ACIFRE Omeprazole 40mg Capsule 1's
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Features
- Omeprazole
Description
Indications/Uses
Injection: Benign gastric ulcer, gastric acid reduction, acid reflux disease, acid-related dyspepsia.
Dosage/Direction for Use
Dyspepsia: 10 to 20 mg daily for 2 to 4 weeks or as prescribed by the physician.
Peptic ulcer disease: 20 mg daily as single dose, or 40 mg in severe cases or as prescribed by the physician.
NSAID-associated ulceration: 20 mg daily or as prescribed by the physician.
Zollinger-Ellison syndrome: 60 mg once daily or as prescribed by the physician.
Acid aspiration prophylaxis during general anesthesia: 40 mg in the evening before surgery and further 40 mg two to six hours before the procedure or as prescribed by the physician.
Injection: Omeprazole inhibits secretion of gastric acid and is irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase (H+/K+ATPase), the proton-pump of the gastric parietal cell.
Relief of Acid-Related Dyspepsia: Usual Dose: 10 or 20 mg daily orally for 2-4 weeks.
Gastroesophageal Reflux Disease: Usual Dose: 20 mg orally once daily for 4 weeks, followed by further 4-8 weeks if not fully healed.
Refractory Esophagitis: 40 mg daily may be used. Children weighing 10-20 kg: 10 mg daily orally; >20 kg: 20 mg daily.
Eradication of Helicobacter pylori in Peptic Ulceration: Omeprazole may be combined with antibacterials in dual triple therapy. Effective triple therapy regimens include omeprazole 20 mg twice daily combined with: Amoxicillin 500 mg and metronidazole 400 mg, both 3 times daily; clarithromycin 500 mg and metronidazole 400 mg or (tinidazole 500 mg both twice daily; or with amoxicillin 1 g and clarithromycin 500 mg both twice daily). These regimens are given for 1 week.
Dual therapy regimens eg, omeprazole 40 mg daily with either amoxicillin 750 mg to 1 g twice daily or clarithromycin 500 mg, 3 times daily, are less effective and must be given for 2 weeks. Omeprazole alone may be continued for a further 4-8 weeks.
Administration: Omeprazole may be given orally as the base or magnesium salt, or IV as the sodium salt.
Overdosage
Management is symptomatic and supportive treatment.
Contraindications
Special Precautions
Use In Pregnancy & Lactation
Adverse Reactions
Drug Interactions
Capsule: Omeprazole may increase gastrointestinal pH, concurrent use with ampicillin esters, iron salts or ketoconazole may result in a reduction in absorption of these medications. Inhibition of the cytochrome P450 enzyme system by omeprazole, especially in high doses, may cause a decrease in the hepatic metabolism of anticoagulants (coumarin or indandione-derivative), diazepam or phenytoin, which may result in delayed elimination and increased blood concentrations, when these medications are used concurrently with omeprazole.
Concurrent use of omeprazole with bone marrow depressants may increase the leukopenic and/or thrombocytopenic effects of both medications. If concurrent use is required, close observation for toxic effects should be considered.
Storage
Injection: Store in a cool, dry place. Protect from light.
Shelf-Life: Vial: 24 months.
Action
Pharmacokinetics: Omeprazole is rapidly but variably absorbed following oral administration. Absorption is not affected by food. Omeprazole is acid-labile and pharmacokinetics may vary between the various formulations developed to improve oral bioavailability. The absorption of omeprazole also appears to be dose-dependent; increasing the dosage above 40 mg has been reported to increase the plasma concentrations in a non-linear fashion because of saturable first-pass hepatic metabolism. In addition, bioavailability is higher after long-term administration. Bioavailability of omeprazole may be increased in elderly patients, in some ethnic groups such as Chinese, and in patients with impaired hepatic function, but is not markedly affected in patients with renal impairment. On absorption, omeprazole is almost completely metabolized in the liver, primarily by the cytochrome P450 isoenzyme CYP2C19 to form hydroxyomeprazole, and to a small extent by CYP3A4 to form omeprazole sulfone. The metabolites are inactive and are excreted mostly in the urine and to a lesser extent in bile. The elimination half-life from plasma is reported to be about 0.5 to 3 hours. Omeprazole is highly bound (about 95%) to plasma proteins.