Roxithromycin

Roxithromycin is used for treating several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, and bacterial infections associated with stomach and intestinal ulcers.

Product dosage: 150mg
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Synonyms Acevor Allolide Aristomycin Asmetic Assoral Azuril Bazuctril Biaxsig Bicofen Biostatik Cadithro Claramid Crolix Delitroxin Delos Dorolid Elrox Erybros Floxid Infectoroxit Inferoxin Ixor Kensodic Klomicina Ladlid Macrolid Macrosil Makrodex Monobac Nirox Odonticina Overal Pedilid Pedrox Ramivan Redotrin Remora Renicin Ridinfect Ritosin Rocky Rokilide Rokithrid Roksimin Roksolit Rolexit Rolicyn Rolid Romac Romyk Rossitrol Rotramin Roxacine Roxithromycine Roxithromycinum Roxitromicina Rulid Subroxine Surlid

Roxithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin, designed to offer enhanced pharmacokinetic properties and a broad spectrum of antibacterial activity. It is particularly valued for its improved acid stability, allowing for oral administration without the need for enteric coating, and its once-daily dosing regimen which supports patient adherence. Clinically, it is indicated for the treatment of a variety of community-acquired respiratory, skin, and soft tissue infections caused by susceptible organisms. Its mechanism involves inhibition of bacterial protein synthesis by binding to the 50S ribosomal subunit, effectively halting microbial growth.

Features

• Chemical structure: 14-membered macrolide ring, (9E)-9-{O-[(2-methoxyethoxy)methyl]oxime} of erythromycin
• Molecular formula: C₄₁H₇₆N₂O₁₅
• Molecular weight: 837.06 g/mol
• Administration: Oral tablets (150 mg, 300 mg)
• Bioavailability: Approximately 50–60% following oral intake
• Protein binding: 85–95%, primarily to albumin
• Metabolism: Hepatic, via cytochrome P450 system (CYP3A4)
• Elimination half-life: Approximately 12 hours
• Excretion: Primarily fecal (53%), with 10–15% renal excretion

Benefits

• Effective against a wide range of Gram-positive and some Gram-negative bacteria, including Streptococcus pneumoniae, Staphylococcus aureus, and Moraxella catarrhalis
• Convenient once-daily dosing improves patient compliance and reduces dosing errors
• Superior tissue penetration, especially in respiratory tissues, skin, and tonsils, ensuring targeted therapeutic action
• Generally well-tolerated with a lower incidence of gastrointestinal side effects compared to older macrolides
• Suitable for patients with penicillin allergies where macrolides are an appropriate alternative
• Demonstrates anti-inflammatory and immunomodulatory effects beyond its antibacterial properties

Common use

Roxithromycin is commonly prescribed for the treatment of mild to moderate bacterial infections, particularly those acquired in community settings. 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 like erysipelas, impetigo, and secondary infected dermatoses. Off-label uses may include treatment of Helicobacter pylori infections as part of combination therapy, and certain sexually transmitted infections like non-gonococcal urethritis caused by Chlamydia trachomatis. Its spectrum makes it a preferred choice when typical pathogens are suspected and in regions with known susceptibility patterns.

Dosage and direction

The standard adult dosage is 300 mg once daily, or alternatively 150 mg twice daily, administered orally. For severe infections, a dose of 300 mg twice daily may be considered under medical supervision. Treatment duration typically ranges from 5 to 10 days, depending on the type and severity of infection. Roxithromycin should be taken on an empty stomach, at least 15 minutes before a meal or 2–3 hours after, to optimize absorption. In patients with hepatic impairment, dosage adjustment may be necessary; however, no specific adjustment is required for renal impairment. Pediatric dosing is based on body weight, usually 2.5–5 mg/kg twice daily, though local guidelines should be consulted.

