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MYLAN-PANTOPRAZOLE T 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: Mylan-Pantoprazole T (pantoprazole magnesium) 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 heartburn) •…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). 1 Pediatrics 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). 2 CONTRAINDICATIONS • Mylan-Pantoprazole T 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. Pantoprazole should not be used in combination treatment for the eradication of H.
pylori in patients with renal dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients. 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. Mylan-Pantoprazole T should not be administered to pregnant women unless the expected benefits outweigh the potential risks to the fetus.
See also 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 should not be given to nursing mothers unless its use is believed to outweigh the potential risks to the infant.
See also 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology. 3 Pediatrics 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 MYLAN-PANTOPRAZOLE T (Pantoprazole Magnesium Enteric-Coated Tablets) Page 12 of 48 of PPIs is required, they should be managed carefully according to established treatment guidelines.
, Immune 10/2023 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 ............................... 7 7 WARNINGS AND PRECAUTIONS ...............................................................................
• Mylan-Pantoprazole T 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. • Mylan-Pantoprazole T is contraindicated with co-administration of rilpivirine. 4 Drug-Drug Interactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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See 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS. 1 Adverse Reaction Overview Mylan-Pantoprazole T (pantoprazole magnesium) is well tolerated. Most adverse events have been mild and transient showing no consistent relationship with treatment.
2%). No differences in adverse reactions are expected between pantoprazole magnesium and pantoprazole sodium. 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.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In a short term study (40 mg pantoprazole magnesium tablet, once daily for 7 days) in patients with GERD, and in a 4 to 8-week clinical trial in 636 GERD patients, the adverse event profile seen with the pantoprazole magnesium 40 mg tablet was similar to that seen with the pantoprazole sodium 40 mg tablet.
No differences in adverse reactions are expected between pantoprazole magnesium and pantoprazole sodium. Adverse events have been recorded during controlled clinical investigations in 13000 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 sodium therapy (20 mg or 40 mg once daily) in long-term clinical trials (duration of at least 6 months).
There were a limited number of H. pylori positive patients in these studies and therefore, definitive conclusions with regard to long-term consequences of H. pylori infection and acid suppressive treatment on gastric inflammation in this sub-group cannot be made.
2 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 sodium therapy (20 mg or 40 mg once daily) in short-term and long-term clinical trials.
Table 3 – Adverse Events with a frequency of >1%, 20 or 40 mg pantoprazole sodium Gastrointestinal Disorders: Diarrhea General Disorders: Influenza Like Illness Nervous System Disorders: Headache A total of 1217 patients were treated with triple combination therapy including pantoprazole sodium and two antibiotics.
Adverse events noted at a frequency of greater than or equal to 1% when pantoprazole sodium was used in combination with antibiotics for the eradication of an H. 0%), […]
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 Drug 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 ..................................................................................... 1 Mechanism of Action .....................................................................................
2 Pharmacodynamics ....................................................................................... 3 Pharmacokinetics .......................................................................................... 23 11 STORAGE, STABILITY AND DISPOSAL ......................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................ 25 PART II: SCIENTIFIC INFORMATION .................................................................................... 26 13 PHARMACEUTICAL INFORMATION ..........................................................................
26 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication .............................................................................
2 Comparative Bioavailability Studies ............................................................... 34 15 MICROBIOLOGY ...................................................................................................... 35 16 NON-CLINICAL TOXICOLOGY ...................................................................................
36 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................. 43 PATIENT MEDICATION INFORMATION ................................................................................ 44 MYLAN-PANTOPRAZOLE T (Pantoprazole Magnesium Enteric-Coated Tablets) Page 4 of 48 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Mylan-Pantoprazole T (pantoprazole magnesium) is indicated for the treatment of conditions where a reduction of gastric acid secretion is required, such as the […]