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DailyMed – DORZOLAMIDE HYDROCHLORIDE solution


Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Sulfonamide Reactions

Dorzolamide Hydrochloride Ophthalmic Solution is a sulfonamide and although administered topically is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration. Advise patients that if serious or unusual reactions including severe skin reactions or signs of hypersensitivity occur, they should discontinue the use of the product
[see Warnings and Precautions (
5.1)].

Intercurrent Ocular Conditions

Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container.

Handling Ophthalmic Solutions

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Contact Lens Use

Advise patients that Dorzolamide Hydrochloride Ophthalmic Solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following Dorzolamide Hydrochloride Ophthalmic Solution administration.

When to Seek Physician Advice

Advise patients that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should discontinue use and seek their physician’s advice.

Distributed by:

Fosun Pharma USA Inc.

Princeton, NJ 08540

Made in India

October 2022

INSTRUCTIONS FOR USE

Dorzolamide Hydrochloride Ophthalmic Solution, USP 2 %

(dor ZOL a mide)

Before using your dorzolamide hydrochloride ophthalmic solution

 

Before using your dorzolamide hydrochloride ophthalmic solution, for the first time, make sure the tamper evident ring of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle. See

Figure A.

Step 1. Wash your hands.

Step 2. Before opening the bottle for the first time, tear off the tamper evident ring to break the seal. See

Figure B.

Figure-B

Step 3.Unscrew the cap by turning in the direction as shown in the

Figure C.

Figure-C

 

Giving your dorzolamide hydrochloride ophthalmic solution drops.

Step 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. See

FIGURE D.

Figure-D

Step 5. Hold the dorzolamide hydrochloride ophthalmic solution, USP 2 % bottle upside down. Place tip as close as possible to the lower eyelid without touching the tip to the eye, and gently squeeze until a single drop is placed in your eye. Do not touch your eye or eyelid with the dropper tip. See

FIGURE E.

Figure-E

Step 6. The dispenser tip is designed to provide a pre-measured drop; therefore, do NOT enlarge the hole of the dispenser tip.

Step 7. If your doctor has told you to use Dorzolamide Hydrochloride Ophthalmic Solution, USP 2 % in both eyes, repeat steps 4 and 5.

After using your dorzolamide hydrochloride ophthalmic solution

Step 8. Replace the cap by turning it until it is firmly touching your bottle. (See

Figure F)

Figure-F

 

After you have used all of your dorzolamide hydrochloride ophthalmic solution, USP 2 % doses, there will be some dorzolamide hydrochloride ophthalmic solution, USP 2 % medicine left in the dispenser. Do not try to remove the extra medicine from the dorzolamide hydrochloride ophthalmic solution, USP 2 % dispenser. Throw away your dorzolamide hydrochloride ophthalmic solution, USP 2 % dispenser in your household trash.

How should I store dorzolamide hydrochloride ophthalmic solution?

• Store dorzolamide hydrochloride ophthalmic solution between 15°C to 30°C (59°F to 86°F)

• Protect from light

• After opening, dorzolamide hydrochloride ophthalmic solution can be used until the expiration date on the bottle.

• Safely throw away medicine that is out of date or no longer needed.

KEEP DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Important information about using dorzolamide hydrochloride ophthalmic solution

• If you have any eye or skin reactions, especially conjunctivitis or eyelid reactions to dorzolamide hydrochloride ophthalmic solution, stop using it and call your doctor right away.

• If you have eye surgery or have a problem such as trauma or infection of your eye while using dorzolamide hydrochloride ophthalmic solution, call your doctor right away.

• If you do not handle eye medicines the right way the medicine can become contaminated. If the tip of the dispenser touches your eye or areas around your eye, the tip can become contaminated with bacteria which can cause an eye infection and other serious problems including loss of eyesight.

• If you use other eye medicines dropped onto the eye like dorzolamide hydrochloride ophthalmic solution, use the medicines at least 5 minutes before or after you use dorzolamide hydrochloride ophthalmic solution.

• Dorzolamide hydrochloride ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. If you wear contact lenses, remove them before you use your dorzolamide hydrochloride ophthalmic solution. You can place your contact lenses back into your eyes 15 minutes after using your dorzolamide hydrochloride ophthalmic solution.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 01/2022



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