Individual generic drug information

pantoprazole

Reference monograph

Part of registered formulation

PANTOPRAZOLE

Reference record: Pantoprazole
Source: BNF 80 (2020–2021)
Printed source pages: 108, 109
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Pantoprazole only.

Indications And Dose

Helicobacter pylori eradication [in combination with other drugs (see Helicobacter pylori infection p. 89)] ▶BY MOUTH ▶Adult: 40 mg twice daily for 7 days for ﬁrst- and second-line eradication therapy; 10 days for third-line eradication therapy Benign gastric ulcer ▶BY MOUTH ▶Adult: 40 mg daily for 8 weeks; increased if necessary up to 80 mg daily, dose increased in severe cases Gastric ulcer ▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult: 40 mg daily until oral administration can be resumed, injection to be given over at least 2 minutes Duodenal ulcer ▶BY MOUTH ▶Adult: 40 mg daily for 4 weeks; increased if necessary up to 80 mg daily, dose increased in severe cases ▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult: 40 mg daily until oral administration can be resumed, injection to be given over at least 2 minutes NSAID-associated peptic ulcer disease ▶BY MOUTH ▶Adult: 40 mg once daily for 8 weeks Prophylaxis of NSAID-associated gastric ulcer in patients with an increased risk of gastroduodenal complications who require continued NSAID treatment | Prophylaxis of NSAID-associated duodenal ulcer in patients with an increased risk of gastroduodenal complications who require continued NSAID treatment ▶BY MOUTH ▶Adult: 20 mg daily Gastro-oesophageal reflux disease ▶BY MOUTH ▶Adult: 40 mg once daily for 4 or 8 weeks ▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult: 40 mg daily until oral administration can be resumed, injection to be given over at least 2 minutes Severe oesophagitis ▶BY MOUTH ▶Adult: 40 mg once daily for 8 weeks, continue as maintenance treatment if appropriate Severe oesophagitis, refractory to initial treatment ▶BY MOUTH ▶Adult: 40 mg twice daily Functional dyspepsia ▶BY MOUTH ▶Adult: 20 mg once daily for 4 weeks Uninvestigated dyspepsia ▶BY MOUTH ▶Adult: 40 mg once daily for 4 weeks Zollinger–Ellison syndrome (and other hypersecretory conditions) ▶BY MOUTH ▶Adult: Initially 80 mg daily (max. per dose 80 mg), adjusted according to response ▶Elderly: 40 mg daily ▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult: Initially 80 mg, alternatively 160 mg in 2 divided doses, if rapid acid control required, then 80 mg once daily (max. per dose 80 mg), adjusted according to response l UNLICENSED USE ▶With oral use g Dose for the treatment of gastro- oesophageal reﬂux disease differs from product literature and adheres to national guidelines. h Pantoprazole may be used as detailed below, although these situations are considered outside the scope of its licence: . g treatment of severe oesophagitis, refractory to initial treatment, h see Gastro-oesophageal reﬂux disease p. 88 for further information; . g treatment of NSAID-associated peptic ulcer disease, h see Peptic ulcer disease p. 76 for further information; . g treatment of functional and uninvestigated dyspepsia, h see Dyspepsia p. 72 for further information.

Source pages 108, 109

Exceptions To Legal Category

Pantoprazole 20 mg tablets can be sold to the public for the short-term treatment of reﬂux symptoms (e.g. heartburn) in adults over 18 years, max. daily dose 20 mg for max. 4 weeks. Gastro-intestinal system

Source page 109

Safety

Extracted information for Pantoprazole only.

Interactions

→Appendix 1: proton pump inhibitors

Source page 109

Side Effects

GENERAL SIDE-EFFECTS ▶Uncommon Asthenia. gastrointestinal discomfort. sleep disorder ▶Rare or very rare Angioedema. hyperlipidaemia. weight change SPECIFIC SIDE-EFFECTS ▶With intravenous use Electrolyte imbalance. muscle spasms

Source page 109

Pregnancy

Manufacturer advises avoid unless potential beneﬁt outweighs risk—fetotoxic in animals.

