Nexipraz 40

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration

It is recommended to take Nexipraz 40 in the morning, swallowed whole. 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.

Posology

Adults and adolescents 12 years of age and above:

Gastro-Esophageal 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 gastro-esophageal 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. An on-demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.

Adults 

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

- healing of Helicobacter pylori associated duodenal ulcer: 20 mg esomeprazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers: 20 mg esomeprazole 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.

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

40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

Treatment of Zollinger Ellison Syndrome

The recommended initial dosage is 40 mg esomeprazole 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.

Adolescents from the age of 12 years

Treatment of duodenal ulcer caused by Helicobacter pylori

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents. The treatment should be supervised by a specialist.

The posology recommendation is:

Weight 30-40 kg: Combination with two antibiotics: Esomeprazole 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administered together twice daily for one week.

Weight > 40 kg: Combination with two antibiotics: Esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administered together twice daily for one week.

Special Populations

Children below the age of 12 years: It is more appropriate to use another dosage form

Patients with renal impairment

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.

Patients with hepatic impairment

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 esomeprazole should not be exceeded.

Elderly

Dose adjustment is not required in the elderly.

CONTRAINDICATIONS

Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients.
Esomeprazole should not be used concomitantly with nelfinavir.

 WARNINGS AND PRECAUTIONS

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 40 may alleviate symptoms and delay diagnosis.

Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.

Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character. When prescribing esomeprazole according to the required regimen, consideration should be given to the potential for interactions with other medicinal products because of variable plasma concentrations of esomeprazole.

When prescribing esomeprazole for eradication of Helicobacter pylori, possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients concurrently taking othe drugs metabolised via CYP3A4 such as cisapride.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

Co-administration of esomeprazole with atazanavir is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.

Esomeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause

hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Risk of fracture: Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexipraz 40. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, [Invented name] treatment should be stopped for at least 5 days before CgA measurements.

Shelf-life

36 months from the manufacturing date. Do not use after the expiry date

Aluminium blister. Box of 05 blisters x 07 gastro-resistant hard capsules.