Precautions

Patients with a history of liver disease should use roxithromycin cautiously, as macrolides can exacerbate hepatic dysfunction. Electrocardiographic monitoring may be advisable in individuals with known QT prolongation or those taking other QT-prolonging drugs, due to the risk of arrhythmias. Use during pregnancy (Category B) should be reserved for cases where benefits outweigh risks, as human data are limited. Breastfeeding mothers should consult a healthcare provider, as the drug is excreted in milk. Prolonged use may lead to superinfection or Clostridium difficile-associated diarrhea. Patients should complete the full course even if symptoms improve earlier to prevent resistance.

Contraindications

Roxithromycin is contraindicated in patients with known hypersensitivity to macrolide antibiotics or any component of the formulation. It should not be used concomitantly with ergot derivatives, cisapride, terfenadine, or astemizole due to the risk of severe cardiotoxicity. Contraindication also applies in those with a history of hepatitis or jaundice associated with prior macrolide use. Severe hepatic impairment without dose adjustment is another contraindication. Concomitant use with colchicine in patients with renal or hepatic impairment is contraindicated due to increased toxicity risk.

Possible side effect

Common side effects include gastrointestinal disturbances such as nausea, abdominal pain, diarrhea, and vomiting, though these are generally mild. Less frequently, patients may experience headache, dizziness, or alterations in taste. Skin reactions like rash or pruritus can occur. Elevated liver enzymes have been reported, and in rare cases, hepatitis or cholestatic jaundice. Cardiac effects, including QT prolongation and ventricular arrhythmias, are rare but serious. Pseudomembranous colitis has been observed with macrolide use. Allergic reactions, though uncommon, may present as urticaria or anaphylaxis in susceptible individuals.

Drug interaction

Roxithromycin is a moderate inhibitor of CYP3A4 and may increase plasma concentrations of drugs metabolized by this enzyme. Significant interactions include:

• Increased risk of QT prolongation with antipsychotics (e.g., pimozide), antiarrhythmics (e.g., amiodarone), and fluoroquinolones
• Elevated levels of statins (e.g., simvastatin), potentially leading to rhabdomyolysis
• Enhanced effects of warfarin, requiring closer INR monitoring
• Reduced efficacy of oral contraceptives; alternative contraception advised
• Increased concentrations of cyclosporine, digoxin, and theophylline, necessitating dose adjustments
• Potential for ergotism with ergot derivatives
• Interaction with colchicine, increasing myelosuppression risk

Missed dose

If a dose 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. Doubling the dose to compensate is not recommended, as it may increase the risk of side effects. Patients should be advised to maintain the prescribed interval between doses to ensure consistent therapeutic levels.

Overdose

Symptoms of overdose may include severe nausea, vomiting, diarrhea, and abdominal cramps. In cases of significant ingestion, QT prolongation and cardiac arrhythmias could occur. Management is primarily supportive: gastric lavage or activated charcoal may be considered if ingestion was recent. Cardiac monitoring is advised if large quantities are consumed. There is no specific antidote; treatment should focus on symptom relief and maintaining hydration and electrolyte balance. Hemodialysis is not effective due to high protein binding.

Storage

Store at room temperature (15–30°C), in a dry place, protected from light and moisture. Keep the container tightly closed. Do not freeze. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Discard any unused medication appropriately via take-back programs or pharmacy disposal; do not flush or pour into drains.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Do not disregard professional medical advice or delay in seeking it because of something you have read here. The efficacy and safety profile may vary based on individual patient factors and local prescribing guidelines.

Reviews

Clinical studies and meta-analyses generally report roxithromycin as effective and well-tolerated in the treatment of respiratory and skin infections. In comparative trials, it demonstrates similar efficacy to other macrolides like clarithromycin and azithromycin, with a favorable side effect profile. Patient reviews often highlight the convenience of once-daily dosing and lower gastrointestinal upset compared to erythromycin. Some studies note its utility in reducing inflammatory markers in chronic respiratory conditions. However, emerging bacterial resistance underscores the importance of prudent use and susceptibility testing.