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Roxipharm® Roxithromycin Pharmacological information Mode of action Roxipharm® (Roxithromycin) is a semisynthetic macrolide antibiotic that acts as an antibacterial by inhibition of protein synthesis. It has a broad antibacterial action against many gram - positive and to a lesser extent some gram - negative bacteria, as well as other organisms including anaerobes, mycoplasma, mycobacteria, and chlamydiae. Following oral administration, Roxithromycin is well absorbed. Absorption is reduced when taken after, but not before, a meal. Small amounts of Roxithromycin are metabolized in liver and the majority of the dose is excreted in faeces as unchanged drug and metabolites. The elimination half-life is reported to range between 8 - 13 hours. Clinical information Indications Roxipharm® is indicated for the treatment of infections caused by Roxithromycin-sensitive organisms, especially in: - Lower respiratory tract infections including pneumonia, atypical pneumonia, chronic obstructive lung disease and bronchitis. - Upper respiratory tract infections including tonsillitis, pharyngitis, otitis media and sinusitis. - Acute or chronic non - gonococcal urethritis, non - gonococcal sexually transmitted infections and cervicovaginitis. - Skin and soft tissue infections including pyoderma, infective dermatitis and leg ulcers. - Prophylaxis of meningococcal meningitis. Dosage and administration Roxipharm® is given by mouth in a dose of 150 mg twice daily before meals, one tablet in the morning and one tablet in the evening, for the treatment of susceptible infections. Contraindications - Allergy to Roxithromycin or any other related macrolide antibiotic. - Taking Roxithromycin in combination with Ergotamine Dihydroergotamine (migrain medications) or Cisapride. 1 and Precautions In case of prescribing Roxipharm® (Roxithromycin), the following conditions should be taken into consideration: - Pregnancy and lactation. - Hepatic insufficiency. - The concomitant administration of other drugs particularly bromocriptine. - Car driving and use of machines may become dangerous because of dizzy sensation. Side effects - Gastro-intestinal disturbances: nausea, vomiting, stomach pain, and diarrhea. - Transient increase in some liver enzymes (ASAT, ALAT). - Other side effects including rashes, headaches, dizziness, and weakness. Pharmaceutical information How supplies Roxipharm® F/C tablets: (Roxithromycin) 150mg / tablet (pack of 10). 2