Dorzolamide Hydrochloride (Page 3 of 3)
16 HOW SUPPLIED/STORAGE AND HANDLING
Dorzolamide Hydrochloride Ophthalmic Solution, USP is a slightly opalescent, colorless to nearly colorless, slightly viscous solution.
Dorzolamide Hydrochloride Ophthalmic Solution, USP 2% is supplied in a natural, LDPE plastic ophthalmic bottle with a natural nozzle and an orange, tamper-evident cap.
NDC 70377-081-11, 10 mL, in an 10 mL capacity bottle.
Storage
Store dorzolamide hydrochloride ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. After opening, dorzolamide hydrochloride ophthalmic solution can be used until the expiration date on the bottle.
KEEP OUT OF THE REACH OF CHILDREN.
TEAR AND DISCARD RING BEFORE USE.
Do not use if tear-off ring is broken or missing.
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 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.
Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
Manufactured for:
Biocon Pharma Inc.
Iselin, NJ 08830-3009 USA
Manufactured by:
Indoco Remedies Limited
L-32, 33, 34, Verna Industrial Area
Verna, Goa-403722, India.
Revised: October 2021
INSTRUCTIONS FOR USE
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 tamper evident ring between the bottle and the cap is unbroken (See Figure A).
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. To open the bottle, remove the cap by turning it in the counterclockwise direction (See 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. 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 dispensed into the eye as directed by your doctor. 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.
After you have used all of your dorzolamide hydrochloride ophthalmic solution doses, there will be some dorzolamide hydrochloride ophthalmic solution medicine left in the dispenser. Do not try to remove the extra medicine from the dorzolamide hydrochloride ophthalmic solution dispenser. Throw away your dorzolamide hydrochloride ophthalmic solution dispenser in your household trash.
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
- 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.
Manufactured for:
Biocon Pharma Inc.
Iselin, NJ 08830-3009 USA
Manufactured by:
Indoco Remedies Limited
L-32, 33, 34, Verna Industrial Area
Verna, Goa-403722, India.
Revised: October 2021
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70377-081-11.
Biocon Pharma Inc.
Dorzolamide Hydrochloride Ophthalmic Solution, USP, 2%. 10 ml in 10 ml bottle Container Label
Rx
NDC 70377-081-11.
Biocon Pharma Inc.
Dorzolamide Hydrochloride Ophthalmic Solution, USP, 2%. 10 ml Carton Label
Rx
| DORZOLAMIDE HYDROCHLORIDE dorzolamide solution/ drops | ||||||||||||||||||
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| Labeler — Biocon Pharma Inc. (080000063) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| INDOCO REMEDIES LIMITED | 915851870 | ANALYSIS (70377-081), LABEL (70377-081), MANUFACTURE (70377-081), PACK (70377-081) | |
Revised: 01/2022 Biocon Pharma Inc.
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