Olopatadine Hydrochloride

Olopatadine hydrochloride ophthalmic solution, 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, 0.2% should not be used to treat contact lens related irritation.

The preservative in olopatadine hydrochloride ophthalmic solution, 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses andwhose eyes are not red,should be instructed to wait at least ten minutes after instillingolopatadine hydrochloride ophthalmic solution, 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 to off-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:

structure 

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 equivalent to 2 mg olopatadine. Inactives: povidone; sodium chloride; sodium phosphate dibasic (anhydrous); edetate disodium dihydrate; benzalkonium chloride 0.01% (preservative);hydrochloric acid/sodium hydroxide (to adjust pH); and water for injection.

It has a pH of approximately 5.0 - 8.0 and an osmolality range of 260 - 320 mOsm/kg.

Results from clinical studies of up to 12 weeks duration demonstrate that olopatadine ophthalmic solution 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 white opaque ophthalmic bottle with a white translucent ophthalmic dropper and a white opaque plastic cap in the following size:

2.5 mL fill in 5 mL bottle: NDC 60505-0586-4

Storage

Keep out of reach of children.

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 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 0.2%. The preservative in olopatadine hydrochloride ophthalmic solution 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted following administration of olopatadine hydrochloride ophthalmic solution 0.2%.

PRINCIPAL DISPLAY PANEL - Bottle

2.5 mL Bottle

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Apotex Corp.

Rx Only

Bottle

PRINCIPAL DISPLAY PANEL - Carton

2.5 mL Bottle Carton

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Apotex Corp.

Rx Only

Carton