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Emedastine (Ophthalmic)

Medically reviewed by Drugs.com. Last updated on Apr 25, 2020.

Pronunciation

(em e DAS teen)

Index Terms

  • Emedastine Difumarate

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]

Brand Names: U.S.

  • Emadine [DSC]

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.

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 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

What is this drug used for?

• It is used to treat eye irritation due to allergies.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.