About
Somac: IndicationsI. For the symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: 1.Duodenal ulcer 2.Gastric ulcer 3.Gastro-oesophageal reflux disease (GORD) - For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) - Reflux oesophagitis 4.Zollinger-Ellison Syndrome II. Eradication of Helicobacter pylori (hereinafter referred to as H. pylori) in combination with -clarithromycin and amoxycillin or -clarithromycin and metronidazole or -amoxycillin and metronidazoleIII. Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. Dosage and AdministrationDuodenal UlcerThe recommended oral dosage is one gastro-resistant tablet SOMAC 40mg per day. A duodenal ulcer generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.Gastric UlcerThe recommended oral dosage is one gastro-resistant tablet SOMAC 40mg per day.A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.GORDFor mild reflux disease and the associated symptoms, the recommended dosage is one SOMAC 20mg tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If symptom control has not been achieved after four weeks treatment with SOMAC 20mg tablets daily, further investigation is recommended.For treatment of reflux oesophagitis, the recommended oral dosage is one SOMAC 40mg tablet per day. A 4-week period is usually required for treatment of reflux oesophagitis, however if this is not sufficient, healing will usually be achieved within a further 4 weeks.Zollinger-Ellison SyndromeThe recommended oral dosage is one gastro-resistant tablet SOMAC 40mg per day.Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.The recommended oral dosage is one gastro-resistant tablet SOMAC 20mg per day.MaintenanceDuodenal and Gastric Ulcer, and Zollinger-Ellison Syndrome:For long-term management, a maintenance dose of one gastro-resistant tablet SOMAC 40mg per day is recommended.Reflux OesophagitisA maintenance dose of one SOMAC 20mg tablet per day is recommended, increasing to 40mg per day if relapse occurs. After healing of the relapse the dosage can be reduced again to 20mg SOMAC.Experience with long-term administration in man over several years is available in a limited number of patients. Therefore, long-term treatment exceeding 1 year may be considered after careful evaluation of the risk benefit ratio. Patients should then be kept under regular surveillance.Use in childrenThere are no data currently available on the use of pantoprazole in children.Use in the elderlyThe daily dose of 20 mg or 40mg can be given. An exception is combination therapy for eradication of H. pylori, where also elderly patients should receive the usual pantoprazole dose (2 x 40mg/day) during 1-week treatment.Impaired Renal FunctionThe daily dose of 20mg or 40mg can be given.Impaired Liver FunctionIn patients with severe liver impairment the dose has to be reduced to 20mg pantoprazole per day.
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Somac Pack
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