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PMSC-ESOMEPRAZOLE DR 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: pmsc-ESOMEPRAZOLE DR (esomeprazole magnesium) 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) (i.e.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations DO NOT administer via naso-gastric feeding tubes. 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 pmsc- ESOMEPRAZOLE DR 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 pmsc-ESOMEPRAZOLE DR 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 pmsc-ESOMEPRAZOLE DRonce 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 pmsc-ESOMEPRAZOLE DR 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 pmsc-ESOMEPRAZOLE DR 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 pmsc- ESOMEPRAZOLE DRonce 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.
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% 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 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. Adults The following adverse reactions, irrespective of causal relationship, were reported in controlled short-term (up to 8 weeks) clinical trials involving 5668 patients: pmsc-ESOMEPRAZOLE DR page 15 of 49 Table 2 Adverse Reactions (>1%), Irrespective of Causal Relationship, in Short Term Clinical Trials (Up to 8 weeks) Treated With Esomeprazole.
3 In clinical trials up to 6 months’ duration, the following adverse reactions were reported. pmsc-ESOMEPRAZOLE DR page 16 of 49 Table 3 Adverse Reactions (>3%) Irrespective of Causal Relationship in Clinical Trials Up to 6 Months Duration Treated With Esomeprazole.
1 Pregnant Women 06-2022 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 ......................................................................
4 Administration........................................................................................................................ 5 Missed Dose ...........................................................................................................................
6 5 OVERDOSAGE ....................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................
7 7 WARNINGS AND PRECAUTIONS ............................................................................................ 1 Special Populations ..............................................................................................................
pmsc-ESOMEPRAZOLE DR (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) pmsc-ESOMEPRAZOLE DR page 5 of 49
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pharmacokinetics). Safety studies in pediatric subjects do not extend beyond 8 weeks.
Reflux esophagitis:
The recommended dose in pediatric patients (12-17 years of age) with reflux esophagitis is 20 mg or 40 mg pmsc-ESOMEPRAZOLE DR once daily for 4 to 8 weeks.
Nonerosive Reflux Disease (NERD):
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 pmsc-ESOMEPRAZOLE DR 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 pmsc-ESOMEPRAZOLE DR based on CYP 2C19 status is not necessary. 3 Pharmacokinetics. Sex Dosage adjustment based on gender is not necessary. 3 Pharmacokinetics. 4 Administration Tablets: The tablets should be swallowed whole with sufficient water.
Do not disperse, divide, crush or chew the tablets. 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.
pmsc-ESOMEPRAZOLE DR page 7 of 49
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.
Clinical experience for up to one year in over 800 patients with doses of esomeprazole of 40 mg have shown a similar adverse reaction pattern to that seen in short-term trials. 1%), overdose (1. 1%). Healing of Gastric Ulcers Associated with NSAID Therapy pmsc-ESOMEPRAZOLE DR page 17 of 49 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 Trials (up to 8 Weeks), for the Healing of Gastric Ulcers Associated with NSAID Therapy.
5 The following adverse events (considered unrelated to esomeprazole by the investigator) were each reported at a frequency of >1% in clinical trials for the healing of gastric ulcers; gastric ulcer aggravated, mucosal discoloration GI, gastrointestinal symptoms NOS, esophageal stricture, esophagitis, vomiting, constipation, duodenitis, rash, anxiety, pharyngitis, respiratory infection, sinusitis, urinary tract infection, accident and/or injury, and back pain.
In addition, the following adverse events of a potentially severe nature (considered unrelated to esomeprazole by the investigator) were reported in these same studies; cardiac failure aggravated, hypertension/hypertension aggravated, syncope, arrhythmia, bradycardia, atrial fibrillation, palpitation/palpitation aggravated.
Risk-reduction of Gastric Ulcers Associated with NSAID Therapy The data presented in this section is derived from two long-term ulcer risk-reduction studies comprising 1390 patients. pmsc-ESOMEPRAZOLE […]
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 ........................................................................................................
6 Drug-Herb Interactions ........................................................................................................ 7 Drug-Laboratory Test Interactions.......................................................................................
24 10 CLINICAL PHARMACOLOGY ............................................................................................... 1 Mechanism of Action .........................................................................................................
2 Pharmacodynamics ............................................................................................................ 3 Pharmacokinetics ...............................................................................................................
25 11 STORAGE, STABILITY AND DISPOSAL ................................................................................. 27 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................................
27 PART II: SCIENTIFIC INFORMATION ........................................................................................ 28 13 PHARMACEUTICAL INFORMATION ....................................................................................
28 14 CLINICAL TRIALS ............................................................................................................... 1 Clinical Trials by Indication ................................................................................................
29 Reflux Esophagitis […]