Roxithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin, designed to offer enhanced pharmacokinetic properties and a broad spectrum of antibacterial activity. It functions by inhibiting bacterial protein synthesis through binding to the 50S ribosomal subunit, making it effective against a wide range of Gram-positive and some Gram-negative pathogens, as well as certain atypical organisms. Its improved acid stability and tissue penetration compared to earlier macrolides contribute to its reliable efficacy in treating respiratory, skin, and soft tissue infections. Roxithromycin is particularly valued for its convenient once- or twice-daily dosing regimen, which supports patient adherence and therapeutic success.

Features

• Semi-synthetic 14-membered ring macrolide antibiotic
• Broad-spectrum activity against Gram-positive cocci, including Streptococcus pyogenes and Streptococcus pneumoniae
• Effective against certain Gram-negative bacteria such as Moraxella catarrhalis and Legionella pneumophila
• Covers atypical pathogens including Chlamydia pneumoniae, Mycoplasma pneumoniae, and Ureaplasma urealyticum
• High oral bioavailability and extensive tissue distribution
• Metabolized primarily in the liver, with elimination via bile and feces
• Available in 150 mg and 300 mg film-coated tablets

Benefits

• Effectively eradicates susceptible bacterial pathogens, resolving infection symptoms
• Convenient dosing schedule improves compliance and reduces missed doses
• Generally well-tolerated profile with a lower incidence of gastrointestinal side effects compared to erythromycin
• Suitable for outpatient treatment of community-acquired infections, potentially reducing hospitalization
• Demonstrates good penetration into respiratory tissues, skin, and soft structures
• May be used in penicillin-allergic patients for indicated infections

Common use

Roxithromycin is commonly prescribed for the treatment of mild to moderate bacterial infections caused by susceptible organisms. Typical indications include upper and lower respiratory tract infections such as pharyngitis, tonsillitis, sinusitis, acute bronchitis, and community-acquired pneumonia. It is also utilized for skin and soft tissue infections including erysipelas, impetigo, and secondary infected dermatoses. Additionally, roxithromycin may be employed in the management of genitourinary infections caused by Chlamydia trachomatis or Ureaplasma urealyticum. Off-label uses sometimes include adjunctive therapy in Helicobacter pylori eradication regimens and prevention of pertussis in exposed individuals.

Dosage and direction

The standard adult dosage of roxithromycin is 300 mg per day, administered either as a single daily dose or as 150 mg twice daily. For more severe infections, the dose may be increased to 300 mg twice daily, though this should be guided by clinical assessment and microbial susceptibility. The medication should be taken before meals to optimize absorption, with a full glass of water. The usual treatment duration ranges from 5 to 10 days depending on the type and severity of infection, though certain conditions may require extended therapy. Pediatric dosing is typically calculated at 2.5-5 mg/kg twice daily, not exceeding the adult dose. Dosage adjustment may be necessary in patients with hepatic impairment.

Precautions

Roxithromycin should be used with caution in patients with pre-existing liver dysfunction, as macrolide antibiotics have been associated with hepatotoxicity. Periodic liver function tests may be advisable during prolonged therapy. Patients with known QT prolongation or those taking other medications that prolong the QT interval should be closely monitored due to the potential risk of cardiac arrhythmias. The presence of renal impairment does not usually require dosage adjustment, as roxithromycin is primarily eliminated hepatically, but caution is still warranted in severe renal failure. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus, as safety data are limited. Breastfeeding mothers should consult their physician, as roxithromycin is excreted in human milk.

Contraindications

Roxithromycin is contraindicated in patients with known hypersensitivity to macrolide antibiotics or any component of the formulation. It should not be administered to patients with a history of hepatitis or jaundice associated with previous macrolide use. Concomitant administration with ergot derivatives, terfenadine, astemizole, cisapride, or pimozide is contraindicated due to the risk of serious cardiac arrhythmias. The antibiotic is also contraindicated in patients with documented prolongation of the QT interval or those with significant electrolyte disturbances that may predispose to arrhythmias.

