Rulide (roxithromycin) is a semi-synthetic macrolide antibiotic designed for the targeted treatment of a wide spectrum of bacterial infections. It functions by inhibiting bacterial protein synthesis, effectively halting the growth and proliferation of susceptible organisms. Clinically valued for its enhanced pharmacokinetic profile, including superior tissue penetration and an extended half-life, Rulide offers a convenient once or twice-daily dosing regimen that supports patient adherence and therapeutic success. Its broad antibacterial coverage makes it a trusted choice for respiratory, skin, and soft tissue infections in both adult and pediatric populations.

Features

• Active ingredient: Roxithromycin 150 mg or 300 mg film-coated tablets
• Pharmacological class: Macrolide antibiotic
• Mechanism of action: Binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis
• Spectrum of activity: Effective against Gram-positive bacteria (e.g., Streptococcus pneumoniae, Staphylococcus aureus), some Gram-negative bacteria, and atypical pathogens (e.g., Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila)
• Bioavailability: Approximately 50%, not significantly affected by food intake
• Half-life: 8–15 hours, allowing for less frequent dosing
• Excretion: Primarily via the liver and bile, with minimal renal excretion

Benefits

• High clinical efficacy against common community-acquired respiratory pathogens
• Convenient dosing schedule improves compliance, especially in outpatient settings
• Generally well-tolerated profile with a lower incidence of severe gastrointestinal side effects compared to earlier macrolides
• Suitable for use in both adults and children, with appropriate weight-based dosing
• Demonstrated anti-inflammatory properties in some studies, potentially aiding symptom relief beyond antibacterial action

Common use

Rulide is indicated for the treatment of mild to moderate bacterial infections caused by susceptible strains of microorganisms. Common uses include:

• Upper and lower respiratory tract infections: pharyngitis, tonsillitis, acute bacterial bronchitis, community-acquired pneumonia, acute sinusitis
• Skin and soft tissue infections: erysipelas, impetigo, secondary infected dermatoses
• Genitourinary infections: non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis
• Dental infections: such as acute odontogenic infections

Dosage and direction

The dosage of Rulide must be individualized based on the type and severity of infection, patient age, renal and hepatic function.

Adults and children over 40 kg:

• The usual dose is 300 mg per day, administered either as a single daily dose or in two divided doses of 150 mg each.
• For severe infections, the dose may be increased to 300 mg twice daily.
• Treatment duration is typically 5 to 10 days, depending on clinical response.

Children under 40 kg:

• The recommended dose is 2.5–5 mg/kg body weight twice daily.
• Rulide tablets should be swallowed whole with a glass of water, with or without food.

Dosage adjustment is recommended in patients with severe hepatic impairment. No adjustment is typically needed for renal impairment, but caution is advised.

Precautions

• Use with caution in patients with a history of hepatic dysfunction; periodic liver function tests are advisable during prolonged therapy.
• May prolong the QT interval; use with caution in patients with known QT prolongation, electrolyte disturbances, or those taking other QT-prolonging drugs.
• As with other antibiotics, Rulide may cause overgrowth of non-susceptible organisms, including fungi; monitor for signs of superinfection.
• Not recommended during pregnancy unless clearly needed; should be used during lactation only if the potential benefit justifies the potential risk to the infant.
• Caution in patients with myasthenia gravis due to risk of symptom exacerbation.

Contraindications

• Hypersensitivity to roxithromycin, other macrolide antibiotics, or any component of the formulation.
• Concurrent administration with ergot derivatives (e.g., ergotamine, dihydroergotamine) or terfenadine (due to risk of serious cardiac events).
• History of cholestatic jaundice/hepatic dysfunction associated with prior roxithromycin use.

Possible side effect

Most side effects are mild to moderate and transient. Common adverse reactions may include:

• Gastrointestinal: nausea, abdominal pain, diarrhea, vomiting, dyspepsia
• Hepatic: elevated liver enzymes, hepatitis (rare)
• Dermatological: rash, pruritus
• Central nervous system: headache, dizziness
• Other: taste perversion, candidiasis

Serious but rare side effects include QT prolongation, hepatic necrosis, and severe hypersensitivity reactions. Discontinue use if severe adverse effects occur.

Drug interaction

Rulide may interact with the following medications:

• Strong CYP3A4 inhibitors or inducers: may alter roxithromycin concentrations.
• Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, fluoroquinolones): increased risk of torsades de pointes.
• Warfarin: may potentiate anticoagulant effect; monitor INR closely.
• Cyclosporine, digoxin: may increase serum levels of these drugs; monitor concentrations.
• Oral contraceptives: potential reduced efficacy; advise backup contraception.
• Theophylline: may increase theophylline levels; monitor and adjust dose if necessary.

Missed dose

If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one.

Overdose

Symptoms of overdose may include severe nausea, vomiting, diarrhea, and transient hearing loss. Management is supportive; gastric lavage may be considered if ingestion was recent. There is no specific antidote. Hemodialysis is not effective due to high protein binding.

Storage

Store below 30°C (86°F), in a dry place, protected from light. Keep out of reach of children. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for medical professionals and should not replace personalized medical advice. Always consult a healthcare provider for diagnosis and treatment recommendations tailored to individual patient needs. The prescriber should verify local prescribing information and approved indications.

Reviews

Rulide is generally well-regarded in clinical practice for its efficacy, tolerability, and convenient dosing. Many clinicians appreciate its role in treating respiratory infections, particularly where atypical pathogens are suspected. Some studies note its favorable side effect profile compared to erythromycin. However, as with all antibiotics, prudent use is encouraged to minimize resistance development.