Drug Catalog - Product Detail
EPINASTINE HCL OPHTH SOLN 0.05% 5 ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 70069-0008-01 | SOMERSET THERAPEUTICS | 5 | 0.05% | SOLUTION |
PACKAGE FILES
Generic Name
EPINASTINE HYDROCHLORIDE
Substance Name
EPINASTINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA090951
Description
11 DESCRIPTION Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula: C 16 H 15 N 3 HCl Mol. Wt. 285.78 Chemical Name: 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo [1,5-a]azepine hydrochloride Each mL contains: Active: epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: benzalkonium chloride 0.01%; Inactives: edetate disodium; water for injection; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Epinastine HCl has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg. Molecular Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Epinastine HCl ophthalmic solution 0.05% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white polypropylene caps as follows: 5 mL in 10 mL bottle; individually packaged NDC 70069- 008 -01 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Keep bottle tightly closed and out of the reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Epinastine HCl Ophthalmic Solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in each eye twice a day. The recommended dosage is one drop in each eye twice a day. Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.