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PANTOPRAZOLE SODIUM FOR is a brand name for Pantoprazole, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PANTOPRAZOLE SODIUM FOR INJECTION (pantoprazole sodium for injection) is indicated for the short-term treatment (up to 7 days) of conditions where a rapid reduction of gastric acid secretion is required, such as the following: • Reflux esophagitis, in hospitalized patients who cannot tolerate oral medication •…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients should be switched to pantoprazole sodium tablets when feasible. In switching, the same dose mg per mg should be administered. Daily doses of up to 272 mg pantoprazole intravenous were administered and were well tolerated.
Pantoprazole sodium for injection has PANTOPRAZOLE SODIUM FOR INJECTION Page 5 of 37 been administered for up to 7 days in clinical trials. Tolerance effects are not associated with the use of pantoprazole sodium for injection as demonstrated in clinical trials.
2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use.
Reflux Esophagitis:
The recommended adult dose of PANTOPRAZOLE SODIUM FOR INJECTION in patients with reflux esophagitis is 40 mg pantoprazole per day, administered either by slow intravenous injection over 2 to 5 minutes, or by intravenous infusion over 15 minutes.
Pathological Hypersecretion Associated With Zollinger-Ellison Syndrome:
For patients with pathological hypersecretion associated with Zollinger-Ellison syndrome, the recommended adult dose is 80 mg every 12 hours, administered by intravenous infusion over 15 minutes. Doses of 120 mg twice daily and 80 mg three times per day were also used to control acid output to below 10 mEq/h.
Patients should use the lowest dose and shortest duration of PPI therapy, appropriate to the condition being treated. 3 Reconstitution: Parenteral Products: PANTOPRAZOLE SODIUM FOR INJECTION should not be simultaneously administered through the same line with other intravenous solutions, and it is recommended that a dedicated line or a flushed line be used for administration.
9%, or Dextrose Injection USP 5%. 9% Sodium Chloride Injection, USP Vial Size (mL) Volume of Diluent (mL) to be added to vial Approximate Available Volume (mL) Nominal Concentration per mL 12 10 10 4 mg PANTOPRAZOLE SODIUM FOR INJECTION Page 6 of 37 For intravenous injection, a ready-to-use solution is prepared by injecting 10 mL of physiological sodium chloride solution into the vial containing the dry substance.
The resulting potency is 4 mg/mL of pantoprazole. 4 mg For intravenous infusion of 40 mg: the solution is prepared by injecting 10 mL of physiological sodium chloride solution into the vial containing the dry substance. 9% Sodium Chloride Injection, USP, or 90 mL of 5% Dextrose Injection, USP.
). • Clostridium Difficile-Associated Diarrhea Decreased gastric acidity due to any means, including proton pump inhibitors (PPIs), increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with PPIs can lead to an increased risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
An increased risk for Clostridium difficile infection (CDI) and Clostridium difficile-associated diarrhea (CDAD) has been observed in association with PPI use in several observational studies. CDI/CDAD should be considered in the differential diagnosis for diarrhea that does not improve.
Additional risk factors for CDI and CDAD include recent hospitalization, the use of antibiotics, old age and the presence of co-morbidities. Patients should be prescribed PPIs at the lowest dose and for the shortest duration required for the condition being treated and be reassessed to ascertain whether continued PPI therapy remains beneficial.
PANTOPRAZOLE SODIUM FOR INJECTION Page 10 of 37 • Concomitant Use with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.
A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate. Carcinogenesis and Mutagenesis Effects of long-term treatment include hypergastrinemia, possible enterochromaffin-like (ECL) cell hyperplasia and carcinoid formation in the stomach, adenomas and carcinomas in the liver and neoplastic changes in the thyroid.
In the rat, the mechanism leading to the formation of gastric carcinoids is considered to be due to the elevated gastrin level occurring during chronic treatment. Similar observations have also been made after administration of other acid secretion inhibitors.
, Gastrointestinal 2025-12 7 WARNINGS AND PRECAUTIONS, Immune 2025-12 7 WARNINGS AND PRECAUTIONS, Skin 2025-12 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ................................................................................................................
1 Pediatrics ............................................................................................................... 2 Geriatrics ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................... 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ....................................................... 3 Reconstitution: ......................................................................................................
4 Administration ....................................................................................................... 7 5 OVERDOSAGE ...............................................................................................................
PANTOPRAZOLE SODIUM FOR INJECTION is contraindicated in patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation, including non-medicinal ingredients, or components of container.
For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. Co-administration with rilpivirine is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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80 mg Intravenous Infusion Two vials of PANTOPRAZOLE SODIUM FOR INJECTION are required. Each vial should be reconstituted with 10 mL of physiological sodium solution. 9% Sodium Chloride Injection, USP, or 80 mL of 5% Dextrose Injection, USP.
4 Administration When preparing the intravenous infusion, polyvinyl chloride (PVC) infusion bags can be used. Incompatibilities of PANTOPRAZOLE SODIUM FOR INJECTION reconstituted in infusion bags made with copolymer of ethylene and propylene have been observed.
Therefore these bags cannot be used in preparing PANTOPRAZOLE SODIUM FOR INJECTION intravenous infusion. 40 mg intravenous injection: Inject 10 mL of physiological sodium chloride solution into the vial containing the dry substance.
