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Natrapharm
Regulatory Class: Rx
C: Esomeprazole (DR cap: Mg; IV: Na)
I: Peprazom PUD & NSAID-associated ulceration, GERD & Zollinger-Ellison syndrome. Peprazom IV GERD in patient w/ esophagitis &/or severe symptoms of reflux; healing & prevention of gastric & duodenal ulcers associated w/ NSAID therapy; prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric & duodenal ulcers in adult. GERD in patient w/ erosive reflux esophagitis &/or severe symptoms of reflux in childn & adolescent 1-18 yr.
D: Peprazom Adult & adolescent (from 12 yr)Erosive reflux esophagitis 40 mg once daily for 4 wk. Long-term management of patient w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patient w/o esophagitis. Subsequently 20 mg once daily when needed. AdultTreatment & prevention of H. pylori-associated ulcers Esomeprazole 20 mg w/ amoxicillin 1 g + clarithromycin 500 mg, all bid for 7 days. Healing of gastric ulcers associated w/ NSAID therapy 20 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patient at risk 20 mg once daily. Prevention of rebleeding of gastric & duodenal ulcers 40 mg once daily for 4 wk after IV-induced prevention of rebleeding of peptic ulcers. Zollinger-Ellison syndrome Initially 40 mg bid. Max: 80-160 mg. Doses >80 mg daily should be divided & given bid. PeprazomIV AdultReflux esophagitis 40 mg once daily. Reflux disease 20 mg once daily. Healing of gastric ulcers associated w/ NSAID therapy 20 mg once daily. Gastric & duodenal ulcers associated w/ NSAID therapy 20 mg once daily. Prevention of rebleeding of gastric & duodenal ulcers 80 mg bolus infusion over 30 min followed by continuous IV infusion of 8 mg/hr over 72 hr. Severe liver impairment in patient w/ GERD Max: 20 mg daily. Severe liver impairment in patient w/ bleeding ulcers Initial bolus dose of 80 mg, followed by continuous IV infusion 4 mg/hr for 71.5 hr. Childn 12-18 yrErosive reflux esophagitis 40 mg once daily. GERD 20 mg once daily. 1-11 yr <20 kg Erosive reflux esophagitis 10 mg once daily. ≥20 kg 10 mg or 20 mg once daily. GERD 10 mg once daily.
A: Take 1 hr before meals. For patients w/ swallowing difficulties, open cap & disperse contents in a glass w/ 15 mL non-carbonated water. Do not use other liqd. Stir gently & leave for a few min to thicken. Stir again & drink immediately or w/in 30 min. Do not chew/crush granules. Mixt may also be administered via a nasogastric tube.
CI: Hypersensitivity to esomeprazole, substituted benzimidazoles. Concomitant use w/ nelfinavir. Childn <12 yr. Peprazom Lactation.
SP: May increase risk of GI infection. Co-administration w/ atazanavir. Pregnancy. Peprazom Exclude malignancy in the presence of significant unintentional wt loss, recurrent vomiting, dysphagia, hematemesis or melena; & when gastric ulcer is suspected or present. Monitor long-term treatment (particularly for >1 yr). Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Contain parahydroxybenzoate. Severe renal or hepatic impairment. Peprazom IV Hypomagnesemia. Risk of hip, wrist & spine fracture. Achlorhydria. Lactation.
AR: Headache; abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting. Peprazom IV Administration site reactions.
INT: Peprazom May decrease absorption of ketoconazole & itraconazole. Increase plasma conc of diazepam, citalopram, imipramine, clomipramine, phenytoin. Warfarin or other coumarine derivatives; cisapride, clarithromycin. Peprazom IV Increased absorption w/ digoxin. Decreased serum levels w/ atazanavir & nelfinavir; rifampicin & St. John's wort. Increased Cmax & AUC w/ voriconazole; cilostazol. Elevated INR w/ warfarin or other coumarin derivatives.
P/P: Peprazom DR cap 20 mg x 14's. 40 mg x 14's. Peprazom IV powd for inj (vial) 40 mg x 1's.
Take 1 hr before meals. For patients w/ swallowing difficulties, open cap & disperse contents in a glass w/ 15 mL non-carbonated water. Do not use other liqd. Stir gently & leave for a few min to thicken. Stir again & drink immediately or w/in 30 min. Do not chew/crush granules. Mixt may also be administered via a nasogastric tube.