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APO-ESOMEPRAZOLE DELAYED-RELEASE 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: APO-ESOMEPRAZOLE DELAYED-RELEASE (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…
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 APO- ESOMEPRAZOLE DELAYED-RELEASE 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 APO-ESOMEPRAZOLE DELAYED-RELEASE 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 APO-ESOMEPRAZOLE DELAYED-RELEASE once APO-ESOMEPRAZOLE DELAYED-RELEASE (Esomeprazole delayed release tablets) Page 7 of 57 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 APO-ESOMEPRAZOLE DELAYED-RELEASE 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:
1 Adverse Reaction Overview Esomeprazole delayed release tablets 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 delayed release tablets.
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 delayed release tablets.
Adverse reactions have also been recorded during a clinical investigation in 149 pediatric patients (12 to 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. 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 delayed release tablets 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.
, significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena), and/or when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.
Antibiotic Combination Therapy:
APO-ESOMEPRAZOLE DELAYED-RELEASE 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.
1 Pregnant Women).
Pseudomembranous Colitis:
APO-ESOMEPRAZOLE DELAYED-RELEASE (Esomeprazole delayed release tablets) Page 11 of 57 Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, which are used together with proton pump inhibitors (PPIs) for the treatment of H.
pylori, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia.
Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
APO-ESOMEPRAZOLE DELAYED-RELEASE (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)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients requiring NSAID therapy, the recommended dose is 20 mg APO-ESOMEPRAZOLE DELAYED-RELEASE once daily for 4 to 8 weeks. No additional clinical benefit was observed for the 40 mg dose over the 20 mg dose.
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 APO-ESOMEPRAZOLE DELAYED-RELEASE 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 APO-ESOMEPRAZOLE DELAYED-RELEASE 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 APO-ESOMEPRAZOLE DELAYED-RELEASE 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. No further treatment with APO- ESOMEPRAZOLE DELAYED-RELEASE is required to ensure healing and/or symptom control.
In Patients with a History of Duodenal Ulcer:
The recommended dose is APO-ESOMEPRAZOLE DELAYED-RELEASE 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 to 17 years of age) APO-ESOMEPRAZOLE DELAYED-RELEASE IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.
3 Pharmacokinetics). • Safety studies in pediatric subjects do not extend beyond 8 weeks.
Reflux Esophagitis:
The recommended dose in pediatric patients (12 to 17 years of age) with reflux esophagitis is 20 mg or 40 mg APO-ESOMEPRAZOLE DELAYED-RELEASE once daily for 4 to 8 weeks.
Nonerosive Reflux Disease (NERD):
In pediatric patients (12 to 17 years of age) with heartburn and/or acid regurgitation, without esophagitis, the recommended dose is 20 mg APO-ESOMEPRAZOLE DELAYED-RELEASE 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 APO-ESOMEPRAZOLE DELAYED-RELEASE 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 […]
Clinical experience for up to one year in over 800 patients with doses of esomeprazole delayed release tablets of 40 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 delayed release tablets 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 esomeprazole delayed release tablets 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 […]
Clostridium Difficile Associated Diarrhea:
Decreased gastric acidity due to any means, including any PPIs, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with PPI’s can lead to an increased risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
An increased risk for Clostridium difficile infection (CDI) and Clostridium difficile associated diarrhea (CDAD) has been observed in association with PPI use in several observational studies. CDI/CDAD should be considered in the differential diagnosis for diarrhea that does not improve.
Additional risk factors for CDI and CDAD include recent hospitalization, the use of antibiotics, old age and the presence of comorbidities. Patients should be prescribed PPIs at the lowest dose and for the shortest duration required for the condition being treated and be reassessed to ascertain whether continued PPI therapy remains beneficial.
Concomitant use of clopidogrel:
Results from studies in healthy subjects have shown a pharmacokinetic/pharmacodynamic interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and esomeprazole (40 mg once daily) resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40%, and resulting in decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 14%.
4 Drug-Drug Interactions).
Concomitant use of PPIs with Methotrexate:
APO-ESOMEPRAZOLE DELAYED-RELEASE (Esomeprazole delayed release tablets) Page 12 of 57 Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.
4 Drug-Drug Interactions). Concomitant use of Antiretroviral Drugs PPIs have been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. A change in gastric pH may change the absorption of the antiretroviral drug.
Other possible mechanisms are via CYP 2C19. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions) (see the REYATAZ AND VIRACEPT Product Monographs). If the combination of APO-ESOMEPRAZOLE DELAYED-RELEASE with atazanavir is judged unavoidable, close clinical monitoring is recommended in combination with the use of 400 mg atazanavir/100 mg ritonavir dose; the dose of APO-ESOMEPRAZOLE DELAYED- RELEASE should not exceed an equivalent dose omeprazole of 20 mg daily (see REYATAZ Product Monograph).
• Saquinavir: If APO-ESOMEPRAZOLE DELAYED-RELEASE is co-administered with saquinavir/ritonavir, caution and monitoring for potential saquinavir toxicities, including gastrointestinal symptoms, increased triglycerides, deep vein thrombosis and QT prolongation are recommended.
4 Drug-Drug Interactions) (see INVIRASE Product Monograph). Carcinogenesis and Mutagenesis Treatment with esomeprazole delayed release tablets for up to 1 year in more than 800 patients resulted in moderate increases in serum gastrin levels.
However, no significant pathological changes in the gastric oxyntic endocrine cells were observed. Short-term treatment and long-term treatment with the racemate, omeprazole, capsules in a limited number of patients for up to 11 years have not resulted in any significant pathological […]