Cosopt PF (Ophthalmic)

Dorzolamide and timolol ophthalmic (eye) drops are used to treat high pressure in the eye due to open-angle glaucoma or a condition called hypertension of the eye. Both of these eye conditions are caused by high pressure in your eye, which can lead to pain and may eventually harm your vision. This medicine can help protect your sight by lowering the pressure in your eye and relieving eye pain.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check the progress of you or your child at regular visits to ensure that this medicine is working correctly. Blood and urine tests may be necessary to look for unwanted effects.

If you or your child experience itching, redness, swelling, or other signs of irritation in the eye or eyelid, stop using this medicine and consult your doctor. These signs may indicate an allergy to this medicine.

This medicine may lead to heart failure in some patients. Contact your doctor immediately if you or your child experience chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.

Serious allergic reactions may happen while using this medicine. Stop using this medicine and consult your doctor right away if you or your child have any of the following symptoms: black, tarry stools; blistering, peeling, or loosening of the skin; chills; dark urine; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; unusual bleeding or bruising; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may affect your blood sugar levels. It may also hide signs of low blood sugar, like a fast pulse rate. Consult your doctor if you or your child experience these issues or notice a change in your blood or urine sugar test results.

Before having any type of surgery, dental treatment, or emergency treatment, inform the medical doctor or dentist that you are using this medicine. You may need to stop using this medicine several days prior to surgery or medical tests.

It is very important to consult your doctor if you sustain an injury or infection in your eye or if you are scheduled for eye surgery. Your doctor will advise whether to continue using the same container of eye drops or start using a new bottle.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you need to think about the risks and benefits. This is a choice you will make with your doctor. Consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific issues that would limit the use of dorzolamide and timolol eye drops in children aged 2 years and older. However, safety and effectiveness have not been established in children younger than 2 years.

Geriatric

Studies have not identified specific problems in elderly patients that would limit the use of dorzolamide and timolol eye drops.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency for one or both medicines.

• Abiraterone Acetate
• Albuterol
• Aspirin
• Bupropion
• Ceritinib
• Clonidine
• Cobicistat
• Crizotinib
• Darunavir
• Desvenlafaxine
• Diltiazem
• Dronedarone
• Duloxetine
• Epinephrine
• Escitalopram
• Fedratinib
• Fenoldopam
• Fingolimod
• Fluoxetine
• Formoterol
• Indacaterol
• Iobenguane I 131
• Iohexol
• Lacosamide
• Levalbuterol
• Memantine
• Metformin
• Olodaterol
• Oxymetazoline
• Paroxetine
• Ponesimod
• Rivastigmine
• Salmeterol
• Sertraline
• Terbutaline
• Topiramate
• Venlafaxine
• Verapamil
• Vilanterol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cimetidine
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dipyrone
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Ertugliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Methyldopa
• Metildigoxin
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific foods, as interactions may happen. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Acute angle-closure glaucoma—The use of dorzolamide and timolol eye drops has not been studied in these patients. This condition may require other medications or treatments.

• Allergy, history of, or
• Sulfonamide allergy (antibiotics or stomach medicines, like sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®)—The severity and duration of allergic reactions to other substances may be increased.

• Asthma, or history of, or
• Bradycardia (unusually slow heartbeat) or
• Cardiogenic shock (shock caused by a heart attack) or
• Chronic obstructive pulmonary disease (COPD), severe or
• Heart block or
• Heart failure—Should not be used in patients with these conditions.

• Bacterial eye infection (e.g., keratitis) or
• Cornea (part of the eye) problems, history of, or
• Recent eye surgery—Use with caution. May worsen these conditions.

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May hide some signs and symptoms of these diseases, like a fast heartbeat.

• Severe kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

• Myasthenia gravis (severe muscle disease)—May worsen symptoms of this condition, such as muscle weakness.

Along with its needed effects, a medicine 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:

More common

• 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

Less common

• 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

Rare

• 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:

Symptoms of overdose

• 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 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:

More common

• Bitter, sour, or unusual taste

Less common

• 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

Rare

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cosopt
• Cosopt Ocumeter
• Cosopt Ocumeter Plus
• Cosopt PF

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma, Beta-Adrenergic Blocker/Carbonic Anhydrase Inhibitor Combination

Pharmacologic Class: Dorzolamide

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

This medicine 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 this medicine 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 this medicine.

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 this medicine 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:

• This medicine 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 this medicine 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 this medicine. 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 this medicine, 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.