Dorzolamide HCl (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-2768

NDC: 50090-2768-0 10 mL in a BOTTLE, DISPENSING / 1 in a CARTON

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Instructions for Use).

17.1 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)].

17.2 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.

17.3 Handling Ophthalmic Solutions

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.

17.4 Concomitant Topical Ocular Therapy

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

17.5 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.

17.6 Patient Instructions

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

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

Manufactured by:
Indoco Remedies Limited
Verna, Goa – 403722, India

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: January 2017

INSTRUCTIONS FOR USE

Dorzolamide Hydrochloride Ophthalmic Solution , USP 2%

Before using your dorzolamide hydrochloride ophthalmic solution
Before using your dorzolamide hydrochloride ophthalmic solution for the first time, be sure the safety band around bottle neck is unbroken. See Figure A.

Figure A

Figure A

Step 1. Wash your hands.

Step 2. Tear off the ring to break the safety band. See Figure B.

Step 2. Tear off the ring to break the safety band. See Figure B.

Figure B

Step 3. To open the bottle, unscrew the cap by turning as indicated. See Figure C.

Step 3. To open the bottle, unscrew the cap by turning as indicated. See Figure C.
(click image for full-size original)

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.

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. Turn your dorzolamide hydrochloride ophthalmic solution dispenser upside down and squeeze lightly with the thumb or index finger (as shown) until a single drop is placed in your eye. Do not touch your eye or eyelid with the dropper tip. See Figure E.

Step 5. Turn your dorzolamide hydrochloride ophthalmic solution dispenser upside down and squeeze lightly with the thumb or index finger (as shown) 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 single 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 drops in both eyes, repeat Steps 4 and 5.

After using your dorzolamide hydrochloride ophthalmic solution

Step 8. Replace the cap by turning until it is firmly on the bottle.

How should I store dorzolamide hydrochloride ophthalmic solution ?

  • Store dorzolamide hydrochloride ophthalmic solution between 68° to 77°F (20° to 25°C)
  • Protect from light
  • 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.

Manufactured by:
Indoco Remedies Limited
Verna, Goa – 403722, India

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: January 2017

Dorzolamide Hydrochloride

Label ImageLabel Image
DORZOLAMIDE HCL
dorzolamide hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2768(NDC:0591-2481)
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
MANNITOL
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
BENZALKONIUM CHLORIDE
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2768-0 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
1 10 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (50090-2768-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202053 02/17/2015
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2768)

Revised: 03/2018 A-S Medication Solutions

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.