Prosome

Prosome

esomeprazole

Manufacturer:

Chempro Pharma

Distributor:

TGP Pharma

Marketer:

Ambica
Full Prescribing Info
Contents
Esomeprazole.
Description
Each enteric-coated tablet contains: Esomeprazole (as magnesium) 40 mg.
Action
Pharmacology: Pharmacokinetics: Esomeprazole is rapidly absorbed after doses, with peak plasma levels occurring after about 1 to 2 hours. Bioavailability of Esomeprazole increases with both dose repeated administration to about 68 and 89 % for doses of 20 mg and 40 mg respectively. Food delays and decreases the absorption of Esomeprazole, but this does not significantly change its effect on intragastric acidity. Esomeprazole is about 97% bound to plasma proteins. It is extensively metabolised in the liver by the cytochrome P450 isoenzyme CY 2C19 to hydroxy and desmethyl metabolites, which has no effect on gastric acid secretion.
Indications/Uses
It is used similarly in the treatment of peptic ulcer disease and NSAID associated ulceration, and in gastro-oesophageal reflux disease.
Dosage/Direction for Use
Adult and Children 12-18 yrs old: Erosive reflux esophagitis: 40 mg once daily for 4-8 weeks. Prevent relapse of healed esophagitis: 20 mg once daily for 4 weeks. Maintenance 20 mg once daily. Upper GI symptoms associated with NSAID therapy: 20 mg daily for 4 weeks. Gastric ulcers associated with NSAID therapy: 20-40 mg once daily for 4-8 weeks. Pathologic hypersecretory conditions: Initially, 40 mg two times a day. Swallow tablets whole. Never chew or crush. Or as prescribed by the Physician.
Contraindications
Hypersensitivity to Esomeprazole and other Proton Pump Inhibitor (PPI).
Special Precautions
Patient with liver problem.
Pregnant women or planning to be pregnant.
Breast feeding mothers or planning to breast feed.
Use In Pregnancy & Lactation
Esomeprazole should be taken with caution in: Pregnant women or planning to be pregnant.
Breast feeding mothers or planning to breast feed.
Drug Interactions
May interact with the following drugs: Warfarin, Ketoconazole, Voriconazole, Atazanavir, Digoxin and products that contain iron.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
EC tab 40 mg x 30's, 100's.
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