Pantoloc Dosage/Direction for Use

Posology: Gastro-resistant tablet 20 mg: Adults and adolescents 12 years of age and above: Symptomatic gastro-oesophageal reflux disease: The recommended oral dosage is one Pantoloc 20 mg 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 Pantoloc 20 mg tablet per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoloc 40 mg tablet is available for this case. After healing of the relapse the dosage can be reduced again to Pantoloc 20 mg tablet.
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 Pantoloc 20 mg tablet per day.
Special populations: Patients with hepatic impairment: A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see Precautions).
Patients with renal impairment: No dose adjustment is necessary in patients with impaired renal function (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is necessary in the elderly (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Pantoloc is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in this age group (see Pharmacology: Pharmacokinetics under Actions).
Gastro-resistant tablet 40 mg: Adults and adolescents 12 years of age and above: Reflux oesophagitis: One tablet of Pantoloc 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoloc 40mg 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: 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 Pantoloc 40 mg gastro-resistant tablet/day + twice daily 1000 mg amoxicillin/day + twice daily 500 mg clarithromycin /day.
b) Twice daily one Pantoloc 40 mg gastro-resistant tablet/day + twice daily 400-500 mg metronidazole (or 500 mg tinidazole)/day + twice daily 250-500 mg clarithromycin/day.
c) Twice daily one Pantoloc 40 mg gastro-resistant tablet/day + twice daily 1000 mg amoxicillin/day + twice daily 400-500 mg metronidazole (or 500 mg tinidazole)/day.
In combination therapy for eradication of H. pylori infection, the second Pantoloc 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 dosage guidelines apply for Pantoloc 40 mg monotherapy: Treatment of gastric ulcer: One tablet of Pantoloc 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoloc 40mg 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 Pantoloc 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoloc 40mg 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 hyper secretory conditions patients should start their treatment with a daily dose of 80 mg (2 tablets of Pantoloc 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 hyper secretory conditions is not limited and should be adapted according to clinical needs.
Patients with hepatic impairment: A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole) should not be exceeded in patients with severe liver impairment. Pantoloc 40mg 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 Pantoloc 40mg in combination treatment of these patients (see Precautions).
Patients with renal impairment: No dose adjustment is necessary in patients with impaired renal function. Pantoloc 40mg 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 Pantoloc 40mg in combination treatment for these patients (see Pharmacology: Pharmacokinetics under Actions).
Older people: No dose adjustment is necessary in older people (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Pantoloc 40mg is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in the age group (see Pharmacology: Pharmacokinetics under Actions).
Powder for solution for injection: This medicine should be administered by a healthcare professional and under appropriate medical supervision.
The intravenous administration of Pantoloc i.v is recommended only if oral application is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Pantoloc i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
Gastric and duodenal ulcer, reflux oesophagitis: The recommended intravenous dosage is one vial (40 mg pantoprazole) Pantoloc i.v. per day.
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 Pantoloc 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 Pantoloc 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.
Special populations: Patients with hepatic impairment: A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) should not be exceeded in patients with severe liver impairment (see Precautions).
Patients with renal impairment: No dose adjustment is necessary in patients with impaired renal function (see Pharmacology: Pharmacokinetics under Actions).
Older people/Elderly: No dose adjustment is necessary in older patients/elderly (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Pantoloc 40 mg powder for solution for injection in children aged under 18 years have not been established. Therefore, Pantoloc 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age. Currently available data are described in Pharmacology: Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: Gastro-resistant tablet: Oral use.
The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.
Powder for solution for injection: A ready-to-use solution is prepared in 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. For instructions for preparation see Special precautions for disposal under Cautions for Usage. The prepared solution may be administrated directly or may be administrated after mixing it with 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 55 mg/mL (5%) solution for injection.
After preparation the solution must be used within 12 hours.
The medicinal product should be administrated intravenously over 2-15 minutes.