DORZOLAMIDE

Posology When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), three times daily. When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), two times daily.

When changing from another ophthalmic anti-glaucoma agent to dorzolamide, discontinue the other agent after completion of dosing on one day, and start dorzolamide on the next day. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.

Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections.

Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should be informed of the correct handling of the Dorzolamide 20 mg/ml eye drops, solution bottles. Method of administration 1.

The tamper-proof seal on the bottle neck must be unbroken before the product is being used for the first time. A gap between the bottle and the cap is normal for an unopened bottle. 2. The cap of the bottle should be taken off. 3. The patient’s head must be tilted back and the lower eyelid must be pulled gently down to form a small pocket between the eyelid and the eye.

4. The bottle should be inverted and squeezed until a single drop is dispensed into the eye. THE EYE OR EYELID MUST NOT BE TOUCHED WITH THE DROPPER TIP. 5. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced.

This may result in a decrease in systemic side effects and an increase in local activity. 6. Steps 3 and 4 should be repeated with the other eye if it is necessary. 7. The cap must be put back on and the bottle must be closed straight after it has been used.

Paediatric use Limited clinical data in paediatric patients with administration of dorzolamide three times a day are available. 1).

Dorzolamide was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. In long-term studies of 1108 patients treated with Dorzolamide as monotherapy or as adjunctive therapy with an ophthalmic beta- blocker, the most frequent cause of discontinuation (approximately 3%) from treatment with Dorzolamide was drug-related ocular adverse reactions, primarily conjunctivitis and lid reactions.

The following adverse reactions have been reported either during clinical trials or during post-marketing experience: [Very Common: (≥ 1/10), Common: (≥ 1/100 to <1/10), Uncommon: (≥ 1/1,000 to <1/100), Rare: (≥ 1/10,000 to <1/1,000)], Very rare: (<1/10,000), Not known: (cannot be estimated from the available data)] Nervous system disorders: Common: headache Rare: dizziness, paraesthesia Eye disorders: Very Common: burning and stinging, Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision Uncommon: iridocyclitis Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery Not known: Photophobia, Foreign body sensation in eye Cardiac disorders Not known: palpitations, tachycardia Vascular disorders Not known: hypertension Respiratory, thoracic, and mediastinal disorders: Rare: epistaxis Not known: dyspnoea Gastrointestinal disorders: Common: nausea, bitter taste Rare: throat irritation, dry mouth Skin and subcutaneous tissue disorders: Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis Renal and urinary disorders: Rare: urolithiasis General disorders and administration site conditions: Common: asthenia/fatigue Rare: Hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm.

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.

Dorzolamide has not been studied in patients with acute angle-closure glaucoma. Dorzolamide contains a sulphonamide group, which also occurs in sulphonamides and although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulphonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

If signs of serious reactions or hypersensitivity occur, discontinue the use of this medicinal product. Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi.

Although no acid-base disturbances have been observed with dorzolamide, urolithiasis has been reported infrequently. Because dorzolamide is a topical carbonic anhydrase inhibitor that is absorbed systemically, patients with a prior history of renal calculi may be at increased risk of urolithiasis while using dorzolamide.

g. conjunctivitis and eyelid reactions) are observed, discontinuation of treatment should be considered. There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide.

The concomitant administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended. Corneal oedemas and irreversible corneal decompensations have been reported in patients with pre-existing chronic corneal defects and/or a history of intra-ocular surgery while using dorzolamide.

1. Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 ml/min) or with hyperchloraemic acidosis. Because dorzolamide and its metabolites are excreted predominantly by the kidney, dorzolamide is therefore contra-indicated in such patients.