Possible side effect

The most commonly reported adverse effects associated with roxithromycin are gastrointestinal in nature, including nausea, abdominal pain, diarrhea, and vomiting. These symptoms are generally mild and transient. Less frequently, patients may experience headache, dizziness, or alterations in taste perception. Hepatic side effects can include transient elevations in liver enzymes and, rarely, hepatitis or cholestatic jaundice. Allergic reactions such as skin rash, pruritus, and urticaria may occur occasionally. Serious but rare adverse effects include QT interval prolongation, ventricular arrhythmias, and Clostridium difficile-associated diarrhea. Patients should report any persistent or severe symptoms to their healthcare provider.

Drug interaction

Roxithromycin may interact with numerous medications due to its inhibition of cytochrome P450 3A4 enzyme. Concomitant use with CYP3A4 substrates such as simvastatin, lovastatin, and atorvastatin may increase the risk of statin-induced myopathy or rhabdomyolysis. It may elevate concentrations of warfarin, potentially increasing anticoagulant effect and bleeding risk. Coadministration with theophylline may increase theophylline levels, requiring monitoring and possible dosage adjustment. Roxithromycin can significantly increase concentrations of ciclosporin, tacrolimus, and sirolimus, necessitating close therapeutic drug monitoring. Concurrent use with oral hypoglycemic agents may enhance their hypoglycemic effect. The antibiotic may reduce the efficacy of oral contraceptives, suggesting the need for additional contraceptive measures.

Missed dose

If a dose of roxithromycin is missed, it should be taken as soon as remembered, unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed one, as this may increase the risk of adverse effects. Maintaining consistent antibiotic levels is important for therapeutic efficacy, so patients should strive to adhere to the prescribed dosing regimen. If multiple doses are missed or uncertainty exists about how to proceed, patients should consult their healthcare provider or pharmacist for guidance.

Overdose

Symptoms of roxithromycin overdose may include severe nausea, vomiting, diarrhea, and abdominal pain. In cases of significant overdose, hepatic dysfunction and hearing loss have been reported with macrolide antibiotics. QT prolongation and subsequent ventricular arrhythmias, including torsades de pointes, represent the most serious potential consequences of overdose. Management should be supportive and symptomatic, with particular attention to cardiac monitoring. Gastric lavage may be considered if performed soon after ingestion. There is no specific antidote for roxithromycin overdose, and dialysis is not expected to be effective due to the drug’s extensive protein binding and large volume of distribution.

Storage

Roxithromycin tablets should be stored at room temperature between 15°C and 30°C (59°F and 86°F), in their original container, protected from light and moisture. The medication should be kept out of reach of children and pets to prevent accidental ingestion. Tablets should not be removed from their blister packaging until immediately before use to maintain stability. Do not store in bathrooms or other areas with high humidity, as moisture may degrade the product. Properly discard any expired or unused medication according to local regulations, typically through medication take-back programs rather than flushing down toilets or throwing in household trash.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Roxithromycin is a prescription medication that should be used only under the supervision of a qualified healthcare professional. The content presented here is not exhaustive and may not include all possible information about the drug’s uses, directions, warnings, precautions, interactions, or adverse effects. Healthcare providers should reference the official prescribing information and consider individual patient factors when making treatment decisions. Patients should not alter their medication regimen without consulting their physician. The manufacturer’s package insert contains the most complete and updated information.

Reviews

Clinical studies and post-marketing surveillance have generally demonstrated favorable efficacy and tolerability profiles for roxithromycin. In comparative trials, it has shown equivalent efficacy to other macrolides and some beta-lactam antibiotics for respiratory tract infections, with potentially improved gastrointestinal tolerability compared to erythromycin. Many physicians appreciate its convenient dosing schedule and reliable tissue penetration. Some reviews note that while resistance patterns vary geographically, roxithromycin remains a valuable option for community-acquired infections in areas with favorable susceptibility profiles. Patient reviews often mention the convenience of once-daily dosing and generally mild side effects, though individual experiences may vary based on specific infections and patient factors.