Esomeprazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO GERD Erosive reflux oesophagitis: 20 or 40 mg once daily for 4 weeks, may extend for further 4 weeks if necessary. Maintenance of healed erosive oesophagitis: 20 mg once daily for up to 6 months. Symptomatic treatment of GERD (without oesophagitis): 20 mg once daily for 4 weeks; assess treatment if symptoms do not resolve after 4 weeks, may extend for further 4 weeks if necessary. Eradication of H. pylori associated with peptic ulcer disease 20 mg bid for 7 days, or 40 mg once daily for 10 days, combined with amoxicillin and clarithromycin. NSAID-associated ulceration 20 mg once daily for 4-8 weeks. Prophylaxis of NSAID-induced ulcers 20 or 40 mg once daily for up to 6 months. Zollinger-Ellison syndrome Initial: 40 mg bid, may be adjusted according to response. Usual range: 80-160 mg/day, may be increased up to 240 mg/day if necessary. Daily doses >80 mg should be given in 2 divided doses. IV GERD Erosive reflux oesophagitis: 40 mg once daily. Symptomatic treatment of GERD: 20 mg once daily, given via slow inj over at least 3 minutes or infusion over 10-30 minutes. NSAID-associated ulceration 20 mg once daily via slow inj over at least 3 minutes or infusion over 10-30 minutes. Prophylaxis of rebleeding of gastric and duodenal ulcers following therapeutic endoscopy 80 mg via infusion over 30 minutes, may be followed by 8 mg/hour continuous infusion over 72 hours, then may switch to oral therapy given as 40 mg once daily for 4 weeks.
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 rilpivirine, atazanavir, and nelfinavir.
Special Precautions
Patient with gastric malignancy, reduced body stores or risk factors for reduced vitamin B12 absorption, or those at risk of fractures and osteoporosis. Severe renal and hepatic impairment. Children. Pregnancy and lactation. CYP2C19 ultrarapid metabolisers. Patient Counselling This drug may cause dizziness and blurred vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor serum Mg levels prior to treatment initiation and periodically thereafter. Assess for signs or symptoms of rebleeding, bone fractures, and Clostridium difficile-associated diarrhoea (CDAD).
Adverse Reactions
Significant: Hypomagnesaemia, osteoporosis-related fractures, fundic gland polyps, subacute cutaneous lupus erythematosus, SLE, acute interstitial nephritis, atrophic gastritis, Clostridium difficile-associated diarrhoea, gastrointestinal infections (e.g. Salmonella, Campylobacter), vitamin B12 deficiency (long-term therapy). Blood and lymphatic system disorders: Rarely, leucopenia, thrombocytopenia. Eye disorders: Blurred vision. Gastrointestinal disorders: Flatulence, diarrhoea, nausea, abdominal pain, vomiting, constipation, xerostomia. General disorders and administration site conditions: Inj site reactions, fever, malaise. Hepatobiliary disorders: Increased liver enzymes. Rarely, hepatitis. Immune system disorders: Rarely, hypersensitivity reactions (e.g. angioedema, anaphylactic shock, urticaria). Investigations: Altered thyroid hormone levels, increased gastrin, increased serum creatinine. Metabolism and nutrition disorders: Peripheral oedema. Rarely, hyponatraemia. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, weakness. Nervous system disorders: Headache, dizziness, drowsiness, vertigo, paraesthesia. Psychiatric disorders: Insomnia, agitation, confusion, depression. Reproductive system and breast disorders: Very rarely, gynaecomastia. Respiratory, thoracic and mediastinal disorders: Cough, bronchospasm. Skin and subcutaneous tissue disorders: Pruritus, rash, dermatitis. Rarely, alopecia.
ROUTE(S) : PO: B
ROUTE(S) : IV / Parenteral: C
Drug Interactions
Increased risk of digoxin-induced cardiotoxic effects. May diminish the therapeutic effects of clopidogrel. Increased risk of hypomagnesaemia with diuretics. May increase serum concentrations of tacrolimus, methotrexate, cilostazol, and drugs metabolised by CYP2C19 (e.g. diazepam, citalopram, imipramine, phenytoin). May reduce absorption of ketoconazole, itraconazole, Fe salts, erlotinib. Concomitant use with warfarin may increase INR and prothrombin time. Esomeprazole serum levels may be decreased with CYP2C19 or CYP3A4 inducers (e.g. rifampicin) and increased with CYP3A4 inhibitors (e.g. voriconazole, clarithromycin). May prolong elimination half-life of cisapride.
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).
Disclaimer: This information is independently developed by CIMS based on esomeprazole 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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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