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MYL-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: Myl-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 Myl- 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 Myl-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 Myl-Esomeprazole once daily for 2 to 4 weeks. If symptom control is not achieved after 4 weeks of treatment, further investigation is recommended.
MYL-ESOMEPRAZOLE (esomeprazole) Page 7 of 58 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 Myl-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 Myl-Esomeprazole 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 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 esomeprazole.
Additionally >1200 adult subjects/patients were exposed to esomeprazole in Phase I studies. Among reactions which occurred with a frequency of >1% MYL-ESOMEPRAZOLE (esomeprazole) Page 17 of 58 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.
Adverse reactions have been recorded during a clinical investigation in 109 pediatric patients (1-11 years of age) exposed to esomeprazole. Among reactions which occurred with a frequency of >1% in clinical studies, only diarrhea, headache and somnolence are associated with the use of esomeprazole.
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 esomeprazole. 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. 3 In clinical trials up to 6 months’ duration, the following adverse reactions were reported.
8 *endoscopic assessment Additionally, the following adverse reactions (irrespective of causality) were each reported at a rate of >1% with esomeprazole 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.
2 Breast-feeding 06/2023 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 .....................................................................
5 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 6 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ..............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration .......................................................................................................... 5 Missed Dose ..............................................................................................................
9 5 OVERDOSAGE............................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
2 Breast-feeding 06/2023 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 .....................................................................
5 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 6 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ..............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration .......................................................................................................... 5 Missed Dose ..............................................................................................................
9 5 OVERDOSAGE............................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Myl-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.
Zollinger-Ellison Syndrome:
The dosage in patients with pathological hypersecretory conditions varies with each individual. The recommended initial dosage is 40 mg Myl-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 Demographics, 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 Myl-Esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. No further treatment with Myl-Esomeprazole is required to ensure healing and/or symptom control.
In Patients with a History of Duodenal Ulcer:
The recommended dose is Myl-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. 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: 20 mg Myl-Esomeprazole once daily for 8 weeks MYL-ESOMEPRAZOLE (esomeprazole) Page 8 of 58 The recommended dose in pediatric patients (12-17 years of age) with reflux esophagitis is 20 mg or 40 mg Myl-Esomeprazole once daily for 4 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 Myl-Esomeprazole 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 Myl-Esomeprazole based on CYP 2C19 status is not necessary. 3 Pharmacokinetics. Sex Dosage adjustment based on gender is not necessary. 3 Pharmacokinetics. 4 Administration • The tablets should be swallowed whole with sufficient water.
• The tablets may also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes.
Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. • Dispersed tablets can also be administered via […]
Clinical experience for up to one year in over 800 patients with doses of esomeprazole of 40 MYL-ESOMEPRAZOLE (esomeprazole) Page 19 of 58 mg have shown a similar adverse reaction pattern to that seen in short-term trials. 1%). H. pylori Eradication Combination Therapy In clinical studies, a total of 446 patients received esomeprazole 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 Myl-Esomeprazole 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 were Assessed by the Investigator to have a Reasonable Causal Relationship with Treatment in Short Term Clinical […]
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
16 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.............................................................................. 23 9 DRUG INTERACTIONS ............................................................................................... 1 Drug Interactions Overview ....................................................................................
2 Drug-Behavioural Interactions ................................................................................ 3 Drug-Drug Interactions ........................................................................................... 4 Drug-Food Interactions ...........................................................................................
5 Drug-Herb Interactions ........................................................................................... 6 Drug-Laboratory Test Interactions.......................................................................... 28 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
31 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 34 PART II: SCIENTIFIC INFORMATION ......................................................................................
35 13 PHARMACEUTICAL INFORMATION ........................................................................... 35 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ............................................................................... 35 Reflux Esophagitis .............................................................................................................
35 Nonerosive Reflux Disease (NERD) ................................................................................... 36 Maintenance Treatment of NERD (On-demand) .............................................................. 36 NSAID Associated Upper GI Ulcers […]
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
16 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.............................................................................. 23 9 DRUG INTERACTIONS ............................................................................................... 1 Drug Interactions Overview ....................................................................................
2 Drug-Behavioural Interactions ................................................................................ 3 Drug-Drug Interactions ........................................................................................... 4 Drug-Food Interactions ...........................................................................................
5 Drug-Herb Interactions ........................................................................................... 6 Drug-Laboratory Test Interactions.......................................................................... 28 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
31 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 34 PART II: SCIENTIFIC INFORMATION ......................................................................................
35 13 PHARMACEUTICAL INFORMATION ........................................................................... 35 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ............................................................................... 35 Reflux Esophagitis .............................................................................................................
35 Nonerosive Reflux Disease (NERD) ................................................................................... 36 Maintenance Treatment of NERD (On-demand) .............................................................. 36 NSAID Associated […]