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Dorzolamide and Timolol (Cosopt): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
20 mg/mL, 5 mg/mL
Brand names:
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Dorzolamide and Timolol

Instructions for Use

Read these instructions before using your dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

Important:

  • Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) is for the eye only. Do not swallow dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free).
  • Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) single-use containers are packaged in a foil pouch.
  • Write down the date you open the foil pouch in the space provided on the pouch.

Every time you use dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free):

Step 1. Wash your hands.
Step 2. Take the strip of single-use containers from the pouch.
Step 3. Pull off 1 single-use container from the strip.
Step 4. Put the remaining strip of single-use containers back in the pouch and fold the edge to close the pouch.

Step 5. Hold the single-use container upright. Make sure

that the solution is in the bottom part of the single-

use container (See Figure A).

Step 6. Open the single-use container by twisting off the

tab (See Figure B).

Step 7. Tilt your head backwards. If you are unable to tilt

your head, lie down.

Step 8. Place the tip of the single-use container close to

your eye. Be careful not to touch your eye with

the tip of the single-use container (See Figure C).

Step 9. Pull the lower eyelid downwards and look up.

Step 10. Gently squeeze the container and let 1 drop of

Dorzolamide hydrochloride-timolol maleate

ophthalmic solution (preservative-free) fall into

the space between your lower eyelid and your

eye. If a drop misses your eye, try again (See

Figure D).

Step 11. Blot any excess solution from the skin around the eye with a tissue.
  • If your doctor has told you to use drops in both eyes, repeat steps 7 to 11 for your other eye.
  • There is enough dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) in 1 single-use container for 1 or both of your eyes.
  • Throw away the opened single-use container with any remaining dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) right away.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for: Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

DZFA0N Rev. 08/18

AK60400

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 202667 · View the label on DailyMed

Revision date stated in the text: August 2018

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Dorzolamide and Timolol

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Carbonic Anhydrase Inhibitor, beta-Adrenergic Blocker
Active ingredients Dorzolamide hydrochloride 20 mg/mL, Timolol maleate 5 mg/mL
Dosage form Solution/ drops
Route Ophthalmic
Marketing status listed in the FDA NDC Directory
Company (applicant) THEA PHARMA
FDA approval NDA 202667New Drug Application (NDA) Approved February 1, 2012
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code AT2Codes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Cosopt, Cosopt PF with the same TE code
Manufacturers 15 labelers list this drug on DailyMed
Recalls
  • July 22, 2026: Class II recall: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Packages (NDC)
Package
20 mg/mL, 5 mg/mL – 0.2 ml in 1 vial, single-use / 15 in 1 pouch / 4 in 1 carton NDC 50383-261-61
20 mg/mL, 5 mg/mL – 0.2 ml in 1 vial, single-use / 15 in 1 pouch / 12 in 1 carton NDC 50383-261-91

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.