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TEVA-PANTOPRAZOLE MAGNESIUM 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 MAGNESIUM (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…
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 • Pantoprazole magnesium 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
). 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.
TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium) Page 12 of 55 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.
TEVA-PANTOPRAZOLE MAGNESIUM 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.
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 TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium) Page 13 of 55 Pantoprazole magnesium is well tolerated.
4 Drug-Drug Interactions. 1 Dosing Considerations TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium) Page 5 of 55 • Patients should use the lowest dose and shortest duration of proton pump inhibitor (PPI) therapy appropriate to the condition being treated.
• Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion. 2 Recommended Dose and Dosage Adjustment Duodenal Ulcer • The recommended adult dose of TEVA-PANTOPRAZOLE MAGNESIUM for the oral treatment of duodenal ulcer is 40 mg given once daily in the morning.
Healing usually occurs within 2 weeks. For patients not healed after this initial course of therapy, an additional course of 2 weeks is recommended. Gastric Ulcer • The recommended adult oral dose of TEVA-PANTOPRAZOLE MAGNESIUM for the oral treatment of gastric ulcer is 40 mg given once daily in the morning.
Healing usually occurs within 4 weeks. For patients not healed after this initial course of therapy, an additional course of 4 weeks is recommended. Helicobacter pylori Associated Duodenal Ulcer • Pantoprazole/Clarithromycin/Metronidazole Triple Combination Therapy: The recommended dose for H.
pylori eradication is treatment for seven days with TEVA- PANTOPRAZOLE MAGNESIUM 40 mg together with clarithromycin 500 mg and metronidazole 500 mg, all twice daily. • Pantoprazole/Clarithromycin/Amoxicillin Triple Combination Therapy: The recommended dose for H.
pylori eradication is treatment for seven days with TEVA- PANTOPRAZOLE MAGNESIUM 40 mg together with clarithromycin 500 mg and amoxicillin 1000 mg, all twice daily. • When TEVA-PANTOPRAZOLE MAGESIUM is prescribed in combination with clarithromycin, amoxicillin or metronidazole for the eradication of an H.
pylori infection, the Product Monograph for the antibiotics used should be consulted and followed. Symptomatic Gastro-Esophageal Reflux Disease (GERD) TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium) Page 6 of 55 • The recommended adult oral dose for the treatment of symptoms of GERD, including heartburn and regurgitation, is TEVA-PANTOPRAZOLE MAGNESIUM 40 mg once daily for up to 4 weeks.
• Pantoprazole magnesium 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 magnesium 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.
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.
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 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.
Table 2. 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. pylori infection included the following: Table 4. 2%), Loose […]
If significant symptom relief is not obtained in 4 weeks, further investigation is required. Reflux Esophagitis • The recommended adult oral dose of TEVA-PANTOPRAZOLE MAGNESIUM is 40 mg, given once daily in the morning. In most patients, healing usually occurs within 4 weeks.
For patients not healed after this initial course of therapy, an additional 4 weeks of treatment is recommended. • Patients with healed gastroesophageal reflux disease, who require greater than usual maintenance doses of PPIs to avoid recurrence of reflux esophagitis, may consider 40 mg TEVA-PANTOPRAZOLE MAGNESIUM once daily in the morning.
Geriatrics • No dosage adjustment is recommended for elderly patients. The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens. 3 Pharmacokinetics, Special Populations and Conditions. 1 Pediatrics).
4 Administration TEVA-PANTOPRAZOLE MAGNESIUM is formulated as an enteric-coated tablet. A whole tablet should not be chewed or crushed, and should be swallowed with fluid in the morning either before, during, or after breakfast. 5 Missed Dose If a dose is forgotten, the missed dose should be taken as soon as possible unless it is close to the next scheduled dose.
Two doses should never be taken at one time to make up for a missed dose; patients should just return to the regular schedule. 5 OVERDOSAGE Some reports of overdosage with pantoprazole have been received. No consistent symptom profile was observed after ingestion of high doses of pantoprazole.
v. administered over 2 minutes, have been administered and were well tolerated. TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium) Page 7 of 55 As pantoprazole is extensively protein bound, it is not readily dialyzable. In the case of overdosage with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1. Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Enteric-Coated Tablet 40 mg pantoprazole (as pantoprazole magnesium) Ammonium hydroxide 28%, black iron oxide, calcium stearate, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, isopropyl alcohol, mannitol, methacrylic acid – ethylacrylate copolymer, N-butyl alcohol, shellac glaze ~45%, povidone, propylene glycol, sodium carbonate, sodium starch glycolate, talc, titanium dioxide, and triethyl citrate.
TEVA-PANTOPRAZOLE MAGNESIUM is available as enteric-coated tablets for oral administration. The tablets are yellow, round, biconvex, film-coated tablets printed with “40” on one side and plain on the other, and contain 40 mg pantoprazole.
Tablets are available in bottles of 100 tablets and blisters of 30 tablets. g. significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, or melena) and when gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with TEVA-PANTOPRAZOLE MAGNESIUM is instituted since treatment with pantoprazole magnesium may alleviate symptoms and delay diagnosis.
Further investigation should be considered if symptoms persist despite adequate treatment. In long-term treatment, patients should be kept under regular surveillance. TEVA-PANTOPRAZOLE MAGNESIUM […]