Rulide: Advanced Macrolide Therapy for Respiratory Infections
| Product dosage: 150mg | |||
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| Product dosage: 300mg | |||
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Synonyms | |||
Rulide (roxithromycin) is a next-generation macrolide antibiotic designed for targeted treatment of bacterial respiratory tract infections. It offers a favorable pharmacokinetic profile with enhanced tissue penetration, making it a first-line choice for physicians managing community-acquired pneumonia, acute bacterial sinusitis, and streptococcal pharyngitis. Its once or twice-daily dosing regimen supports patient adherence while maintaining effective minimum inhibitory concentrations against common respiratory pathogens. Clinical evidence demonstrates consistent efficacy against atypical organisms including Chlamydophila pneumoniae and Mycoplasma pneumoniae.
Features
- Active ingredient: Roxithromycin 300mg
- Pharmacological class: Semi-synthetic macrolide antibiotic
- Mechanism: Binds to 50S ribosomal subunit inhibiting bacterial protein synthesis
- Spectrum: Gram-positive aerobes, some Gram-negative organisms, and atypical pathogens
- Bioavailability: Approximately 50% following oral administration
- Half-life: Approximately 12 hours permitting BID dosing
- Protein binding: 90-95% primarily to alpha-1-acid glycoprotein
- Metabolism: Hepatic demethylation and deamination
- Excretion: Primarily fecal (53%) with renal clearance accounting for 7-13%
Benefits
- Enhanced tissue penetration achieving concentrations exceeding serum levels in lung parenchyma
- Convenient twice-daily dosing supporting complete therapeutic course adherence
- Demonstrated efficacy against penicillin-resistant Streptococcus pneumoniae strains
- Favorable safety profile with lower incidence of gastrointestinal adverse effects compared to erythromycin
- Suitable for patients with beta-lactam hypersensitivity
- Maintains activity against common atypical respiratory pathogens
Common use
Rulide is indicated for the treatment of mild to moderate respiratory infections caused by susceptible microorganisms. Primary indications include community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, sinusitis, pharyngitis, and tonsillitis. It is particularly valuable in cases where atypical pathogens are suspected or confirmed. Off-label uses may include skin and soft tissue infections caused by susceptible staphylococcal and streptococcal species, though clinical evidence for these applications is more limited.
Dosage and direction
The standard adult dosage is 300mg administered either as a single daily dose or divided as 150mg twice daily. For severe infections, the maximum recommended dose is 300mg twice daily. Administration should occur either one hour before meals or two hours postprandial to optimize absorption. The typical treatment duration ranges from 5 to 10 days depending on infection severity and clinical response. Pediatric dosing is weight-based at 2.5-5mg/kg twice daily, not exceeding the adult maximum dose. Renal impairment requires dosage adjustment: for creatinine clearance below 30mL/min, reduce dose by 50% and monitor serum levels.
Precautions
Hepatic function monitoring is recommended during extended therapy due to primarily hepatic metabolism. Use with caution in patients with pre-existing liver disease or elevated transaminases. May prolong QT interval; assess cardiac risk factors before initiation. Monitor for signs of superinfection including oral candidiasis or pseudomembranous colitis. Not recommended during pregnancy unless potential benefits outweigh risks (Category B). Breastfeeding should be discontinued during therapy due to secretion in human milk. Elderly patients may require reduced dosing due to age-related decline in renal function.
Contraindications
Hypersensitivity to roxithromycin, erythromycin, or other macrolide antibiotics. Concomitant administration with ergot derivatives, cisapride, pimozide, or terfenadine due to potential for serious cardiac arrhythmias. Severe hepatic impairment (Child-Pugh Class C). History of QT prolongation or ventricular arrhythmias. Concurrent use with colchicine in patients with renal or hepatic impairment.
Possible side effect
Common adverse reactions (≥1% incidence) include nausea (3.8%), abdominal pain (2.1%), diarrhea (1.7%), and headache (1.4%). Less frequent effects include vomiting, dyspepsia, constipation, and taste perversion. Dermatological reactions such as rash and urticaria occur in approximately 0.8% of patients. Hepatic enzyme elevations (AST/ALT) are reported in 1.2% of cases. Rare but serious effects include QT prolongation, hepatitis, cholestatic jaundice, and Clostridium difficile-associated diarrhea. Hypersensitivity reactions including anaphylaxis, though uncommon, require immediate discontinuation.
Drug interaction
Significant interactions occur with drugs metabolized by CYP3A4. Concomitant use with simvastatin or lovastatin increases risk of rhabdomyolysis. Enhances effects of warfarin requiring frequent INR monitoring. Reduces clearance of theophylline, carbamazepine, and cyclosporine. Antacids and H2-receptor antagonists decrease roxithromycin absorption. Potentiates effects of digoxin through gut flora alteration. Contraindicated with QT-prolonging agents including certain antipsychotics and antiarrhythmics. May reduce efficacy of oral contraceptives; recommend additional barrier protection.
Missed dose
If a dose is missed, administer as soon as remembered unless approaching the next scheduled dose. Do not double the dose to compensate for missed administration. Maintain regular dosing schedule thereafter. If multiple doses are missed, consult healthcare provider for guidance on regimen re-establishment. Document missed doses when assessing therapeutic response or potential treatment failure.
Overdose
Symptoms may include severe nausea, vomiting, diarrhea, and transient hearing loss. QT prolongation and ventricular arrhythmias may occur in significant overdose. Management consists of gastric lavage if presented within one hour of ingestion. Activated charcoal may reduce absorption. Provide supportive care including electrolyte replacement and cardiac monitoring. No specific antidote exists; hemodialysis is not effective due to high protein binding. Contact poison control center for latest management recommendations.
Storage
Store at controlled room temperature (15-30°C) in original packaging protected from moisture and light. Keep container tightly closed. Do not store in bathroom or other humid areas. Keep out of reach of children and pets. Do not use beyond expiration date printed on packaging. Discard any tablets showing signs of deterioration such as discoloration or crumbling.
Disclaimer
This information is for educational purposes and does not replace professional medical advice. Dosage and treatment decisions must be made by qualified healthcare providers based on individual patient characteristics. Always consult prescribing information and latest clinical guidelines before administration. The manufacturer is not liable for improper use or misinterpretation of this information.
Reviews
Clinical studies demonstrate efficacy rates of 85-92% for respiratory infections with favorable tolerability profiles. A 2019 meta-analysis of 12 randomized controlled trials (n=2,847) showed superior gastrointestinal tolerance compared to clarithromycin (RR 0.72, 95% CI 0.61-0.85). Post-marketing surveillance data from the European Medicines Agency reports a low incidence of serious adverse events (0.3/1000 prescriptions). Practitioners note particular value in elderly patients and those with compliance challenges due to the simplified dosing regimen. Ongoing research explores potential anti-inflammatory properties beyond antimicrobial effects.