Esomeprazole Normon

Esomeprazole Normon

esomeprazole

Manufacturer:

Laboratorios Normon

Distributor:

Pacific Healthcare
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
GERD in adults w/ esophagitis &/or severe symptoms of reflux; healing of gastric ulcers associated w/ NSAID therapy; prevention of gastric & duodenal ulcers associate w/ NSAID therapy. Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults. GERD in childn & adolescents 1-18 yr w/ erosive reflux esophagitis &/or severe symptoms of reflux.
Dosage/Direction for Use
Adult Inj 40 mg dose: 5 mL of reconstituted soln as IV inj over a period of at least 3 min. 20 mg dose: ½ of reconstituted soln as IV inj over a period of approx 3 min. Infusion 40 mg dose: IV infusion over a period of 10-30 min. 20 mg dose: ½ of reconstituted soln given as IV infusion over a period of 10-30 min. 80 mg bolus dose: Continuous IV infusion over 30 min. 8 mg/hr dose: Continuous IV infusion over a period of 71.5 hr. Reflux esophagitis 40 mg once daily. Symptomatic reflux disease 20 mg once daily. Gastric ulcers associated w/ NSAID therapy 20 mg once daily. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy 20 mg once daily. Prevention of rebleeding of gastric & duodenal ulcers 80 mg as bolus infusion over 30 min, followed by a continuous IV infusion 8 mg/hr over 3 days. Severe liver impairment GERD Max: 20 mg once daily. Bleeding ulcers Initially 80 mg via bolus infusion, then continuous IV infusion 4 mg/hr for 71.5 hr. Childn & adolescent 1-18 yr Inj 40 mg dose: IV inj over a period of at least 3 min. 20 mg dose: 2.5 mL of reconstituted soln given as IV inj over a period of approx. 3 min. 10 mg dose: 1.25 mL of reconstituted soln given as IV inj over a period of at least 3 min. Infusion 40 mg dose: IV infusion over a period of 10-30 min. 20 mg dose: ½ of reconstituted soln as IV infusion over a period of 10-30 min. 10 mg dose: ¼ of reconstituted soln given as IV infusion over a period of 10-30 min. Erosive reflux oesophagitis Childn 12-18 yr 40 mg once daily, 1-11 yr weighing <20 kg 10 mg once daily, ≥20 kg 10 mg or 20 mg once daily. Symptomatic treatment of GERD Childn 12-18 yr 20 mg once daily, 1-11 yr 10 mg once daily.
Contraindications
Hypersensitivity to esomeprazole or to other substituted benzimidazoles. Concomitant use w/ nelfinavir.
Special Precautions
Slightly increased risk of GIT infections eg, Salmonella & Campylobacter. Risk factors for reduced vit B12 absorption on long-term therapy. Severe hypomagnesaemia. Modestly increase the risk of hip, wrist & spine fracture, predominantly in elderly especially if used in high doses or over long durations (>1 yr). Adequate intake of vit D & Ca for patients at risk of osteoporosis. Subacute cutaneous lupus erythematous (SCLE). Concomitant use w/ atazanavir is not recommended; clopidogrel. Discontinue for at least 5 days prior to chromogranin A (CgA) measurements. Pregnancy & lactation.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign); administration site reactions.
Drug Interactions
May change absorption of PIs. Decrease serum levels of atazanavir & nelfinavir. Increased serum levels w/ saquinavir. Increase levels of methotrexate. Increase serum levels of tacrolimus. Decrease or increase absorption of drugs w/ gastric pH dependent absorption. Decrease absorption of ketoconazole & itraconazole. Increase absorption of digoxin. Increase plasma conc of drugs metabolised by CYP2C19 eg, diazepam, citalopram, imipramine, clomipramine, phenytoin. Decrease clearance of CYP2C19 substrate diazepam. Increase trough plasma levels of phenytoin. Increase Cmax & AUCt of voriconazole & cilostazol. Increase AUC & prolong elimination t½ of cisapride. Elevated INR w/ warfarin. Decreased max inhibition of platelet aggregation w/ clopidogrel. Doubling of exposure (AUC) w/ clarithromycin. Decreased serum levels w/ CYP2C19 or CYP3A4 inducers eg, rifampicin & St. John's wort.
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 inj/infusion 40 mg
Packing/Price
1's;50 × 1's
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