OLOPATADINE HYDROCHLORIDE

Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

The recommended dose is one drop in each affected eye once a day.

Ophthalmic solution 0.2%: each ml contains 2.22 mg of olopatadine hydrochloride.

None.

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.

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.

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.

Results from clinical studies of up to 12 weeks duration demonstrate that olopatadine hydrochloride ophthalmic solution USP, 0.2% when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.

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)

17.1 Topical Ophthalmic Use Only
For topical ophthalmic administration only.

17.2 Sterility of Dropper Tip
Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.

17.3 Concomitant Use of Contact Lenses
Patients should be advised not to wear a contact lens if their eyes are red. Patients should be advised that olopatadine hydrochloride ophthalmic solution USP, 0.2% should not be use to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of olopatadine hydrochloride ophthalmic solution USP, 0.2%. The preservative in olopatadine hydrochloride ophthalmic solution, USP benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration

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