MAXIMA

Esomeprazole

GASTROINTESTINAL

INDICATION

Gastroesophageal Reflux Disease (GERD), NSAID associated gastric ulcer, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence and Zollinger-Ellison syndrome.

DOSAGE AND ADMINISTRATION

Adults: Gastroesophageal Reflux Disease, Healing of Erosive Esophagitis: 20 or 40 mg once daily for 4-8 weeks, followed by a further 4-8 weeks if not fully healed. Maintenance of Healing of Erosive Esophagitis: 20 mg once daily. Symptomatic Treatment of Gastroesophageal Reflux Disease: 20 mg once daily for 4 weeks. An additional 4 weeks of treatment may be considered if symptoms do not resolve completely. Risk Reduction of NSAID-Associated Gastric Ulcer:  20 mg or 40 mg once daily for up to 6 months. Helicobacter pylori Associated Ulcer: One MAXIMA® 20, Amoxicillin (Moxilin) 1 g & Clarithromycin (Claricin) 500 mg all twice daily for 10 days. Zollinger-Ellison Syndrome: 40 mg twice daily. Injection: Gastroesophageal Reflux Disease: 40 mg once daily; Symptomatic reflux disease without esophagitis, treatment of NSAID-associated gastric ulcer and prevention of NSAID-associated gastric or duodenal ulcer: 20 mg dialy. Children: 1-11 years: 10 to 20 mg once daily. 12-17 years: 20-40 mg once daily. Injection:  No data available for the children. Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Impaired hepatic function: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg should not be exceeded. Elderly: Dose adjustment is not required in the elderly patient.

COMPOSITION

Maxima 20 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg as enteric coated pellets.

Maxima 40 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 40 mg as enteric coated pellets.

Maxima 20 Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.

Maxima 40 Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 40 mg.

Maxima MUPS 20 Tablet: Each MUPS (Multiple-Unit Pellet System) tablet contains 20 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP enteric coated pellets)

Maxima MUPS 40 Tablet: Each MUPS (Multiple-Unit Pellet System) tablet contains 40 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP enteric coated pellets)

Maxima IV 40 Injection: Each vial contains Esomeprazole 40 mg (as Esomeprazole Sodium INN lyophilized sterile powder) and each ampoule contains 5 ml 0.9% Sodium Chloride BP for intravenous injection.