Method of administration: Film-coated tablet: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Dosage Regimen: Dose (adults): The recommended dose for Moxifloxacin is 400 mg once daily (1 film coated tablet) for the previously 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 Moxifloxacin I.V. may be switched to Moxifloxacin 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.
Moxifloxacin 400 mg film-coated tablets and Moxifloxacin 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).
Additional information on special populations: Children and adolescents: Efficacy and safety of Moxifloxacin in children and adolescents have not been established.
Geriatric patients: No adjustment of dosage is required in elderly.
Ethnic differences: No adjustment of dosage is required in ethnic groups.
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).
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.