia, leukocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia (postmarketing).
Anaphylactic shock, anaphylaxis, bronchospasm, interstitial nephritis, urticaria (postmarketing).
Hypoglycemia, hyponatremia (postmarketing).
Back pain (1%); joint pain, leg pain, muscle cramps, muscle weakness, myalgia (postmarketing).
Upper respiratory tract infection (2%); cough (1%); epistaxis (postmarketing).
Fever (children, 33%); accidental injury (4%); pain (postmarketing).
Category C .
Excreted in breast milk.
Safety and efficacy not established in children younger than 1 yr of age.
No dosage adjustment is necessary in elderly patients.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving penicillin therapy. Before starting combination therapy with amoxicillin therapy, assess if patient has an allergy to penicillins, cephalosporins, or other allergens.
No dosage adjustment is needed.
Consider dosage adjustment in patients with hepatic function impairment, especially for maintenance of healing of erosive esophagitis.
Has been reported in gastric corpus biopsies in patients treated with long-term omeprazole.
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Blurred vision, confusion, diaphoresis, drowsiness, dry mouth, flushing, headache, nausea, tachycardia, vomiting.
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