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Pronunciation

(em e DAS teen)

U.S. Brand Names

• Emadine®

Index Terms

• Emedastine Difumarate

Pharmacologic Category

• Histamine H1 Antagonist
• Histamine H1 Antagonist, Second Generation

Pharmacologic Category Synonyms

• Antihistamine
• Antihistamine, H₁ Selective
• H₁ Antagonist
• H₁ Blocker
• Second Generation H₁ Antagonist

Use: Labeled Indications

Treatment of allergic conjunctivitis

Pregnancy Risk Factor

B

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to emedastine or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.

Special populations:

• Contact lens wearers: Contains benzalkonium chloride which may be absorbed by contact lenses; remove contact lenses prior to use and wait 15 minutes before reinserting.

• Pediatrics: Safety and efficacy have not been established in children <3 years of age.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only.

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

Drug Interactions

There are no known significant interactions.

Storage

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: Other

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.

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

Mental Health: Effects on Mental Status

May cause drowsiness or abnormal dreams

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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

Pricing: U.S. (www.drugstore.com)

Solution (Emadine)

0.05% (5): $71.66

International Brand Names

• Daren (JP)
• Emadine (AT, BE, BG, BR, CH, CL, CZ, DE, DK, EE, FI, FR, GB, GR, HK, HN, IE, IL, IT, KP, NL, NO, PK, PL, PT, RU, SE, TH, TR, TW, ZA)
• Remicut SR (KP)

Lexi-Comp.com

Last full review/revision February 2009

Content last modified February 2009