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TECTA is a brand name for Pantoprazole, supplied as a tablet (enteric-coated). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS).
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). 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.
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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. TECTA® should not be administered to pregnant women unless the expected benefits outweigh the potential risks to TECTA® (pantoprazole magnesium) Page 11 of 50 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 of PPIs is required, they should be managed carefully according to established treatment guidelines.
4 Drug- Drug Interactions. DOSAGE AND ADMINISTRATION Dosing Considerations • Patients should use the lowest dose and shortest duration of proton pump inhibitor (PPI) therapy appropriate to the condition being treated. TECTA® (pantoprazole magnesium) Page 5 of 50 • Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion.
Recommended Dose and Dosage Adjustment Duodenal Ulcer • The recommended adult dose of TECTA® 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 TECTA® 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 TECTA® 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 TECTA® 40 mg together with clarithromycin 500 mg and amoxicillin 1000 mg, all twice daily.
• When TECTA® 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 TECTA® 40 mg once daily for up to 4 weeks.
Atazanavir and Nelfinavir Co-administration with atazanavir or nelfinavir is not recommended due to decreased atazanavir and nelfinavir exposure (see the REYATAZ® and VIRACEPT® Product Monographs). If the combination of TECTA® with atazanavir is judged unavoidable, close clinical monitoring is recommended in combination with the use of 400 mg atazanavir/100 mg ritonavir dose; the dose of TECTA® should not exceed an equivalent dose of omeprazole of 20 mg daily (see REYATAZ® Product Monograph).
Saquinavir If TECTA® is co-administered with saquinavir/ritonavir, caution and monitoring for potential saquinavir toxicities, including gastrointestinal symptoms, increased triglycerides, deep vein thrombosis and QT prolongation, are recommended.
Dose reduction of saquinavir should be TECTA® (pantoprazole magnesium) Page 9 of 50 considered from the safety perspective for individual patients (see INVIRASE® Product Monograph). Endocrine and Metabolism Hypomagnesemia Hypomagnesemia, symptomatic and asymptomatic, has been reported in patients treated with PPIs for at least three months, in most cases after a year of therapy.
Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia. 5 Post-Market Adverse Reactions. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
, diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically. The chronic use of PPIs may lead to hypomagnesemia. 2 Drug Interactions Overview, Other). Gastrointestinal Long-term use of TECTA® is associated with an increased risk of fundic gland polyps, especially beyond one year.
5 Post-Market Adverse Reactions. Most fundic gland polyps are asymptomatic. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Hepatic/Biliary/Pancreatic Pantoprazole 40 mg daily is not recommended in patients with severe liver disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
See 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS. ADVERSE REACTIONS Adverse Reaction Overview TECTA® (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. 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. TECTA® (pantoprazole magnesium) Page 12 of 50 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 TECTA® (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: TECTA® (pantoprazole magnesium) Page 13 of 50 Table 4.
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If significant symptom relief is not obtained in 4 weeks, further investigation is required. Reflux Esophagitis • The recommended adult oral dose of TECTA® 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 TECTA® once daily in the morning.
TECTA® (pantoprazole magnesium) Page 6 of 50 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.
Health Canada has not authorized an indication for pediatric use. 1 Pediatrics. Administration TECTA® 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.
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.
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 management of a suspected drug overdose, contact your regional poison control centre. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1. Dosage Forms, Strengths, Composition and Packaging TECTA® is available as enteric-coated tablets for oral administration.
The tablets are yellow, Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Tablet (Enteric-Coated), 40 mg pantoprazole (as pantoprazole magnesium) Calcium Stearate, Crospovidone, Ferric Oxide, Hypromellose, Mannitol, Poly (ethylacrylate, methacrylic acid), Povidone, Propylene Glycol, Sodium Carbonate (Anhydrous), Titanium Dioxide, Triethyl Citrate.
TECTA® (pantoprazole magnesium) Page 7 of 50 round, biconvex tablets marked 40 on one side, as they contain 40 mg pantoprazole. Tablets are available in bottles of 7 or 100 tablets, and in blisters of 7 and 30 tablets. Not all pack sizes may be marketed.
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 TECTA® 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. Antibiotic Combination Therapy Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia.
Studies indicate […]
3 Pharmacokinetics, Special Populations and Conditions. Pantoprazole should not be used in combination treatment for the eradication of H. pylori in patients with severe hepatic dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients.
Immune Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs.
Discontinue pantoprazole at the first signs or symptoms of SCARs or other signs of hypersensitivity and consider further evaluation. At the TECTA® (pantoprazole magnesium) Page 10 of 50 time of prescription, patients should be informed of the signs and symptoms, and advised to monitor closely for skin reactions.
5 Post-Market Drug Reactions. Subacute cutaneous lupus erythematosus Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of PPIs. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping TECTA®.
The occurrence of SCLE with previous PPI treatment may increase the risk of SCLE with other PPIs. 5 Post-Market Drug Reactions. Monitoring and Laboratory Tests During treatment with antisecretory drugs, chromogranin A (CgA) increases due to decreased gastric acidity.
Increased CgA levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, TECTA® treatment should be stopped 14 days before CgA measurements. See 9 DRUG INTERACTIONS.
Musculoskeletal Bone Fracture:
Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
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