AVELOX TABLET 400 mg

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Dosage and method of administration** **4.2.1 Method of administration** Film-coated tablet: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals. **4.2.2 Dosage Regimen** **Dose (adults):** The recommended dose for Avelox is 400 mg once daily (1 film coated tablet) for the above mentioned indications and should not be exceeded. For complicated skin and skin structure infections, therapy should usually be initiated with intravenous formulation. When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Avelox I.V. may be switched to Avelox Tablets when clinically indicated at the discretion of the physician. **Duration of treatment:** The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations are made: Acute exacerbation of chronic bronchitis, 5 days Acute sinusitis, 7 days Uncomplicated skin and skin structure infections, 7 days Community acquired pneumonia (mild to moderate in severity) 10 days Community acquired pneumonia: total recommended duration for sequential administration (intravenous followed by oral therapy) is 7–14 days Complicated skin and skin structure infections: total treatment duration for sequential therapy (intravenous followed by oral therapy) is 7–21 days Mild to moderate pelvic inflammatory disease, 14 days The recommended duration of treatment for the indication being treated should not be exceeded. Avelox 400 mg film-coated tablets and Avelox 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections). **4.2.3 Missed dose** If a dose is missed, it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose. **4.2.4 Additional information on special populations:** **4.2.4.1 Children and adolescents** Efficacy and safety of Avelox in children and adolescents have not been established (see “Contraindications”). **4.2.4.2 Geriatric patients** No adjustment of dosage is required in elderly. **4.2.4.3 Ethnic differences** No adjustment of dosage is required in ethnic groups. **4.2.4.4 Patients with hepatic impairment** No dosage adjustment is required in patients with mild or moderate impaired liver function. The use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C) (see “Special warnings and precautions for use” in Child Pugh C patients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.4.5 Patients with renal impairment** No dose adjustment is required in patients with any degree of renal impairment (including creatinine clearance ≤ 30 mL/min/1.73m2) and in patients on chronic dialysis i.e. hemodialysis and continuous ambulatory peritoneal dialysis.