Dorzolamide

What it is used for

Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is a prescription sterile eye drop solution that contains 2 medicines, dorzolamide hydrochloride (a sulfonamide carbonic anhydrase inhibitor) and timolol maleate (a beta-adrenergic blocker). Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is used to lower the pressure in the eye (intraocular pressure) in people with open-angle glaucoma or ocular hypertension, when their eye pressure is too high and beta-adrenergic blocker medicines alone have not adequately lowered the pressure.

It is not known if dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is safe and effective in children under 2 years of age.

How to take it

Read the Instructions for Use at the end of this Patient Information leaflet for additional instructions about the right way to use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free.

• Use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free exactly as your healthcare provider tells you.
• Use 1 drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free in your eye (or eyes) in the morning and 1 drop in the evening.
• If you use other medicines in your eye, wait at least 5 minutes between using dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free and your other eye medicines.
• Use your dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free right away after opening. Each dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free single-dose container is sterile and is to be used 1 time then thrown away.
• Do not save any dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free that may be left over after you use a single-dose container. Using dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free that is not sterile may cause other eye problems.

Side effects, and when to stop

Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free may cause serious side effects including:

• severe breathing problems. These breathing problems can happen in people who have asthma, chronic obstructive pulmonary disease, or heart failure and can cause death. Tell your healthcare provider right away if you have breathing problems while taking dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free.
• heart failure. This can happen in people who already have heart failure and in people who have never had heart failure before. Tell your healthcare provider right away if you get any of these symptoms of heart failure while taking dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free:

• shortness of breath
• irregular heartbeat (palpitations)
• swelling of your ankles or feet
• sudden weight gain

• severe allergic reactions. These allergic reactions can happen the first time you use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free or after you have been using dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free for a while and may cause death. Stop taking dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free and call your healthcare provider right away or get emergency help if you get any of these symptoms of an allergic reaction:

• swelling of your face, lips, mouth, or tongue
• trouble breathing
• wheezing
• severe itching
• skin rash, redness, or swelling
• dizziness or fainting
• fast heartbeat or pounding in your chest (tachycardia)
• sweating

• worsening muscle weakness. Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis).
• kidney problems. Your healthcare provider may do tests to check your kidney function while you use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free.
• swelling of your eye (cornea)

The most common side effects of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free include:

• a bitter, sour, or unusual taste in your mouth after using dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free
• burning, stinging, redness, or itching of the eye
• blurred vision
• painful, red, watery eyes with increased sensitivity (superficial punctate keratitis)

Tell your healthcare provider if you have any new eye problems while using dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free including:

• an eye injury
• an eye infection
• a sudden loss of vision eye surgery
• swelling and redness of and around your eye (conjunctivitis) problems with your eyelids

Tell your healthcare provider if you have any other side effects that bother you.

These are not all the possible side effects of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider about medical advice about side effects. You may report side effects to FDA at 1-800­ FDA-1088.

Who should not take it

Do not use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free if you:

• have or have had asthma
• have or have had severe lung problems (chronic obstructive pulmonary disease)
• have heart problems, including slow or irregular heartbeat or heart failure
• are allergic to dorzolamide hydrochloride, timolol maleate, or any of the ingredients in dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free. See the end of this leaflet for a complete list of ingredients in dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What to say before you start

Before you use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free, tell your healthcare provider if you:

• have problems with muscle weakness (myasthenia gravis)
• have diabetes or problems with low blood sugar (hypoglycemia)
• have thyroid, kidney, or liver problems
• are planning to have surgery
• are allergic to sulfa drugs
• have or have had eye problems, including any surgery on your eye or eyes, or are using any other eye medicines
• have any other medical problems
• are pregnant or plan to become pregnant. It is not known if dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free will harm your unborn baby. If you become pregnant while using dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free talk to your healthcare provider right away.
• are breastfeeding or plan to breastfeed. It is not known whether dorzolamide or timolol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free and other medicines may affect each other causing side effects. Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free may affect the way other medicines work, and other medicines may affect how dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storing it

• Store dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze.
• Keep the dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free single-dose containers in their original foil pouch to protect from light.
• Write down the date you open the foil pouch in the space provided on the pouch.
• Throw away all unused dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free single-dose containers 15 days after first opening the pouch.

Keep dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free and all medicines out of the reach of children.

General information about the safe and effective use of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free for a condition for which it was not prescribed. Do not give dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free that is written for health professionals.

What should I do in case of an overdose?

If you swallow the contents of the container, contact your healthcare provider immediately. Among other effects, you may feel light-headed, have difficulty breathing, or feel your heart rate has slowed.