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TEVA-PANTOPRAZOLE is a brand name for Pantoprazole, supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Teva-Pantoprazole (pantoprazole sodium sesquihydrate) is indicated for the treatment of conditions where a reduction of gastric acid secretion is required, such as the following: • Duodenal ulcer • Gastric ulcer • Reflux esophagitis • Symptomatic gastro-esophageal reflux disease (such as, acid regurgitation and…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics). 2 CONTRAINDICATIONS • Pantoprazole sodium is contraindicated in patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
Renal The daily dose used in renal insufficient patients, as a rule, should not exceed the recommended dosage regimens. 3 Pharmacokinetics, Special Populations and Conditions. Skin See 7 WARNINGS AND PRECAUTIONS – Immune. 1 Pregnant Women There are no adequate or well-controlled studies in pregnant women.
Studies in animals have shown reproductive toxicity, the potential risk for humans is unknown. Pantoprazole sodium should not be administered to pregnant women unless the expected benefits outweigh the potential risks to the fetus. See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology.
2 Breast-feeding Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Pantoprazole sodium should not be given to nursing mothers unless its use is believed to outweigh the potential risks to the infant.
3 Pediatrics TEVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) Page 11 of 52 Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Geriatrics (> 65 years of age): No dose adjustment is recommended based on age.
The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens. 3 Pharmacokinetics, Special Populations and Conditions. Benefits of use of PPIs should be weighed against the increased risk of fractures as patients in this category (> 71 years of age) may already be at high risk for osteoporosis-related fractures.
If the use of PPIs is required, they should be managed carefully according to established treatment guidelines. See 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS. 1 Adverse Reaction Overview Pantoprazole sodium is well tolerated.
Most adverse events have been mild and transient showing no consistent relationship with treatment. 2%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
, Immune 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization 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.........................................................
4 Administration.......................................................................................................... 5 Missed Dose .............................................................................................................
6 5 OVERDOSAGE ........................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS .................................................................................
• Pantoprazole sodium is contraindicated in patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Pantoprazole sodium is contraindicated with co-administration of rilpivirine. 4 Drug- Drug Interactions. TEVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) Page 5 of 52
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pantoprazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse events have been recorded during controlled clinical investigations in over 13,000 patients exposed to pantoprazole sodium as the single therapeutic agent for treatment of conditions requiring acid suppression.
The following adverse reactions considered possibly, probably, or definitely related by the investigator have been reported in individuals receiving pantoprazole therapy (20 mg or 40 mg once daily) in long-term clinical trials (duration of at least 6 months).
Table 2. 2 TEVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) Page 12 of 52 For long-term treatment with 20 mg, no such events were reported with a frequency of more than 1%. In addition, the following adverse events with a frequency of ≥ 1% considered unrelated, or unlikely related by the investigator have been reported in individuals receiving pantoprazole therapy (20 mg or 40 mg once daily) in short-term and long-term clinical trials.
Table 3. 1 to 1% related to 40 mg pantoprazole are listed below by body system: Cardiovascular System: Blood pressure increased, Hypertension, ECG abnormal TEVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) Page 13 of 52 Gastrointestinal Disorders: Flatulence, Abdominal distension, Abdominal pain, Abdominal pain upper, Loose stools, Esophageal reflux aggravated, Gastric polyps, Abdominal discomfort, Abdominal tenderness, Constipation, Eructation, Vomiting, Dyspepsia, Gastroesophageal reflux, Esophagitis General Disorders: Fatigue, Peripheral edema, Pyrexia Hepatobiliary Disorders: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function tests abnormal, Transaminases increased Laboratory Parameters: Hypertriglyceridemia Metabolism and Nutrition Disorders: Appetite decreased, Weight increase Nervous System Disorders: Dysgeusia, Dizziness, Migraine, Vertigo Respiratory System: Cough Skin and Subcutaneous Tissue Disorders: Pruritus, Rash Special Senses: Mouth dry, Vision blurred Other: Neoplasm TEVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) Page 14 of 52 The following adverse […]
1 Special Populations ................................................................................................ 1 Pregnant Women ...................................................................................................
2 Breast-feeding ........................................................................................................ 3 Pediatrics ................................................................................................................
4 Geriatrics ................................................................................................................ 11 8 ADVERSE REACTIONS ...............................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ......................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .................................................................................................. 5 Post-Market Adverse Reactions ..............................................................................
16 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview ................................................................................... 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions........................................................................................... 6 Drug-Herb Interactions........................................................................................... 7 Drug-Laboratory Test Interactions .........................................................................
20 10 CLINICAL PHARMACOLOGY.............................................. Error! Bookmark not defined. 1 Mechanism of Action ................................................ Error! Bookmark not defined. 2 Pharmacodynamics ................................................................................................
3 Pharmacokinetics ................................................................................................... 27 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 29 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
29 13 PHARMACEUTICAL INFORMATION…………………………………………………………………………….
PART II:
SCIENTIFIC INFORMATION ...................................................................................... 30 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trial by Indications ....................................................................................... 37 Reduction of Gastric Acid Secretion ................................................................................
37 Symptomatic Gastro-Esophageal Reflux Disease ............................................................ 37 Prevention of Relapse of Reflux Esophagitis .................................................................... 3 Comparative Bioavailability Studies.........................................................................
46 15 MICROBIOLOGY ....................................................................................................... 48 16 NON-CLINICAL TOXICOLOGY .....................................................................................
48 17 SUPPORTING PRODUCT MONOGRAPHS […]