Dosage and administration | Dosage: |
---|---|
Contraindications | Hypersensitivity to omeprazole and any of the excipients of this medicine. |
Warnings and precautions for use | In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis. |
Recommendation for pregnancy and breastfeeding | Pregnancy: |
Effects on ability to drive and use machines | Caution should be exercised when driving vehicles and operating machinery because this medicine may cause headache, drowsiness, dizziness. |
Interactions, incompatibilities of medicine | Effects of omeprazole on the pharmacokinetics of other active substances: |
Undesirable effects (ADRs) | The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. |
Overdose and management | Single doses up to 160 mg have been well tolerated. |
Pharmacodynamic properties | Omeprazole is a substituted benzimidazole which has structures and effects similar to pantoprazole, lansoprazole, esomeprazole. Omeprazole inhibits gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system, also called proton pump, at the secretory surface of the gastric parietal cell. Maximum effects are achieved within 4 days of commencing treatment. In duodenal ulcer patients, a mean decrease of at least 80% in 24-hour intragastric acidity can be maintained. |
Pharmacokinetic properties | Absorption: |
Storage conditions, shelf-life, quality specification of the medicine | Storage conditions: Protect from humidity and light, below 30 degrees C. |
AGIMEPZOL®20
Composition: Each hard capsule contains:
AGIMEPZOL 20
Omeprazole . . . . . . . . . . . . . . . . . . . . . . 20 mg
(as Omeprazole enteric coated pellet 8.5%).
Presentation:
AGIMEPZOL 20: Box of 10 blisters x 10 hard capsules; HD bottle contains 200 hard capsules.
Indications:
Agimepzole hard capsules are indicated for:
Adults:
Treatment of duodenal ulcers.
Prevention of relapse of duodenal ulcers.
Treatment of gastric ulcers.
Prevention of relapse of gastric ulcers.
Combination with appropriate antibiotics to eradicate H. pylori in peptic ulcer disease.
Treatment of NSAID-associated gastric and duodenal ulcers.
Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk.
Treatment of reflux esophagitis.
Long-term management of patients with healed reflux esophagitis.
Treatment of symptomatic gastro-esophageal reflux disease.
Treatment of Zollinger-Ellison syndrome.
Children:
Children aged over 1 year and ≥ 10kg:
Treatment of reflux esophagitis.
Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease.
Children and adolescents over 4 years of age:
Treatment of duodenal ulcer caused by H. pylori in combination with antibiotics.
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