The resulting potency of the solution is 4 mg/mL of pantoprazole, and can be administered by slow injection over 2 to 5 minutes. After preparation, the reconstituted (ready-to-use) solution for intravenous injection must be used within 6 hours of initial puncture of the stopper.
9% Sodium Chloride Injection, USP 6 hours 40 mg intravenous infusion: Prepare the 40 mg intravenous injection as described above. 9% Sodium Chloride Injection, USP, or 90 mL of 5% Dextrose Injection, USP. 4 mg / mL of pantoprazole and can be administered by infusion over 15 minutes.
PANTOPRAZOLE SODIUM FOR INJECTION Page 8 of 37 80 mg intravenous infusion:
Two vials of PANTOPRAZOLE SODIUM FOR INJECTION are required. Each vial should be reconstituted with 10 mL of physiological sodium chloride solution. 9% Sodium Chloride Injection, USP, or 80 mL 5% Dextrose Injection, USP. 8 mg / mL of pantoprazole, and can be administered by infusion over 15 minutes.
After preparation, the reconstituted (ready-to-use) solution or further diluted solution for intravenous infusion must be used within 6 hours of initial puncture of the stopper. As with all parenteral admixtures, the reconstituted or further diluted solution should be examined for change in colour, precipitation, haziness or leakage.
Discard unused portion.
(For further details, see 16 NON-CLINICAL TOXICOLOGY). Short-term and long-term treatment with pantoprazole sodium in a limited number of patients up to 6 years have not resulted in any significant pathological changes in gastric oxyntic exocrine cells.
• Drug Interactions with Antiretroviral Drugs PPIs have been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. A change in gastric pH may change the absorption of the antiretroviral drug.
Other possible mechanisms are via CYP 2Cl9. Rilpivirine Co-administration is contraindicated due to significant decrease in rilpivirine exposure and loss of therapeutic effect (see 2 CONTRAINDICATIONS). Atazanavir and Nelfinavir Co-administration with atazanavir or nelfinavir is not recommended due to decreased atazanavir, nelfinavir and rilpivirine exposure (see the atazanavir and nelfinavir Product Monographs).
PANTOPRAZOLE SODIUM FOR INJECTION Page 11 of 37 If the combination of PANTOPRAZOLE SODIUM FOR INJECTION with atazanavir is judged unavoidable, close clinical monitoring is recommended in combination with the use of 400 mg atazanavir/100 mg ritonavir dose; the dose of PANTOPRAZOLE SODIUM FOR INJECTION should not exceed an equivalent dose of omeprazole of 20 mg daily (see atazanavir Product Monograph).
Saquinavir If PANTOPRAZOLE SODIUM FOR INJECTION is co-administered with saquinavir/ritonavir, caution and monitoring for potential saquinavir toxicities, including gastrointestinal symptoms, increased triglycerides, deep vein thrombosis and QT prolongation, are recommended.
Dose reduction of saquinavir should be considered from the safety perspective for individual patients (see saquinavir Product Monograph). Endocrine and Metabolism • Hypomagnesemia Hypomagnesemia, symptomatic and asymptomatic, has been reported in patients treated with PPIs for at least three months, in most cases after a year of therapy.
Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. , diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
The chronic use of PPIs may lead to hypomagnesemia. Moreover, hypokalemia and hypocalcemia have been reported in the literature as accompanying electrolyte disorders. • Cyanocobalamin (Vitamin B12) Deficiency The prolonged use of proton pump inhibitors may impair the absorption of protein-bound Vitamin B12 and may contribute to the development of cyanocobalamin (Vitamin B12) deficiency.
Interference with Laboratory Tests During treatment with antisecretory drugs, chromogranin A (CgA) increases due to decreased gastric acidity. Increased CgA levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, PANTOPRAZOLE SODIUM FOR INJECTION treatment should be stopped 14 days before CgA measurements (see
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS.................................................................................... 1 Special Populations ..............................................................................................
4 Geriatrics 13 8 ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview .................................................................................
2 Clinical Trial Adverse Reactions............................................................................ 5 Post-Market Adverse Reactions ........................................................................... 15 9 DRUG INTERACTIONS .................................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions ............................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions .......................................................................
17 10 CLINICAL PHARMACOLOGY......................................................................................... 1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ..............................................................................................
3 Pharmacokinetics ................................................................................................. 19 11 STORAGE ,STABILITY AND DISPOSAL .......................................................................... 20 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
20 PART II: SCIENTIFIC INFORMATION ........................................................................................ 21 13 PHARMACEUTICAL INFORMATION .............................................................................
21 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ...................................................................................
22 15 MICROBIOLOGY .......................................................................................................... 23 16 NON-CLINICAL TOXICOLOGY .......................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 29 PATIENT MEDICATION INFORMATION ................................................................................... 30 PANTOPRAZOLE SODIUM FOR INJECTION Page 4 of 37 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PANTOPRAZOLE SODIUM FOR INJECTION (pantoprazole sodium for injection) is indicated for the short-term treatment (up to 7 days) of conditions where a rapid reduction of gastric acid secretion is required, such as the following: • Reflux esophagitis, in hospitalized patients who cannot tolerate oral medication • Pathological hypersecretion associated with Zollinger-Ellison Syndrome, in hospitalized patients who cannot tolerate oral medication.
1 Pediatrics The safety and effectiveness of pantoprazole sodium in children have not yet been established. Therefore, Health Canada has not authorized an indication for […]