Rhea Esomeprazole

Esomeprazole Mg trihydrate

Erosive reflux esophagitis; long-term management of patients w/ healed esophagitis; symptomatic treatment of GERD. Upper GI symptoms associated w/ NSAID therapy; healing of gastric ulcers & prevention of gastric & duodenal ulcers associated w/ NSAID therapy eg, COX-2 selective NSAIDS. Prevention of gastric &/or duodenal ulcers associated w/ low dose aspirin. Maintenance of hemostasis & prevention of rebleeding of gastric or duodenal ulcers. In combination w/ an appropriate antibacterial therapeutic regimen for the eradication of H. pylori & healing of H. pylori associated duodenal ulcer & prevention of relapse of peptic ulcers in patients w/ H. pylori associated ulcers. Pathological hypersecretory conditions including Zollinger-Ellison syndrome & idiopathic hypersecretion.

Erosive reflux esophagitis Adult & childn 12-18 yr 40 mg once daily for 4 wk. An additional 4 wk treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms. Childn 1-11 yr weighing ≥20 kg 10 mg or 20 mg once daily for 8 wk, <20 kg 10 mg once daily for 8 wk. Long-term management of patients w/ healed esophagitis to prevent relapse Adult & childn 12-18 yr 20 mg once daily. Childn 1-11 yr 10 mg once daily. Symptomatic treatment of GERD Adult & childn 12-18 yr 20 mg once daily in patients w/o esophagitis. Subsequent symptom control can be achieved using an on-demand regimen taking 20 mg once daily, when needed. Childn 1-11 yr 10 mg once daily for up to 8 wk. Adult Upper GI symptoms associated w/ NSAID therapy 20 mg once daily. Healing of gastric ulcers associated w/ NSAID therapy 20 mg or 40 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy 20 mg or 40 mg once daily. Prevention of gastric &/or duodenal ulcers associated w/ low dose aspirin 20 mg or 40 mg once daily. Maintenance of hemostasis & prevention of rebleeding of gastric or duodenal ulcers 40 mg once daily for 4 wk. In combination w/ an appropriate antibacterial therapeutic regimen for the eradication of H. pylori & healing of H. pylori associated duodenal ulcer & prevention of relapse of peptic ulcers in patient w/ H. pylori associated ulcers 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg, all bid for 7 days. Pathological hypersecretory conditions including Zollinger-Ellison syndrome & idiopathic hypersecretion Initially 40 mg bid. May be individually adjusted (up to 120 mg bid) & continued as long as clinically indicated. Childn 12-18 yr Duodenal ulcer caused by H. pylori 20 mg bid for 1 wk. GERD diagnostically confirmed through pH probe or endoscopy Childn 1-11 mth weighing >7.5-12 kg 10 mg once daily for up to 6 wk, 1-11 mth weighing >5-7.5 kg 5 mg once daily for up to 6 wk, 1-11 mth weighing 3-5 kg 2.5 mg once daily for up to 6 wk; 0-1 mth weighing >2.5 kg 2.5 mg once daily for up to 4 wk. Severe hepatic impairment Max: 20 mg daily.

Should be taken on an empty stomach: Swallow whole, do not chew/crush. Tab may be dispersed in ½ glass of non-carbonated water. No other liqd should be used. Drink immediately or w/in 30 min. Rinse glass w/ another ½ glass of water & drink. Do not chew or crush. For patients w/ difficulty swallowing, tab can be dispersed in non-carbonated water & administered via gastric tube.

Hypersensitivity to esomeprazole & substituted benzimidazoles.

Presence of alarm symptom (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, hematemesis or melaena). Exclude malignancy as treatment may alleviate symptoms & delay diagnosis. Long-term treatment (>1 yr) & on-demand treatment. Consider drug interactions for all components in triple therapy eg, clarithromycin in patients on other drugs metabolized via CYP3A4 eg, cisapride. Not recommended w/ atazanavir & nelfinavir. Avoid concomitant use w/ clopidogrel. Patients at risk for developing osteoporosis or osteoporotic fractures. Severe renal impairment. Pregnancy. Not to be used during lactation.

Headache; abdominal pain, diarrhea, flatulence, nausea/vomiting, constipation.

Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. Decrease in clearance of the CYP2C19 substrate diazepam. Increase in trough plasma levels of phenytoin. Elevated INR w/ warfarin; closely monitor when initiating & ending treatment w/ warfarin or other coumarin derivatives. Decreased exposure to the active metabolite of clopidogrel resulting in decreased max inhibition of platelet aggregation. Increased in C_max & AUC of cilostazol & its active metabolite. Increase in AUC & prolongation of elimination t_½ of cisapride. Increased serum levels of tacrolimus; saquinavir. Increased MTX levels. Decreased serum levels of atazanavir & nelfinavir. Doubling of exposure w/ CYP3A4 inhibitor eg, clarithromycin & combined inhibitor of CYP2C19 & CYP3A4 eg, voriconazole. Decreased serum levels by increasing metabolism w/ drugs known to induce CYP2C19 or CYP3A4 or both (eg, rifampicin & St. John's wort).

Antacids, Antireflux Agents & Antiulcerants

A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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