Esomeprazole Normon

Esomeprazole Normon

esomeprazole

Manufacturer:

Laboratorios NORMON

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
Short-term treatment of GERD in adults, adolescents & childn; stomach ulcers in adults caused by NSAIDs. Prevention of rebleeding in adults following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in adult patients at risk.
Dosage/Direction for Use
IV infusion/inj Adult 20 or 40 mg once daily. Max: 20 mg daily for patients w/ severe liver problems. Healing of gastric ulcers; prevention of gastric & duodenal ulcers associated w/ NSAID 20 mg once daily. Prevention of rebleeding of gastric or duodenal ulcer 80 mg IV infusion over 30 min, followed by continuous infusion of 8 mg/hr given over 3 days. In case of severe liver problems, 4 mg/hr continuous infusion over 3 days may be sufficient. Childn 12-18 yr 20 or 40 mg once daily, 1-11 yr 10 or 20 mg once daily.
Contraindications
Hypersensitivity to esomeprazole or to other PPIs. Concomitant use w/ nelfinavir.
Special Precautions
History of skin reaction after treatment w/ medicine similar to esomeprazole. May hide symptoms of other disease. Risk of fracture in the hip, wrist or spine, especially in >1 yr treatment. Potential risk of low serum Mg levels. Slightly increased risk of GI infections eg, Salmonella, Campylobacter, Clostridium difficile. Associated w/ very infrequent cases of subacute cutaneous lupus erythematosus. Patients w/ severe liver or kidney problems. Pregnancy & lactation.
Adverse Reactions
Headache; stomach pain, constipation, diarrhoea, flatulence; nausea, vomiting; inj site reaction.
Drug Interactions
Must not be given w/ nelfinavir. Potential interaction w/ ataznavir, clopidogrel, ketoconazole, itraconazole, voriconazole, erlotinib, citalopram, imipramine, clomipramine, diazepam, phenytoin, anticoagulants eg, warfarin, cilostazol, cisapride, digoxin, MTX, tacrolimus, rifampicin; St. John's wort. Concomitant use w/ clopidogrel (CYP219 substrate) should be discouraged. Concomitant use of PPIs w/ MTX may elevate & prolong serum levels of MTX &/or its metabolite, possibly leading to MTX toxicities.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
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
Form
Esomeprazole Normon powd for soln for inj/infusion 40 mg
Packing/Price
1's
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