Dorzolamide Hydrochloride (Page 3 of 4)

14 CLINICAL STUDIES

The efficacy of dorzolamide hydrochloride ophthalmic solution was demonstrated in clinical studies in the treatment of elevated intraocular pressure in patients with glaucoma or ocular hypertension (baseline IOP ≥ 23 mmHg). The IOP-lowering effect of dorzolamide hydrochloride ophthalmic solution was approximately 3 to 5 mmHg throughout the day and this was consistent in clinical studies of up to one year duration.

The efficacy of dorzolamide hydrochloride ophthalmic solution when dosed less frequently than three times a day (alone or in combination with other products) has not been established.

In a one year clinical study, the effect of dorzolamide hydrochloride ophthalmic solution 2% three times daily on the corneal endothelium was compared to that of betaxolol ophthalmic solution twice daily and timolol maleate ophthalmic solution 0.5% twice daily. There were no statistically significant differences between groups in corneal endothelial cell counts or in corneal thickness measurements. There was a mean loss of approximately 4% in the endothelial cell counts for each group over the one year period.

16 HOW SUPPLIED/STORAGE AND HANDLING

Dorzolamide Hydrochloride Ophthalmic Solution 2% is supplied sterile in 10 mL white LDPE plastic dropper bottles with white LDPE dropper tips and orange P/P caps of the following

sizes: 10 mL

Storage

Store Dorzolamide Hydrochloride Ophthalmic Solution at 20°-25°C (68°-77°F). Protect from light. After opening, Dorzolamide Hydrochloride Ophthalmic Solution can be used until the expiration date on the bottle.

17 PATIENT COUNSELING INFORMATION

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 Advise

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

Rx only

Manufactured by:

Akorn Operating Company LLC

Lake Forest, IL 60045

Rev.232:05 04/21

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

INSTRUCTIONS FOR USE

Dorzolamide Hydrochloride Ophthalmic Solution 2%

Before using your Dorzolamide Hydrochloride Ophthalmic Solution

Before using your Dorzolamide Hydrochloride Ophthalmic Solution for the first time, make sure the safety seal around the tip cap is unbroken.

Step 1. Wash your hands.

Step 2. Tear off the safety seal.

Step 3. To open the bottle, unscrew the cap by turning counterclockwise. Giving your Dorzolamide Hydrochloride Ophthalmic Solution drops

Giving your Dozolamide Hydrochloride Ophthalmic Drops

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

Image_32
(click image for full-size original)

Step 5. Invert the bottle, and press lightly with the thumb or index finger until a single drop is dispensed into the eye as directed by your doctor.

Image 4
(click image for full-size original)

DO NOT TOUCH YOUR EYES OR EYE LIDS WITH THE DROPPER TIP.

Step 6. If your doctor has told you to use Dorzolamide Hydrochloride Ophthalmic Solution drops in both eyes, repeat Steps 4 and 5.

After using your Dorzolamide Hydrochloride Ophthalmic Solution

Step 7. Replace the cap by turning until it is firmly touching the bottle. Do not overtighten the cap.

Step 8. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.

After you have used all doses, there will be some Dorzolamide Hydrochloride Ophthalmic Solution left in the bottle. Do not try to remove the extra medicine from the Dorzolamide Hydrochloride Ophthalmic Solution bottle. Throw away your Dorzolamide Hydrochloride Ophthalmic Solution bottle in your household trash.

How should I store Dorzolamide Hydrochloride Ophthalmic Solution?

  • Store Dorzolamide Hydrochloride Ophthalmic Solution between 68° F to 77° F (20° C to
    • 25° C)
  • 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.

Call your doctor for medical advice about side effects. You may report side effects to Akorn Operating Company LLC at 1-800-932-5676 or FDA at 1-800-FDA-1088.

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

Manufactured by:

Akorn Operating Company LLC

Lake Forest, IL 60045

Rev.232:05 04/21

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

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