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 substituting dorzolamide for another ophthalmic anti-glaucoma agent, discontinue the other agent after proper 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.

The dosage and duration of the treatment should be as recommended by the doctor. If one dose is missed, treatment should continue with the next dose as normal. Patients should be instructed to wash their hands before use and avoid allowing the tip of the bottle 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 containers. Paediatric population Limited clinical data in paediatric patients with administration of dorzolamide three times a day are available. 1). 1. Method of administration First wash your hands.

2. Avoid touching the eye (or any other surface) with the tip of the bottle. 3. If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting. 4. These drops are supplied in a plastic bottle with an insert cap assembly, with a tamper proof dust cover.

When using the bottle for the first time, snap off the dust cover by turning it clockwise to break the seal. 5. Unscrew the inner cap. 6. Tilt your head back and look at the ceiling. 7. Pull the lower eyelid gently downwards to form a pocket between your eyelid and your eye.

8. Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP. 9. Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 2 minute.

Dorzolamide 20mg/ml Eye Drops Solution BP was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. In long-term studies of 1108 patients treated with Dorzolamide 20mg/ml Eye Drops Solution BP as monotherapy or as adjunctive therapy with an ophthalmic beta-blocker, the most frequent cause of discontinuation (approximately 3%) from treatment with Dorzolamide 20mg/ml Eye Drops Solution BP 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 with dorzolamide: [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) , Not known: (cannot be estimated from the available data] Nervous system disorders: Common: headache Rare: dizziness, paraesthesia Cardiac disorders: Not known: Palpitations, tachycardia 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: foreign body sensation in eye, photophobia 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 Investigations: Dorzolamide was not associated with clinically meaningful electrolyte disturbances.

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 sulphonamido 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 preparation. 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.

, conjunctivitis and eye-lid 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 20mg/ml Eye Drops Solution BP Topical dorzolamide should be used with caution in such patients.

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.