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 Nexium
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:
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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