Sompraz IV

Sompraz IV

esomeprazole

Manufacturer:

Sun Pharma

Distributor:

DKLL

Marketer:

Ranbaxy
Concise Prescribing Info
Contents
Esomeprazole Na
Indications/Uses
Gastric antisecretory treatment when oral route 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. Short-term maintenance of haemostasis & prevention of rebleeding in patients following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
Dosage/Direction for Use
IV inj 40 mg dose: Administer reconstituted soln over a period of at least 3 min. 20 mg dose: ½ of reconstituted soln over a period of approx 3 min. IV infusion 40 mg dose: Administer reconstituted soln over a period of 10-30 min. 20 mg dose: ½ of reconstituted soln 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. Gastric antisecretory treatment when oral route is not possible 20-40 mg once daily. Reflux oesophagitis 40 mg once daily. Symptomatic reflux disease, gastric ulcers healing associated w/ NSAID therapy, prevention of gastric & duodenal ulcers associated w/ NSAID therapy 20 mg once daily. Maintenance of haemostasis & prevention of gastric & duodenal ulcer rebleeding Following therapeutic endoscopy, administer 80 mg as bolus infusion, followed by continuous IV infusion of 8 mg/hr given over 3 days (72 hr). Parenteral treatment period should be followed by acid-suppression therapy w/ esomeprazole 40 mg tab once daily for 4 wk. Severe hepatic impairment GERD Max daily dose: 20 mg. Bleeding ulcers Initially 80 mg bolus, then continuous infusion of 4 mg/hr for 71.5 hr.
Contraindications
Hypersensitivity to esomeprazole or other substituted benzimidazoles.
Special Precautions
May alleviate symptoms & delay diagnosis of malignancy. Exclude malignancy in the presence of any alarm symptom & when gastric ulcer is suspected or present. Patients at risk for developing osteoporosis or osteoporotic fractures. Not recommended to use concomitantly w/ atazanavir & nelfinavir. Avoid concomitant use w/ clopidogrel. Severe renal insufficiency. Pregnancy. Not to be used during lactation. Not to be used in childn.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting; administration site reactions. SJS, TEN.
Drug Interactions
Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. Decreased clearance of CYP2C19 substrate diazepam. Increased trough plasma levels of phenytoin. Slight elevation in trough plasma conc of less potent R-isomer of warfarin. Decreased exposure to active metabolite of clopidogrel. Increased Cmax & AUC of cilostazol. Increased AUC & prolongation of elimination t½ of cisapride. Increased serum levels of tacrolimus; saquinavir. Increased MTX levels. Decreased serum levels of atazanavir & nelfinavir. Doubled exposure (AUC) w/ clarithromycin; voriconazole. Decreased serum levels w/ CYP2C19 or CYP3A4 inducers eg, rifampicin & St. John's wort.
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
Sompraz IV powd for inj 40 mg
Packing/Price
1's
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