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.
Dosage Details
Oral
Susceptible infections
Adult: 150 mg bid or 300 mg once daily for 5-10 days.
Child: ≥40 kg: 150 mg bid for 5-10 days.
Hepatic Impairment
150 mg once daily. Severe: Contraindicated.
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.
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 admin 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.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor ECG, LFT, kidney functions, and blood counts.
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.
Potentially Fatal: Severe vasoconstriction (ergotism) and with possible necrosis of extremities with vasoconstrictive ergot alkaloids (e.g. ergotamine, dihydroergotamine).
Food Interaction
Decreased absorption with food.
Action
Description: Roxithromycin is a macrolide which acts as bactericidal at high concentrations and bacteriostatic at low concentrations. It inhibits bacterial protein synthesis by binding to the 50S subunit of the 70S ribosome.
Pharmacokinetics:
Absorption: Food delays absorption. Absolute bioavailability: Approx 50%. Time to peak plasma concentration: Approx 1-2 hours.
Distribution: Distributed in the tonsils and paranasal sinuses, respiratory tract tissues and secretions, genital tracts, skin, and synovial fluid. Enters breastmilk (small amounts). Plasma protein binding: Approx 92- 96% mainly to α1-acid glycoprotein, and albumin.
Metabolism: Undergoes limited metabolism in the liver into major metabolite, descladinose roxithromycin.
Excretion: Via urine (approx 7%); lungs (13%); faeces (approx 53%). Half-life: Approx 12 hours.
Chemical Structure

Chemical Structure Image
Roxithromycin

Source: National Center for Biotechnology Information. PubChem Database. Rulide, CID=6915744, https://pubchem.ncbi.nlm.nih.gov/compound/Rulide (accessed on Jan. 23, 2020)

Storage
Store below 25°C.
MIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
References
Anon. Roxithromycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/12/2018.

Arrow-Roxithromycin (Teva Pharma Limited). Medsafe. http://www.medsafe.govt.nz/. Accessed 06/12/2018.

Buckingham R (ed). Roxithromycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.new.medicinescomplete.com. Accessed 06/12/2018.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 MIMS. All rights reserved. Powered by MIMS.com
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