Product Information
Registration Status: ActiveSIN14381P
EMADINE STERILE OPHTHALMIC SOLUTION 0.05% is approved to be sold in Singapore with effective from 2013-07-18. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14381P.
This product contains Emedastine 0.5mg/ml in the form of SOLUTION, STERILE. It is approved for OPHTHALMIC use.
This product is manufactured by S.A. Alcon-Couvreur N.V. in SINGAPORE, andALCON SINGAPORE MANUFACTURING PTE. LTD. in BELGIUM.
It is a has been granted the exemption for supply without a presciption if it met certain criteria.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Emedastine is an antihistamine used in eye drops to treat allergic conjunctivitis.
Indication
For the temporary relief of the signs and symptoms of allergic conjunctivitis.
Mechanism of Action
Emedastine is a relatively selective, histamine H1 antagonist. In vitro examinations of emedastine's affinity for histamine receptors demonstrate relative selectivity for the H1 histamine receptor. In vivo studies 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.
Pharmacokinetics
- Absorption
- Ophthalmic use of emedastine usually does not produce measurable plasma concentrations.
- Distribution
- Metabolism
- Two primary metabolites, 5-hydroxyemedastine and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms. The 5'-oxoanalogs of 5-hydroxyemedastine and 6-hydroxy-emedastine and the N-oxide are also formed as minor metabolites.
- Elimination
Toxicity
Somnolence and malaise have been reported following daily oral administration.
Active Ingredient/Synonyms
1-(2-Ethoxy-ethyl)-2-(4-methyl-[1,4]diazepan-1-yl)-1H-benzoimidazole | 1-(2-Ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)benzimidazole | 1-[2-(Ethoxy)ethyl]-2-(4-methyl-1-homopiperazinyl)benzimidazole | Emedastina | Emedastinum | Emedastine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.