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Acifre

Acifre

omeprazole

Manufacturer:

GXI

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Omeprazole
Indications/Uses
Cap: Conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, GERD, PUD & Zollinger-Ellison syndrome. Powd for inj: Duodenal ulcer, gastric ulcer & reflux oesophagitis & Zollinger-Ellison syndrome.
Dosage/Direction for Use
Cap GERD 20 mg once daily for 4 wk. Dyspepsia 10-20 mg daily for 2-4 wk. PUD 20 mg daily as single dose, or 40 mg in severe cases. NSAID-associated ulceration 20 mg daily. Zollinger-Ellison syndrome 60 mg once daily. Acid aspiration prophylaxis during general anesth 40 mg in the evening before surgery & further 40 mg 2-6 hr before the procedure. Powd for inj Administer in IV infusion for 20-30 min. Alternative to oral therapy 40 mg once daily in patients where use of oral medicinal products is inappropriate. Patient w/ Zollinger-Ellison syndrome Initially 60 mg IV daily. Higher daily doses may be required & dose should be adjusted individually. When doses exceed 60 mg daily, dose should be divided & given bid. Patient w/ impaired hepatic function 10-20 mg as daily dose may be sufficient.
Contraindications
Hypersensitivity to omeprazole or substituted benzimidazoles. Not to be used concomitantly w/ nelfinavir.
Special Precautions
Cap: Consider possibility of malignancy prior to treatment in patients w/ gastric ulcers. Hepatic impairment. Powd for inj: 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/ atazanavir. May reduce absorption of vit B12 (cyanocobalamin) due to hypo- or achlorhydria especially in 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 in patients treated for at least 3 mth, & in most cases for a yr. Measure Mg levels prior to & periodically during treatment for patients expected to be on prolonged treatment or who take PPIs w/ digoxin or medicinal products that may cause hypomagnesaemia (eg, diuretics). May modestly increase risk of hip, wrist & spine fracture, predominantly in elderly or in presence of other recognised risk factors if used in high doses & over long durations (>1 yr). Subacute cutaneous lupus erythematosus (SCLE); discontinue if lesions occur, especially in sun-exposed areas of skin, & if accompanied by arthralgia. SCLE after previous treatment may increase risk of SCLE w/ other PPIs. Stop IV treatment for at least 5 days before CgA measurements to avoid increased chromogranin A (CgA) level which may interfere w/ investigations for neuroendocrine tumours; repeat measurements 14 days after cessation of treatment if CgA & gastrin levels have not returned to reference range after initial measurement.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Cap: Skin rashes. Pruritus, dizziness, fatigue, arthralgia & myalgia, urticaria & dry mouth. Increased risk of GI infections because of acid suppressive effects. Powd for inj: Fundic gland polyps (benign).
Drug Interactions
Cap: May increase GI pH & reduced absorption of ampicillin esters, Fe salts or ketoconazole. Decrease in hepatic metabolism, delayed elimination & increase blood conc of anticoagulants (coumarin or indandione-derivative), diazepam or phenytoin. May increase leukopenic &/or thrombocytopenic effects w/ bone marrow depressants. Powd for inj: 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 the active metabolite of clopidogrel & diminished mean inhibition of platelet aggregation of clopidogrel. Significantly reduced absorption & thus 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 of cilostazol; plasma levels of saquinavir; serum levels of tacrolimus. Increased serum levels by decreasing rate of metabolism w/ CYP2C19 &/or CYP3A4 inhibitors (eg, clarithromycin & voriconazole). Concomitant voriconazole treatment resulted in more than doubling of omeprazole exposure. Decreased serum levels by increasing rate of metabolism 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
Acifre cap 40 mg
Packing/Price
24's (P38.11/cap)
Form
Acifre powd for inj 40 mg
Packing/Price
(+ 10 mL amp diluent) 10 mL x 1's (P528/box)
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