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Nexpro-20/Nexpro-40/Nexpro IV

Nexpro-20/Nexpro-40/Nexpro IV

esomeprazole

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Esomeprazole (tab: Mg; inj: Na)
Indications/Uses
Tab: GERD. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. In combination w/ appropriate antibacterial therapeutic regimens for the eradication of H. pylori. Inj: PUD, NSAID associated ulceration, GERD & Zollinger-Ellison syndrome.
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Dosage/Direction for Use
Tab Adult GERD: Erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk is recommended for patient 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. Patient should be further investigated if symptom control has not been achieved after 4 wk. Prevention of gastric & duodenal ulcer associated w/ NSAID therapy in patient at risk 20 or 40 mg once daily. In combination w/ appropriate antibacterial regimens for H. pylori eradication, prevention of relapse of peptic ulcer associated w/ H. pylori Esomeprazole 20 mg + amoxicillin 1 g & clarithromycin 500 mg bid for 7 days. Patient w/ 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).
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Overdosage
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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.
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Special Precautions
Possible malignancy should be excluded in the presence of any alarm symptom (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena) & when gastric ulcer is suspected or present. Patients on long-term treatment (>1 yr) should be kept under regular surveillance. Instruct patients on on-demand treatment to contact physician if symptoms change in character. May lead to slightly increased risk of GI infections eg, Salmonella & Campylobacter. Not recommended w/ atazanavir. Caution in patients w/ severe renal or hepatic impairment. Safety has not been established during pregnancy & lactation. No experience in childn.
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Use In Pregnancy & Lactation
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Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Inj: Pain, swelling or redness at the inj site.
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Drug Interactions
Might increase or decrease the absorption of drugs if the mechanism of absorption is influenced by gastric acidity. May decrease absorption of ketoconazole & itraconazole. Decreased clearance of CYP2C19 substrate diazepam. Increased trough plasma levels of phenytoin. May double the exposure (AUC) w/ concomitant administration of clarithromycin (CYP3A4 inhibitor).
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Storage
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Description
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Action
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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).
Regulatory Classification
Rx
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)