Vaxcel Esomeprazole

Vaxcel Esomeprazole

esomeprazole

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Concise Prescribing Info
Contents
Esomeprazole Na
Indications/Uses
Gastric antisecretory treatment when PO is not possible eg, GERD in patients w/ esophagitis &/or severe symptoms of reflux. Healing of gastric ulcers associated w/ NSAID therapy. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
Dosage/Direction for Use
Gastric antisecretory treatment when PO is not possible 20-40 mg once daily. Reflux esophagitis 40 mg once daily. Symptomatic treatment of reflux disease, healing of gastric ulcers associated w/ NSAID therapy, prevention of gastric & duodenal ulcers associated w/ NSAID therapy 20 mg once daily. Prevention of gastric & duodenal ulcer rebleeding 80 mg bolus infusion over 30 min followed by 8 mg/hr continuous IV infusion over 3 days. Severe hepatic impairment GERD Max: 20 mg daily. Bleeding ulcers Initially 80 mg IV infusion followed by 4 mg/hr continuous IV infusion over 71.5 hr.
Contraindications
Hypersensitivity. Not to be used concomitantly w/ nelfinavir.
Special Precautions
Exclude gastric malignancy prior to treatment. Increased risk of GI infections eg, Salmonella & Campylobacter; subacute cutaneous lupus erythematosus; hip, wrist & spine fracture; Clostridium difficile-associated diarrhea. Severe hypomagnesaemia; vit B12 deficiency. Ensure adequate Ca & vit D intake in patients at risk of osteoporosis. Discontinue use for at least 5 days before CgA measurements. Long-term use. Not recommended in concomitant use w/ atazanavir. Concomitant use w/ digoxin, drugs causing hypomagnesaemia eg, diuretics. Severe renal insufficiency. Pregnancy. Not to be used during lactation.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting, benign fundic gland polyps; administration site reactions.
Drug Interactions
Decreased absorption of ketoconazole, itraconazole. Decreased serum levels of atazanavir, nelfinavir. Increased plasma conc of CYP2C19-metabolised drugs eg, diazepam, citalopram, imipramine, clomipramine, phenytoin. Decreased clearance of diazepam. Increased trough plasma levels of phenytoin. Increased voriconazole Cmax & AUC. Increased AUC & prolonged t½ of cisapride. Doubled exposure by CYP3A4 inhibitors eg, clarithromycin. Monitor w/ warfarin or other coumarin derivatives.
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
Vaxcel Esomeprazole powd for inj 40 mg
Packing/Price
10 × 1's;1's
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