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Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION

Manufacturer: Alembic Pharmaceuticals Inc.

Score: 142.0

Quick Summary

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The solution is a combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. It works by decreasing aqueous humor secretion, which reduces intraocular pressure. The recommended dose is one drop in the affected eye(s) two times daily. The solution is contraindicated in patients with bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock, and hypersensitivity to any component of the product.

Key Clinical Findings and Indications

  • Reduces elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
  • Decreases aqueous humor secretion
  • Combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent

Important Safety Information

Warning

Contraindicated in patients with bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock, and hypersensitivity to any component of the product

Contraindications

  • Bronchial asthma
  • Severe chronic obstructive pulmonary disease
  • Sinus bradycardia
  • Second or third degree atrioventricular block
  • Overt cardiac failure
  • Cardiogenic shock
  • Hypersensitivity to any component of the product

Adverse Reactions

  • Taste perversion
  • Ocular burning and/or stinging
  • Conjunctival hyperemia
  • Blurred vision
  • Superficial punctate keratitis or eye itching

Dosing Recommendations

General Guidance

None specified

Open-angle glaucoma or ocular hypertension

Adult Dose

One drop in the affected eye(s) two times daily

Pediatric Dose

Not established for pediatric patients under 2 years of age

Special Population Considerations

Pregnancy

  • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Developmental toxicity studies with dorzolamide hydrochloride in rabbits revealed malformations of the vertebral bodies

Nursing Mothers

  • It is not known whether dorzolamide is excreted in human milk
  • Timolol maleate has been detected in human milk following oral and ophthalmic drug administration
  • A decision should be made whether to discontinue nursing or to discontinue the drug

Pediatric Use

  • Safety and effectiveness established in pediatric patients aged 2 years and older
  • Use in pediatric patients under 2 years of age is not established

Geriatric Use

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

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