ROXID 150MG TABLETS

Indications

• Community-acquired pneumonia
• Acute bronchitis
• Chronic obstructive pulmonary disease exacerbations
• Skin and soft tissue infections
• Pharyngitis
• Sinusitis
• Chlamydia infections

Dosage

Children: Refer to appropriate clinical guidelines and local protocols for specific dosing information.

Adults: Refer to appropriate clinical guidelines and local protocols for specific dosing information.

Mechanism of action

Roxithromycin exerts its antibacterial effect primarily by binding to the 50S ribosomal subunit of bacteria. This binding inhibits the translocation step of protein synthesis, ultimately leading to the cessation of bacterial growth. The specific pathway involves interference with the peptidyl transferase activity of the ribosome, which is critical for protein chain elongation.

Pharmacodynamics

Roxithromycin demonstrates time-dependent antibacterial activity, meaning that the duration of exposure to the drug is more important than the peak concentration for its effectiveness. It is bacteriostatic at lower concentrations and can be bactericidal at higher concentrations against certain susceptible organisms. It has a broad spectrum of activity, including coverage for Streptococcus pneumoniae, Haemophilus influenzae, and Mycoplasma pneumoniae.

Pharmacokinetics

Roxithromycin is well-absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 2-3 hours after oral administration. It has a high volume of distribution, indicating extensive tissue binding. Roxithromycin is metabolized in the liver and has a relatively long half-life, allowing for once-daily dosing in many cases. It is excreted mainly in bile, with a small fraction excreted in urine.

Contra-indications

• Hypersensitivity to roxithromycin or any macrolide antibiotic
• Severe hepatic impairment

Adverse effects

• Gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain)
• Headache
• Dizziness
• Rash or other allergic reactions
• QT interval prolongation
• Hepatotoxicity

Interactions

• May interact with drugs that affect liver metabolism, particularly those that inhibit or induce CYP3A4
• Increased risk of arrhythmias when used with other drugs that prolong the QT interval
• May enhance the effects of anticoagulants such as warfarin

Precautions

• Use with caution in patients with liver disease
• Monitor for signs of superinfection due to antibiotic resistance
• Careful consideration in patients with known cardiac conditions due to potential QT prolongation

Pregnancy

Roxithromycin is categorized as a category B drug. Limited data in humans suggest it is generally safe during pregnancy, but it should only be used if clearly needed.

Breast-feeding

Roxithromycin is excreted in breast milk, but it is considered to be safe in nursing mothers. Monitor the infant for any adverse effects.

Storage

Store at room temperature, away from moisture and heat. Protect from light.

Formulations

• Tablets (150 mg, 300 mg)
• Oral suspension (50 mg/5 mL)