Proton

Proton

omeprazole

Manufacturer:

Farmalabor

Distributor:

CNW
Concise Prescribing Info
Contents
Omeprazole
Indications/Uses
Treatment of GERD in adults, & childn >1 yr & weighing ≥10 kg. In combination w/ antibiotics for the treatment of H. pylori-infected ulcers in adults, adolescents, & childn >4 yr. Treatment of duodenal/gastric ulcers & Zollinger-Ellison syndrome in adults. Treatment & prevention of NSAID-associated ulcers in adults.
Dosage/Direction for Use
Adult Treatment of GERD Slightly damaged gullet: 20 mg once a day for 4-8 wk, may be increased to 40 mg for further 8 wk. Healed/undamaged gullet: 10 mg once a day. Treatment of duodenal ulcer 20 mg once a day for 2 wk. Ulcers not yet healed: 20 mg once a day for further 2 wk. Ulcers not fully healed: 40 mg once a day for 4 wk. Treatment of gastric ulcer 20 mg once a day for 4 wk. Ulcers not yet healed: 20 mg once a day for further 4 wk. Ulcers not fully healed: 40 mg once a day for 8 wk. Prevention of duodenal/gastric ulcer recurrence 10 mg or 20 mg once a day, may be increased to 40 mg once a day. Treatment & prevention of NSAID-associated duodenal/gastric ulcer 20 mg once a day. Treatment of H. pylori-infected ulcer & prevention of recurrence 20 mg bd for 1 wk in combination w/ 2 antibiotics among amoxicillin, clarithromycin & metronidazole. Treatment of Zollinger-Ellison syndrome 60 mg daily. Childn & adolescent Based on wt.
Administration
May be taken with or without food: Swallow whole w/ sufficient liqd. In case of difficulty in swallowing, open cap & swallow contents directly w/ water (do not chew/crush granules).
Contraindications
Hypersensitivity to omeprazole or other PPIs. Concomitant use w/ nelfinavir.
Special Precautions
Slightly increased risk of GI infections eg, Salmonella, Campylobacter, & possibly Clostridium difficile. Rare reports of symptomatic & asymptomatic hypomagnesemia in patients treated w/ PPIs for at least 3 mth, in most cases after a yr of therapy. Monitor Mg levels prior to treatment initiation & periodically in patients expected to be on prolonged treatment or those w/ concomitant digoxin or drugs that may cause hypomagnesemia (eg, diuretics). Increased risk of osteoporosis-related fractures of the hip, wrist or spine w/ long-term therapy (≥1 yr) & multiple daily doses. Associated w/ very infrequent cases of subacute cutaneous lupus erythematosus; consider stopping therapy if lesions occur, especially in sun-exposed areas of the skin & if accompanied by arthralgia. Do not drive or operate machinery if dizziness & visual disturbances occur. Caution in patients w/ stomach pain, indigestion, severe or persistent diarrhoea, severe liver problems, or history of skin reaction w/ other medicines that reduce stomach acid; losing wt for no reason & w/ problems swallowing; vomiting food or blood; passing black stools; undergoing chromogranin A blood test; w/ osteoporosis or taking corticosteroids; w/ sugar intolerance. Pregnancy & lactation. Do not give to childn <1 yr or weighing <10 kg.
Adverse Reactions
Headache, diarrhoea, stomach pain, constipation, flatulence, nausea, vomiting, benign polyps in stomach.
Drug Interactions
Potential interaction w/ ketoconazole, itraconazole, posaconazole, voriconazole, digoxin, diazepam, phenytoin, warfarin or other vit K blockers, rifampicin, atazanavir, tacrolimus, St. John's wort, cilostazol, saquinavir, erlotinib. Elevated & prolonged serum levels of MTX &/or its metabolite hydroxymethotrexate. Reduced pharmacological activity of clopidogrel.
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
Proton gastro-resistant cap 20 mg
Packing/Price
14's;28's
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