Trusopt

Trusopt is part of the drug class:

• Carbonic anhydrase inhibitors

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using dorzolamide ophthalmic. Do not use the medications at the same time.

Dorzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Tell your doctor about all other medicines you use, especially:

• acetazolamide (Diamox);

• brinzolamide (Azopt); or

• methazolamide (Neptazane).

This list is not complete and other drugs may interact with dorzolamide ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Carbonic anhydrase inhibitor;1 2 3 4 5 6 7 8 9 10 nonbacteriostatic sulfonamide derivative.1 2 3 4 5 6 7 8 9

• Risk of adverse effects, including sensitivity reactions; discontinue therapy and consult clinician if serious or unusual ocular or systemic reactions (e.g., conjunctivitis, lid reactions) or signs of sensitivity occur.1 32

• Importance of learning and adhering to proper administration techniques to avoid contamination of the solution with common bacteria that can cause ocular infections (e.g., bacterial keratitis).1 32 Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.1 8

• Importance of informing clinicians if an intercurrent ocular condition (e.g., trauma, infection) develops or ocular surgery is planned.1 32

• Importance of administering different topical ophthalmic preparations at least 10 minutes apart.1 32

• Importance of removing soft contact lenses prior to administering the drug and of delaying reinsertion of the lenses for at least 15 minutes after administration.1 32

• Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 32

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 32

• Importance of informing patient of other important precautionary information.1 32 (See Cautions.)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eye or eyelid swelling.
• Very bad and rarely deadly effects have happened with sulfa (sulfonamide) drugs like this one. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Trusopt, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trusopt. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Trusopt.

Review Date: October 4, 2017

Sulfonamide Hypersensitivity

Trusopt contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of Trusopt. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation [see Contraindications (4) and Patient Counseling Information (17.3)].

Bacterial Keratitis

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

Corneal Endothelium

Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing Trusopt to this group of patients.

Allergic Reactions

In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of Trusopt. Many of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. If such reactions are observed, Trusopt should be discontinued and the patient evaluated before considering restarting the drug [see Adverse Reactions (6)].

Acute Angle-Closure Glaucoma

The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.

Pregnancy

Teratogenic Effects. Pregnancy Category C. Developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. These malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. No treatment-related malformations were seen at 1 mg/kg/day. These doses represent estimated plasma Cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively.

There are no adequate and well-controlled studies in pregnant women. Trusopt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

In a study of dorzolamide hydrochloride in lactating rats, decreases in body weight gain of 5 to 7% in offspring at an oral dose of 7.5 mg/kg/day were seen during lactation. A slight delay in postnatal development (incisor eruption, vaginal canalization and eye openings), secondary to lower fetal body weight, was noted. This dose represents an estimated plasma Cmax level in rats, 52 times higher than the lower limit of detection in human plasma following ocular administration.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Trusopt, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Trusopt have been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Renal and Hepatic Impairment

Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 mL/min). Because dorzolamide and its metabolite are excreted predominantly by the kidney, Trusopt is not recommended in such patients.

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.

Applies to dorzolamide ophthalmic: ophthalmic solution

Along with its needed effects, dorzolamide ophthalmic (the active ingredient contained in Trusopt) 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 ophthalmic:

• Burning, stinging, or discomfort when medicine is applied
• itching, redness, swelling, or other sign of the eye or eyelid irritation

• 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

• Blood in the urine
• blurred vision
• nausea or vomiting
• pain in the side, back, or abdomen
• skin rash
• tearing

• 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 while taking dorzolamide ophthalmic:

• 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 of dorzolamide 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 taste
• feeling of something in the eye

• Changes in color vision
• difficulty seeing at night
• dryness of the eyes
• eyelid reactions
• headache
• increased sensitivity of the eyes to sunlight

• 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