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NEXIUM is a brand name for Esomeprazole, supplied as a granules for suspension, delayed release. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NEXIUM (esomeprazole delayed release tablets or esomeprazole delayed release granules) 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 …
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 NEXIUM 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 NEXIUM 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 NEXIUM 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 NEXIUM 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 NEXIUM once daily for 4 to 8 weeks. No additional clinical benefit was observed for the 40 mg dose over the 20 mg dose.
1 Adverse Reaction Overview NEXIUM (esomeprazole) 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 NEXIUM.
Additionally >1200 adult subjects/patients were exposed to NEXIUM 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 NEXIUM.
Adverse reactions have been recorded during a clinical investigation in 109 pediatric patients (1-11 years of age) exposed to NEXIUM. Among reactions which occurred with a NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC.
Page 14 of 49 frequency of >1% in clinical studies, only diarrhea, headache and somnolence are associated with the use of NEXIUM. No new safety concerns were identified. Adverse reactions have also been recorded during a clinical investigation in 149 pediatric patients (12-17 years of age) exposed to NEXIUM.
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. 7 NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC. 3 In clinical trials up to 6 months’ duration, the following adverse reactions were reported.
1 Pregnant Women 09-2021 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 ................ 8 7 WARNINGS AND PRECAUTIONS ...................................................................... 1 Special Populations ..................................................................................
1 Pregnant Women ................................................................................ 2 Breast-feeding..................................................................................... 3 Pediatrics............................................................................................
NEXIUM (esomeprazole) 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.
4 Drug-Drug Interactions) NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC. Page 5 of 49
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Esomeprazole in Canada.
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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 NEXIUM 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.
Zollinger-Ellison Syndrome:
The dosage in patients with pathological hypersecretory conditions varies with each individual. The recommended initial dosage is 40 mg NEXIUM 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 2 1) 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 Demographics, and Study Results).
Safety information is limited in doses above 80 mg a day. NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC.
Page 6 of 49 Helicobacter pylori Eradication:
In patients with H. pylori-associated active duodenal ulcer: The recommended dose is NEXIUM 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. No further treatment with NEXIUM is required to ensure healing and/or symptom control.
This dosing regimen can also be known as NEXIUM 1 -2- 3A®.
In Patients with a History of Duodenal Ulcer:
The recommended dose is NEXIUM 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. This dosing regimen can also be known as NEXIUM 1-2-3A®. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
3 Pharmacokinetics). Safety studies in pediatric subjects do not extend beyond 8 weeks.
Reflux Esophagitis:
The recommended dose in pediatric patients (1-11 years of age) with reflux esophagitis is: Weight < 20 kg: 10 mg NEXIUM once daily for 8 weeks Weight ≥ 20 kg: 10 mg or 20 mg NEXIUM once daily for 8 weeks The recommended dose in pediatric patients (12-17 years of age) with reflux esophagitis is 20 mg or 40 mg NEXIUM once daily for 4 to 8 weeks.
Nonerosive Reflux Disease (NERD):
In children (1-11 years of age) with heartburn and/or acid regurgitation, without esophagitis, the recommended dose is 10 mg NEXIUM once daily for up to 8 weeks. Doses over 1 mg/kg/day have not been studied. 3 Pediatrics). In pediatric patients (12-17 years of age) with heartburn and/or acid regurgitation, without esophagitis, the recommended dose is 20 mg NEXIUM once daily for 2 to 4 weeks.
If symptom control is not achieved after 4 weeks of treatment, further investigation is recommended.
Special Populations Patients with Renal Insufficiency:
No dose adjustment is required (see Renal).
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 (see Hepatic/Biliary/Pancreatic). 4 Geriatrics).
Genetic Polymorphism:
Dosage adjustment of NEXIUM based on CYP 2C19 status is not necessary. 3 Pharmacokinetics. Sex Dosage adjustment based on gender is not necessary. 3 Pharmacokinetics. NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC.
3 Reconstitution Granules for oral suspension (sachet): The contents of each sachet should be emptied into a container containing 1 tablespoon (15 mL) of water. Stir the […]
NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC. 8 *endoscopic assessment Additionally, the following adverse reactions (irrespective of causality) were each reported at a rate of >1% with NEXIUM in these same long-term studies (n=519): rash, fracture, hernia, dizziness, duodenitis, dyspepsia, epigastric pain, serum gastrin increased, gastroenteritis, GI mucosal discoloration, esophageal disorder, tooth disorder, SGPT (serum glutamic pyruvic transaminase) increased, hypertension, coughing, rhinitis, anemia, benign GI neoplasm, back pain, chest pain, and fatigue.
Clinical experience for up to one year in over 800 patients with doses of NEXIUM of 40 mg have shown a similar adverse reaction pattern to that seen in short -term trials. 7%), NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC.
1%). H. pylori Eradication Combination Therapy In clinical studies, a total of 446 patients received NEXIUM in combination with amoxicillin and clarithromycin for 7 days. 1%). However, it should be noted that taste perversion is commonly associated with clarithromycin treatment and diarrhea is commonly associated with antibiotic treatment.
When NEXIUM is used in combination with amoxicillin and clarithromycin, the Product Monographs for those agents must be consulted and followed. Healing of Gastric Ulcers Associated with NSAID Therapy The data presented in this section is derived from two short-term gastric ulcer healing studies comprising 836 patients.
Table 4 Adverse Reactions (>1%) that […]
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 ................................................................
20 NEXIUM® Product Monograph COPYRIGHT 2001 - 2021 ASTRAZENECA CANADA INC. Page 3 of 49 9 DRUG INTERACTIONS ..................................................................................... 2 Drug Interactions Overview.......................................................................
3 Drug-Behavioural Interactions................................................................... 4 Drug-Drug Interactions.............................................................................. 5 Drug-Food Interactions .............................................................................
6 Drug-Herb Interactions.............................................................................. 7 Drug-Laboratory Test Interactions ............................................................. 24 10 CLINICAL PHARMACOLOGY ...........................................................................
1 Mechanism of Action ........................................................................... 2 Pharmacodynamics............................................................................. 3 Pharmacokinetics................................................................................
27 11 STORAGE, STABILITY AND DISPOSAL .......................................................... 30 12 SPECIAL HANDLING INSTRUCTIONS ............................................................. 30 PART II: SCIENTIFIC INFORMATION ..........................................................................
31 13 PHARMACEUTICAL INFORMATION ................................................................ 31 14 CLINICAL TRIALS ............................................................................................ 1 Clinical Trials by Indication ..................................................................
31 Reflux Esophagitis.............................................................................. 31 Nonerosive Reflux Disease (NERD) .................................................... 31 Maintenance Treatment of NERD (On-demand) ..................................
32 NSAID Associated Upper GI Ulcers..................................................... 32 In Patients with Zollinger-Ellison Syndrome ......................................... 35 In Patients with H. pylori-Associated Active Duodenal Ulcer and a History of Duodenal Ulcer ...............................................................................
36 In Pediatrics (1-17 years of age) ......................................................... 2 Comparative Bioavailability Studies ..................................................... 38 15 MICROBIOLOGY...............................................................................................
38 16 NON-CLINICAL […]