Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied as follows: 5 mL in 5 mL screw neck white low density polyethylene bottle. 5 mL: NDC 62332-501-05 Storage : Store at 4° to 25°C (39° to 77°F) Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Manufactured by: Gland Pharma Limited D.P. Pally, Dundigal Post, Hyderabad-500 043, India Revised: 12/2018; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 62332-501-05 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% Rx only 5 ml Sterile Almebic NDC 62332-501-05 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% Rx only 5 ml Sterile Almebic olopatadine-bottle-label olopatadine-carton-label
- HOW SUPPLIED Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied as follows: 5 mL in 5 mL screw neck white low density polyethylene bottle. 5 mL: NDC 62332-501-05 Storage : Store at 4° to 25°C (39° to 77°F) Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Manufactured by: Gland Pharma Limited D.P. Pally, Dundigal Post, Hyderabad-500 043, India Revised: 12/2018
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 62332-501-05 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% Rx only 5 ml Sterile Almebic NDC 62332-501-05 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% Rx only 5 ml Sterile Almebic olopatadine-bottle-label olopatadine-carton-label
Overview
Olopatadine hydrochloride ophthalmic solution USP, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H 1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride, USP is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below: Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride Each mL of olopatadine hydrochloride ophthalmic solution USP, 0.1 % contains: Active : 1.11 mg olopatadine hydrochloride, USP equivalent to 1 mg olopatadine. Preservative: Benzalkonium chloride 0.01%. Inactives: Dibasic sodium phosphate; Sodium chloride; Hydrochloric acid/Sodium hydroxide (adjust pH); and Water for Injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg. chemical-structure
Indications & Usage
Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
Dosage & Administration
The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.
Warnings & Precautions
WARNINGS Olopatadine hydrochloride ophthalmic solution USP, 0.1% is for topical use only and not for injection or oral use.
Contraindications
Olopatadine hydrochloride ophthalmic solution USP, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride, USP or any components of olopatadine hydrochloride ophthalmic solution USP, 0.1%.
Adverse Reactions
Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritis, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.
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