Gastrazole ( omeprazole ) is indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as : Duodenal ulcer. Gastric ulcer. NSAID-associated gastric and duodenal ulcers. Reflux esophagitis. Symptomatic gastroesophageal reflux disease ( GERD), i.e., heartburn and regurgitation. Zollinger-Ellison syndrome ( pathological hypersecretory condition). Eradication of Helicobacter pylori ( H. pylori ).

DOSAGE OF Gastrazole CAP

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The recommended dose is : –

Gastrazole capsules are recommended to be given in the morning 7 swallowed whole with a glass of water. The capsules should not be chewed or crushed. For patients with swallowing difficulties: The capsule can be opened & contents swallowed directly with half a glass of water or after mixing the contents in a slightly acidic fluid e.g. fruit juice or in a non-carbonated water. The dispersion should be taken immediately ( or within 30 minutes). Always stir just before drinking. Rinse it down with glass of water. Alternatively patients can suck the capsule and swallow the pellets with half a glss of water. Ingest without chewing the enteric-coated pellets. Duodenal ulcer: The recommended oral dose is 20 mg given once daily. Healing usually occures within two weeks. For patients not healed after this initial course of therapy, an additional two weeks of treatment is recommended. Refractory patients: In patients with duodenal ulcer refractory to other treatment regimens, the recommended adult doses are 20 mg or 40 mg given once daily. Healing is usually achieved within four weeks. For prevention of relapse in patients with Duodenal ulcer: The recommended Gastrazole ( omeprazole) dose is 10 mg once daily, increased to 20-40 mg once daily, as necessary. For NSAID associated duodenal ulcers see NSAID associated gastroduodenal lesions. For eradiaction of Helicobacter pylori see Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease. Gastric ulcer: The recommended adult dose is 20 mg given once daily. Healing usually occurs within four weeks . For patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended. Refractory patients: In patients with gastric ulcer refractory to other treatment regimens, the recommended dose is 40 mg given once daily. Healing is usually achieved within eight weeks. For prevention of relapse in patients with poorly responsive gastric ulcer: The recommended Gastrazole dose is 20 mg once daily, increased to 40 mg once daily, as necessary. For NSAID associated duodenal ulcers see NSAID associated gastroduodenal lesions. For eradiaction of Helicobacter pylori see Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease. NSAID-Associated Gastric or Duodenal ulcers or gastroduodenal erosions in patients with or without continued NSAID treatment. The recommended adult dose is 20 mg given once daily. Symptom resolution is rapid and healing usually occurs within four weeks. For those patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended. For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions & dyspeptic symptoms the recommended adult dose is 20 mg given once daily. Helicobacter pylori-Associated peptic ulcer disease. Triple therapy regimen: Gastrazole 20 mg , amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. Or Gastrazole 20 mg , metronidazole 500 mg and clarithromycin 250 mg, all twice daily for seven days. Or 40 mg Gastrazole once daily with amoxicillin 500 mg & metronidazole 400 mg both three times a day for one week. Dual therapy regimes: Gastrazole 40-80 mg daily with amoxicillin 1.5 g daily in divided doses for two weeks. In clinical studies daily doses of 1.5-3 g of amoxicillin have been used. Or Gastrazole 40 mg once daily and clarithromycin 500 mg three times a day for two weeks. To ensure healing in patients with active peptic ulcer disease. In each regimen if the patient is still Hp positive, therapy must be repeated. Helicobacter pylori-Associated peptic ulcer disease. Triple therapy regimen: Gastrazole 20 mg , amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. Or Gastrazole 20 mg , metronidazole 500 mg and clarithromycin 250 mg, all twice daily for seven days. Or 40 mg Gastrazole once daily with amoxicillin 500 mg & metronidazole 400 mg both three times a day for one week. Dual therapy regimes: Gastrazole 40-80 mg daily with amoxicillin 1.5 g daily in divided doses for two weeks. In clinical studies daily doses of 1.5-3 g of amoxicillin have been used. Or Gastrazole 40 mg once daily and clarithromycin 500 mg three times a day for two weeks. To ensure healing in patients with active peptic ulcer disease. In each regimen if the patient is still Hp positive, therapy must be repeated. Reflux Esophagitis: The recommended adult dose is 20 mg given once daily . Symptoms resolution is rapid & in most patients , healing occurs within four weeks. For patients not healed after this initial course of therapy, healing usually occurs during a further four weeks treatment period. In patients with severe reflux esophagitis Gastrazole 40 mg given once daily. Healing is usually achieved within eight weeks. Maintenance therapy ( long-term management) patients with healed reflux esophagitis, the recommended dose is 10 mg omeprazole, if needed the dose can be increased to 20-40 mg Gastrazole once daily. Symptomatic Gastroesophageal reflux disease: The recommended adult dose is 20 mg given once daily. Symptoms relief should be rapid. Patients respond adequately to 10 mg given once daily, individual dose adjustment should be considered. If symptom control is not achieved after four weeks, further investigation is recommended. Acid related dyspepsia: In the relief of symptoms in patients with epigastricpain/ discomfort with or without heartburn the recommended adult dose is 20 mg given once daily. Patients may respond adequately to 10 mg given once daily, individual dose adjustment . Should be considered as a starting dose . If symptom control has not been achieved after 4 weeks treatment with Gastrazole 20 mg daily, further invesrigation is recommended. Zollinger-Ellison Syndrome: The dose used in the treatment of Zollinger-Ellison Syndrome will vary with the individual patient. The recommended initial dose is 60 mg , giveb once daily. More than 90% of the patients with the severe form of the disease and inadequate response to other therapies have been adequaltely controlled with doses of 20 mg to 120 mg daily. With doses greater than 80 mg, the dose should be divided and given twice daily. Patients with renal insufficiency: No dose adjustment is required. Patients with hepatic insufficiency: As the bioavailability & plasma half life of omeprazole are increased in patients with impaired hepatic function a daily dose of 10-20 mg is sufficient. Elderly patients: No dose adjustment is required. Children: There is only limited experience of treatment in children.

OVER-DOSAGE OF Gastrazole CAP

Probably low acute toxicity, 320-800 mg to adults resulted in low intoxication, 560 mg to adults resulted in moderate intoxication. Symptoms: naused, vomiting, dizziness, abdominal pain, apathy, flatulence, blood vessels dilatation, tachycardia, diarrhea and headache. Single cases of , depression and confusion have been described. Treatment: If necessary, gastric lavage, charcoal. Symptomatic therapy.

CONTRA-INDICATION OF Gastrazole CAP

Known hypersensitivity to omeprazole. Omeprazole like other PPIs should not be administered with atazanavir.

STORAGE OF Gastrazole CAP

Store at room temperature not exceeding 30 °C. Store in a dry place.
PACK OF Gastrazole CAP
A carton box containing a plastic bottle of ( 14 Scarlet red H.G. Capsules containing off-white micro granules and desiccant capsule ) and inner leaflet.
Gastrazole CAP MANUFACTURED BY
EUROPEAN EGYPTIAN PHARM. IND. ALEXANDRIA – EGYPT.

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