TECTA Εnteric-coated tablets (2020)
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Name of the medicinal product
TECTA Pantoprazole enteric-coated tablets.
Summary product information
Route of Administration Dosage Form / Strength Clinically Relevant Non-medicinal Ingredients oral Enteric-Coated Tablet 40 mg pantoprazole (as pantoprazole magnesium) None<br>For a complete listing see ...
Indications and clinical use
TECTA (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 ...
Contraindications
Patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION ...
Warnings and precautions
General In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, or melena) and when gastric ulcer is suspected, the possibility ...
Adverse reactions
Adverse Drug Reaction Overview Pantoprazole is well tolerated. Most adverse events have been mild and transient showing no consistent relationship with treatment. The following adverse events (the most ...
Drug interactions
Overview Pantoprazole undergoes extensive hepatic metabolism via cytochrome P450-mediated oxidation. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways which include oxidation ...
Dosage and administration
Recommended Dose and Dosage Adjustment DUODENAL ULCER The recommended adult dose of TECTA (pantoprazole magnesium) for the oral treatment of duodenal ulcer is 40 mg given once daily in the morning. Healing ...
Overdosage
For management of a suspected drug overdose, consult your regional Poison Control Centre. Some reports of overdosage with pantoprazole have been received. No consistent symptom profile was observed after ...
Action and clinical pharmacology
Mechanism of Action TECTA (pantoprazole magnesium) is a specific inhibitor of the gastric H+, K+-ATPase enzyme (the proton pump) that is responsible for gastric acid secretion by the parietal cells of ...
Storage and stability
Store at 15°C to 30°C in the recommended packaging.
Special handling instructions
None.
Dosage forms, composition and packaging
TECTA (pantoprazole magnesium) is available as enteric-coated tablets for oral administration. The tablets are yellow, round, biconvex tablets marked 40 on one side and contain 40 mg pantoprazole. Tablets ...
Pharmaceutical information
Drug Substance Proper name: Pantoprazole magnesium Chemical name: magnesium bis [5-(difluoromethoxy)- 2 -[[(3,4-dimethoxy-2-pyridinyl) -methyl]-sulfiny1]-1-H-benzimidazolide] dihydrate Molecular formula ...
Detailed pharmacology
ANIMAL PHARMACOLOGY Pharmacodynamics In vivo, pantoprazole sodium produced marked and long-lasting inhibition of basal and stimulated gastric acid secretion with median effective dose (ED50) values ranging ...
Clinical trials
A double-blind, randomized, parallel group clinical study comparing 40 mg pantoprazole magnesium to 40 mg pantoprazole sodium was performed in 636 patients with GERD grades 1-3 (Savary-Miller classification, ...
Microbiology
In vivo Studies Female mice were infected with Helicobacter felis on Days 1, 3, and 5 by gavage with 108-109 bacteria per animal. Starting on Day 8, the mice were treated three times daily with placebo ...
Toxicology
Acute Toxicity In single dose rodent (rat and mice) studies with pantoprazole magnesium, no toxic effects were noted under any of the doses administered (100, 300, 1000 mg/kg). In acute toxicity studies ...
Marketing authorization holder
Takeda Canada Inc., Toronto, Ontario, M5H 4E3
Submission control number
242002
Date of revision
December 30, 2020
References
1. Escourrou J, Deprez P, Saggioro A, et al. Maintenance therapy with pantoprazole 20 mg prevents relapse of reflux esophagitis. Aliment Pharmacol Ther 1999 Nov; 13 (11): 1481- 91. 2. Gugler R., Hartmann ...