Dorzolamide

— THERAPEUTIC CATEGORIES —
  • Glaucoma
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Dorzolamide Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dorzolamide HCl 2%; oph soln; contains benzalkonium chloride.

    Pharmacological Class

    Carbonic anhydrase inhibitor (sulfonamide).

    How Supplied

    Contact supplier

    How Supplied

    Dorzolamide hydrochloride ophthalmic solution is a slightly opalescent, nearly colorless, slightly viscous solution.

    Dorzolamide hydrochloride ophthalmic solution is supplied in a 10mL white LDPE plastic bottle, a natural dropper tip and an orange polypropylene cap.

     

    Storage

    Store dorzolamide hydrochloride ophthalmic solution at 2° to 25°C (36° to 77°F). Protect from light. After opening, dorzolamide hydrochloride ophthalmic solution can be used until the expiration date on the bottle.

    Manufacturer

    Various generic manufacturers

    Dorzolamide Indications

    Indications

    Open-angle glaucoma. Ocular hypertension.

    Dorzolamide Dosage and Administration

    Adults and Children

    1 drop 3 times daily.

    Adults and Children

    Instill 1 drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily.

    Dorzolamide hydrochloride ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

    Dorzolamide hydrochloride ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

    Dorzolamide Contraindications

    Not Applicable

    Dorzolamide Boxed Warnings

    Not Applicable

    Dorzolamide Warnings/Precautions

    Warnings/Precautions

    Discontinue if ocular effects (eg, conjunctivitis, lid reactions) occur. Low endothelial cell counts. Contact lenses: remove prior to administration; may reinsert 15mins after dose. Hepatic impairment. Severe renal impairment (CrCl <30mL/min): not recommended. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Sulfonamide Hypersensitivity

    • 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.

    • Discontinue use of this preparation if signs of serious reactions or hypersensitivity occur.

    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

    • Increased potential for developing corneal edema in patients with low endothelial cell counts. Use caution when prescribing dorzolamide hydrochloride ophthalmic solution to this group of patients.

    Allergic Reactions

    • In clinical studies, the chronic administration of dorzolamide hydrochloride ophthalmic solution have reported local ocular adverse reactions, primarily conjunctivitis and lid reactions. 

    • Discontinue and evaluate before considering restarting the drug if such reactions are observed.

    Acute Angle-Closure Glaucoma

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

    Pregnancy Considerations

    Risk Summary

    • There are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution.

    Nursing Mother Considerations

    Risk Summary

    • There are no data on the presence of dorzolamide hydrochloride ophthalmic solution in human milk, the effects on the breastfed infant, or the effects on milk production. 

    • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for dorzolamide hydrochloride ophthalmic solution and any potential adverse effects on the breast-fed child from dorzolamide hydrochloride ophthalmic solution. Dorzolamide is present in the milk of lactating rats.

    Pediatric Considerations

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

     

    Geriatric Considerations

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

    Renal Impairment Considerations

    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, dorzolamide is not recommended in such patients.

    Hepatic Impairment Considerations

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

    Dorzolamide Pharmacokinetics

    Distribution

    Plasma concentrations of dorzolamide and metabolite are generally below the assay limit of quantitation (15nM). Dorzolamide binds moderately to plasma proteins (approximately 33%).

    Elimination

    Dorzolamide is primarily excreted unchanged in the urine; the metabolite also is excreted in urine. After dosing is stopped, dorzolamide washes out of RBCs nonlinearly, resulting in a rapid decline of drug concentration initially, followed by a slower elimination phase with a half-life of about 4 months.

    Dorzolamide Interactions

    Interactions

    Concomitant oral carbonic anhydrase inhibitors: not recommended. May increase salicylate toxicity (acidosis).

    Dorzolamide Adverse Reactions

    Adverse Reactions

    Burning, stinging, bitter taste, punctate keratitis, ocular allergic reaction, blurred vision, tearing, dryness, photophobia; corneal edema, possible sulfa-like systemic effects.

    Dorzolamide Clinical Trials

    Clinical Trials

    The efficacy of dorzolamide hydrochloride ophthalmic solution was demonstrated in clinical studies in the treatment of elevated intraocular pressure in patients with glaucoma or ocular hypertension (baseline IOP ≥23 mmHg). The IOP-lowering effect of dorzolamide hydrochloride ophthalmic solution was approximately 3 to 5 mmHg throughout the day and this was consistent in clinical studies of up to one year duration.

    The efficacy of dorzolamide hydrochloride ophthalmic solution when dosed less frequently than three times a day (alone or in combination with other products) has not been established.

    In a one year clinical study, the effect of dorzolamide hydrochloride ophthalmic solution, 2% three times daily on the corneal endothelium was compared to that of betaxolol ophthalmic solution twice daily and timolol maleate ophthalmic solution 0.5% twice daily. There were no statistically significant differences between groups in corneal endothelial cell counts or in corneal thickness measurements. There was a mean loss of approximately 4% in the endothelial cell counts for each group over the one year period.

    Dorzolamide Note

    Notes

    Formerly known under the brand name Trusopt.

    Dorzolamide Patient Counseling

    Patient Counseling

    Sulfonamide Reactions

    • Advise patients to discontinue the use of the product if serious or unusual reactions including severe skin reactions or signs of hypersensitivity occur.

    Intercurrent Ocular Conditions

    • Immediately seek their physician’s advice concerning the continued use of the present multidose container if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection).

    Handling Ophthalmic Solutions

    • Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

    • Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

    Concomitant Topical Ocular Therapy

    • If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

    Contact Lens Use

    • Advise patients that dorzolamide hydrochloride ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Remove contact lenses prior to administration of the solution. Lenses may be reinserted 15 minutes following dorzolamide hydrochloride ophthalmic solution administration.

    When to Seek Physician Advice

    • Advise patients that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should discontinue use and seek their physician’s advice.

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