NEXIPRAZ Capsule

Adults

- Gastroesophageal reflux disease - treatment of erosive reflux esophagitis.

- Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.

- Treatment of Zollinger-Ellison syndrome.

Children

Adolescents from the age or 12 years

Gastroesophageal reflux disease - treatment of erosive reflux esophagitis.

Dosage

Adults

- Gastroesophageal reflux disease - treatment of erosive reflux esophagitis: 40mg 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.

- Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers: 40mgonce daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

- Treatment of Zollinger-Ellison syndrome: The recommended dosage is 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 80-160mg esomeprazole daily. With doses above 80mg daily, the dose should be divided and given trice daily.

Children

Adolescents from the age or 12 years:

Gastroesophageal reflux disease - treatment of erosive reflux esophagitis: 40mg 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.

Children under the age of 12 years: Nexipraz 40 are not recommended for children less than 12 years old.

Renal impairment

Hepatic impairment

Elderly

See the package insert about the details.

Administration

- It is recommended to take this medicine in the morning, swallowed whole with half a glass of water. The capsules must not be chewed or crushed.

- For patients with swallowing difficulties and for children who can drink or swallow semi-solid food: Patients can open the capsule and swallow the contents with half a glass of water or mix the contents in a slightly acidic fluid, swallowed immediately.

- Hypersensitivity to the active substance, substituted benzimidazoles or any other constituents of the formulation.

- Esomeprazole should not be used concomitantly with nelfinavir.

See the package insert about the details below.

- Protease inhibitors

- Methotrexate

- Tacrolimus

- Medicinal products with pH dependent absorption

- Active substances metabolised by CYP2C19

- Cisapride

- Warfarin

- Clopidogrel

- Effect of other medicine products on the pharmacokinetic esomeprazole.

Pregnancy

Caution should be exercised when prescribing to pregnant women.

Lactation

It is not known whether esomeprazole is excreted in human breast milk. Therefore esomeprazole should not be used during breast-feeding.

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Nexipraz 4- may alleviate symptoms and delay diagnosis.

See the package insert about the details below.

- Long term use

- Helicobacter pylori eradication

- Gastrointestinal infections

- Absorption of vitamin B12

- Hypomagnesaemia

- Risk of fracture

- Subacute cutaneous lupus erythematosus

- Combination with other medicinal products (Atazanavir, Drugs metabolised through CYP2C19).

- Interference with laboratory tests (increased Chromogranin A level may interfere with investigations for neuroendocrine tumors. To avoid this interference, esomeprazole treatment should be stopped for at least five days before CgA measurements).

- Esomeprazole is the S-isomer of omeprazole, used similar to omeprazole in the treatment of peptic ulcer disease, gastroesophageal reflux disease and Zollinger Ellison syndrome. Esomeprazole reduces gastric acid secretion by inhibiting the enzyme H+K+-ATPase - the acid pump (proton pump) in the parietal cell of the stomach. By inhibiting the functioning of this transported, the drug prevents formation of stomach acid. Therefore, esomeprazole inhibits both basal and stimulated acid secretion. The drug has strong and lasting effect.

- Proton pump inhibitors only inhibit but can not eradiate Helicobacter pylori, therefore, esomeprazole should be combined with the antibiotics (such as amoxicillin, tetracycline, clarithromycin) to effectively eradicate of these bacteria.