Roxithromycin is indicated for the treatment of infections caused by susceptible microorganisms.

• Respiratory tract infections such as pneumonia, acute and chronic bronchitis, and bronchopneumonia.
• ENT infections such as tonsillitis, pharyngitis, sinusitis, and otitis media.
• Skin and soft tissue infections such as folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo, and infected dermatitis.
• Genital infections such as urethritis, prostatitis, cervicitis, and salpingitis, especially when caused by Chlamydia trachomatis.

Roxithromycin is a macrolide antibiotic with antibacterial properties similar to erythromycin. It is active against Gram-positive bacteria such as staphylococci, streptococci, listeria, and corynebacteria, as well as Gram-negative bacteria including gonococci, Haemophilus influenzae, Haemophilus ducreyi, Legionella, and Campylobacter. It is also effective against atypical pathogens such as Mycoplasma and Chlamydia. It is widely used in upper and lower respiratory tract infections, ENT infections, skin, dental, and genital infections. It is generally well tolerated in both adults and children.

Roxithromycin inhibits bacterial protein synthesis by irreversibly binding to the 50S ribosomal subunit. This blocks transpeptidation and translocation processes in susceptible organisms, leading to inhibition of bacterial cell growth.

Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms; a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.

Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed:

• 6 to 11 kg: 25 mg Roxithromycin 12 hourly.
• 12 to 23 kg: 50 mg Roxithromycin 12 hourly.
• 24 to 40 kg: 100 mg Roxithromycin 12 hourly.

A normal course of therapy is between 5 and 10 days.

Roxithromycin does not bind to cytochrome P-450 enzyme systems and therefore is unlikely to cause clinically significant drug interactions mediated by this pathway. A mild interaction has been observed with theophylline, but it is not considered clinically relevant. No significant pharmacokinetic interactions have been reported with carbamazepine or warfarin. Antacids, H2-receptor antagonists, and food do not affect the absorption of roxithromycin.

Roxithromycin should not be used concomitantly with ergotamine or its derivatives due to the risk of arterial spasm and severe ischemia.

Roxithromycin is generally well tolerated. Less than 4% of patients experience side effects such as nausea, abdominal pain, diarrhea, and hypersensitivity rash. Other reported effects include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo, and constipation. These effects are usually mild and do not require discontinuation of therapy.

The safety of Roxithromycin during pregnancy has not been established. It is excreted in small amounts in breast milk but has not been shown to cause adverse effects in breastfed infants.

Roxithromycin should not be used in patients with known hypersensitivity to the drug. In patients with hepatic impairment, the dose should not exceed 150 mg twice daily.

Macrolide antibiotics