Controloc Dosage/Direction for Use

20 mg tab: Unless otherwise prescribed, the following oral doses apply. Follow these instructions otherwise there is the risk that the drug may not act properly.
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.
Type and duration of treatment: Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing): Symptom relief is generally accomplished within 2-4 weeks, and a 4-week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.
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.
40 mg tab: The following information applies unless Controloc 40 mg has been otherwise prescribed by the doctor. Follow these instructions, as otherwise Controloc 40 mg may not have the desired effect.
Adults and adolescents 12 years of age and above: Treatment of moderate and severe reflux oesophagitis: One tablet of Controloc 40 mg per day. In individual cases, the dose may be doubled (increase to 2 tablets Controloc 40 mg daily) especially when there has been no response to other treatment.
Adults: Eradication of H. pylori in combination with two appropriate antibiotics: In cases of duodenal or gastric ulcer in which infection with Helicobacter pylori has been confirmed, the microorganism should be eradicated by combination treatment. Depending on the resistance pattern, the following combinations are recommended: a) 2 x 1 Controloc 40 mg gastro-resistant tablet/day + 2 x 1000 mg amoxicillin/day + 2 x 500 mg clarithromycin/day.
b) 2 x 1 Controloc 40 mg gastro-resistant tablet/day + 2 x 500 mg metronidazole/day + 2 x 500 mg clarithromycin/day.
c) 2 x 1 Controloc 40 mg gastro-resistant tablet/day + 2 x 1000 mg amoxicillin/day + 2 x 500 mg metronidazole/day.
Treatment of gastric and duodenal ulcer: One tablet of Controloc 40 mg per day. In individual cases, the dose may be doubled (increase to 2 tablets Controloc 40 mg daily) especially when there has been no response to other treatment.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions: For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg (2 tablets of "Controloc 40 mg" 40 mg). Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. Treatment duration in Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.
Children below 12 years of age: Controloc 40 mg is not recommended for use in children below 12 years of age due to limited data in this age group.
Type and duration of treatment: Combination therapy for eradication of Helicobacter pylori infection usually lasts 7 days and can be extended to a maximum of 2 weeks. If after this time further treatment with Controloc 40 mg is indicated to ensure that the ulcer heals completely, the dose recommendations for gastric and duodenal ulcers must be observed. In the majority of cases, a duodenal ulcer heals completely within 2 weeks. If a two-week treatment period is not sufficient, healing will be achieved in almost all cases within a further 2 weeks. Gastric ulcers and reflux esophagitis usually require a 4-week course of treatment. If this should be inadequate, healing will in most cases be achieved within a further 4 weeks. Treatment should not exceed 8 weeks as experience with long-term use is limited. Treatment duration in Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.
Special Patient Populations: Impaired hepatic function: A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole or half a vial of 40 mg pantoprazole I.V.) should not be exceeded in patients with severe liver impairment.
Impaired renal function: No dose adjustment is necessary in patients with impaired renal function.
Inj: The intravenous administration of Controloc i.v. is recommended only if oral application is not appropriate. The recommended dose for gastric and duodenal ulcer and moderate and severe reflux esophagitis is one vial of 40 mg Controloc IV per day. For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions, the recommended daily dose at the beginning of the treatment is 80 mg Controloc i.v.. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. In case a rapid acid control is required, a starting dose of 2 x 80 mg Controloc i.v. is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients. Transition from Controloc i.v. to the oral formulation of Controloc should be performed as soon as it is clinically justified.
Special Patient Populations: Impaired Hepatic function: A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole I.V.) should not be exceeded in patients with severe liver impairment (see Precautions).
Impaired renal function: No dose adjustment is necessary in patients with impaired renal function.
Type and duration of treatment: As soon as oral therapy is possible, treatment with Controloc i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.