Ducressa Adverse Reactions

Summary of the safety profile: In clinical studies, 438 patients have been treated with Ducressa. No serious adverse reactions occurred. The most commonly reported non-serious adverse reactions are eye irritation, ocular hypertension and headache.
Tabulated list of adverse reactions: The following adverse reactions have been reported with Ducressa during clinical trials that enrolled patients after cataract surgery (within each frequency grouping, adverse reactions are presented in order of decreasing frequency). (See Tables 1 and 2.)

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Adverse reactions that have been seen with either of the ophthalmic active substances (levofloxacin or dexamethasone), and may potentially occur also with Ducressa are listed as follows: (See Tables 3 and 4.)

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Description of selected adverse reactions: Increase of intraocular pressure: Increase of the intra-ocular pressure (IOP) and glaucoma may occur. Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous high IOP induced by steroids or with pre-existing high IOP or glaucoma). Children and elderly patients may be particularly susceptible to steroid-induced IOP rise (see Precautions).
Cataracts: Diabetics are also more prone to develop subcapsular cataracts following prolonged topical steroid administration.
Post procedural adverse reactions: Ocular disorders (e.g. corneal oedema, eye irritation, abnormal sensation in the eye, lacrimation increased, asthenopia, corneal disorder, dry eye, eye pain, ocular discomfort, uveitis, blurred vision, visual brightness, conjunctivitis) and nausea have been reported during clinical trials. These reactions are usually mild and transient and are assessed to be related to the cataract surgery itself.
Possible adverse reactions related to cornea: In diseases causing thinning of the cornea, topical use of steroids could lead to cornea perforation in some cases (see Precautions).
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Additional adverse reactions that have been observed with prolonged use of the active substance levofloxacin and may potentially occur also with Ducressa: Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see Precautions).