Trusopt Ocumeter (Ophthalmic)

Dorzolamide ophthalmic (eye) drops are used to treat high pressure in the eye caused by open-angle glaucoma or a condition known as hypertension of the eye. Both of these conditions happen due to increased pressure in your eye, which can cause pain and may eventually damage your vision. This medicine can help protect your eyesight 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 monitor the progress of you or your child during regular visits. Your doctor may want to perform certain tests to check if the medicine is working correctly or to see if any side effects are happening without you or your child being aware.

If you or your child experience itching, redness, swelling, or other signs of irritation in the eye or eyelid, consult your doctor. These signs could indicate an allergy to dorzolamide eye drops.

This medicine may cause some people to experience blurred vision for a short time. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be risky if you cannot see clearly. Also, since blurred vision could be a side effect that requires medical attention, check with your doctor if it persists.

Ophthalmic dorzolamide may make your eyes more sensitive to light than usual. Wearing sunglasses and avoiding excessive exposure to bright light may help reduce discomfort. If the discomfort continues, consult your doctor.

If you injure your eye, develop an eye infection, or need eye surgery, contact your doctor immediately. You or your child may need a new bottle of the eye drops to help prevent an eye infection or to prevent an existing infection from worsening.

Serious allergic reactions may occur while using this medicine. Contact your doctor right away if you or your child experience 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 yellowing of the eyes or skin.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies performed so far have not shown any pediatric-specific problems that would limit the usefulness of dorzolamide eye drops in children.

Geriatric

Studies performed so far have not shown any geriatric-specific problems that would limit the usefulness of dorzolamide eye drops in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In such cases, your doctor may adjust the dose, or other precautions may be necessary. When you are taking this medicine, 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 are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Aspirin
• Memantine
• Metformin
• Topiramate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

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

• Acute angle-closure glaucoma—The use of dorzolamide eye drops in these patients has not been studied. This condition may require other medicine or treatment besides dorzolamide.

• Allergy to sulfa drugs—Use with caution. This may increase the risk of more serious side effects.

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

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

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning, stinging, or discomfort when the medicine is applied
• Itching, redness, swelling, or other signs of irritation in the eye or eyelid

Less common

• Burning, dry, or itching eyes
• Discharge from the eye
• Excessive tearing
• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Rare

• Blood in the urine
• Blurred vision
• Nausea or vomiting
• Pain in the side, back, or abdomen
• Skin rash
• Tearing

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• Change in vision
• Chills
• Cough
• Diarrhea
• Difficult or labored breathing
• Flashes of light
• Floaters in vision
• Hives or welts
• Itching skin
• Joint or muscle pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Noisy breathing
• Redness of the skin
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Tightness in the chest
• Unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion
• Irregular heartbeat
• 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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bitter taste
• Feeling of something in the eye

Less common

• Changes in color vision
• Difficulty seeing at night
• Dryness of the eyes
• Eyelid reactions
• Headache
• Increased sensitivity of the eyes to sunlight

Incidence not known

• Bloody nose
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Change in distance vision
• Difficulty in focusing the eyes
• Dizziness
• Dry mouth
• Eyelid crusting
• Lack or loss of strength
• Scaling of the skin
• Severe redness, soreness, or swelling of the skin

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.

• Trusopt Ocumeter
• Trusopt Ocumeter Plus

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Carbonic Anhydrase Inhibitor

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 should come with a patient instruction leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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

To use the eye drops:

• 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 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 eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to cover 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.
• Wash your hands after using the eye drops to remove any medicine.
• Never touch the applicator tip to any surface, including the eye, and keep the container tightly closed. This will keep the medicine as germ-free as possible.

If your doctor ordered two different eye drops to be used together, wait at least 5 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 and teenagers—Use one drop in the affected eye three times a day. Children—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

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

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.