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SANDOZ ESOMEPRAZOLE is a brand name for Esomeprazole, supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Esomeprazole (esomeprazole delayed release tablets) is indicated in adults (18 years of age and above) for treatment of conditions where a reduction in gastric acid secretion is required such as: • reflux esophagitis • maintenance treatment of patients with reflux esophagitis • nonerosive reflux disease (NERD)…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations When used in combination with amoxicillin and clarithromycin, please refer to the Product Monographs of these drugs for prescribing information regarding Contraindications, Warnings and Dosing (in elderly and patients with renal and hepatic insufficiency).
2 Recommended Dose and Dosage Adjustment Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Adults Reflux Esophagitis:
The recommended dose in patients with reflux esophagitis is 40 mg Sandoz Esomeprazole once daily for 4 to 8 weeks in order to optimize the healing rate and symptom resolution. Healing occurs in the majority of patients within 4 weeks.
Sustained freedom from symptoms is achieved rapidly for most patients. An additional 4 weeks of treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.
Maintenance of Healing of Erosive Esophagitis:
For the long-term treatment of patients whose reflux esophagitis has been healed with acid suppression therapy, the recommended dose is 20 mg Sandoz Esomeprazole once daily. Controlled studies do not extend beyond 6 months.
Nonerosive reflux disease:
In patients with heartburn and/or acid regurgitation, without esophagitis, the recommended dose is 20 mg Sandoz Esomeprazole once daily for 2 to 4 weeks. If symptom control is not achieved after 4 weeks of treatment, further investigation is recommended.
Maintenance Treatment of NERD (On-demand):
For the maintenance of symptom relief in patients whose symptoms were initially controlled after daily doses for 2 to 4 weeks, the recommended dose is 20 mg Sandoz Esomeprazole once daily taken as needed. Despite treatment, the possibility for development of esophagitis in patients cannot be excluded.
Healing of Gastric Ulcers Associated with NSAID Therapy:
In patients requiring NSAID therapy, the recommended dose is 20 mg Sandoz Esomeprazole once daily for 4 to 8 weeks. No additional clinical benefit was observed for the 40 mg dose over the 20 mg dose.
Post-Market Adverse Drug Reactions for effects on liver functioning).
Musculoskeletal Bone Fracture:
Several published observational studies suggest that proton pump inhibitor (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 (see 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS).
Renal Since the kidney is responsible for the excretion of metabolites of esomeprazole but not for the elimination of the parent compound, the metabolism of esomeprazole is not expected to be changed in patients with impaired renal function.
Esomeprazole is extensively protein-bound and is, therefore, not expected to be readily dialyzable. 2 Recommended Dose and Dosage Adjustment). 1 Pregnant Women There are no adequate or well-controlled studies in pregnant women. Therefore, the safety of esomeprazole magnesium in pregnancy has not been established.
Sandoz Esomeprazole should not be administered to pregnant women unless the expected benefits outweigh the potential risks. Esomeprazole is indicated in combination with antibiotics for the treatment of duodenal ulcer disease and eradication of Helicobacter Pylori.
One of the recommended antibiotics, clarithromycin, should not be used in pregnancy except where no alternative therapy is appropriate, particularly during the first 3 months of pregnancy. Refer to the Product Monograph for clarithromycin before using the product.
1 Pregnant Women 07/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ............................................................................................................... 1 Pediatrics..............................................................................................................
4 2 CONTRAINDICATIONS.................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 3 Reconstitution ...................................................................................................... 4 Administration .....................................................................................................
5 Missed Dose ......................................................................................................... 7 5 OVERDOSAGE..............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations.............................................................................................
Sandoz Esomeprazole (esomeprazole magnesium) is contraindicated: • in patients who are hypersensitive to esomeprazole, 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. Sandoz Esomeprazole Page 5 of 49 • when used for eradication of Helicobacter pylori, the contraindications for amoxicillin and clarithromycin as found in the corresponding Product Monographs should be taken into consideration.
4 Drug-Drug Interactions)
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.
Risk-Reduction of Gastric Ulcers Associated with NSAID Therapy:
In patients requiring NSAID therapy who are at risk of gastric ulcers, the recommended dose is 20 mg Sandoz Esomeprazole once daily. No additional clinical benefit was observed for the 40 mg dose over the 20 mg dose. Controlled studies did not extend beyond 6 months.
Sandoz Esomeprazole Page 6 of 49 Zollinger-Ellison Syndrome:
The dosage in patients with pathological hypersecretory conditions varies with each individual. The recommended initial dosage is 40 mg Sandoz Esomeprazole twice a day. Dosages should then be adjusted to individual patient’s needs and treatment should continue as long as clinically indicated.
d. In a clinical study, 90% of patients (19 out of 21) with a hypersecretory condition such as Zollinger-Ellison syndrome had gastric acid outputs appropriately controlled at various doses and were maintained through 12 months (see 14 CLINICAL TRIALS, In Patients with Zollinger-Ellison Syndrome, Trial Design and Study Demongraphics, and Study Results).
Safety information is limited in doses above 80 mg a day.
Helicobacter pylori Eradication:
In patients with H. pylori-associated active duodenal ulcer: The recommended dose is Sandoz Esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. No further treatment with Sandoz Esomeprazole is required to ensure healing and/or symptom control.
In patients with a history of duodenal ulcer:
The recommended dose is Sandoz Esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Pediatrics (12-17 years of age) Sandoz Esomeprazole (esomeprazole magnesium dihydrate) is not recommended for use in children under 12 years of age.
3 Pharmacokinetics, Special Populations, Pediatrics). • Safety studies in pediatric subjects do not extend beyond 8 weeks.
