Description
Contents
Pantoprazole
Indications/Uses
20 mg tab: For the treatment of mild gastroesophageal reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). For long-term management and prevention of relapse in reflux oesophagitis. Prevention of gastroduodenal ulcers induced by nonselective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
Dosage/Direction for Use
Adults and adolescents 12 years of age and above: Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing): The recommended oral dosage is one gastro-resistant tablet Controloc 20 mg per day.
Long-term management and prevention of relapse in reflux oesophagitis: For long-term management, a maintenance dose of one gastro-resistant tablet Controloc 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Controloc 40 mg is available for this case. After healing of the relapse the dosage can be reduced again to 20 mg pantoprazole.
Adults: 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 coated tablet Controloc 20 mg per day. The use of Controloc 20 mg as a preventive of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications. The increased risk should be assessed according to individual risk factors, e.g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
Children below 12 years of age: Controloc 20 mg is not recommended for use in children below 12 years of age due to limited data in this age group.
Note: A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment. No dose adjustment is necessary in elderly patients or in those with impaired renal function.
Long-term management and prevention of relapse in reflux oesophagitis: For long-term management, a maintenance dose of one gastro-resistant tablet Controloc 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Controloc 40 mg is available for this case. After healing of the relapse the dosage can be reduced again to 20 mg pantoprazole.
Adults: 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 coated tablet Controloc 20 mg per day. The use of Controloc 20 mg as a preventive of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications. The increased risk should be assessed according to individual risk factors, e.g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
Children below 12 years of age: Controloc 20 mg is not recommended for use in children below 12 years of age due to limited data in this age group.
Note: A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment. No dose adjustment is necessary in elderly patients or in those with impaired renal function.
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