Pantoloc

Pantoloc Dosage/Direction for Use

pantoprazole

Manufacturer:

Takeda

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Children below 5 years of age: Pantoprazole (Pantoloc) is not recommended for use in children below 5 years of age as there is insufficient experience in children under 5 to justify a general recommendation.
20 mg: 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 tablet Pantoprazole (Pantoloc) 20 mg per day.
Adults and Adolescents aged 12 years and above: For symptomatic improvement (e.g. heartburn, acid regurgitation, pain in swallowing) and healing of mild reflux esophagitis. The recommended oral dosage is one gastro-resistant tablet Pantoprazole (Pantoloc) 20 mg per day. Symptom relief is generally accomplished within 2-4 weeks, and a 4-week treatment period is usually required for healing of associated esophagitis. If this is not sufficient, healing 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, 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 esophagitis: For long term management, a maintenance dose of one gastro-resistant tablet Pantoprazole (Pantoloc) 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoprazole (Pantoloc) 40 mg is available for this case. After healing of the relapse the dosage can be reduced again to 20 mg pantoprazole.
Children aged from 5 to 11 years: Symptomatic GERD (Treatment of symptomatic reflux): The recommended dosage is one Pantoprazole (Pantoloc) 20 mg tablet per day for children aged 5 to 11 years of age. If symptom control has not been achieved after four weeks treatment with Pantoprazole (Pantoloc) 20 mg tablets daily, further investigation is recommended, for example endoscopy.
Treatment of reflux esophagitis: The recommended oral dosage is one Pantoprazole (Pantoloc) 20 mg or 40 mg tablet per day.
In children aged 5 to 11 years of age, the dosage should be adjusted according to weight: Pantoprazole (Pantoloc) 20 mg (for children 19-35 kg) or Pantoprazole (Pantoloc) 40 mg (for children > 35 kg) per day.
A 4 week period is usually required for healing, however if this is not sufficient, healing will usually be achieved within a further 4 weeks.
Treatment duration in children with symptomatic GERD or reflux esophagitis should not exceed 8 weeks.
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.
General instructions: Pantoprazole (Pantoloc) 20 mg tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
40 mg: Adults: Treatment of moderate and severe reflux esophagitis: One tablet of Pantoprazole 40 mg (Pantoloc) per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole 40 mg (Pantoloc) daily) especially when there has been no response to other treatment.
Eradication of H. pylori in combination with two appropriate antibiotics: In Helicobacter pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved.
Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori: twice daily one 40 mg tablet Pantoprazole (Pantoloc) + twice daily 1000 mg amoxicillin + twice daily 500 mg clarithromycin.
Twice daily one 40 mg tablet Pantoprazole (Pantoloc) + twice daily 500 mg metronidazole + twice daily 500 mg clarithromycin.
Twice daily one 40 mg tablet Pantoprazole (Pantoloc) + twice daily 1000 mg amoxicillin + twice daily 500 mg metronidazole.
If combination therapy is not an option, e.g. if the patient has tested negative for Helicobacter pylori, the following dosage guidelines apply for Pantoprazole (Pantoloc) monotherapy: Treatment of gastric and duodenal ulcer: One 40 mg tablet of Pantoprazole (Pantoloc) per day.
In individual cases the dose may be doubled (increase to 2 tablets of 40 mg Pantoprazole (Pantoloc) 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 "Pantoprazole (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 hypersecretory conditions is not limited and should be adapted according to clinical needs.
Children aged from 5 to 17 years: Treatment of reflux esophagitis: The recommended oral dosage is one Pantoprazole (Pantoloc) 20 mg or 40 mg tablet per day.
In children 5 to 17 years of age, the dosage should be adjusted according to weight: Pantoprazole (Pantoloc) 20 mg (for children 19-35 kg) or Pantoprazole (Pantoloc) 40 mg (for children > 35 kg) per day. A 4 week period is usually required for healing, however if this is not sufficient, healing will usually be achieved within a further 4 weeks. This dosage may be increased up to 80 mg pantoprazole per day in adolescents 12 years of age and above. Treatment duration in children aged 5 to 17 years with reflux esophagitis should not exceed 8 weeks.
Special populations: In patients with severe liver impairment the dose has to be reduced to 1 tablet (40 mg pantoprazole) every other day. Furthermore, in these patients the liver enzymes should be monitored during Pantoprazole (Pantoloc) therapy. In case of a rise of the liver enzymes, Pantoprazole (Pantoloc) should be discontinued.
The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in those with impaired renal function. An exception is combination therapy for eradication of H. pylori, where also elderly patients should receive the usual pantoprazole dose (2x40 mg/day) during 1-week treatment.
General instructions: Pantoprazole (Pantoloc) tablets should not be chewed or crushed, and should be swallowed whole with water 1 hour before breakfast. In combination therapy for eradication of Helicobacter pylori infection, the second Pantoprazole (Pantoloc) tablet should be taken before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged to up to two weeks maximum. If, to ensure healing of the ulcers, further treatment with pantoprazole is indicated, the dosage recommendations for duodenal and gastric ulcers should be considered.
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.
A 4-week period is usually required for the treatment of gastric ulcers and reflux esophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
IV: The intravenous administration of Pantoprazole (Pantoloc) IV is recommended only if oral application is not appropriate.
As soon as oral treatment becomes possible, intravenous administration of Pantoprazole (Pantoloc) IV should be discontinued, and the treatment should be continued with oral doses of 40 mg pantoprazole.
Recommended dosage: Duodenal ulcer, gastric ulcer, moderate and severe reflux esophagitis: The recommended intravenous dosage is one vial (40 mg pantoprazole) Pantoprazole (Pantoloc) IV per day.
Long-term management of Zollinger-Ellison Syndrome and other pathological: Hypersecretory conditions: Patients should start their treatment with a daily dose of 80 mg Pantoprazole (Pantoloc) IV. 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 Pantoprazole (Pantoloc) IV 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 Pantoprazole (Pantoloc) to the oral formulation of Pantoprazole (Pantoloc) should be performed as soon as it is clinically justified.
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: No dose adjustment is necessary in older patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Pantoprazole (Pantoloc) 40 mg powder for solution for injection in children aged under 18 years have not been established. Therefore, Pantoprazole (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.
Treatment of upper digestive hemorrhage (complimentary to endoscopic therapy), and prevention of rebleeding. Bolus administration of 80 mg Pantoprazole (Pantoloc) IV followed by infusion of 8 mg/h Pantoprazole (Pantoloc) IV during 72 hours is recommended.
Prophylaxis of acute bleeding due to stress ulcer: The following dosage schedules are recommended: 40 mg to 80 mg Pantoprazole (Pantoloc) IV, once to twice daily.
The solution may be given as a bolus (for at least 2 minutes), or as an infusion, after dilution of the reconstituted solution in 100 mL of saline or 100 mL of 5% or 10% dextrose solution, in which case, a time of 15 minutes is recommended for administration.
General instructions: A ready-to-use solution is prepared by injecting 10 mL of physiological sodium chloride solution into the vial containing the dry substance. This solution may be administered directly or may be administered after mixing with 100 mL physiological sodium chloride solution or 5% Glucose.
After preparation the solution must be used within 12 hours. Pantoprazole (Pantoloc) IV should not be manufactured or mixed with solvents other than those stated.
As soon as oral therapy is possible, treatment with Pantoprazole (Pantoloc) IV should be discontinued and 40 mg pantoprazole p. o. should be administered instead. The drug should be administered intravenously over 2-15 minutes.
The experience in children is limited. Therefore, Pantoprazole (Pantoloc) IV 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age until further data become available.
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