Dorzolamide

Trusopt

The most common side effects of dorzolamide include:

• irritation,
• eye burning,
• eye stinging,
• discomfort of the eye.

These effects generally are temporary and occur immediately after administration. Approximately 1 in 4 patients complain of a bitter taste, and 1 in 10 patients experience an allergic eye reaction or eye inflammation (superficial punctate keratitis).

Other important, but less common side effects include:

• blurred vision,
• excessive tearing,
• dry eyes, and
• increased sensitivity to light.

Bacterial infections of the eye have been reported and may be due to accidental contamination of the containers with bacteria during handling. Dorzolamide is a sulfonamide and can be absorbed into the body. Individuals who are allergic to sulfonamides may react to dorzolamide. Therefore, dorzolamide should not be administered to patients with allergies to sulfonamides, and it can cause some of the side effects of sulfonamides. Severe skin reactions also have been reported.

The usual dose is one drop into the affected eye(s) three times daily.

Patients should wash both hands before each use of dorzolamide or any other eye medication to prevent contamination of the eye. Contact lenses should be removed since dorzolamide solution contains benzalkonium chloride which can be absorbed by contact lenses. The head is tilted back, and the lower eyelid is pulled down with the index finger to form a pouch. The bottle is squeezed slightly to allow the prescribed number of drops into the pouch. The tip of the dropper should not touch the eye or eyelid. The eye then is closed gently for one to two minutes without blinking.

Dorzolamide may be found in some form under the following brand names:

• Cosopt

• Trusopt

Serious side effects have been reported with dorzolamide. See "Dorzolamide Precautions" section.

Common side effects of dorzolamide include:

• bitter taste in the mouth
• burning sensation in the eye
• inflammation of the cornea
• eye discomfort

This is not a complete list of dorzolamide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a sulfa (sulfonamide) allergy, talk with your doctor.
• Have your eye pressure and eyesight checked as you have been told by the doctor.
• Use care when driving or doing other tasks that call for clear eyesight.
• Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
• Bright lights may bother you. Wear sunglasses.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using dorzolamide while you are pregnant.

Solution containing 20 mg/mL Dorzolamide (22.3 mg of Dorzolamide hydrochloride, USP).

Sulfonamide Hypersensitivity

Dorzolamide HCl Ophthalmic Solution 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 Dorzolamide HCl Ophthalmic Solution. 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 Dorzolamide HCl Ophthalmic Solution 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 Dorzolamide HCl Ophthalmic Solution. 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, Dorzolamide HCl Ophthalmic Solution 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.

Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

Refer to adult dosing.

Store at 15°C to 30°C (59°F to 86°F). Protect from light.

Adverse events have been observed in animal reproduction studies following systemic administration. IOP is usually lower during pregnancy. If topical medications for the treatment of glaucoma in pregnant women cannot be discontinued because small increases in IOP cannot be tolerated, the minimum effective dose should be used in combination with punctual occlusion to decrease exposure to the fetus (Johnson, 2001).