Delayed-release cap: Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals.
Tab: May be taken with or without food.
Administration
Delayed-release cap: Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals.
Tab: May be taken with or without food. |
Contraindications
Concomitant use with nelfinavir or rilpivirine.
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Special Precautions
Patient with reduced body stores or risk factors for reduced vitamin B12 absorption, at risk of osteoporosis-related fractures. Hepatic and severe renal impairment. Children. Pregnancy and lactation. Monitoring Parameters Obtain serum Mg (particularly when used with agents that may cause hypomagnesaemia) and Ca (in at risk-patients [e.g. hypoparathyroidism]) at baseline and periodically thereafter. Monitor for rebleeding in patients with peptic ulcer bleed. Consider further follow-up and diagnostic testing in patients with suboptimal response or early symptomatic relapse following completion of therapy. Rule out malignancy in case of any alarm symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, melaena or haematemesis).
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Adverse Reactions
Significant: Hypomagnesaemia (prolonged use), osteoporosis-related fractures of the hip, wrist, and spine (particularly in high doses and prolonged use), may increase the risk of Clostridium difficile-associated diarrhoea or gastrointestinal infections (e.g. Salmonella, Campylobacter); fundic gland polyps, acute tubulointerstitial nephritis; vitamin B12 deficiency (prolonged use), subacute cutaneous lupus erythematosus (SCLE), SLE.
Blood and lymphatic system disorders: Rarely, leucopenia, thrombocytopenia.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Rarely, blurred vision.
Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhoea, abdominal pain, flatulence, dry mouth.
General disorders and administration site conditions: Inj site reactions (IV). Rarely, malaise, increased sweating.
Hepatobiliary disorders: Rarely, hepatitis with or without jaundice.
Immune system disorders: Rarely, hypersensitivity reactions (e.g. fever, angioedema, anaphylactic shock/reaction).
Investigations: Increased liver enzymes.
Metabolism and nutrition disorders: Peripheral oedema. Rarely, hyponatraemia.
Musculoskeletal and connective tissue disorders: Rarely, myalgia, arthralgia.
Nervous system disorders: Headache, dizziness, somnolence, paraesthesia.
Psychiatric disorders: Insomnia. Rarely, agitation, confusion, depression.
Reproductive system and breast disorders: Very rarely, gynaecomastia.
Respiratory, thoracic and mediastinal disorders: Rarely, bronchospasm.
Skin and subcutaneous tissue disorders: Dermatitis, pruritus, rash, urticaria. Rarely, alopecia, photosensitivity.
Potentially Fatal: Very rarely, severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis). |
ROUTE(S) : PO: B
ROUTE(S) : IV / Parenteral: C
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Drug Interactions
May decrease the exposure and efficacy of atazanavir. May diminish the therapeutic effect of clopidogrel. Increased risk of hypomagnesaemia with digoxin or diuretics. May increase the serum concentrations of saquinavir, tacrolimus, methotrexate, cilostazol, and drugs metabolised by CYP2C19 (e.g. diazepam, citalopram, imipramine, phenytoin). May reduce the absorption of agents dependent on gastric pH for absorption (e.g. ketoconazole, itraconazole, Fe salts, erlotinib, dasatinib, mycophenolic acid). Concomitant use with warfarin may increase INR and prothrombin time. Esomeprazole serum levels may be decreased with CYP2C19 and/or CYP3A4 inducers (e.g. rifampicin) and increased with CYP3A4 inhibitors (e.g. clarithromycin) or combined inhibitors of CYP2C19 and CYP3A4 (e.g. voriconazole). May prolong the elimination half-life of cisapride.
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CIMS Class
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ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
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