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Losec

Losec

omeprazole

Manufacturer:

AstraZeneca AB

Distributor:

Zuellig
Concise Prescribing Info
Contents
Omeprazole
Indications/Uses
Treatment of duodenal ulcer, gastric ulcer, NSAID-associated gastric & duodenal ulcers or erosions, H. pylori eradication in PUD, reflux esophagitis, symptomatic GERD, acid-related dyspepsia, Zollinger-Ellison syndrome. Acid aspiration prophylaxis.
Dosage/Direction for Use
Duodenal ulcer 20 mg once daily. Poorly responsive duodenal ulcer 40 mg once daily. Prevention of relapse of duodenal ulcer 10 mg once daily, may be increased to 20-40 mg once daily. Gastric ulcer 20 mg once daily. Poorly responsive gastric ulcer 40 mg once daily. Prevention of relapse of gastric ulcer 20 mg once daily, may be increased to 40 mg once daily. NSAID-associated gastric & duodenal ulcers or gastroduodenal erosions 20 mg once daily. Prevention of NSAID-associated gastric & duodenal ulcers, gastroduodenal erosions & dyspeptic symptoms 20 mg once daily. H. pylori eradication in PUD Triple therapy regimens: Omeprazole 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg, all bid for 1 wk, or omeprazole 20 mg w/ metronidazole 400 mg (or tinidazole 500 mg) & clarithromycin 250 mg, all bid for 1 wk, or omeprazole 40 mg once daily w/ amoxicillin 500 mg & metronidazole 400 mg, both tid for 1 wk. Dual therapy regimens: Omeprazole 40-80 mg daily w/ amoxicillin 1.5 g daily in divided doses for 2 wk, or omeprazole 40 mg once daily w/ clarithromycin 500 mg tid for 2 wk. Reflux esophagitis 20 mg once daily. Severe reflux esophagitis 40 mg once daily. Long-term management: 10 mg once daily, increased to 20-40 mg once daily, if needed. Symptomatic GERD 20 mg daily. Patients may respond to 10 mg daily. Acid-related dyspepsia 20 mg once daily. Patients may respond to 10 mg daily. Zollinger-Ellison syndrome Initially 60 mg once daily. When dose exceeds >80 mg daily, dose should be divided & given bid. Acid aspiration prophylaxis 40 mg in the evening before surgery, followed by 40 mg in the morning after surgery. Patient w/ hepatic impairment 10-20 mg daily. Childn ≥2 yr, weighing >20 kg 20 mg once daily, may be increased to 40 mg if needed, 10-20 kg 10 mg once daily, may be increased to 20 mg if needed. Childn 0-24 mth, weighing 10-20 kg 10 mg once daily, may be increased to 20 mg if needed, <10 kg 1 mg/kg/day. Childn 0-3 mth 0.5 mg/kg/day. H. pylori eradication Childn ≥4 yr, weighing >40 kg Adult dose, 30-40 kg Omeprazole 20 mg w/ amoxicillin 750 mg & clarithromycin 7.5 mg/kg, all bid for 1 wk, 15-30 kg Omeprazole 10 mg w/ amoxicillin 25 mg/kg & clarithromycin 7.5 mg/kg, all bid for 1 wk.
Administration
May be taken with or without food: Swallow whole, do not chew/crush cap. For patients w/ swallowing difficulties, the cap may be opened & the contents swallowed or suspended in a slightly acidic fluid (eg, fruit juice or in non-carbonated water). The dispersion should be taken immediately or w/in 30 min. Alternatively, patients can suck the cap & swallow the pellets. Ingest w/o chewing the EC pellets.
Contraindications
Hypersensitivity to omeprazole & other substituted benzimidazoles.
Special Precautions
In the presence of any alarm symptom (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, hematemesis or melena) & when gastric ulcer is suspected or present, malignancy should be excluded. Concomitant use w/ atazanavir & nelfinavir is not recommended. Avoid concomitant use w/ clopidogrel. Appropriate clinical monitoring is advised in patients at risk for developing osteoporosis or osteoporotic fractures.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.
Drug Interactions
Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. May delay metabolism of diazepam, phenytoin, warfarin (R-warfarin) or other vit K antagonists & cilostazol. Pharmacokinetic/pharmacodynamic interaction w/ clopidogrel resulting in decreased exposure to clopidogrel active metabolite & decreased max inhibition of platelet aggregation. Increased serum levels of tacrolimus & saquinavir. Increased levels of MTX. Increased gastric pH during omeprazole treatment may change the absorption of antiretroviral drugs. Decreased serum levels of atazanavir & nelfinavir. Increased serum levels w/ CYP2C19 &/or CYP3A4 inhibitors (eg, clarithromycin & voriconazole). Decreased serum levels w/ CYP2C19 &/or CYP3A4 inducers (eg, rifampicin & St. John's wort).
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).
Presentation/Packing
Form
Losec cap 10 mg
Packing/Price
14's
Form
Losec cap 20 mg
Packing/Price
14's
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