Rulide: Advanced Macrolide Antibiotic for Effective Bacterial Control
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| Product dosage: 300mg | |||
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Synonyms | |||
Rulide (roxithromycin) is a semi-synthetic macrolide antibiotic designed for the targeted treatment of a wide range of bacterial infections. It operates by inhibiting bacterial protein synthesis, effectively halting the growth and proliferation of susceptible organisms. Clinicians favor Rulide for its favorable pharmacokinetic profile, including excellent tissue penetration and a prolonged half-life that supports convenient twice-daily dosing. This medication is particularly valued in respiratory, skin, and soft tissue infections where typical pathogens demonstrate sensitivity.
Features
- Active ingredient: Roxithromycin 300 mg per tablet
- Pharmacological class: Macrolide antibiotic
- Mechanism: Binds to the 50S ribosomal subunit, inhibiting protein synthesis
- Bioavailability: Approximately 50%, not significantly affected by food
- Half-life: Approximately 12 hours, allowing for b.i.d. dosing
- Excretion: Primarily hepatic, with biliary elimination
- Spectrum: Effective against Gram-positive bacteria, some Gram-negative bacteria, and intracellular pathogens
Benefits
- Provides broad-spectrum coverage against common community-acquired pathogens
- Demonstrates high tissue concentration, particularly in the lungs, tonsils, and skin
- Supports patient adherence through convenient twice-daily oral dosing
- Generally well-tolerated with a lower incidence of gastrointestinal side effects compared to earlier macrolides
- Suitable for patients with penicillin allergies where macrolides are indicated
- Available in scored tablets for accurate dosing adjustment when necessary
Common use
Rulide is indicated for the treatment of mild to moderate bacterial infections caused by susceptible strains of microorganisms. Its primary applications include upper and lower respiratory tract infections such as pharyngitis, tonsillitis, acute bronchitis, community-acquired pneumonia, and acute sinusitis. Dermatological applications include impetigo, erysipelas, and secondary infected dermatoses. Additionally, it may be employed in genitourinary infections including non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis. Off-label uses may include dental infections and prophylaxis against bacterial endocarditis in high-risk patients undergoing dental procedures, though these applications require specific clinical justification.
Dosage and direction
The standard adult dosage is 300 mg daily, administered either as a single dose or in two divided doses of 150 mg every 12 hours. For more severe infections, the dosage may be increased to 300 mg twice daily, not to exceed 600 mg daily. Pediatric dosing is typically calculated at 2.5-5 mg/kg body weight twice daily, with specific adjustments based on the severity of infection and patient factors. Tablets should be swallowed whole with a full glass of water and may be taken with or without food, though consistent administration with food may minimize potential gastrointestinal discomfort. The usual duration of treatment ranges from 5 to 10 days depending on the type and severity of infection, with continuation for at least 48 hours after symptoms have resolved.
Precautions
Exercise caution in patients with hepatic impairment, as roxithromycin is extensively metabolized in the liver; consider dosage reduction or alternative therapy in severe hepatic dysfunction. Monitor for potential development of Clostridium difficile-associated diarrhea, which may range from mild to life-threatening colitis. Use with caution in patients with known QT prolongation or those taking other medications that prolong the QT interval due to potential arrhythmogenic effects. Consider periodic liver function tests during prolonged therapy exceeding 10-14 days. Be aware of possible exacerbation of myasthenia gravis symptoms. Prescribe with caution to patients with renal impairment (creatinine clearance <30 mL/min), though dosage adjustment is generally not required.
Contraindications
Hypersensitivity to roxithromycin, other macrolide antibiotics, or any component of the formulation. Concomitant administration with ergot derivatives due to risk of ergotism. Concurrent use with cisapride, pimozide, or terfenadine due to potential for serious cardiac arrhythmias. History of cholestatic jaundice/hepatic dysfunction associated with prior macrolide use. Patients with known predisposition to QT interval prolongation or documented history of torsades de pointes.
Possible side effect
Common adverse reactions (≥1%) include gastrointestinal disturbances such as nausea (3-4%), abdominal pain (2%), diarrhea (2-3%), and vomiting (1%). Dermatological reactions including rash (1%) and pruritus may occur. Headache (2%) and dizziness (1%) have been reported. Less frequently (<1%), patients may experience alterations in taste, stomatitis, transient elevations in liver enzymes, and vaginal candidiasis. Rare but serious side effects include pseudomembranous colitis, hepatitis, cholestatic jaundice, QT prolongation, and severe hypersensitivity reactions including anaphylaxis and Stevens-Johnson syndrome.
Drug interaction
Rulide may increase plasma concentrations of drugs metabolized by CYP3A4, including warfarin (monitor INR), theophylline (monitor levels), digoxin (monitor levels), cyclosporine (monitor levels), and midazolam. Concomitant use with statins may increase risk of rhabdomyolysis. Antacids and H2-receptor antagonists may slightly decrease roxithromycin absorption. Potentially serious interactions occur with other QT-prolonging agents including antiarrhythmics, antipsychotics, and certain antidepressants. Avoid concurrent administration with colchicine in patients with renal or hepatic impairment. May reduce effectiveness of oral contraceptives; recommend additional barrier method.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed administration. Maintain consistent timing between doses to ensure stable antibiotic concentrations. If multiple doses are missed, contact the prescribing healthcare provider for guidance on how to proceed with the treatment regimen.
Overdose
Symptoms of overdose may include severe nausea, vomiting, diarrhea, and abdominal pain. In severe cases, hearing loss, pancreatitis, and QT prolongation with potential arrhythmias may occur. Management is primarily supportive with careful monitoring of cardiac function via ECG. Gastric lavage may be considered if presentation is early after ingestion. Activated charcoal may be administered if the patient presents within one hour of ingestion. There is no specific antidote; hemodialysis is not effective due to high protein binding and extensive tissue distribution. Symptomatic treatment should be provided for specific manifestations.
Storage
Store at room temperature between 15-30°C (59-86°F) in the original container. Protect from light and moisture. Keep the container tightly closed when not in use. Do not store in bathroom or other areas with high humidity. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly discard any unused medication after completion of therapy or upon expiration.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional before starting, changing, or stopping any medication. The prescribing physician should be aware of the patient’s complete medical history, current medications, and potential allergies. Dosage and administration should be determined by a healthcare provider based on individual patient factors. Not all possible interactions, side effects, or precautions are listed here.
Reviews
Clinical studies demonstrate roxithromycin’s efficacy with clinical success rates of 85-95% in respiratory infections. Physicians report good tolerability profile compared to erythromycin, particularly regarding gastrointestinal side effects. Patients appreciate the convenient twice-daily dosing that supports adherence to therapy. Some studies note superior tissue penetration compared to other macrolides in tonsillar and pulmonary tissue. Microbiological efficacy remains strong against common respiratory pathogens including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Emerging resistance patterns should be considered in geographic areas with high macrolide utilization.