DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE

DDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE

Manufacturer: Indoco Remedies Limited

Score: 142.0

Quick Summary

Dorzolamide hydrochloride and timolol maleate ophthalmic solution is used for the reduction of 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 reducing aqueous humor secretion, thereby decreasing intraocular pressure. The recommended dosage is one drop in the affected eye(s) twice daily. The drug has several contraindications, including bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, and hypersensitivity to any component of the product. Adverse reactions may include taste perversion, ocular burning, and conjunctival hyperemia.

Key Clinical Findings and Indications

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Decreases aqueous humor secretion, thereby decreasing intraocular pressure

Important Safety Information

Warning

The concomitant use of dorzolamide hydrochloride and timolol maleate ophthalmic solution with oral carbonic anhydrase inhibitors is not recommended due to the potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition.

Contraindications

Bronchial asthma or a history of bronchial asthma
Severe chronic obstructive pulmonary disease
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock
Hypersensitivity to any component of the product

Adverse Reactions

Taste perversion (bitter, sour, or unusual taste)
Ocular burning and/or stinging
Conjunctival hyperemia
Blurred vision
Superficial punctate keratitis or eye itching

Dosing Recommendations

General Guidance

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

Open-angle glaucoma or ocular hypertension

Adult Dose

One drop in the affected eye(s) twice daily

Pediatric Dose

Not established for pediatric patients under 2 years of age

Special Population Considerations

Pregnancy

Dorzolamide hydrochloride and timolol maleate ophthalmic solution should be used 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 at doses of ≥ 2.5 mg/kg/day.

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.

Pediatric Use

The safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older.
Use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults.