Omee

Omee

omeprazole

Manufacturer:

Furen Pharma

Distributor:

Alkem Lab
Concise Prescribing Info
Contents
Omeprazole Na
Indications/Uses
Duodenal & gastric ulcers, reflux oesophagitis & Zollinger-Ellison syndrome.
Dosage/Direction for Use
IV Administer as IV infusion for 20-30 min. Alternative to oral therapy 40 mg IV once daily. Zollinger-Ellison syndrome Initially 60 mg IV daily. When dose is >60 mg daily, dose should be divided & given bid. Impaired hepatic function 10-20 mg daily may be sufficient.
Contraindications
Hypersensitivity to omeprazole or substituted benzimidazoles. Not to be used concomitantly w/ nelfinavir.
Special Precautions
Exclude malignancy in presence of any alarm symptoms (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melena) & when gastric ulcer is suspected or present, as treatment may alleviate symptoms & delay diagnosis. Not recommended w/ co-administration of atazanavir. May reduce absorption of vit B12 (cyanocobalamin) due to hypo- or achlorhydria. Patients w/ reduced body stores or risk factors for reduced vit B12 absorption on long-term therapy. Potential for interactions w/ medicinal products metabolised through CYP2C19. Discourage concomitant use w/ clopidogrel. Slightly increased risk of GI infections eg, Salmonella & Campylobacter. Severe hypomagnesaemia. Measure Mg levels before starting & periodically during treatment for patients on prolonged treatment or who take PPIs w/ digoxin or medicinal products that may cause hypomagnesaemia (eg, diuretics). High doses & over long durations (>1 yr) may increase risk of hip, wrist & spine fracture, predominantly in elderly or in presence of other recognised risk factors. Patients at risk of osteoporosis. Subacute cutaneous lupus erythematosus. Increased chromogranin A (CgA) level may interfere w/ investigations for neuroendocrine tumours; stop treatment for at least 5 days before CgA measurements to avoid interference. Childn.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign).
Drug Interactions
Decreased intragastric acidity during treatment might increase or decrease absorption of active substances w/ gastric pH dependent absorption. Decreased plasma levels of nelfinavir & atazanavir. Increased bioavailability of digoxin. Decreased exposure to active metabolite of clopidogrel & diminished mean inhibition of platelet aggregation. Significantly reduced absorption & impaired clinical efficacy of posaconazole, erlotinib, ketoconazole & itraconazole. Decreased metabolism & increased systemic exposure of active substances metabolised by CYP2C19 eg, R-warfarin & other vit K antagonists, cilostazol, diazepam & phenytoin. Increased Cmax & AUC for cilostazol & one of its active metabolites. Monitor phenytoin plasma conc during 1st 2 wk after initiating treatment. Concomitant administration w/ saquinavir/ritonavir resulted in increased plasma levels for saquinavir associated w/ good tolerability in HIV-infected patients. Increased serum levels of tacrolimus. Increased serum levels by decreasing rate of metabolism w/ inhibitors of CYP2C19 &/or CYP3A4 (eg, clarithromycin & voriconazole). Decreased serum levels by increasing rate of metabolism w/ inducers of CYP2C19 &/or CYP3A4 (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
Omee lyo powd for inj 40 mg
Packing/Price
(vial + 10 mL amp diluent) 10 × 1's; (vial + 10 mL amp diluent) 1's
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