Clarithromycin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Respiratory tract infections; Skin and soft tissue infections Usual dose: As conventional tab: 250 mg bid, may be increased to 500 mg bid for severe infections. As modified-release tab: 500 mg once daily, may be increased to 1,000 mg/day for severe infections. Usual treatment duration: 7-14 days. H. pylori eradication associated with peptic ulcer disease As conventional tab: Triple therapy regimen in combination with another antibiotic and a PPI: 500 mg bid for 7-14 days. Dual therapy regimen in combination with omeprazole: 500 mg tid for 14 days, followed by omeprazole for an additional 14 days. Mycobacterium avium complex infections Treatment of disseminated cases in patients with advanced HIV infection in combination with other antimycobacterial agents: As conventional tab or oral susp: 500 mg 12 hourly, may continue therapy if clinical response is observed. IV Respiratory tract infections; Skin and soft tissue infections Usual dose: 500 mg 12 hourly given via infusion over 60 minutes for 2-5 days, then switch to oral clarithromycin therapy whenever possible.
Administration
Standard release tab & oral susp: May be taken with or without food.
XL & MR tab: Should be taken with food. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to clarithromycin or any macrolide antibiotics. History of cholestatic jaundice/hepatic dysfunction associated with previous clarithromycin use; hypokalaemia, history of QT prolongation (congenital or documented acquired), ventricular cardiac arrhythmia including torsades de pointes; severe hepatic failure in combination with renal impairment. Concomitant use with ergot alkaloids (e.g. ergotamine, dihydroergotamine), oral midazolam, astemizole, cisapride, domperidone, pimozide, terfenadine, ticagrelor, ranolazine, lovastatin, simvastatin, colchicine, lomitapide. Modified-release tab: Significant renal impairment (CrCl <30 mL/min).
Special Precautions
Patient with coronary artery disease, severe cardiac insufficiency, clinically relevant bradycardia or conduction disturbances; electrolyte disturbances (e.g. hypomagnesaemia), myasthenia gravis. Patient taking other drugs known to prolong QT interval (e.g. class IA or III antiarrhythmic, antipsychotic agents, antidepressants, fluoroquinolones). Patient with renal impairment concurrently taking atazanavir or ritonavir-containing regimens. Hepatic and moderate to severe renal impairment. Children. Pregnancy and lactation. Monitoring Parameters Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor BUN and serum creatinine; CBC with differential.
Adverse Reactions
Significant: Hepatic dysfunction (e.g. increased liver enzymes, hepatocellular and/or cholestatic hepatitis with or without jaundice); exacerbation or new onset of myasthenia gravis. Gastrointestinal disorders: Abdominal pain, diarrhoea, nausea, vomiting, dysgeusia, dyspepsia. General disorders and administration site conditions: Inj site reactions (e.g. phlebitis, pain, inflammation). Infections and infestations: Candidiasis. Investigations: Prolonged prothrombin time, increased BUN. Nervous system disorders: Headache. Psychiatric disorders: Insomnia. Skin and subcutaneous tissue disorders: Rash, hyperhidrosis. Vascular disorders: Vasodilation (IV).
Potentially Fatal: Hepatic failure, pseudomembranous colitis or C. difficile-associated diarrhoea (CDAD); QT prolongation, arrhythmias including torsades de pointes; anaphylaxis, severe cutaneous adverse reactions (e.g. acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, Henoch-Schonlein purpura or IgA vasculitis).
Drug Interactions
May result in significant hypoglycaemia with oral hypoglycaemics (e.g. sulfonylureas, repaglinide, nateglinide) and insulin. Increased risk of haemorrhage and elevated INR and prothrombin time with warfarin. May induce metabolism and decrease efficacy with CYP3A inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital). May reduce the plasma levels with strong CYP450 inducers (e.g. efavirenz, nevirapine, rifabutin, rifapentine). Decreased exposure with etravirine. Increased plasma concentration and exposure with fluconazole. May elevate the serum concentrations of digoxin and CYP450 substrates (e.g. alprazolam, carbamazepine, cilostazol, ciclosporin, methylprednisolone, omeprazole, quetiapine, sildenafil, sirolimus, tacrolimus, vinblastine, theophylline, valproate, tolterodine). May increase the risk of torsades de pointes with quinidine or disopyramide. May decrease the plasma concentrations of zidovudine. Ritonavir significantly inhibits the metabolism of clarithromycin. Concomitant use with atazanavir, itraconazole, saquinavir, or certain Ca channel blockers (e.g. verapamil, amlodipine, diltiazem) may result in bi-directional drug interactions. Increased or prolongation of sedation with triazolam.
CIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by CIMS based on clarithromycin 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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