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Omeprazole IP 20 mg Capsules


Omeprazole Capsules contain the active substance omeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid that your stomach produces.

Theraupeutic Indication

Omeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid. It is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).
Uses:
ADULTS:
  • To treat symptoms of GERD such as heartburn and acid regurgitation
  • To treat ulcers in the upper part of the intestine (duodenal ulcer)
  • To treat ulcers in the stomach (gastric ulcer)
  • To prevent the duodenal and stomach ulcers from coming back:
  • To treat duodenal and stomach ulcers caused by NSAIDs
  • To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
  • To treat too much acid in the stomach caused by a growth in the pancreas (ZollingerEllison syndrome)
CHILDREN:
To treat symptoms of GORD such as heartburn and acid regurgitation
  • Children over 1 year of age and with a body weight of more than 10 kg may take Omeprazole Capsules. The dose for children is based on the child's weight and the doctor will decide the correct dose
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
  • Children aged over 4 years may take Omeprazole Capsules. The dose for children is based on the child's weight and the doctor will decide the correct dose

Pharmacology

Mechanism of Action:
Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Pharmacokinetic:
Absorpation: The gastro-resistant capsule formulation of omeprazole is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 mL/min.
Distribution:Protein binding is approximately 95%.
Metabolism: Omeprazole is extensively metabolized by the cytochrome P450 (CYP) enzyme system.
Excretion: Following single dose oral administration of a buffered solution of omeprazole, little if any unchanged drug was excreted in urine. The majority of the dose (about 77%) was eliminated in urine as at least six metabolites. Two were identified as hydroxyomeprazole and the corresponding carboxylic acid. The remainder of the dose was recoverable in feces. This implies a significant biliary excretion of the metabolites of omeprazole. Three metabolites have been identified in plasma -the sulfide and sulfone derivatives of omeprazole, and hydroxyomeprazole. These metabolites have very little or no antisecretory activity.

Contraindications

Omeprazole gastro resistant capsules are contraindicated in patients with known hypersensitivity to any component of the formulation.

Adverse Effects

  • fever
  • cold symptoms such as stuffy nose, sneezing, sore throat
  • stomach pain, gas;
  • nausea, vomiting, mild diarrhea; or
  • headache

Pregnancy And Breast-Feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeprazole Capsules if you are breast-feeding.

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