Description
Dorzolamide 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. This medicine can help you keep your sight by reducing the pressure in your eye and stopping eye pain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. 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 tell your health care 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
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dorzolamide eye drops in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dorzolamide eye drops in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aspirin
- Memantine
- Metformin
- Topiramate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Acute angle-closure glaucoma—Use of dorzolamide eye drops in these patients have not been studied. This condition may need other medicine or treatment besides dorzolamide.
- Allergy to sulfa drugs—Use with caution. May increase risk for more serious side effects.
- Bacterial eye infection (eg, keratitis) or
- Cornea (part of the eye) problems, history of or
- Eye surgery, recent—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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.
- For glaucoma or hypertension of the eye:
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.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. Your doctor may want to do certain tests to see if the medicine is working properly or to see if certain side effects may be occurring without you or your child knowing it.
If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you or your child are allergic to dorzolamide eye drops.
This medicine may cause some people to have blurred vision for a short time. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you cannot see properly. Also, since blurred vision may be a sign of a side effect that needs medical attention, check with your doctor if it continues.
Ophthalmic dorzolamide may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort. If the discomfort continues, check with your doctor.
If you hurt your eye, develop an eye infection, or need to have eye surgery, talk with your doctor right away. You or your child may need to get a new bottle of the eye drops to help prevent an eye infection or keep an infection from getting worse.
Serious allergic reactions may occur while using this medicine. Check with your doctor right away if you or your child have any of the following symptoms: black, tarry stools, blistering, peeling, or loose 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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
- Burning, stinging, or discomfort when medicine is applied
- itching, redness, swelling, or other sign of the eye or eyelid irritation
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 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 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.
CON-XXXXXXXX
