Cravit Ophthalmic Adverse Reactions

0.5% w/v ophthalmic solution: Clinically significant adverse reactions ["rarely" (<0.1%), occasionally (5%> ≥0.1%), and no specific designation (≥5% or incidence unknown)]: Shock, anaphylaxis: Since shock and anaphylaxis may occur, patients should be carefully observed. If any symptoms such as erythema, rash, dyspnoea, decreased blood pressure, and eyelid oedema, etc. are observed, administration should be discontinued and appropriate measures should be taken.
Other adverse reactions: If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 3.)

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1.5% w/v ophthalmic solution: Adverse reactions were reported in 7 of 238 patients (2.9%) in clinical trials in Japan. The adverse reactions were eye irritation in 3 patients (1.3%), dysgeusia in 2 patients (0.8%), eye itching in 1 patient (0.4%), and urticaria in 1 patient (0.4%) (at the time of approval).
Clinically significant adverse reactions: Shock, anaphylactoid reaction (incidences unknown): Since shock and anaphylactoid reaction may occur on levofloxacin ophthalmic solution 0.5% (0.5% product), patients should be carefully observed. If any symptoms such as erythema, rash, dyspnoea, decreased blood pressure, and eyelid oedema, etc. are observed, administration should be discontinued and appropriate measures should be taken.
Other adverse reactions: If any adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 4.)

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