DORZOLAMIDE HYDROCHLORIDE (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5280

NDC: 50090-5280-0 10 mL in a 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 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.

Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc., Princeton, NJ 08540

Rev. January 2021

INSTRUCTIONS FOR USE

Dorzolamide Hydrochloride Ophthalmic Solution, 2%

(door-ZOLE-ah-mide)

HOW TO USE THE BOTTLE

The bottle is designed to assure the delivery of a precise dose of medication. Before using your bottle, read the complete instructions carefully.

howtousebottleimage
(click image for full-size original)

1. Wash hands before each use.

2. Before using the medication for the first time, be sure the Safety Seal on the bottle is unbroken.

3. Tear off the Safety Seal to break the seal.

4. Before each use, shake once and remove the screw cap.

5. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you.

additionalhowtousebottleimage
(click image for full-size original)

6. Tilt your head back and position the bottle above the affected eye.

7. With the opposite hand, place a finger under the eye. Gently pull down until a “V” pocket is made between your eye and lower lid.

8. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication.

DO NOT TOUCH THE EYE WITH THE TIP OF THE DROPPER.

DO NOT SQUEEZE THE SIDES OF THE BOTTLE.

KEEP YOUR HEAD TILTED BACKWARD AND CLOSE YOUR EYE TO ALLOW ABSORPTION OF THE MEDICATION INTO THE EYE.

9. Repeat 6, 7, 8, & 9 with other eye if instructed to do so.

10. Replace screw cap by turning until firmly touching the bottle.

Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think that your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.

The dispenser tip is designed to provide a pre-measured 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. You should not be concerned since an extra amount of dorzolamide hydrochloride ophthalmic solution has been added and you will get the full amount of dorzolamide hydrochloride ophthalmic solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.

How should I store Dorzolamide Hydrochloride Ophthalmic Solution?

Store dorzolamide hydrochloride ophthalmic solution at 2° to 25°C (36° to 77°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.

If you have any questions about the use of dorzolamide hydrochloride ophthalmic solutions, please consult your doctor.

Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc., Princeton, NJ 08540

Rev. January 2021

DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS

Label ImageLabel Image
DORZOLAMIDE HYDROCHLORIDE
dorzolamide hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5280(NDC:61314-019)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE) DORZOLAMIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
MANNITOL
Trisodium Citrate Dihydrate
SODIUM HYDROXIDE
WATER
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5280-0 10 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078981 06/01/2009
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5280)

Revised: 04/2021 A-S Medication Solutions

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