ACTIONS & CLINICAL PHARMACOLOGY

Dorzolamide Hydrochloride is a non-bacteriostatic sulfonamide derivative and topical carbonic anhydrase (CA) inhibitor that treats elevated intraocular pressure (IOP) associated with open-angle glaucoma and ocular hypertension. It works by blocking an enzyme in the ciliary process that regulates ion balance and fluid pressure in the eyes. Unlike oral CA inhibitors, dorzolamide has negligible effects of acid-base or electrolyte disturbances and other systemic adverse effects.

INDICATIONS

Dorzolamide Eye Drops is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

CONTRAINDICATIONS

Dorzolamide Eye Drops is contraindicated in patients with hypersensitivity to active substance or to any of the excipients used in the formulation.

WARNINGS

Acute Angle-Closure Glaucoma: The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.

Corneal Endothelium: Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing Dorzolamide Eye Drops to this group of patients.

PREGNANCY

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Dorzolamide Eye Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dorzolamide Eye Drops, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Dorzolamide Eye Drops have been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial.

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

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

DOSAGE AND ADMINISTRATION

The dose is one drop of Dorzolamide Eye Drop in the affected eye(s) three times daily. Dorzolamide Eye Drop 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 5 minutes apart.

SPECIAL INSTRUCTIONS

Patients should be advised to avoid contamination of the dispensing tip.

STORAGE

Store in a cool & dark place below 30°C.

PRESENTATION

Dorfort Eye Drops are available in 5 ml sterile plastic bottles.