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Emedastine

Pronunciation

(em e DAS teen)

Index Terms

  • Emedastine Difumarate

Dosage Forms

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

Solution, Ophthalmic, as difumarate:

Emadine: 0.05% (5 mL) [contains benzalkonium chloride]

Brand Names: U.S.

  • Emadine

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation

Pharmacology

Selective histamine H1-receptor antagonist for topical ophthalmic use

Absorption

Ocular: Minimal

Half-Life Elimination

Oral: Plasma: 3 to 4 hours

Use: Labeled Indications

Allergic conjunctivitis: For the temporary relief of the signs and symptoms of allergic conjunctivitis

Contraindications

Hypersensitivity to emedastine or any component of the formulation

Dosing: Adult

Allergic conjunctivitis: Ophthalmic: Instill 1 drop in affected eye up to 4 times daily

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Allergic conjunctivitis: Children ≥3 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Administration

Ophthalmic: For topical ophthalmic use only, not for injection. Wash hands before use. To avoid contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Remove contact lenses prior to administration. Wait ≥10 minutes before reinserting lenses. Do not wear contact lenses if eyes are red.

Storage

Store at 4°C to 30°C (39°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not always defined.

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

1% to 10%:

Cardiovascular: Hyperemia

Central nervous system: Abnormal dreams

Dermatologic: Dermatitis, pruritus

Gastrointestinal: Dysgeusia

Neuromuscular & skeletal: Weakness

Ophthalmic: Blurred vision, corneal infiltrates, corneal staining, keratitis, lacrimation, transient burning or stinging in the eyes, xerophthalmia

Respiratory: Rhinitis, sinusitis

Warnings/Precautions

Special populations:

• Contact lens wearers: Contains benzalkonium chloride which may be absorbed by soft contact lenses; remove contact lenses prior to use and wait ≥10 minutes before reinserting.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only. Do not wear contact lens if eye is red; not for the treatment of contact lens irritation. To avoid contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Systemic absorption is limited following ocular administration. Use during pregnancy is not expected to result in significant exposure to the fetus.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache or blurred vision. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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