Finished product reference
Dorzolamide / Timolol
Solution, Drops · Ophthalmic · 2 %/0.5 % · 10 mL
- List code
- 53227
- Salt form
- Hydrochloride
What it is and how it works
Mechanism of Action Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is comprised of two components: dorzolamide hydrochloride and timolol maleate. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma, by reducing aqueous humor secretion. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage. Dorzolamide hydrochloride is an inhibitor of human carbonic anhydrase II.
Indications
Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day . Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor inhibitor, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
Dosage and administration (summary)
The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free in the affected eye(s) two times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart . The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration. The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free in the affected eye(s) two times daily.
Contraindications
Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is contraindicated in patients with: Bronchial asthma or a history of 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 this product.
Warnings and precautions
Potentiation of Respiratory Reactions Including Asthma Cardiac Failure Sulfonamide Hypersensitivity Obstructive Pulmonary Disease Increased Reactivity to Allergens Potentiation of Muscle Weakness Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus Masking of Thyrotoxicosis Renal and Hepatic Impairment Impairment of Beta-Adrenergically Mediated Reflexes During Surgery Potentiation of Respiratory Reactions Including Asthma Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free contains timolol maleate, a beta-adrenergic blocking agent.
Pregnancy
Pregnancy Risk Summary There are no adequate and well-controlled studies of dorzolamide hydrochloride and timolol maleate ophthalmic solution in pregnant women to inform a drug-associated risk. No evidence of teratogenicity has been observed in mice, rat, and rabbits with dorzolamide hydrochloride or timolol at clinically relevant doses .
Storage and supply
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP (Preservative Free) is supplied in a 0.2 mL low density polyethylene single-dose containers in a foil pouch containing 15 low density polyethylene 0.2 mL single-dose containers.
Source: Dorzolamide Hydrochloride And Timolol Maleate Preservative Free (Dorzolamide Hydrochloride And Timolol Maleate) — US FDA prescribing information, 2026-04-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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