Nexium 24HR formulation

Name of product: Nexium 24HR esomeprazole magnesium delayed release capsules USP

Active ingredient: Esomeprazole magnesium trihydrate

Drug Identification Number (DIN): 02444712

Name and address of the product license holder: GlaxoSmithKline Consumer Healthcare ULC, 450-55 Standish Court, Mississauga, Ontario, Canada L5R 4B2

NAPRA Scheduling: 3 (Over the Counter). Individual provinces and territories may not follow the NAPRA scheduling.

Indications:

Adults: Nexium 24HR (esomeprazole magnesium delayed release capsules USP) capsules are indicated for the treatment of frequent heartburn (heartburn that occurs 2 or more days a week). Nexium 24HR capsules are not indicated for infrequent heartburn (i.e., one episode of heartburn a week or less) or immediate relief of heartburn. This drug may take 1 to 4 days for full effect.

Pediatrics: Health Canada has not authorized an indication for children <18 years of age.

Side Effects:

Common: nausea, stomach upset, diarrhea, headache

Uncommon: dry mouth, dizziness, insomnia, feeling of burning/prickliness/numbing, swelling of extremities, feeling sleepy, vertigo

Precautions:

Patients should be advised to consult a physician if they have any alarming symptoms or if symptoms get worse or persist for more than 2 weeks.

Patients should be advised to consult their doctor if they:

• Had heartburn over 3 months;
• Have heartburn with light headedness, sweating, or dizziness;
• Have chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or light headedness;
• Have frequent chest pain;
• Have frequent wheezing, particularly with heartburn;
• Have unexplained weight loss;
• Have dysphagia (trouble swallowing);
• Have nausea or vomiting;
• Have haematemesis and melena;
• Have stomach pain;
• Had previous gastric ulcer or gastrointestinal surgery;
• Have jaundice or severe liver disease;
• Are aged >55 with new or recently changed symptoms.

During treatment with antisecretory drugs, chromogranin A (CgA) increases due to the decreased gastric acidity. Increased CgA levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, NEXIUM 24 HR treatment should be stopped 14 days before CgA measurements.

Contraindications:

Esomeprazole is contraindicated:

• With co-administration of rilpivirine;
• In patients who are hypersensitive to this drug, other proton pump inhibitors or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Dosage and Administration:

Dosing Considerations

• Swallow 1 capsule with a glass of water before eating in the morning.

Recommended Dose and Dosage Adjustment

• Adults ≥ 18 years of age: Take one capsule once daily for 14 days. Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

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.

Administration

Special Populations

• Patients with Renal Insufficiency: No dose adjustment is required.
• 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.
• Elderly Patients: No dose adjustment is required.

January 2024