DIMAZ is a brand name for Dorzolamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dimaz is indicated for the treatment of elevated intra-ocular pressure in the case of: - ocular hypertension, - open-angle glaucoma, - pseudo-exfoliative glaucoma. Dimaz is used as adjunctive therapy or monotherapy in patients who do not respond to treatment with beta-adrenolytics, or in whom administration of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology In monotherapy, the dose is 1 drop of dorzolamide in the conjunctival sac of the affected eye (eyes), three times daily. As adjunctive therapy with an ophthalmic beta-adrenolytic, the dose is 1 drop of dorzolamide in the conjunctival sac of the affected eye (eyes) 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 administrated at least 10-minute apart.
Eye ointment should be used as the last. 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. Dimaz is a sterile solution that does not contain a preservative. The solution from the multi-dose bottle can be used for up to 28 days after first opening for administration to the affected eye(s).
1). Method of administration Ocular use. Before instillation of the eye drops - Users should be instructed to wash their hands before opening the bottle. - Users should also be instructed to not use this medicine if they notice that the tamperproof seal on the bottle neck is broken before they first use it.
- When used for the first time, before delivering a drop to the eye, the patient should practice using the dropper bottle by squeezing it slowly to deliver one drop away from the eye. - When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).
Instructions of use: 1. To avoid contamination of the solution, the tip of the bottle must not touch anything. 2. The patient should tilt their head backwards and hold the bottle above their eye. 3. Pull the lower eyelid down and look up (Picture 2).
Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. ). Patients should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine.
In a multiple-dose, double-masked, active-treatment (dorzolamide multidose) controlled, two period crossover multiclinic study, the safety profile of dorzolamide preservative-free was similar to that of dorzolamide multidose. Dorzolamide (preserved formulation) was evaluated in 1,400 individuals in controlled and uncontrolled clinical studies.
In the long term studies in 1,108 patients treated with dorzolamide as monotherapy or as adjunctive therapy with an ophthalmic beta- adrenolytics, the most frequent cause of discontinuations from treatment were drug- related ocular adverse effects in approximately 3% of patients were primarily conjunctivitis and eyelid reactions.
The following adverse effects 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.
Eye disorders:
Very Common: burning and stinging. Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eyelid itching, eyelid irritation, blurred vision. Uncommon: iridocyclitis. Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of the therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery.
Not known: foreign body sensation in the eye, photophobia.
Cardiac disorders:
Not known: palpitations, tachycardia.
Vascular disorders:
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 have 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, treatment discontinuation should be considered. Patients with a history of contact hypersensitivity to silver should not use this product, as dispensed drops may contain traces of silver from the bottle.
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 (preserved formulation). Topical dorzolamide should be used with caution in such patients.
1. Dorzolamide has not been studied in patients with severe renal impairment (with creatinine clearance lower than 30 ml/minute) or with hyperchloraemic acidosis. Because dorzolamide and its metabolites are excreted predominantly by the kidney, dorzolamide is therefore contraindicated in such patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4. Close your eye and press the inner corner of the eye with your finger for about two minutes. 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.
2. Repeat instructions 2-4 to deliver a drop into the other eye, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.
3. ), the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid from the tip. This is necessary in order to ensure delivery of subsequent drops. 7. Wipe off any excess solution from the skin around the eye.
8. The product should be used within 28 days after the bottle is first opened Therefore, you must throw away the bottle 28 days after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.
Picture 1. Picture 2. Picture 3. Picture 4.
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 a 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. 1. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Choroidal detachment concomitant with ocular hypotony have been reported after filtration procedures with administration of aqueous suppressant therapies. Contact Lens Use Dimaz has not been studied in patients wearing contact lenses.
Paediatric population Dorzolamide has not been studied in patients less than 36 weeks gestational age and less than 1 week of age. Patients with significant renal tubular immaturity should only receive dorzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.