Nexpro-20/Nexpro-40/Nexpro IV Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use 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, 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.

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

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).

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

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.

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

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.

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

Use In Pregnancy & Lactation

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

Adverse Reactions

Headache; abdominal pain, constipation, diarrhoea, dry mouth, gas, flatulence, nausea/vomiting, stomach pain. Inj: Pain, swelling or redness at the inj site.

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

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.

Click to view Nexpro-20/Nexpro-40/Nexpro IV detailed prescribing information

Storage

View Nexpro-20/Nexpro-40/Nexpro IV storage conditions for details to ensure optimal shelf-life.

Description

View Nexpro-20/Nexpro-40/Nexpro IV description for details of the chemical structure and excipients (inactive components).

Action

View Nexpro-20/Nexpro-40/Nexpro IV mechanism of action for pharmacodynamics and pharmacokinetics details.

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

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)

Nexpro-20/Nexpro-40/Nexpro IV

esomeprazole

Manufacturer:

Torrent

Distributor:

Torrent