Nexpro-20/Nexpro-40/Nexpro IV

Nexpro-20/Nexpro-40/Nexpro IV

esomeprazole

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Esomeprazole (tab: Mg; inj: Na)
Indications/Uses
Tab: GERD, patients requiring continued NSAID therapy. In combination w/ appropriate antibacterial therapeutic regimens for the eradication of H. pylori. Inj: PUD, NSAID associated ulceration, GERD & Zollinger-Ellison syndrome.
Dosage/Direction for Use
Tab GERD: Erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk is recommended for patients w/ esophagitis that has not healed or w/ persistent symptoms. Long-term management of healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD w/o esophagitis 20 mg once daily for 4 wk. Prevention of gastric & duodenal ulcer associated w/ NSAID therapy in patients at risk 20 or 40 mg once daily. In combination w/ appropriate antibacterial regimens for H. pylori eradication, prevention of relapse of peptic ulcer w/ H. pylori-associated ulcer disease 20 mg + amoxicillin 1 g & clarithromycin 500 mg bid for 7 days. Severe liver impairment Max: 20 mg daily. Inj Adult 20 or 40 mg once daily by IV inj (no less than 3 min) or IV infusion (10-30 min).
Administration
May be taken with or without food: Best taken before meals/breakfast. Swallow whole, do not chew/crush. For patients w/ swallowing difficulties, disperse tab in ½ glass of non-carbonated water. No other liqd should be used. Stir until tab dissolves into little pellets & drink immediately or w/in 30 min. Rinse the glass w/ ½ glass of water & drink. The dispersion may also be administered via gastric tube.
Contraindications
Hypersensitivity to esomeprazole or substituted benzimidazoles.
Special Precautions
Possible malignancy should be excluded in the presence of symptoms (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena) & when gastric ulcer is suspected or present. Long-term treatment (>1 yr). Increased risk of GI infections eg, Salmonella & Campylobacter. Concurrent use of clarithromycin & other drugs metabolized by CYP3A4 eg, cisapride. Not recommended use w/ atazanavir. Severe renal insufficiency. Pregnancy & lactation. Childn.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, dry mouth, gas, flatulence, nausea/vomiting, stomach pain. Inj: Pain, swelling or redness at the inj site.
Drug Interactions
May decrease absorption of ketoconazole & itraconazole (take at least 2 hr before using esomeprazole). Decreased in clearance of CYP2C19 substrate diazepam. Increased trough plasma levels of phenytoin. May double the exposure (AUC) w/ concomitant administration of clarithromycin.
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
Nexpro-20 EC tab 20 mg
Packing/Price
30's (P1,500/box)
Form
Nexpro-40 EC tab 40 mg
Packing/Price
30's (P2,100/box)
Form
Nexpro IV powd for inj 40 mg
Packing/Price
((+ 10-mL diluent in amp)) 1's (P994/box)
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