Source: Health Products and Food Branch (CA) Revision Year: 2020
TECTA (pantoprazole magnesium) is indicated for the treatment of conditions where a reduction of gastric acid secretion is required, such as the following:
The safety and effectiveness of pantoprazole in children have not yet been established.
No dosage adjustment is recommended based on age. The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens. See PHARMACOLOGY.
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 usually occurs within 2 weeks. For patients not healed after this initial course of therapy, an additional course of 2 weeks is recommended.
The recommended adult oral dose of TECTA (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.
Pantoprazole/Clarithromycin/Metronidazole Triple Combination Therapy: The recommended dose for H. pylori eradication is treatment for seven days with TECTA (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 TECTA (pantoprazole magnesium) 40 mg together with clarithromycin 500 mg and amoxicillin 1000 mg, all twice daily.
The recommended adult oral dose for the treatment of symptoms of GERD, including heartburn and regurgitation, is TECTA (pantoprazole magnesium) 40 mg once daily for up to 4 weeks. If significant symptom relief is not obtained in 4 weeks, further investigation is required.
The recommended adult oral dose of TECTA (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 TECTA once daily in the morning.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
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.
TECTA (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.
Not Applicable.
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 ingestion of high doses of pantoprazole. Daily doses of up to 272 mg pantoprazole sodium i.v. and single doses of up to 240 mg i.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.
Store at 15°C to 30°C in the recommended packaging.
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