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Controlled clinical trials

The most frequent adverse events associated with TRUSOPT (dorzolamide hydrochloride ophthalmic solution) were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10-15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. Events occurring in approximately 1-5% of patients were conjunctivitis and lid reactions (see PRECAUTIONS, General), blurred vision, eye redness, tearing, dryness, and photophobia. Other ocular events and systemic events were reported infrequently, including headache, nausea, asthenia/fatigue; and, rarely, skin rashes, urolithiasis, and iridocyclitis.

In a 3-month, double-masked, active-treatment-controlled, multicenter study in pediatric patients, the adverse experience profile of TRUSOPT (dorzolamide hydrochloride ophthalmic solution) was comparable to that seen in adult patients.

Clinical practice: The following adverse events have occurred either at low incidence ( < 1%) during clinical trials or have been reported during the use of TRUSOPT (dorzolamide hydrochloride ophthalmic solution) in clinical practice where these events were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely. They have been chosen for inclusion based on factors such as seriousness, frequency of reporting, possible causal connection to TRUSOPT (dorzolamide hydrochloride ophthalmic solution) , or a combination of these factors: signs and symptoms of systemic allergic reactions including angioedema, bronchospasm, pruritus, and urticaria; Stevens-Johnson syndrome and toxic epidermal necrolysis; dizziness, paresthesia; ocular pain, transient myopia, choroidal detachment following filtration surgery, eyelid crusting; dyspnea; contact dermatitis, epistaxis, dry mouth and throat irritation.

Although acid-base and electrolyte disturbances were not reported in the clinical trials with TRUSOPT (dorzolamide hydrochloride ophthalmic solution) , these disturbances have been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e.g., toxicity associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving TRUSOPT (dorzolamide hydrochloride ophthalmic solution) .

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.