ASMOZOL-ES 40 Tablet

INDICATIONS:

Adults

ASMOZOL-ES 40 tablets are indicated for:

+Gastro-Oesophageal Reflux Disease (GORD)

  - Treatment of erosive reflux oesophagitis

  - Long-term management of patients with healed oesophagitis to prevent relapse

  - Symptomatic treatment of gastro-oesophageal reflux disease (GORD)

+In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pyloriand

  - 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

+Adolescents from the age of 12 years

+Gastro-Oesophageal Reflux Disease (GORD)

  - Treatment of erosive reflux oesophagitis

  - Long-term management of patients with healed oesophagitis to prevent relapse

  - symptomatic treatment of gastro-oesophageal reflux disease (GORD)

+In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori

 

DOSAGE AND ADMINISTRATION:

+Method of administration: Oral

The tablets should be swallowed whole with liquid. The tablets should not be chew 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 the 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.

+Adults and adolescents from the age of 12 years

Gastro-oesophageal Reflux Disease (GORD)

  - Treatment of erosive reflux oesophagitis: 40mg esomeprazole once daily for 4 weeks.

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

+Adults

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

40 mg esomeprazole 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 160mg esomeprazole daily.

With doses above 80 mg daily, the dose should be divided and given twice daily.

+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.

+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 esomeprazole should not be exceeded.

+Elderly

Dose adjustment is not required in the elderly.

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

Hypersensitivity to esomeprazole, substituted benzimedazoles or to any other constituents of the formulation.

Esomeprazole should not be used concomitantly with nelfinavir.

Pregnancy

For esomeprazole clinical data on exposed pregnancies are insufficient. With the racemic mixture, omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Breastfeeding

It is not known whether esomeprazole is excreted in human breast milk. No studies in lactation women have been performed. 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 NEXIUM MUPS 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 for on demand therapy, the implications for interactions with other pharmaceuticals, due to fluctuating plasma concentrations of esomeprazole should be considered.