Dorzolamide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi
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Overview
Dorzolamide is a carbonic anhydrase inhibitor that is FDA approved for the {{{indicationType}}} of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Common adverse reactions include taste alteration, hypersensitivity reaction, punctate keratitis, and visual discomfort.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Elevated Intraocular Pressure or Open-Angle Glaucoma
- Dosing Information
- One drop in the affected eye(s) three times daily
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dorzolamide in adult patients.
Non–Guideline-Supported Use
Prophylaxis of Ocular Hypertension
- Dosing Information
- One drop 1–4 hours after anterior segment laser surgery
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Elevated Intraocular Pressure or Open-Angle Glaucoma
- Dosing Information
- One drop in the affected eye(s) three times daily
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dorzolamide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dorzolamide in pediatric patients.
Contraindications
- Hypersensitivity
- Dorzolamide HCl Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product.
Warnings
- Dorzolamide HCl Ophthalmic Solution is a sulfonamide and, although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration with 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.
Precautions
- The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Dorzolamide HCl Ophthalmic Solution has not been studied in patients with acute angle-closure glaucoma.
- Dorzolamide HCl Ophthalmic Solution has not been studied in patients with severe renal impairment (CrCl < 30 mL/min). Because Dorzolamide HCl Ophthalmic Solution and its metabolite are excreted predominantly by the kidney, Dorzolamide HCl Ophthalmic Solution is not recommended in such patients.
- Dorzolamide HCl Ophthalmic Solution has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.
- 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.
- There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and Dorzolamide HCl Ophthalmic Solution. The concomitant administration of Dorzolamide HCl Ophthalmic Solution and oral carbonic anhydrase inhibitors is not recommended.
- 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. Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g., dorzolamide) after filtration procedures.
- There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Precautions should be used when prescribing Dorzolamide HCl Ophthalmic Solution to this group of patients.
Adverse Reactions
Clinical Trials Experience
- The most frequent adverse events associated with 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, 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 Dorzolamide HCl Ophthalmic Solution was comparable to that seen in adult patients.
Postmarketing Experience
- The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of Dorzolamide HCl 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 Dorzolamide HCl 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.
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dorzolamide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dorzolamide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dorzolamide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Dorzolamide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Dorzolamide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dorzolamide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dorzolamide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dorzolamide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dorzolamide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dorzolamide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dorzolamide in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Dorzolamide in the drug label.
Condition1
Description
IV Compatibility
There is limited information regarding IV Compatibility of Dorzolamide in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Dorzolamide in the drug label.
Pharmacology
There is limited information regarding Dorzolamide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Dorzolamide Mechanism of Action in the drug label.
Structure
There is limited information regarding Structure of Dorzolamide in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dorzolamide in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dorzolamide in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dorzolamide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Dorzolamide in the drug label.
Condition1
Description
How Supplied
There is limited information regarding Dorzolamide How Supplied in the drug label.
Storage
There is limited information regarding Dorzolamide Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Dorzolamide in the drug label.
Precautions with Alcohol
Alcohol-Dorzolamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Trusopt Ocumeter[1]
Look-Alike Drug Names
N/A[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "DORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]".
- ↑ "http://www.ismp.org". External link in
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