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nexiumNexium

Esomeprazole

Tablets 20 mg and 40 mg

 

Composition

Each tablet contains: 20mg or 40mg esomeprazole (as magnesium trihydrate). For excipients see "List of excipients".

 

Description

NEXIUM is a proton pump inhibitor. The active ingredient in Nexium is esomeprazole magnesium trihydrate, a substituted benzimidazole. Esomeprazole is the S-isomer of omeprazole. It is optically stable in vivo, with negligible conversion to the R-isomer. The chemical name is di-(S)-5-methoxy-2-[[4- methoxy-3,5-dimethyl-2-pyridinyl)methyl] sulfinyl] -1H- benzimidazole magnesium salt trihydrate.

 

The chemical structure of esomeprazole magnesium trihydrate is:

Nexium

 

CAS Number: 217087-09-7

Molecular formula: C34H36N6O6S2Mg.3H2O

Molecular weight: 767.2 (trihydrate)

 

Therapeutic Indication

Nexium tablets are indicated for:

 

Gastroesophageal Reflux Disease (GERD)

treatment of erosive reflux esophagitis

long-term management of patients with healed esophagitis to prevent relapse

symptomatic treatment of gastroesophageal reflux disease (GERD)

 

In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

healing of Helicobacter pylori associated duodenal ulcer and

prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

 

Patients requiring continued NSAID therapy

healing of gastric ulcers associated with NSAID therapy.

prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.

 

Treatment of Zollinger Ellison Syndrome

Posology and method of administration

The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. For patients who have difficulty in swallowing the tablets can 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 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.

 

For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested. For preparation and administration instructions please see section "Instructions for use and handling".

 

Adults and adolescents from the age of 12 years

Gastroesophageal Reflux Disease (GERD)

treatment of erosive reflux esophagitis

40 mg once daily for 4 weeks.

An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

 

long-term management of patients with healed esophagitis to prevent relapse

20 mg once daily.

 

symptomatic treatment of gastroesophageal reflux disease (GERD)

20 mg once daily in patients without esophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. In adults, an on demand regimen taking 20mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric cancer and duodenal ulcers, subsequent symptom treatment using an on demand regimen is not recommended.

 

Adults

In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

healing of Helicobacterpylori associated duodenal ulcer and

prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers

20 mg Nexium with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

 

Patients requiring continued NSAID therapy

healing of gastric ulcers associated with NSAID therapy: The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.

 

prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily

 

Treatment of Zollinger Ellison Syndrome

The recommended initial dosage is Nexium 40mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily.

 

Children below the age of 12 years

Nexium should not be used in children younger than 12 years since no data is available.

 

Impaired renal function

Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution. (See "Pharmacokinetics Properties").

 

Impaired hepatic function

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg Nexium should not be exceeded (see "Pharmacokinetics Properties").

 

Elderly

Dose adjustment is not required in the elderly.

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