Source: FDA, National Drug Code (US) Revision Year: 2023
ELESTAT (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:
C16H15N3HCl 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; purified water; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). ELESTAT has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.
| Dosage Forms and Strengths |
|---|
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Solution containing 0.5 mg/mL epinastine HCl. |
| How Supplied |
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ELESTAT (epinastine HCl ophthalmic solution) 0.05% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 0023-9201-05. Allergan, Inc., Irvine, CA 92612, U.S.A. |
| Drug | Countries | |
|---|---|---|
| ELESTAT | Mexico, United States |
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