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ALTA-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: ALTA-PANTOPRAZOLE (Pantoprazole Sodium Delayed-Release Tablets) 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…
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. 2 Geriatrics Geriatrics (> 65 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of pantoprazole sodium in geriatric patients has been established; therefore, Health Canada has authorized all indications for geriatric use.
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. ALTA-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. ALTA-PANTOPRAZOLE should not be administered to pregnant women unless the expected benefits outweigh the potential risks to the fetus. See 16 NON-CLINICALTOXICOLOGY, 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.
Page 5 of 49 4 DOSAGE AND ADMINISTRATION Note:
ALTA-PANTOPRAZOLE is only available as a 40 mg delayed-release tablet. 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, pantoprazole 40 mg (and a lower dose of 20 mg) once daily have been used for 3 years in controlled clinical trials and demonstrated to be effective in the maintenance of healing of reflux esophagitis.
2 Recommended Dose and Dosage Adjustment Duodenal ulcer • The recommended adult dose of ALTA-PANTOPRAZOLE 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 ALTA-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 ALTA-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 ALTA-PANTOPRAZOLE 40 mg together with clarithromycin 500 mg and amoxicillin 1000 mg, all twice daily.
• 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. Page 5 of 49
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%). 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 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 Page 13 of 49 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 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 autonomic nervous system disorders and “body as a whole”, or generalized disorders.
1 to 1% related to 20 mg pantoprazole are listed below by body system: Page 14 of 49 Gastrointestinal Disorders: Diarrhea, Flatulence, Abdominal pain, […]
• When ALTA-PANTOPRAZOLE 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) • The recommended adult oral dose for the treatment of symptoms of GERD, including heartburn and regurgitation, is ALTA-PANTOPRAZOLE 40 mg once daily for up to 4 weeks.
If significant symptom relief is not obtained in 4 weeks, further investigation is required. Page 6 of 49 Reflux Esophagitis • The recommended adult oral dose of ALTA-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. • ALTA-PANTOPRAZOLE 40 mg once daily may be given to patients who fail to maintain healing of reflux esophagitis after the initial course of maintenance therapy with pantoprazole 20 mg once daily.
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 ALTA-PANTOPRAZOLE 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. 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 the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764- 7669). Page 7 of 49 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, 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) Calcium stearate, colloidal silicon dioxide, crospovidone, mannitol, hydroxypropylmethyl cellulose, polyethylene glycol, sodium carbonate anhydrous, sodium starch glycollate, sodium hydroxide, Eudragit (contains: methacrylic acid- ethyl acrylate copolymer, sodium lauryl sulfate and polysorbate), opadry yellow (contains: lecithin (soy), titanium dioxide, yellow iron oxide, polyvinyl alcohol, talc and xanthan gum), imprinting ink (contains Shellac, isopropyl alcohol, black iron oxide, n-butyl alcohol, propylene glycol and ammonium hydroxide) ALTA-PANTOPRAZOLE (pantoprazole sodium) is available as delayed-release tablets for oral administration.
ALTA-PANTOPRAZOLE 40 mg tablets are yellow colored, oval, biconvex enteric coated tablets ‘P40’ printed in black on one side and plain on other side. 1 mg pantoprazole sodium sesquihydrate). ALTA-PANTOPRAZOLE 40 mg tablets are available in bottles of 100 tablets and 500 tablets, and blister packs […]