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SANDOZ 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: Sandoz 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.
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 sodium sesquihydrate 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 severe 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. 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 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.
4 Drug-Drug Interactions. 1 Dosing Considerations • 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.
• For the maintenance treatment of patients with reflux esophagitis and the resolution of symptoms associated with reflux esophagitis, such as heartburn with or without regurgitation, 20 or 40 mg pantoprazole once daily have been used for 3 years in controlled clinical trials.
In continuous maintenance treatment, 20 mg pantoprazole has been used in a limited number of patients for up to eight years. 2 Recommended Dose and Dosage Adjustment Duodenal Ulcer • The recommended adult dose of Sandoz Pantoprazole for the oral treatment of duodenal ulcer is 40 mg as pantoprazole 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 Sandoz Pantoprazole 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 Sandoz Pantoprazole 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 Sandoz Pantoprazole 40 mg together with clarithromycin 500 mg and amoxicillin 1000 mg, all twice daily. • When Sandoz Pantoprazole is prescribed in combination with clarithromycin, amoxicillin or metronidazole for the eradication of an H.
• Pantoprazole sodium sesquihydrate 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 sesquihydrate is contraindicated with co-administration of rilpivirine. 4 Drug-Drug Interactions. Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) Page 6 of 53
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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).
There were a limited number of H. pylori positive patients in these studies and Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) Page 14 of 53 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 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. 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. 1%) Regardless of the combination regimen, the most frequently reported events were gastrointestinal system disorders, followed by […]
pylori infection, the Product Monograph for the antibiotics used should be consulted and followed. Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) Page 7 of 53 Symptomatic Gastro-Esophageal Reflux Disease (GERD) • The recommended adult oral dose for the treatment of symptoms of GERD, including heartburn and regurgitation, is Sandoz Pantoprazole 40 mg once daily for up to 4 weeks.
If significant symptom relief is not obtained in 4 weeks, further investigation is required. Reflux Esophagitis • The recommended adult oral dose of Sandoz Pantoprazole 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. • Both 20 mg and 40 mg once daily have been demonstrated to be effective in the maintenance of healing of reflux esophagitis.
If maintenance therapy fails when using 20 mg once daily, consideration may be given to the 40 mg daily dose as maintenance therapy. Prevention of Gastrointestinal Lesions Induced by NSAIDs • The recommended adult oral dose of Sandoz Pantoprazole is 20 mg, given once daily in the morning.
Geriatrics • No dose 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. Health Canada has not authorized an indication for pediatric use.
1 Pediatrics. 4 Administration Sandoz Pantoprazole is formulated as a delayed-release 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. ), and single doses of up to 240 mg IV administered over 2 minutes, have been administered and were well tolerated.
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 Delayed-Release Tablet, 20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) Calcium stearate, cellulose microcrystalline, crospovidone, ferric oxide yellow, hydroxypropylcellulose, hypromellose, macrogol, methacrylic acid – ethyl acrylate copolymer, polysorbate 80, ponceau 4R aluminium lake, povidone, quinoline yellow aluminium lake, silica-colloidal anhydrous, sodium carbonate anhydrous, sodium laurilsulfate, titanium dioxide, triethyl citrate.
Only for the 20 mg: ferric oxide black, ferric oxide red, shellac. Dosage Forms Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) is available for oral administration as delayed-release tablets of 20 mg and 40 mg. 1 mg pantoprazole sodium […]