Dorzolamide and timolol Ophthalmic

• Cosopt^®
• Cosopt^® PF

Dorzolamide and timolol ophthalmic (eye) drops is used to treat increased pressure in the eye caused by open-angle glaucoma or a condition called hypertension of the eye. Both eye conditions are caused by high pressure in your eye and can lead to pain from pressure in your eye and then can eventually harm your vision. dorzolamide and timolol can help you keep your sight by reducing the pressure in your eye and stopping eye pain.

dorzolamide and timolol is available only with your doctor's prescription.

Your eye doctor will tell you how much of dorzolamide and timolol to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

dorzolamide and timolol comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Use only the brand of dorzolamide and timolol that your doctor prescribed. Do not replace preservative-containing (Cosopt®) with the product without preservative (Cosopt® PF).

Cosopt® PF eye drops is a sterile solution that does not contain any preservatives. Use the solution in the single-unit containers immediately after opening. Throw away any unused medicine after each use.

If you normally wear soft contact lenses, remove them before you use Cosopt® eye drops. Wait at least for 15 minutes before putting the contact lenses back in.

If you are using Cosopt® PF eye drops, you may not need to remove your contact lenses while using dorzolamide and timolol.

To use the Cosopt® eye drops:

• The bottle is only partially full to provide proper drop control.
• First, wash your hands with soap and water.
• Before using dorzolamide and timolol for the first time, make sure that the safety strip on the bottle is unbroken.
• Tear off the safety strip to break the seal and open the bottle by unscrewing the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the bottle.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space.
• Invert the bottle, and press lightly the "finger push area" using your thumb or index finger.
• Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, replace the cap on the bottle and tighten. Then, remove by turning the cap in the opposite direction as indicated by the arrows on the top of the cap and repeat the process with another drop.
• Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

To use the Cosopt® PF eye drops:

• dorzolamide and timolol is packaged in a foil pouch containing a strip of single-use containers.
• First, wash your hands with soap and water.
• Pull off one single-use container from the strip. Return the remaining strip of single-use container back in the pouch.
• Hold the single-use container upright. Twist off the tab to open the container.
• Tilt your head backwards or lie down, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space.
• Blot any excess solution from the skin around the eye with a tissue.
• Discard and unused portion from the single use container.

If your doctor ordered two different eye drops to be used together, wait at least 5 or 10 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.

Dosing

The dose of dorzolamide and timolol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dorzolamide and timolol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For glaucoma or hypertension of the eye:
    • Adults—Use one drop in the affected eye two times a day (morning and evening).
    • Children 2 years of age or older—Dose must be determined by your doctor.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of dorzolamide and timolol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the Cosopt® PF single-use containers in the original pouch to protect from light. Write down the date you open the foil pouch in the space provided in the pouch. Throw away any unused single-use containers 15 days after opening the pouch.

You should not use this medication if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or a serious heart condition such as "AV block," slow heartbeats, heart failure, or if you have recently had a heart attack.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Tell your doctor right away if you have any eye injury or infection, or if you need to have any type of surgery, especially eye surgery. You may need to stop using dorzolamide and timolol ophthalmic for a short time.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Other drugs may interact with dorzolamide and timolol ophthalmic, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to dorzolamide / timolol ophthalmic: ophthalmic solution

Along with its needed effects, dorzolamide / timolol ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dorzolamide / timolol ophthalmic:

• Blurred vision
• burning or stinging of the eye (when medicine is applied)
• feeling of something in the eye
• itching of the eye
• redness of the eye and lining of the eyelid
• sensitivity of the eyes to light

• Back, abdominal, or stomach pain
• change in vision
• coughing, shortness of breath, troubled breathing, tightness in the chest, or wheezing
• discharge from the eye
• dizziness
• eye or eyelid pain, swelling, discomfort, or irritation
• increased blood pressure
• increased frequency of urination or painful urination
• itching of the eyelid
• seeing flashes or sparks of light
• seeing floating spots before the eyes
• swelling of lining of the eyelid
• tiny bumps on lining of the eyelid

• Blistering, peeling, or loosening of the skin
• blood in the urine
• blue lips, fingernails, or skin
• chest pain or discomfort
• chills
• cough
• diarrhea
• difficult or troubled breathing
• fainting
• headache or weakness, severe and sudden
• irregular, fast or slow, or shallow breathing
• itching
• joint or muscle pain
• lightheadedness
• mental depression
• nausea or vomiting
• pain, numbness, tingling, or burning feeling in the hands or feet
• red, irritated eyes
• red skin lesions, often with a purple center
• shortness of breath
• skin rash
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking dorzolamide / timolol ophthalmic:

• Confusion
• muscle cramps or pain
• numbness, tingling, pain, or weakness in the hands or feet
• seizures
• trembling
• weakness and heaviness of the legs

Some side effects of dorzolamide / timolol ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bitter, sour, or unusual taste

• Cold- or flu-like symptoms
• crusting or scales on eyelid
• dryness of the eyes
• indigestion or upset stomach
• sore throat
• stuffy or runny nose
• tearing of the eye

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• depression
• dry mouth
• stuffy nose

2 years or older:
1 drop in the affected eye(s) 2 times per day

Comments:
-If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.
-The solution from one individual unit is to be used immediately after opening for administration to one or both eyes.
-The remaining contents should be discarded immediately after administration.

Use: To reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time)

Hepatic impairment: Use with caution