Pantoprazol Farmoz

Pantoprazol Farmoz Dosage/Direction for Use

pantoprazole

Manufacturer:

Tecnimede

Distributor:

T-BOMA
Full Prescribing Info
Dosage/Direction for Use
Posology: Adults and adolescents 12 years of age and above: 20 mg: Symptomatic gastro-oesophageal reflux disease: The recommended oral dose is one pantoprazole 20 mg gastro-resistant tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally 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, taking one tablet 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 pantoprazole 20 mg gastro-resistant tablet per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoprazole 40 mg tablet is available for this case. After healing of the relapse the dose can be reduced again to 20 mg pantoprazole.
40 mg: Reflux oesophagitis: One tablet of Pantoprazole per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
Adults: 20 mg: Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patientsat risk with a need for continuous NSAID treatment.
The recommended oral dose is one pantoprazole 20 mg tablet per day.
40 mg: Eradication of H. pylori in combination with two appropriate antibiotics: In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori: a) twice daily one tablet Pantoprazole + twice daily 1000 mg amoxicillin + twice daily 500 mg clarithromycin; b) twice daily one tablet Pantoprazole + twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole) + twice daily 250 - 500 mg clarithromycin; c) twice daily one tablet Pantoprazole + twice daily 1000 mg amoxicillin + twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole).
In combination therapy for eradication of H. pylori infection, the second Pantoprazole tablet should be taken 1 hour before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged for a further 7 days to a total duration of up to two weeks. If, to ensure healing of the ulcers, further treatment with pantoprazole is indicated, the dose recommendations for duodenal and gastric ulcers should be considered.
If combination therapy is not an option, e.g. if the patient has tested negative for H. pylori, the following dose guidelines apply for Pantoprazole tablets monotherapy: Treatment of gastric ulcer: One tablet of Pantoprazole per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoprazole daily) especially when there has been no response to other treatment. 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.
Treatment of duodenal ulcer: One tablet of Pantoprazole tablets per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoprazole daily) especially when there has been no response to other treatment. 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.
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 Pantoprazole 40 mg). Thereafter, the dose 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 dose 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.
Patients with Hepatic Impairment: 20 mg: A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see Precautions).
40 mg: A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole) should not be exceeded in patients with severe liver impairment. Pantoprazole must not be used in combination treatment for eradication of H. pylori in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of Pantoprazole in combination treatment of these patients (see Precautions).
Patients with Renal Impairment: 20 mg: No dose adjustment is necessary in patients with impaired renal function (see Pharmacology: Pharmacokinetics under Actions).
40 mg: No dose adjustment is necessary in patients with impaired renal function. Pantoprazole must not be used in combination treatment for eradication of H. pylori in patients with impaired renal function since currently no data are available on the efficacy and safety of Pantoprazole tablets in combination treatment for these patients (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is necessary in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Pantoprazole is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Oral use: The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.
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