Generic Medicine Info
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. Patient Counselling 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.
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.
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).
CIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
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