Source page 109

Breast Feeding

Manufacturer advises avoid unless potential beneﬁt outweighs risk—small amount present in milk.

Source page 109

Hepatic Impairment

Manufacturer advises caution in severe impairment (increased half-life)—monitor liver function and discontinue if deterioration. Dose adjustments Manufacturer advises maximum dose of 20 mg daily in severe impairment.

Source page 109

Renal Impairment

Dose adjustments Max. oral dose 40 mg daily.

Source page 109

Dose and formulations

Extracted information for Pantoprazole only.

Directions For Administration

For intravenous infusion (Protium ®), give intermittently in Glucose 5% or Sodium chloride 0.9%; reconstitute 40 mg with 10 mL sodium chloride 0.9% and dilute with 100 mL of infusion ﬂuid; give 40 mg over 15 minutes.

Source page 109

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Gastro-resistant tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Pantoprazole (Non-proprietary) Pantoprazole (as Pantoprazole sodium sesquihydrate) 20 mg Pantoprazole 20mg gastro-resistant tablets | 28 tablet P £12.11 DT = £2.27 Pantoprazole (as Pantoprazole sodium sesquihydrate) 40 mg Pantoprazole 40mg gastro-resistant tablets | 28 tablet P £20.57 DT = £2.99 Powder for solution for injection ▶Pantoprazole (Non-proprietary) Pantoprazole (as Pantoprazole sodium sesquihydrate) 40 mg Pantoprazole 40mg powder for solution for injection vials | 1 vial P £5.00 DT = £5.00 | 5 vial P £4.50–£22.50 DT = £22.50 (Hospital only) | 5 vial P s DT = £22.50 ▶Protium (Takeda UK Ltd) Pantoprazole (as Pantoprazole sodium sesquihydrate) 40 mg Protium I.V. 40mg powder for solution for injection vials | 5 vial P £25.53 DT = £22.50 eiiii F 82

Source page 109

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

40 mg twice daily for 7 days for ﬁrst- and

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily for 8 weeks; increased if necessary

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily until oral administration can be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily for 4 weeks; increased if necessary

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily until oral administration can be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 8 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

20 mg daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 4 or 8 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily until oral administration can be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 8 weeks, continue as

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

40 mg twice daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

20 mg once daily for 4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

Initially 80 mg daily (max. per dose 80 mg),

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Older adults

First line only; read the complete Indications and dose section above.

40 mg daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

Initially 80 mg, alternatively 160 mg in 2 divided

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

pantoprazole

Reference monograph

Part of registered formulation

PANTOPRAZOLE

Reference record: Pantoprazole
Source: BNF 80 (2020–2021)
Printed source pages: 108, 109
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Pantoprazole only.

Indications And Dose

Source pages 108, 109

Exceptions To Legal Category

Source page 109

Safety

Extracted information for Pantoprazole only.

Interactions

→Appendix 1: proton pump inhibitors

Source page 109

Side Effects

Source page 109

Pregnancy

Manufacturer advises avoid unless potential beneﬁt outweighs risk—fetotoxic in animals.

Source page 109

Breast Feeding

Manufacturer advises avoid unless potential beneﬁt outweighs risk—small amount present in milk.

Source page 109

Hepatic Impairment

Source page 109

Renal Impairment

Dose adjustments Max. oral dose 40 mg daily.

Source page 109

Dose and formulations

Extracted information for Pantoprazole only.

Directions For Administration

Source page 109

Medicinal Forms

Source page 109

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

40 mg twice daily for 7 days for ﬁrst- and

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily for 8 weeks; increased if necessary

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily until oral administration can be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily for 4 weeks; increased if necessary

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily until oral administration can be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 8 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

20 mg daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 4 or 8 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg daily until oral administration can be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 108

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 8 weeks, continue as

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

40 mg twice daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

20 mg once daily for 4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily for 4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

Initially 80 mg daily (max. per dose 80 mg),

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Older adults

First line only; read the complete Indications and dose section above.

40 mg daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Adults

First line only; read the complete Indications and dose section above.

Initially 80 mg, alternatively 160 mg in 2 divided

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 109

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.