Generic

Esomeprazole

Therapeutic Class

Antiulcerant

Pack Size

Exium 20 mg capsule: Each box contains 100 capsules (10 x 10's) in Alu-Alu blister pack.
Exium 40 mg capsule: Each box contains 60 capsules (10 x 6's) in Alu-Alu blister pack.
Exium 40 mg IV Injection: Each box contains 1 vial and 1 ampoule for intravenous injection.

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 •In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in-patients with duodenal ulcer disease. •Zollinger-Ellison Syndrome •Acid related Dyspepsia •Duodenal & Gastric ulcer

Therapeutic Class

Antiulcerant

Dosage & Administration

Esomeprazole capsules 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, an 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. Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days. Zollinger-Ellison Syndrome: The dose is 40 mg twice daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. Acid related Dyspepsia: 20-4o 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 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. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects.

Precautions

General Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy. Information for patients Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole. Pregnancy There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. Nursing Mothers The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential. Paediatric Use Safety and effectiveness in paediatric patients have not been established. Geriatric Use No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Insufficiency No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in-patients with severe hepatic insufficiency a dose of 20 mg once daily should not be exceeded. Renal Insufficiency The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in urine.

Storage Conditions

Protect from light, Store in dry place. Keep out of reach of children