Generic Medicine Info
Indications and Dosage
Acute bronchitis, Acute exacerbations of chronic bronchitis, Acute pharyngitis, Community-acquired pneumonia, Nongonococcal urethritis, Sinusitis, Skin and soft tissue infections, Tonsillitis
Adult: Recommended dose: 150 mg bid or 300 mg once daily for 5-10 days. Duration of treatment may be longer depending on the indication and clinical response.
Child: 6-40 kg: 5-8 mg/kg daily given in 2 divided doses; ≥40 kg: 150 mg bid. Usual treatment duration: 5-10 days. Duration of treatment must not exceed 10 days.
Hepatic Impairment
Severe: Contraindicated.
Should be taken on an empty stomach. Take at least 15 min before meals.
Hypersensitivity. Severe hepatic impairment. Concomitant use with vasoconstrictive ergot alkaloids.
Special Precautions
Patient with risk factors for prolonged cardiac repolarisation, history of torsade de pointes, congenital or documented QT prolongation, electrolyte disturbances (particularly hypokalaemia and hypomagnesaemia); clinically significant bradycardia, cardiac arrhythmia, or other cardiac insufficiencies; myasthenia gravis. Patients currently receiving agents known to prolong QT interval (e.g. class IA or class III antiarrhythmic agents, astemizole, cisapride, pimozide). Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Bacterial or fungal superinfection (prolonged-use), aggravation of myasthenia gravis. Rarely, hepatocellular and/or cholestatic hepatitis (with or without jaundice).
Blood and lymphatic system disorders: Eosinophilia, neutropenia, thrombocytopenia.
Ear and labyrinth disorders: Tinnitus, vertigo, temporary deafness, hypoacusis.
Eye disorders: Blurred vision, visual impairment.
Gastrointestinal disorders: Nausea, vomiting, epigastric pain, diarrhoea, flatulence, taste disorders, pancreatitis.
General disorders and administration site conditions: Malaise.
Infections and infestations: Candidiasis.
Immune system disorders: Angioedema.
Investigations: Increased serum AST, ALT, and alkaline phosphatase levels.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Dizziness, headache, paraesthesia.
Psychiatric disorders: Hallucinations, confusion.
Respiratory, thoracic and mediastinal disorders: Smell disorders, bronchospasm.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme; antibiotic-associated pseudomembranous colitis or Clostridium difficile-associated diarrhoea; QT prolongation, ventricular tachycardia, and torsades de pointes.
Patient Counseling Information
This drug may cause dizziness and visual impairment such as blurred vision, if affected, do not drive or operate machinery.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor LFTs and CBC with differential.
Drug Interactions
Increased risk of CV adverse effects, including QT prolongation, torsades de pointes, and other ventricular arrhythmias with class IA (e.g. quinidine, procainamide) and class III (e.g. amiodarone, dofetilide) antiarrhythmic agents, terfenadine, astemizole, cisapride, and pimozide. May increase the absorption of digoxin and other cardiac glycosides. Increased INR levels resulting in bleeding episodes with anticoagulants (e.g. warfarin). May increase the plasma concentrations of theophylline, disopyramide, and ciclosporin. May enhance and prolong the effect of midazolam. May increase the exposure to drugs metabolised by CYP3A (e.g. bromocriptine, rifabutin).
Potentially Fatal: May result in severe vasoconstriction (ergotism) and possible necrosis of extremities when given with vasoconstrictive ergot alkaloids (e.g. ergotamine, dihydroergotamine).
Food Interaction
Decreased extent of absorption with food.
Mechanism of Action: Roxithromycin is a macrolide that acts as bactericidal at high concentrations and bacteriostatic at low concentrations. It disrupts bacterial protein synthesis by binding to the 50S subunit of the 70S ribosome.
Absorption: Rapidly absorbed from the gastrointestinal tract. Food reduces the extent of absorption. Bioavailability: Approx 50%. Time to peak plasma concentration: Approx 1-2 hours.
Distribution: Widely distributed into tissues and body fluids; highly concentrated in polymorphonuclear leucocytes and macrophages (approx 30 times serum levels). Enters breastmilk (small amounts). Plasma protein binding: 92-96%, mainly to α1-acid glycoprotein and albumin.
Metabolism: Undergoes limited metabolism in the liver into the major metabolite, descladinose roxithromycin.
Excretion: Mainly via faeces (approx 53% as unchanged drug and metabolites); lungs (13%); urine (approx 7%). Elimination half-life: Approx 12 hours (adults); 20 hours (children).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6915744, Rulide. Accessed June 27, 2022.

Store between 15-30°C. Protect from light and moisture.
MIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Anon. Roxithromycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 16/06/2022.

Buckingham R (ed). Roxithromycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 06/06/2022.

Roxy Tablet 150 mg (IMEKS Pharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. Accessed 06/06/2022.

Sanofi-Aventis New Zealand Limited. Rulide D 50 mg Dispersible Tablets data sheet 11 November 2020. Medsafe. Accessed 16/06/2022.

Teva Pharma (New Zealand) Limited. Arrow - Roxithromycin 150 mg, 300 mg Coated Tablets data sheet 10 February 2017. Medsafe. Accessed 06/06/2022.

Uplores 150 mg Capsule (Euro Asia Medico Pte. Ltd.). MIMS Singapore. Accessed 16/06/2022.

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 © 2024 MIMS. All rights reserved. Powered by
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