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EMADINE
Overview
What is EMADINE?
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:
Structural Formula:
Chemical Name:
1H-benzimidazole,1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl),(E)-2-butenedioate (1:2)
Each mL of EMADINE (emedastine difumarate ophthalmic solution) 0.05% contains: Active:
Preservative:
Inactives:
What does EMADINE look like?
What are the available doses of EMADINE?
Sorry No records found.
What should I talk to my health care provider before I take EMADINE?
Sorry No records found
How should I use EMADINE?
EMADINE (emedastine difumarate ophthalmic solution) 0.05% is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis.
The recommended dose is one drop in the affected eye up to four times daily.
What interacts with EMADINE?
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What are the warnings of EMADINE?
Sorry No Records found
What are the precautions of EMADINE?
Sorry No Records found
What are the side effects of EMADINE?
Sorry No records found
What should I look out for while using EMADINE?
EMADINE (emedastine difumarate ophthalmic solution) 0.05% is contraindicated in persons with a known hypersensitivity to emedastine difumarate or any of its components.
FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION OR ORAL USE.
What might happen if I take too much EMADINE?
Somnolence and malaise have been reported following daily oral administration. Oral ingestion of the contents of a 15 mL DROP-TAINER dispenser would be equivalent to 7.5 mg. In case of overdosage, treatment is symptomatic and supportive.
How should I store and handle EMADINE?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:5 mL in opaque, plastic DROP-TAINER dispenser.5 mL: NDC 0065-0325-05STORAGERx Only©2002, 2003, 2009, 2018 Novartis Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon a Novartis companyRevised:T2018-34
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Emedastine is a relatively selective, histamine H1 antagonist. examinations of emedastine's affinity for histamine receptors (H1: Ki = 1.3 nM, H2: Ki = 49,067 nM, and H3: Ki = 12,430 nM) demonstrate relative selectivity for the H1-histamine receptor. have shown concentration-dependent inhibition of histamine-stimulated vascular permeability in the conjunctiva following topical ocular administration.
Emedastine appears to be devoid of effects on adrenergic, dopaminergic and serotonin receptors.
Following topical administration in man, emedastine was shown to have low systemic exposure. In a study involving 10 normal volunteers dosed bilaterally twice daily for 15 days with emedastine ophthalmic solution 0.05%, plasma concentrations of the parent compound were generally below the quantitation limit of the assay (less than 0.3 ng/mL).
Samples in which emedastine was quantifiable, ranged from 0.30 to 0.49 ng/mL. The elimination half-life of oral emedastine in plasma is 3-4 hours. Approximately 44% of the oral dose is recovered in the urine over 24 hours with only 3.6% of the dose excreted as parent drug. Two primary metabolites, 5- and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms. The 5’-oxoanalogs of 5- and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites.
In an environmental study, patients with allergic conjunctivitis were treated with EMADINE (emedastine difumarate ophthalmic solution) 0.05% for six weeks. The results demonstrated that EMADINE (emedastine difumarate ophthalmic solution) 0.05% provides relief of the signs and symptoms of allergic conjunctivitis. In conjunctival antigen challenge studies, in which subjects were challenged with antigen both initially and up to four hours after dosing, EMADINE (emedastine difumarate ophthalmic solution) 0.05% was demonstrated to be significantly more effective than placebo in preventing ocular itching associated with allergic conjunctivitis.
Non-Clinical Toxicology
EMADINE (emedastine difumarate ophthalmic solution) 0.05% is contraindicated in persons with a known hypersensitivity to emedastine difumarate or any of its components.FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION OR ORAL USE.
To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. Do not use if the solution has become discolored.
Patients should be advised not to wear a contact lens if their eye is red. EMADINE (emedastine difumarate ophthalmic solution) 0.05% should not be used to treat contact lens related irritation. The preservative in EMADINE (emedastine difumarate ophthalmic solution) 0.05%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and , should be instructed to wait at least ten minutes after instilling EMADINE (emedastine difumarate ophthalmic solution) 0.05% before they insert their contact lenses.
In controlled clinical studies of EMADINE (emedastine difumarate ophthalmic solution) 0.05% lasting for 42 days, the most frequent adverse reaction was headache 11%. The following adverse experiences were reported in less than 5% of patients: Abnormal dreams, asthenia, bad taste, blurred vision, burning or stinging, corneal infiltrates, corneal staining, dermatitis, discomfort, dry eye, foreign body sensation, hyperemia, keratitis, pruritus, rhinitis, sinusitis and tearing. Some of these events were similar to the underlying disease being studied.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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