COMPOSITION :

Esobest 20 Tablet: Each enteric coated tablet contains 20 mg of Esomeprazole as

Esomeprazole Magnesium Trihydrate BP.

Esobest 40 Tablet: Each enteric coated tablet contains 40 mg of Esomeprazole as

Esomeprazole Magnesium Trihydrate BP.

Esobest 20 Capsule: Each capsule contains 20 mg of Esomeprazole as

Esomeprazole Magnesium Trihydrate USP in enteric coated pellets.

Esobest 40 Capsule: Each capsule contains 40 mg of Esomeprazole as

Esomeprazole Magnesium Trihydrate USP in enteric coated pellets.

PHARMACOLOGY:

The proton pump inhibitor Esomeprazole inhibits gastric acid by blocking the

hydrogen-potassium adenosine triphosphatase enzyme system (the proton pump)

of the gastric parietal cell. Proton pump inhibitors are effective for short-term

treatment of gastric and duodenal ulcers. Esomeprazole is also used in the

prevention and treatment of NSAID associated gastric ulcers.

INDICATIONS:

Esomeprazole is indicated

• To relieve from chronic heartburn symptoms and other symptoms associated

with GERD

• For the healing of erosive esophagitis

• For maintenance of healing of erosive esophagitis

• NSAID associated gastric ulcers

• Zollinger-Ellison Syndrome

• Acid related Dyspepsia

• Gastric & Duodenal ulcer

DOSAGE AND ADMINISTRATION:

Esomeprazole tablets should be swallowed whole and taken one hour before

meal.

Healing of Erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. The

majority of patients are healed within 4 to 8 weeks. For patients who don’t heal

after 4-8 weeks, additional 4-8 weeks of treatment may be considered.

Maintenance of Healing of Erosive Esophagitis: 20 mg once daily (Clinical

studies did not extend 6 months).

Symptomatic GERD: 20 mg once daily for 4 Weeks. If symptoms do not resolve

completely after 4 weeks, an additional 4 weeks of treatment may be considered.

NSAID associated gastric ulcers: 20 mg tablet once daily for 4-8 weeks.

Zollinger-Ellison Syndrome: The dose is 40 mg twice daily.

Acid related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to response.

Duodenal ulcer: 20 mg once daily for 2-4 weeks.

Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

CONTRAINDICATIONS:

Esomeprazole is contraindicated in-patient with known hypersensitivity to any

contents of the formulation.

SIDE EFFECTS:

The most frequently occurring adverse events reported with Esomeprazole include

headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry

mouth.

DRUG INTERACTIONS:

Drug interaction studies have shown that Esomeprazole does not have any

clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin

or amoxicillin.

USE IN PREGNANCY & LACTATION:

Esomeprazole should be used during pregnancy & lactation only if clearly needed.

STORAGE:

Store in a cool and dry place, protected from light. Keep out of reach of children.

PACKING:

Esobest 20 Capsule: Each box contains 6x10 capsules in Alu-Alu blister pack.

Esobest 40 Capsule: Each box contains 3x10 capsules in Alu-Alu blister pack.