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Zaditor (Ketotifen Fumarate) Ophthalmic Solution
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Ophthalmic/Otic agent
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Ophthalmic decongestant agent
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Adults and children over 3 years: 1 drop in the affected eye(s) every 8 to 12 hours
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Category C
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Headache, runny nose, burning or stinging, allergic reaction, dry eyes, eye pain, tearing, itching, pupil dilatation, photophobia, rash, flu-like symptoms, sore throat
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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