Avelox 400 mg film-coated tablets
Because of the risk of prolonged, disabling and potentially irreversible serious adverse drug reactions (see section 4.4 and section 4.8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where: • there is resistance to other first-line antibiotics recommended for the infection; • other first-line antibiotics are contraindicated in an individual patient; • other first-line antibiotics have caused side effects requiring treatment to be stopped; • treatment with other first-line antibiotics has failed. Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1): - Acute bacterial sinusitis - Acute exacerbation of chronic obstructive pulmonary disease including bronchitis - Community acquired pneumonia, except severe cases - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1). Avelox 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications: - Community-acquired pneumonia - Complicated skin and skin structure infections Avelox 400 mg film-coated tablets should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia. Consideration should be given to official guidance on the appropriate use of antibacterial agents.