Rulide: Advanced Macrolide Therapy for Respiratory Infections
Rulide
| Product dosage: 150mg | |||
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| Product dosage: 300mg | |||
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Synonyms | |||
Rulide (roxithromycin) is a semi-synthetic macrolide antibiotic specifically engineered to target a broad spectrum of bacterial pathogens responsible for upper and lower respiratory tract infections. Its advanced molecular structure provides enhanced stability against gastric acid degradation, resulting in superior bioavailability and predictable pharmacokinetics compared to earlier macrolides. Clinicians favor Rulide for its targeted efficacy, favorable tolerability profile, and convenient once-daily dosing regimen that supports patient adherence. This next-generation antibiotic represents a cornerstone in empirical and directed antimicrobial therapy for community-acquired infections.
Features
- Active pharmaceutical ingredient: Roxithromycin 150mg or 300mg tablets
- Pharmacological class: Macrolide antibiotic, protein synthesis inhibitor
- Mechanism: Binds to 50S ribosomal subunit, inhibiting bacterial protein synthesis
- Spectrum: Gram-positive aerobes (Streptococcus pneumoniae, S. pyogenes), some Gram-negative organisms (Moraxella catarrhalis, Legionella pneumophila), and atypical pathogens (Chlamydia pneumoniae, Mycoplasma pneumoniae)
- Pharmacokinetics: Peak plasma concentration within 2 hours post-administration, 85-90% oral bioavailability
- Elimination half-life: Approximately 12 hours, enabling once-daily dosing
- Administration: Oral tablet formulation, may be taken with or without food
Benefits
- Targeted respiratory coverage: Specifically effective against common and atypical pathogens causing community-acquired pneumonia, bronchitis, and sinusitis
- Superior bioavailability: Advanced molecular stability ensures consistent absorption and predictable serum concentrations
- Convenient dosing regimen: Once-daily administration improves patient compliance and reduces treatment complexity
- Favorable safety profile: Generally well-tolerated with lower incidence of gastrointestinal adverse effects compared to erythromycin
- Bacteriostatic action: Inhibits bacterial replication while allowing host immune mechanisms to effectively clear infection
- Established clinical efficacy: Demonstrated success in numerous clinical trials across diverse patient populations
Common use
Rulide is primarily indicated for the treatment of mild to moderate bacterial infections involving the respiratory tract. Its spectrum of activity makes it particularly valuable for community-acquired pneumonia where atypical pathogens are suspected or confirmed. Physicians frequently prescribe Rulide for acute bacterial exacerbations of chronic bronchitis, especially in patients with comorbidities where broader-spectrum antibiotics might be excessive. The medication demonstrates excellent efficacy in treating streptococcal pharyngitis and tonsillitis, offering an alternative for penicillin-allergic patients. Otolaryngologists utilize Rulide for acute sinusitis cases where coverage includes both typical respiratory flora and potential atypical organisms. Dermatologists may also employ Rulide for uncomplicated skin and soft tissue infections caused by susceptible streptococcal species.
Dosage and direction
The standard adult dosage for Rulide is 300mg administered once daily, either as a single 300mg tablet or two 150mg tablets. For more severe infections or immunocompromised patients, some clinicians may initiate therapy at 300mg twice daily for the first 48-72 hours before transitioning to maintenance dosing. Pediatric dosing is calculated at 2.5-5mg/kg body weight every 12 hours, not to exceed 300mg daily. Administration may occur with or without food, though taking with meals may minimize potential gastrointestinal discomfort. The typical treatment duration ranges from 5 to 10 days depending on infection severity and clinical response. Patients should complete the full prescribed course even if symptoms improve earlier to prevent recurrence and antimicrobial resistance. Renal impairment requires dosage adjustment: for creatinine clearance 10-40 mL/min, reduce dose by 50%; for clearance below 10 mL/min, avoid use or monitor serum levels closely.
Precautions
Patients with pre-existing hepatic impairment require careful monitoring as roxithromycin is primarily metabolized by the liver and may accumulate. Regular liver function tests are recommended during extended therapy beyond 10 days. Caution is advised in patients with known QT prolongation or those taking other medications that may prolong the QT interval due to potential arrhythmogenic effects. Elderly patients may experience increased sensitivity to side effects and often require closer monitoring. The medication may cause dizziness or visual disturbances in some patients, advising against driving or operating machinery until response is established. Superinfection with resistant organisms, including Clostridium difficile-associated diarrhea, may occur during or following treatment. Patients should be advised to maintain adequate hydration throughout therapy to support renal clearance of the medication.
Contraindications
Rulide is absolutely contraindicated in patients with documented hypersensitivity to roxithromycin, other macrolide antibiotics, or any component of the formulation. Concurrent administration with ergot derivatives is contraindicated due to risk of severe vasoconstriction and ergotism. The medication must not be used with drugs that are potent CYP3A4 inhibitors and also prolong the QT interval. Patients with known history of congenital long QT syndrome or ventricular arrhythmias should avoid Rulide therapy. Severe hepatic impairment (Child-Pugh Class C) represents a contraindication due to inadequate metabolic clearance. The safety profile in pregnancy Category B indicates animal studies show no risk but human studies are inadequate; therefore, use during pregnancy requires careful risk-benefit assessment and is generally contraindicated unless clearly needed.
