Product Description:
EMADINE ? (emedastine difumarate ophthalmic solution) 0.05% is a sterile ophthalmic solution containing emedastine, a relatively selective, H1-receptor antagonist for topical administration to the eyes.
Each mL of EMADINE contains: Active: 0.884 mg emedastine difumarate equivalent to 0.5 mg emedastine. Preservative: benzalkonium chloride 0.01%. Inactives: tromethamine sodium chloride hydroxypropyl methylcellulose hydrochloric acid/sodium hydroxide (adjust pH) and purified water. It has a pH of approximately 7.4 and an osmolality of approximately 300 mOsm/kg.
INDICATIONS
EMADINE? (emedastine difumarate ophthalmic solution) 0.05% is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis.
DOSAGE AND ADMINISTRATION
The recommended dose is one drop in the effected eye up to four times daily.
SIDE EFFECTS
In controlled clinical studies of EMADINE lasting for 42 days, the most frequent adverse reaction was headache (11%). The following adverse experiences were reported in less than 5% of patients: Abnormal dreams, asthenia, bad taste, blurred vision, burning or stinging, corneal infiltrates, corneal staining, dermatitis, discomfort, dry eye, foreign body sensation, hyperemia, keratitis, pruritus, rhinitis, sinusitis, and tearing. Some of these events were similar to the underlying disease being studied.
