Generic Medicine Info
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.
Concomitant use with nelfinavir or rilpivirine.
Special Precautions
Patient with reduced body stores or risk factors for reduced vitamin B12 absorption; at risk of osteoporosis. May mask symptoms of gastric malignancy. CYP2C19 ultrarapid, rapid, normal, intermediate, and poor metabolisers. Hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness and visual disturbances, if affected, do not drive or operate machinery. Monitoring Parameters Rule out presence of gastric malignancy prior to initiation of treatment. Monitor serum Mg levels before starting therapy and periodically thereafter; signs and symptoms of cutaneous lupus erythematosus or SLE, CDAD; bone loss and fractures (for those receiving high dose or in long-term therapy).
Adverse Reactions
Significant: Hypomagnesaemia, vitamin B12 deficiency, fundic gland polyps (long-term use); cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus (SCLE), SLE; osteoporosis-related fractures of the hip, wrist or spine (long term use or high doses); Clostridium difficile-associated diarrhoea (CDAD), gastrointestinal infections (e.g. Salmonella, Campylobacter). Rarely, acute interstitial nephritis, hypersensitivity reactions (e.g. urticaria, angioedema, anaphylaxis, maculopapular rash). Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain. General disorders and administration site conditions: Asthenia, malaise. Investigations: Increased liver enzymes. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, dizziness, somnolence, paraesthesia. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: Cough, URTI.
Potentially Fatal: Very rarely, severe cutaneous adverse reactions (e.g. acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Drug Interactions
May decrease the plasma concentrations of nelfinavir, rilpivirine, and atazanavir. Increased risk of hypomagnesaemia with diuretics. May increase the plasma concentrations of saquinavir, tacrolimus, methotrexate, citalopram. May significantly decrease the absorption of itraconazole, ketoconazole, posaconazole and erlotinib. May decrease metabolism of diazepam, phenytoin and cilostazol. May reduce the antiplatelet effect of clopidogrel; avoid concomitant use. May increase the bioavailability of digoxin. Increased INR and prothrombin time with warfarin. Concomitant use with CYP2C19 or CYP3A4 inhibitors (e.g. clarithromycin, voriconazole) may increase the plasma concentrations of omeprazole. Concomitant use with CYP2C19 or CYP3A4 inducers (e.g. rifampicin) may decrease the plasma concentrations of omeprazole.
CIMS 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).
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 © 2023 CIMS. All rights reserved. Powered by
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