Omeprazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Peptic ulcer 20 mg or 40 mg once daily. Treatment duration: 4 weeks (duodenal ulcer); 8 weeks (gastric ulcer). Maintenance: 10-20 mg once daily, may increase up to 40 mg according to response. Eradication of H. pylori associated with peptic ulcer disease 20 mg bid for 1 week in combination with clarithromycin and with either amoxicillin or metronidazole. Alternatively, 40 mg once daily for 1 week in combination with amoxicillin and metronidazole. NSAID-associated ulceration 20 mg once daily for up to 8 weeks. Maintenance: 20 mg once daily. Gastro-oesophageal reflux disease 20 mg once daily for 4-8 weeks. For severe case: 40 mg once daily for 8 weeks. Maintenance: 10 mg once daily, may increase to 20-40 mg once daily if necessary. Zollinger-Ellison syndrome Initial: 60 mg/day, adjust as required. Usual dose: 20-120 mg/day. Doses >80 mg should be given in 2 divided doses. IV Zollinger-Ellison syndrome Initial: 60 mg/day via infusion over 20-30 minutes, adjust dose according to response. Daily doses >60 mg should be given in 2 divided doses. Gastric and duodenal ulcers; Eradication of H. pylori associated with peptic ulcer disease; NSAID-associated ulceration; Gastro-oesophageal reflux disease 40 mg once daily given via infusion over 20-30 minutes until oral administration is possible.
Administration
Delayed-release cap: Should be taken on an empty stomach. Take at least 1 hr before meals. Swallow whole, do not chew/crush. For patients w/ difficulty swallowing, cap may be carefully opened & entire contents sprinkled in a spoonful of applesauce. Swallow drug/food mixt w/o chewing immediately after prep. Drug/food mixt should not be stored for future use.
Powd for oral susp: Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before a meal.
MUPS tab: May be taken with or without food.
Cap: Should be taken with food. Take immediately before a meal.
Contraindications
Concomitant use with nelfinavir.
Special Precautions
Patient with reduced body store or risk factors for reduced vitamin B12 absorption; risk of osteoporosis. Hepatic impairment. Children, elderly. Pregnancy and lactation. CYP2C19 ultrarapid metabolisers. Monitoring Parameters Rule out gastric malignancy prior to initiation of treatment. Monitor Mg concentrations prior to initiation and periodically thereafter.
Adverse Reactions
Significant: Hypomagnasaemia, cutaneous lupus erythematosus, SLE, osteoporosis-related fractures, fundic gland polyp, carcinoma, Clostridium) difficile-associated diarrhoea, interstitial nephritis, Vitamin B12 deficiency (long-term therapy), gastrointestinal infection (e.g. salmonella, Campylobacter). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain. General disorders and administration site conditions: Weakness, malaise. Hepatobiliary disorders: Increased liver enzymes. Immune system disorders: Urticaria. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, dizziness, somnolence, paraesthesia, vertigo. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: Cough. Skin and subcutaneous tissue disorders: Rash, dermatitis, pruritus.
Drug Interactions
May decrease plasma concentrations of nelfinavir and atazanavir. Increased risk of hypomagnesaemia with diuretics. May increase plasma concentration of tacrolimus, methotrexate. May decreased absorption of itraconazole, ketoconazole, posaconazole, erlotinib. May decrease metabolism of diazepam, phenytoin, cilostazol. May reduce the antiplatelet activity of clopidogrel. May increase bioavailability of digoxin.
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).
Disclaimer: This information is independently developed by CIMS based on omeprazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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