Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic, as difumarate:
Emadine: 0.05% (5 mL [DSC]) [contains benzalkonium chloride]
Pharmacology
Mechanism of Action
Selective histamine H1-receptor antagonist for topical ophthalmic use
Pharmacokinetics/Pharmacodynamics
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
Dosage and Administration
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.
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
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. 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 health care 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.