Possible side effect
The most frequently reported adverse reactions involve the gastrointestinal system, including nausea (approximately 4% of patients), abdominal pain (2-3%), diarrhea (3%), and vomiting (1-2%). These symptoms are typically mild to moderate and often resolve without intervention. Dermatological reactions may occur in 1-2% of patients, manifesting as rash, urticaria, or pruritus. Headache and dizziness have been reported in approximately 2% of clinical trial participants. Transient elevations in liver enzymes (AST, ALT) occur in less than 1% of patients but usually normalize after discontinuation. Rare but serious side effects include QT interval prolongation, hepatitis, cholestatic jaundice, and pseudomembranous colitis. Hypersensitivity reactions ranging from mild skin eruptions to anaphylaxis occur in less than 0.1% of patients. Oral candidiasis and vaginal mycosis may develop due to alteration of normal flora.
Drug interaction
Rulide demonstrates significant interaction potential due to its metabolism through cytochrome P450 3A4 and mild inhibitory effects on this enzyme system. Concurrent use with cisapride, pimozide, or terfenadine is contraindicated due to risk of fatal arrhythmias. The medication may increase concentrations of warfarin, requiring frequent INR monitoring and potential anticoagulant dose adjustment. Concurrent administration with theophylline may increase theophylline levels, necessitating therapeutic drug monitoring. Rulide may reduce clearance of digoxin, potentially leading to digitalis toxicity. Ergot alkaloids (ergotamine, dihydroergotamine) may cause acute ergot toxicity when combined with roxithromycin. Statins metabolized by CYP3A4 (atorvastatin, simvastatin) may experience increased exposure and elevated risk of myopathy. Antacids containing aluminum or magnesium may slightly decrease roxithromycin absorption, recommending separation of administration by at least 2 hours.
Missed dose
If a dose is missed, patients should take it 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 never double the dose to make up for a missed administration. Consistency in dosing maintains effective antibiotic concentrations above the minimum inhibitory concentration for susceptible organisms. If multiple doses are missed, patients should contact their healthcare provider for guidance, as this may compromise therapeutic efficacy and potentially contribute to antibiotic resistance. Setting daily reminders or using pill organizers can help prevent missed doses, particularly important for antibiotics where maintaining steady-state concentrations is crucial for clinical success.
Overdose
Roxithromycin overdose may manifest as severe nausea, vomiting, diarrhea, and abdominal cramping. In massive overdoses, hearing loss, QT prolongation, and ventricular arrhythmias have been reported. Management is primarily supportive with careful monitoring of cardiac function via ECG, particularly assessing QT interval. Gastric lavage may be considered if presentation occurs within 1-2 hours of ingestion. Activated charcoal may help reduce absorption if administered promptly. Electrolyte abnormalities should be corrected, and antiemetics may be provided for symptomatic relief. No specific antidote exists for roxithromycin overdose. Hemodialysis is not effective due to high protein binding and extensive tissue distribution. Patients should be observed for at least 24 hours with cardiac monitoring if a substantial overdose is suspected. Contact poison control center for latest management recommendations.
Storage
Store Rulide tablets at controlled room temperature between 15-30Β°C (59-86Β°F) in their original packaging to protect from light and moisture. Keep the container tightly closed and out of reach of children and pets. Do not store in bathrooms or other areas with high humidity that could compromise tablet integrity. Avoid freezing the medication. Proper storage ensures stability throughout the product’s shelf life, typically 24-36 months from manufacturing date when stored appropriately. Discard any medication that appears discolored, shows signs of deterioration, or has passed the expiration date printed on packaging. Do not flush medications down the toilet or pour down drains unless specifically instructed; instead, utilize medication take-back programs or follow local disposal guidelines.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Healthcare professionals should exercise their own professional judgment when considering the use of Rulide. Prescribing decisions must be based on the individual patient’s clinical condition, susceptibility testing when available, and local resistance patterns. The prescribing physician should reference the complete prescribing information and latest clinical guidelines before initiating therapy. Patients should not self-medicate with antibiotics and must complete the full course as prescribed. Antibiotic stewardship principles should guide appropriate use to minimize resistance development. The manufacturer provides no warranty regarding this information and is not liable for any treatment decisions made based on this content.
Reviews
Clinical studies demonstrate Rulide’s efficacy with success rates of 85-92% in respiratory infections across multiple trials. A meta-analysis of 23 studies involving over 4,000 patients found roxithromycin significantly superior to placebo and equivalent to comparator antibiotics for bronchitis and pneumonia. Physicians appreciate its predictable pharmacokinetics and convenience of once-daily dosing, noting improved adherence compared to multiple-daily regimens. The lower incidence of gastrointestinal side effects relative to erythromycin is frequently cited as a significant advantage in clinical practice. Some infectious disease specialists express concern about increasing macrolide resistance in certain regions, emphasizing the importance of susceptibility testing and appropriate use. Patients generally report satisfaction with the tolerability and convenience of the dosing schedule, though some note the higher cost compared to older macrolides. Ongoing post-marketing surveillance continues to support the favorable benefit-risk profile established during clinical development.