Reflux esophagitis:
The recommended dose in pediatric patients (12 to 17 years) with reflux esophagitis is 20 mg or 40 mg Sandoz Esomeprazole once daily for 4 to 8 weeks.
Nonerosive Reflux Disease (NERD):
In pediatric patients (12 to 17 years) with heartburn and/or acid regurgitation, without esophagitis, the recommended dose is 20 mg Sandoz Esomeprazole once daily for 2 to 4 weeks. If symptom control is not achieved after 4 weeks of treatment, further investigation is recommended.
Safety studies do not extend beyond 8 weeks.
Special Populations Patients with Renal Insufficiency:
No dose adjustment is required (see 7 WARNINGS AND PRECAUTIONS).
Patients with Hepatic Insufficiency:
No dose adjustment is required for patients with mild to moderate hepatic impairment. The daily doses of 20 mg in patients with severe hepatic impairment should not, as a rule, be exceeded (see7 WARNINGS AND PRECAUTIONS).
Elderly Patients:
No dose adjustment is required (see 7 WARNINGS AND PRECAUTIONS).
Genetic Polymorphism:
Dosage adjustment of Sandoz Esomeprazole based on CYP 2C19 status is not necessary. 3 Pharmacokinetics. Sex Dosage adjustment based on gender is not necessary. 3 Pharmacokinetics. 3 Reconstitution Not applicable. 4 Administration Tablets: • The tablets should be swallowed whole with sufficient water.
5 Missed Dose A missed dose should be taken as soon as possible within 12 hours. If more than 12 hours have passed, then the next scheduled dose should be taken at the appropriate time.
2 Breast-feeding It has not been investigated whether or not esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Precaution should be exercised because many drugs can be excreted in human milk.
Esomeprazole is the S-isomer of omeprazole, which is secreted in breast milk Therefore, Sandoz Esomperazole should not be given to nursing mothers unless its use is considered essential. 3 Pharmacokinetics, and in Pediatrics (12-17 years of age) -Study Results).
Sandoz Esomeprazole (esomeprazole magnesium dihydrate) is not recommended for use in children under 12 years of age.
Pediatrics (<1 years of age):
The safety and effectiveness of esomeprazole magnesium have not yet been established in pediatric patients <1 years of age. 4 Geriatrics Geriatrics (> 71 years of age): The metabolism of esomeprazole magnesium is not significantly changed in elderly subjects.
Following repeated oral dosing with 40 mg esomeprazole magnesium in healthy elderly subjects (6 males, 8 females; 71 to 80 years of age), AUC and Cmax values measured were similar to those previously measured in young GERD patients (ratio of AUC values in elderly vs.
18). Therefore, dose adjustment is not required in the elderly. Benefits of use of PPIs should be weighed against the increased risk of fractures as patients in this category 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 Esomeprazole magnesium is well-tolerated.
Most adverse reactions have been mild and transient, showing no consistent relationship with treatment. Adverse reactions have been recorded during controlled clinical investigations in >8500 adult patients exposed to esomeprazole magnesium.
Additionally >1200 adult subjects/patients were exposed to esomeprazole magnesium in Phase I studies. Among reactions which occurred with a frequency of >1% in clinical studies, only headache, diarrhea, flatulence, abdominal pain, nausea, vomiting, dizziness and dry mouth are thought to be associated with the use of esomeprazole magnesium.
Adverse reactions have also been recorded during a clinical investigation in 149 pediatric patients (12-17 years of age) exposed to esomeprazole magnesium. The treatment related adverse event profile was found to be consistent with that seen in adults.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, 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. Adults The following adverse reactions (>1%), irrespective of causal relationship, were reported in controlled short-term (up to 8 weeks) clinical trials involving 5668 patients: Sandoz Esomeprazole Page 14 of 49 Table 2 Adverse Reactions (>1%) Irrespective of Causal Relationship in Short Term Clinical Trials (Up to 8 weeks) Treated With Esomeprazole Magnesium Adverse Reaction All studies Placebo controlled studies Esomeprazole Magnesium 20 and 40 mg n = 5668 (%) […]
1 Pregnant Women ............................................................................................. 2 Breast-feeding ................................................................................................. 3 Pediatrics.........................................................................................................
4 Geriatrics ......................................................................................................... 13 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview ................................................................................ 2 Clinical Trial Adverse Reactions ........................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ....................................................
3 Less Common Clinical Trial Adverse Reactions ..................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.....................................................................................................
5 Post-Market Adverse Reactions .......................................................................... 19 9 DRUG INTERACTIONS ................................................................................................ 2 Drug Interactions Overview ................................................................................
3 Drug-Behavioural Interactions ............................................................................ 4 Drug-Drug Interactions ....................................................................................... 5 Drug-Food Interactions .......................................................................................
7 Drug-Laboratory Test Interactions....................................................................... 23 10 CLINICAL PHARMACOLOGY........................................................................................ 1 Mechanism of Action ........................................................................................
2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ............................................................................................. 26 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
28 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 28 PART II: SCIENTIFIC INFORMATION ......................................................................................
29 13 PHARMACEUTICAL INFORMATION ............................................................................ 29 14 CLINICAL TRIALS ........................................................................................................
1 Clinical Trials by Indication ................................................................................ 3 Comparative Bioavailability Studies .................................................................. 34 15 MICROBIOLOGY ........................................................................................................
37 16 NON-CLINICAL TOXICOLOGY...................................................................................... 37 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 41 PATIENT MEDICATION INFORMATION .................................................................................
42 Sandoz Esomeprazole Page 4 of […]