Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Olopatadine hydrochloride ophthalmic solution USP, 0.2% is supplied in a 5 mL screw neck white bottle with nozzle made with low density polyethylene and white color screw cap made with high density polyethylene Tamper evidence is provided with a tamper evident ring around the closure and neck area of the package. 2.5 mL fill in 5 mL bottle (NDC 62332-502-03) Storage Store at 2°C to 25°C (36°F to 77°F); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 62332-502-03 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Rx only 2.5 mL Alembic NDC 62332-502-03 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Rx only 2.5 mL Alembic olopatadine-container olopatadine-carton11
- 16 HOW SUPPLIED/STORAGE AND HANDLING Olopatadine hydrochloride ophthalmic solution USP, 0.2% is supplied in a 5 mL screw neck white bottle with nozzle made with low density polyethylene and white color screw cap made with high density polyethylene Tamper evidence is provided with a tamper evident ring around the closure and neck area of the package. 2.5 mL fill in 5 mL bottle (NDC 62332-502-03) Storage Store at 2°C to 25°C (36°F to 77°F)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 62332-502-03 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Rx only 2.5 mL Alembic NDC 62332-502-03 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% Rx only 2.5 mL Alembic olopatadine-container olopatadine-carton11
Overview
Olopatadine hydrochloride ophthalmic solution USP, 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88 and a molecular formula of C21H23NO3 • HCl. The chemical structure is presented below: Chemical Name: 11-[(Z)-3(Dimethylamino) propylidene]-6-11dihydrodibenz[b,e] oxepin-2-acetic acid, hydrochloride Each mL of olopatadine hydrochloride ophthalmic solution USP, 0.2% contains: Active : 2.22 mg olopatadine hydrochloride, USP equivalent to 2 mg olopatadine. Inactives: Povidone; Dibasic sodium phosphate; Sodium chloride; Edetate disodium; Benzalkonium chloride 0.01% ( preservative ); 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. olopatadine-structure
Indications & Usage
INDICATIONSAND USAGE Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis. Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Dosage & Administration
The recommended dose is one drop in each affected eye once a day. The recommended dose is one drop in each affected eye once a day.
Warnings & Precautions
5.1 For topical ocular use only. Not for injection or oral use. 5.2 Contamination of Tip and Solution As with any eye drop, 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 bottle tightly closed when not in use. 5.3 Contact Lens Use Patients should be advised not to wear a contact lens if their eye is red. Olopatadine hydrochloride ophthalmic solution USP, 0.2% should not be used to treat contact lens related irritation. The preservative in Olopatadine hydrochloride ophthalmic solution USP 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling olopatadine hydrochloride ophthalmic solution USP, 0.2% before they insert their contact lenses. For topical ocular use only. Not for injection or oral use (5.1).
Contraindications
None.
Adverse Reactions
Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus. Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion. Some of these events were similar to the underlying disease being studied. Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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