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Pronunciation:

(em e DAS teen)

U.S. Brand Names:

Emadine®

Synonyms:

Emedastine Difumarate

Use:

Treatment of allergic conjunctivitis

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to emedastine or any component of the formulation

Warnings/Precautions:

Emadine® is for topical ophthalmic use only, not for injection. Soft contact lenses should not be worn during treatment if eyes are red; if there is no redness, wait 10 minutes following emedastine instillation before inserting contact lenses. Safety and efficacy in children <3 years of age have not been established.

Adverse Reactions:

>10%: Central nervous system: Headache (11%)

1% to 10%:

Cardiovascular: Hyperemia

Central nervous system: Abnormal dreams

Dermatologic: Dermatitis, keratitis, pruritus

Gastrointestinal: Taste (unpleasant)

Neuromuscular & skeletal: Weakness

Ocular: Blurred vision, corneal infiltrates, corneal staining, dry eyes, transient burning or stinging

Respiratory: Rhinitis, sinusitis

Miscellaneous: Tearing

Overdosage/Toxicology:

Somnolence and malaise reported following daily oral administration. Treatment is symptomatic and supportive.

Drug Interactions:

No data reported.

Stability:

Store at 4°C to 30°C (39°F to 86°F). Solution should not be used if it becomes discolored.

Mechanism of Action:

Selective histamine H1-receptor antagonist for topical ophthalmic use

Pharmacodynamics/Kinetics:

Absorption: Ocular: Minimal

Half-life elimination: Oral: Plasma: 3-4 hours

Dosage:

Ophthalmic: Children 3 years and Adults: Instill 1 drop in affected eye up to 4 times/day

Administration:

Emadine® is for topical ophthalmic use only, not for injection. Soft contact lenses should not be worn during treatment if eyes are red; if there is no redness, wait 10 minutes following emedastine instillation before inserting contact lenses. Do not allow dropper tip to touch eyelids or surrounding area of the eye.

Patient Education:

Do not wear soft contact lenses during treatment if eyes are red; if eyes are not red, wait 10 minutes after instilling emedastine before inserting contact lenses. This medication may cause drowsiness in some patients. Take care to not touch dropper tip to eyelids or area surrounding the eye. Do not use if solution has become discolored. Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Solution, ophthalmic, as difumarate: 0.05% (5 mL) [contains benzalkonium chloride]

International Brand Names:

Daren® (JP); Emadine® (AT, BE, CH, CZ, DE, DK, ES, FI, FR, GB, HU, IE, IL, IT, NL, NO, PL, PT, RO, SE, SI, TH, YU, ZA); Remicut® (JP)

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