Prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults.

Levofloxacin (anti-infective) : Levofloxacin is a fluoroquinolone antibacterial agent, that inhibits bacterial type II topoisomerases—DNA gyrase and topoisomerase IV. The spectrum of activity against ocular pathogens includes aerobic Gram-positive microorganisms (e.g. S. aureus MSSA, S. pyogenes, S. pneumoniae, viridans group streptococci), aerobic Gram-negative bacteria (e.g. E. coli, H. influenzae, M. catarrhalis, P. aeruginosa community isolates), other organisms (e.g. Chlamydia trachomatis). Dexamethasone (anti-inflammatory) : Reduced expression of proinflammatory mediators and the suppression of adhesion of circulating leukocytes to the vascular endothelium, thereby preventing their migration into inflamed ocular tissue.

The ocular instillation of Ducressa results in absorption of both actives to the ocular tissues and, at a much lower extent, to the systemic circulation. Both levofloxacin and dexamethasone are eliminated via urine.

■Hypersensitivity to active substance levofloxacin or to other quinolones, to dexamethasone, or to other steroids. ■ Herpes simplex keratitis, varicella and other viral disease of the cornea and conjunctiva. ■ Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. ■ Fungal diseases of ocular structures. ■ Untreated purulent infection of the eye.

Since a relevant systemic corticosteroid exposure cannot be excluded after ocular administration, treatment with Ducressa is not recommended during pregnancy, and especially during the first three months, should only take place after a careful benefit-risk assessment.

A risk to the suckling child cannot be excluded.

Eye irritation, ocular hypertension, abnormal sensation in eye, headache, dysgeusia

One drop instilled into the conjunctival sac after surgery every 6 hours. Duration of treatment is 7 days.

Ducressa is not recommended for use in children and adolescents below the age of 18 years.

Ducressa has not been studied in patients with renal impairment and Ducressa should therefore be used with caution in such patients.

Ducressa has not been studied in patients with hepatic impairment and Ducressa should therefore be used with caution in such patients.

Ducressa does not require any special storage conditions. Discard within 28 days after first opening.