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(emedastine difumarate) Ophthalmic Solution 0.05%
EMADINE ® (emedastine difumarate ophthalmic solution) 0.05% is a sterile ophthalmic solution containing emedastine, a relatively selective, H1-receptor antagonist for topical administration to the eyes. Emedastine difumarate is a white, crystalline, water-soluble fine powder with a molecular weight of 534.57. The chemical structure is presented below:
lH-Benzimidazole, 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl), (E)-2-butenedioate (1:2)
Each mL of EMADINE contains: Active: 0.884 mg emedastine difumarate equivalent to 0.5 mg emedastine. Preservative: benzalkonium chloride 0.01%. Inactives: tromethamine; sodium chloride; hydroxypropyl methylcellulose; hydrochloric acid/sodium hydroxide (adjust pH); and purified water. It has a pH of approximately 7.4 and an osmolality of approximately 300 mOsm/kg.
What are the possible side effects of emedastine ophthalmic (Emadine)?
Serious side effects are not expected to occur with the use of emedastine ophthalmic.
Commonly, some eye burning, irritation, itching, dryness, other eye discomfort, or blurred vision may occur. Headache and a bad taste in the mouth have also been reported.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...
What are the precautions when taking emedastine difumarate ophthalmic solution (Emadine)?
Before using emedastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This drug may cause temporary blurred or unstable vision after you apply it. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known if this drug passes...
Last reviewed on RxList: 11/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Emadine Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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