Esomeprazole Tablets

COMPOSITION:

Each enteric coated tablet contains :

• Esomeprazole Magnesium Trihydrate BP
• Eq. to Esomeprazole .............. 40 mg
• Excipients .................................. q.s.
• Colour : Red Oxide of Iron

INDICATION:

ESOMZ 40 is indicated for:

Adults

• In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori
• Healing of Helicobacterpylori associated duodenal ulcer
• Prevention of relapse of peptic ulcers in patients with Helicobacter  pylori-associatedulcers. Patients requiring continued NSAID therapy
• Healing of gastric ulcers associated with NSAID therapy.
• Prolonged treatment after IV induced prevention of rebleeding of pepticulcers.
• Treatment of Zollinger Ellison Syndrome
• For Adult and Adolescents from the age of 12 years: Gastro-oesophageal Reflux Disease (GERD)
• In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori.

DOSAGE AND ADMINISTRATION:

Posology:

• Adults: GERD- 40 mg once daily for 4 weeks.
• Symptomatic treatment of GERD: 20 mg once daily
• Patients requiring continued NSAID therapy: 20 mg once daily- 4-8 weeks
• Prolonged treatment after IV induced prevention of rebleeding of pepticulcers 40 mg once daily for 4 weeks after IV induced prevention of rebleeding of peptic ulcers.
• Zollinger Ellison Syndrome: 40 mg twice daily.
• Special populations: Dose adjustment is not required in patients with impaired renal function & mild to moderate liver impairment
• Elderly:  Dose adjustment is not required in the elderly.
• Paediatric population: Adolescents from the age of 12 years
• Gastroesophageal Reflux Disease (GERD): 40 mg once daily for 4 weeks.
• Treatment of duodenal ulcer: For 30-40 kg and > 40 kg- with combination of two antibiotics: Esomeprazole 20 mg.
• Children below the age of 12 years: Other forms of this medicine may be more suitable for children below the age of 12 years.

Method of Administration:For oral use. The tablets should be swallowed whole with liquid.