VIZO-PF

What it is

VIZO-PF DORZOLATIM is dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop solution supplied in a multi-dose bottle. It is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution containing 20.00 mg (2.0% w/v) dorzolamide and 5.00 mg (0.5% w/v) timolol as the active ingredients. It is a combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent.

Approved indications

— Treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

Dosing overview

The dose is one drop of VIZO-PF DORZOLATIM in the affected eye(s) two times daily. If another topical ophthalmic agent is being used, VIZO-PF DORZOLATIM and the other agent should be administered at least ten minutes apart.

Key safety warnings

The timolol component is a beta-blocker and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of beta-blockers may occur with topical administration. Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and rarely death in association with cardiac failure, have been reported following administration of timolol maleate ophthalmic solution. At the first sign or symptom of cardiac failure, VIZO-PF DORZOLATIM eye drops should be discontinued. Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy. The dorzolamide component is a sulfonamide and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides may occur with topical administration, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of dorzolamide hydrochloride ophthalmic solution. Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. Similar reactions have been reported with dorzolamide/timolol eye drops. If such reactions are observed, discontinuation of treatment should be considered. Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycaemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycaemic agents. Beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycaemia. Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents.

Contraindications

VIZO-PF DORZOLATIM is contraindicated in patients with reactive airway disease, bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease; sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock; or hypersensitivity to any component of this product. Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 millilitre/min) or with hyperchloremic acidosis. Because dorzolamide hydrochloride and its metabolite are excreted predominantly by the kidney, dorzolamide is therefore contraindicated in such patients.

Regulatory history

VIZO-PF DORZOLATIM was first listed on the Australian Register of Therapeutic Goods on 2021-09-22 (ARTG 341770). The Pharmaceutical Benefits Scheme Advisory Committee recommended against listing in July 2022, with the recommendation subsequently revoked.