Emedastine: Uses, Dosage, Side Effects and More

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Ophthalmic
Allergic conjunctivitis

Adult: As 0.05% emedastine difumarate solution: Instil 1 drop to the affected eye(s) up to 4 times daily.
Child: ≥3 years Same as adult dose.

Special Precautions

Not intended to treat contact lens-related irritation. Pregnancy and lactation.

Adverse Reactions

Eye disorders: Ocular corneal infiltrates, blurred vision, burning or stinging, foreign body sensation, pain, lacrimation, keratitis, dry eye, corneal staining.
Gastrointestinal disorders: Dysgeusia.
General disorders and administration site conditions: Asthenia.
Nervous system disorders: Headache, abnormal dreams.
Respiratory, thoracic and mediastinal disorders: Rhinitis, sinusitis.
Skin and subcutaneous tissue disorders: Dermatitis, pruritus.
Vascular disorders: Hyperaemia.

Pregnancy Category (US FDA)

Ophth: B

Patient Counseling Information

This drug may cause blurred vision or other visual disturbances, if affected, do not drive or operate machinery. Remove contact lenses before administration and reinsert them after at least 10 minutes.

Action

Description:
Mechanism of Action: Emedastine is a potent selective histamine H₁ antagonist for ophthalmic use.
Pharmacokinetics:
Absorption: Minimally absorbed.
Excretion: Elimination half-life: 10 hours.

Chemical Structure

Storage

Store between 4-30°C.

MIMS Class

Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories

ATC Classification

S01GX06 - emedastine ; Belongs to the class of other ophthalmologic antiallergics.

References

Buckingham R (ed). Emedastine Fumarate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/05/2024.

Emadine (Novartis Pharmaceuticals [HK] Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 31/05/2024.

Emadine 0.5 mg/mL, Eye Drops, Solution (Immedica Pharma AB). European Medicines Agency [online]. Accessed 31/05/2024.

Emedastine (Ophthalmic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 31/05/2024.

Emedastine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 31/05/2024.

Disclaimer: This information is independently developed by MIMS based on Emedastine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com