Full Prescribing Info
Each film coated tablet contains: Roxithromycin 150 mg.
Roxithromycin is a macrolide antibiotic with actions and uses similar to those of erythromycin. It has a wide spectrum of activity which has been used in the treatment of a wide variety of infections caused by susceptible organisms.
Pharmacology: Pharmacokinetics: Following oral administration, Roxithromycin is well absorbed, with a bioavailability of about 50%. Peak plasma concentrations of about 6 to 8 μg/mL occurring around 2 hours after a single dose of 150 mg. Absorption is reduced when taken after, but not before, a meal. It is widely distributed in tissues and body fluids. It is reported to be about 96% bound to plasma protein (mainly a,-acid glycoprotein) at trough concentrations, but binding is saturable, and only about 86% is bound at usual peak concentrations. Small amounts of roxithromycin are metabolized in the liver, and the majority of a dose is excreted in the feces as unchanged drug; about 7 to 12% is excreted in the urine and up to 15% via the lungs. The elimination half-life is reported to range between about 8 to 13 hours, but may be more prolonged in children.
Roxithromycin, like erythromycin, is used in the treatment of a wide variety of infections caused by susceptible organisms. Its uses have included bronchitis, severe campylobacter enteritis, chancroid, diphtheria, legionnaire's disease and other Legionella infections, neonatal conjunctivitis, pertussis, pneumonia (as well as streptococcal), sinusitis and combined with neomycin, for the prophylaxis of surgical infection in patients undergoing bowel surgery.
Dosage/Direction for Use
150 mg twice daily or 300 mg once daily before meals or as prescribed the physician.
Special Precautions
Roxithromycin, like Erythromycin and its other derivatives should be avoided in those known to be hypersensitive to it, or in those who have previously developed liver disorders while receiving it. It should be used with care in patients with existing liver disease or hepatic impairment.
Adverse Reactions
Gastrointestinal disturbances are the most frequent adverse effect, but are less frequent than erythromycin. Increases in liver enzyme values and hepatitis have been reported. Rashes, headache, dizziness, weakness and changes in blood cell counts have also occurred.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
FC tab 150 mg x 100's.
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