Roxithromycin


Concise Prescribing Info
Indications/Uses
Susceptible infections.
Dosage/Direction for Use
Adult: PO 150 mg bid or 300 mg once daily for 5-10 days.
Administration
Should be taken on an empty stomach. Take at least 15 min before meals.
Contraindications
Hypersensitivity. Severe hepatic impairment. Concomitant use with vasoconstrictive ergot alkaloids and drugs which delay peristalsis.
Special Precautions
Patients with congenital prolongation of QT interval or other cardiac diseases; myasthenia gravis. Renal and hepatic impairment. Elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor ECG, LFT, kidney functions, and blood counts.
Adverse Reactions
Significant: Ventricular tachycardia, Torsades de pointes, myasthenia gravis aggravation. Blood and lymphatic system disorders: Eosinophilia. Ear and labyrinth disorders: Temporary deafness, tinnitus. Gastrointestinal disorders: Nausea, vomiting, epigastric pain, diarrhoea, flatulence. General disorders and administration site conditions: Taste and/or smell disorders, malaise. Hepatobiliary disorders: Increases in serum transaminases/alkaline phosphatase levels, acute cholestatic hepatitis, pancreatitis, hepatocellular injury. Immune system disorders: Bronchospasm. Infections and infestations: Pseudomembranous colitis, candidiasis. Metabolism and nutrition disorders: Anorexia. Nervous system disorders: Paraesthesia, vertigo, dizziness, headache. Psychiatric disorders: Hallucinations, confusion.
Potentially Fatal: Hypersensitivity reactions such as Stevens Johnson Syndrome or toxic epidermal necrolysis; antibiotic-associated pseudomembranous colitis; QT prolongation.
Drug Interactions
Increased risk of cardiovascular adverse effects (e.g. QT prolongation, Torsades de pointes, ventricular arrhythmias) with Class IA and Class III antiarrhythmic agents, terfenadine, astemizole, cisapride, and pimozide. May increased absorption of digoxin and other cardiac glycosides. Increased INR levels with anticoagulants (e.g. warfarin). May increases plasma concentration of theophylline, disopyramide and ciclosporin. May enhance and prolongs effect of midazolam.
CIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by CIMS based on roxithromycin 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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