Rulide (roxithromycin) is a next-generation macrolide antibiotic designed for the effective treatment of a wide spectrum of bacterial infections, primarily those affecting the upper and lower respiratory tracts. Its advanced formulation ensures high tissue penetration, sustained antibacterial activity, and a favorable tolerability profile, making it a trusted choice among healthcare professionals. This semi-synthetic antibiotic derives from erythromycin but offers improved pharmacokinetics, including enhanced acid stability and prolonged half-life, allowing for convenient twice-daily dosing. Clinically, it is indicated for community-acquired pneumonia, acute bacterial sinusitis, pharyngitis, tonsillitis, and skin/soft tissue infections, providing reliable coverage against common pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus.

Features

• Active ingredient: Roxithromycin 150 mg or 300 mg per tablet
• Pharmacological class: Macrolide antibiotic
• Mechanism: Binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis
• Spectrum: Broad-spectrum activity against Gram-positive and some Gram-negative bacteria, atypical pathogens
• Formulation: Film-coated tablets for oral administration
• Bioavailability: Approximately 50%, not significantly affected by food
• Half-life: Approximately 12 hours, permitting b.i.d. dosing
• Excretion: Primarily hepatic metabolism, fecal and urinary elimination

Benefits

• High clinical efficacy in eradicating common respiratory pathogens, leading to rapid symptom resolution.
• Convenient twice-daily dosing regimen supports patient adherence and simplifies treatment schedules.
• Favorable safety profile with generally mild and transient side effects compared to older macrolides.
• Effective against atypical bacteria including Mycoplasma pneumoniae and Chlamydophila pneumoniae.
• Reduced potential for gastrointestinal disturbances relative to erythromycin due to improved acid stability.
• Suitable for use in both adult and pediatric populations (in appropriate formulations and doses).

Common use

Rulide is commonly prescribed for bacterial infections where macrolide antibiotics are indicated. Its primary use includes community-acquired pneumonia, acute exacerbations of chronic bronchitis, sinusitis, pharyngitis, and tonsillitis. It is also effective in treating skin and soft tissue infections such as erysipelas and impetigo. Off-label, it may be used in some cases for Helicobacter pylori eradication regimens and certain sexually transmitted infections, though these are not primary indications. Healthcare providers choose Rulide for its reliable coverage of typical and atypical respiratory pathogens and its tolerability.

Dosage and direction

The standard adult dosage is 300 mg daily, administered as one 300 mg tablet or two 150 mg tablets, taken either as a single daily dose or divided into 150 mg twice daily. For more severe infections, the dose may be increased to 300 mg twice daily under medical supervision. The tablet should be swallowed whole with a glass of water, and can be taken with or without food, though administration with food may help minimize potential gastrointestinal discomfort. Treatment duration typically ranges from 5 to 10 days, depending on infection type and severity. In pediatric patients, dosage is weight-based, usually 2.5–5 mg/kg twice daily, not exceeding adult doses. Always complete the full prescribed course even if symptoms improve earlier.

Precautions

Use with caution in patients with hepatic impairment, as roxithromycin is metabolized by the liver; consider dose adjustment or monitoring of liver function. Exercise caution in those with renal impairment (CrCl <30 mL/min); although primarily hepatically cleared, accumulation may occur. Monitor for signs of superinfection, including fungal or bacterial overgrowth. May prolong QT interval; avoid in patients with known QT prolongation, electrolyte disturbances, or concurrent use of other QT-prolonging drugs. Use during pregnancy only if clearly needed and after benefit-risk assessment (Category B). Breastfeeding should be reconsidered during treatment as roxithromycin is excreted in milk. Not recommended in patients with known hypersensitivity to macrolides.

Contraindications

Hypersensitivity to roxithromycin, any macrolide antibiotic, or any component of the formulation. Concomitant use with ergot derivatives or terfenadine due to risk of severe adverse reactions such as ergotism or cardiotoxicity. Patients with history of hepatitis or jaundice associated with prior macrolide use. Severe hepatic impairment without appropriate monitoring and dose adjustment. Known congenital or acquired QT prolongation syndromes.

Possible side effect

Common side effects (≥1/100 to <1/10) include nausea, abdominal pain, diarrhea, headache, and dizziness. Uncommon side effects (≥1/1,000 to <1/100) may include vomiting, rash, pruritus, altered taste, and transient elevations in liver enzymes. Rare side effects (<1/1,000) include pseudomembranous colitis, hepatitis, anaphylaxis, QT prolongation, and hearing impairment (usually reversible). Most adverse effects are mild to moderate and self-limiting. Discontinue and seek medical attention if severe diarrhea, persistent headache, jaundice, palpitations, or signs of allergic reaction occur.

Drug interaction

Rulide may interact with drugs metabolized by CYP3A4, increasing their plasma levels. Avoid concurrent use with ergot alkaloids (ergotamine), terfenadine, astemizole, cisapride, or pimozide due to risk of serious cardiotoxicity. Use caution with warfarin (may enhance anticoagulant effect), theophylline (increased theophylline levels), digoxin (elevated digoxin concentrations), and cyclosporine (increased nephrotoxicity risk). May reduce efficacy of oral contraceptives; advise alternative non-hormonal contraception during treatment. Concurrent use with other QT-prolonging agents (e.g., antipsychotics, antiarrhythmics) should be avoided.

Missed dose

If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose. Do not double the dose to make up for the missed one. Resume the regular dosing schedule. Consistent adherence is important to maintain effective antibiotic concentrations and prevent resistance development.

Overdose

Symptoms of overdose may include severe nausea, vomiting, diarrhea, and abdominal pain. In cases of significant overdose, QT prolongation and hearing loss are potential risks. Management is supportive; there is no specific antidote. Gastric lavage may be considered if ingestion was recent. Monitor ECG for QT interval prolongation and provide symptomatic treatment. Hemodialysis is not effective due to high protein binding and extensive tissue distribution.

Storage

Store at room temperature (15–30°C), in a dry place, protected from light and moisture. Keep in the original packaging to prevent degradation. Do not use after the expiration date printed on the packaging. Keep out of reach of children and pets. Do not dispose of medication in wastewater or household waste; return unused or expired medication to a pharmacy for proper disposal.

Disclaimer

This information is for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any new medication or changing your treatment plan. Do not disregard professional medical advice or delay seeking it based on content provided here. The manufacturer and publisher are not liable for any outcome resulting from the use or misuse of this information.

Reviews

Rulide is generally well-regarded in clinical practice for its efficacy in respiratory infections and favorable side effect profile. Physicians appreciate its convenient dosing and reliable coverage of common pathogens. Some note that it serves as a useful alternative for patients intolerant to penicillin or beta-lactams. Patient feedback often highlights symptom improvement within a few days, though occasional gastrointestinal complaints are mentioned. Overall, it remains a valued option in the macrolide class for appropriate indications.