Omepradex EC

Omepradex EC



Dexcel Pharma/AmediusTec


Apex Pharma Marketing
Concise Prescribing Info
Treatment of duodenal & gastric ulcers; NSAID-associated gastric & duodenal ulcers or erosions; reflux oesophagitis, symptomatic GERD, acid-related dyspepsia & Zollinger-Ellison syndrome.
Dosage/Direction for Use
Duodenal ulcer 20 mg once daily. Patient w/ poorly responsive duodenal ulcer 2 tab (40 mg) once daily. Gastric ulcer 20 mg once daily. Patient w/ poorly responsive gastric ulcer 2 tab (40 mg) once daily. Prevention of relapse in patient w/ poorly responsive gastric ulcer 20 mg once daily. Dose can be increased to 40 mg once daily if needed. NSAID-associated gastric or duodenal ulcers, or gastroduodenal erosions in patient w/ or w/o continued NSAID treatment 20 mg once daily. Prevention of NSAID-associated gastric or duodenal ulcers, or gastroduodenal erosions & dyspeptic symptoms 20 mg once daily. Reflux oesophagitis 20 mg once daily. Severe reflux oesophagitis Adult 2 tab (40 mg) once daily. Childn ≥1 yr w/ >20 kg body wt 20 mg, 10-20 kg body wt 10 mg once daily. Dose may be increased to 20 & 40 mg, respectively if needed. Duration of treatment: 2-8 wk. Symptomatic GERD 20 mg daily. Acid-related dyspepsia: Relief of symptoms in patient w/ epigastric pain/discomfort w/ or w/o heartburn 20 mg once daily. Zollinger-Ellison syndrome Individualized dosage. Initially 60 mg daily. Maintenance: 20-120 mg daily. Doses >80 mg daily should be divided & given bd. Patient w/ hepatic function A daily dose of 10-20 mg may be sufficient.
Should be taken on an empty stomach: Take in the morning, at least 1 hr before a meal. Swallow whole, do not chew/crush.
Hypersensitivity. Concomitant use w/ atazanavir.
Special Precautions
Exclude malignancy if significant unintentional wt loss, repeated vomiting, dysphagia, haematemesis or melaena occur. Clostridium difficile-associated diarrhoea (CDAD) should be considered for diarrhoea that does not improve. Increased risk of osteoporosis-related fractures of the hip, wrist or spine in high and long-term therapy. Monitor Mg levels prior to initiation of treatment & periodically. Concomitant use may elevate & prolong serum levels of methotrexate &/or its metabolite leading to methotrexate toxicity. Hepatic impairment. Pregnancy & lactation.
Adverse Reactions
Headache; diarrhoea, nausea/vomiting, constipation, abdominal pain, flatulence.
Drug Interactions
Affects plasma conc of ketoconazole & itraconazole. Increases plasma/serum levels of diazepam, warfarin, phenytoin, tacrolimus. Increased plasma conc w/ clarithromycin or erythromycin. Reduces atazanavir exposure. Possible increase in plasma conc w/ drugs inhibiting CYP2C19 or CYP3A (eg, HIV-PIs). Increase AUC w/ voriconazole.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Omepradex EC enteric-coated tab 20 mg
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