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TIDOMAT is a brand name for Dorzolamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tidomat is indicated in the treatment of elevated intra-ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose is one drop of Tidomat in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic medicinal product is being used, Tidomat and the other agent 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. In order to secure correct dose - the dropper tip should not be enlarged.
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 Tidomat bottles. Paediatric population Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of 2 years has not been established.
1). 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. Steps 3 & 4 should be repeated with the other eye if it is necessary. 6. The cap must be put back on and the bottle must be closed straight after it has been used. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced.
This may result in a decrease in systemic adverse reactions and an increase in local activity.
In clinical studies for dorzolamide/timolol eye drops, solution the observed adverse reactions have been consistent with those that were reported previously with dorzolamide hydrochloride and/or timolol maleate. During clinical studies, 1,035 patients were treated with dorzolamide/timolol eye drops, solution.
2% of all patients discontinued because of local adverse reactions suggestive of allergy or hypersensitivity (such as lid inflammation and conjunctivitis). Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic circulation.
This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 4) itching, tearing, redness, blurred vision, corneal erosion Ear and labyrinth disorders Timolol maleate eye drops, solution tinnitus* Dorzolamide hydrochloride eye drops, solution palpitationsCardiac disorders Timolol maleate eye drops, solution bradycardia* chest pain*, palpitation*, oedema*, arrhythmia*, congestive heart failure*, cardiac arrest*, heart block atrioventricular block, cardiac failure Vascular disorders Timolol maleate eye drops, solution hypotension*, claudication, Raynaud's phenomenon*, cold hands and feet* Dorzolamide/ timolol eye drops, solution sinusitis shortness of breath, respiratory failure, rhinitis, rarely bronchospasm Dorzolamide hydrochloride eye drops, solution epistaxis* Respiratory, thoracic and mediastinal disorders Timolol maleate eye drops, solution dyspnoea* bronchospasm (predominantly in patients with pre-existing bronchospastic disease)*, respiratory failure, cough* Dorzolamide/ timolol eye drops, solution dysgeusia Dorzolamide hydrochloride eye drops, solution nausea* throat irritation, dry mouth* Gastrointestinal disorders Timolol maleate eye drops, solution nausea*, dyspepsia* diarrhoea, dry mouth* dysgeusia, abdominal pain, vomiting Dorzolamide/ timolol eye drops, solution contact dermatitis, Stevens- Johnson syndrome, toxic epidermal necrolysis Dorzolamide hydrochloride eye drops, solution rash* Skin and subcutaneous tissue disorders Timolol maleate eye drops, solution alopecia*, psoriasiform rash or exacerbation of psoriasis* skin rash Musculoskeletal and connective tissue disorders Timolol maleate eye drops, solution systemic lupus erythematosus myalgia Renal and Dorzolamide/ urolithiasis urinary disorders timolol eye drops, solution Reproductive system and breast disorders Timolol maleate eye drops, solution Peyronie's disease*, decreased libido sexual dysfunction Dorzolamide hydrochloride eye drops, solution asthenia/ fatigue* General disorders and administration site conditions Timolol maleate eye drops, solution asthenia/ fatigue* *These adverse reactions were also observed with dorzolamide/timolol ophthalmic solution during post-marketing experience.
Cardiovascular/Respiratory Reactions Like other topically applied ophthalmic agents timolol is absorbed systemically. Due to beta- adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur.
Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 2. g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered.
Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions. Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
e. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution. Respiratory disorders Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.
Tidomat should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk. Hepatic impairment Dorzolamide/timolol eye drops, solution has not been studied in patients with hepatic impairment and therefore, should be used with caution in such patients.
Immunology and Hypersensitivity As with other topically-applied ophthalmic agents, this medicinal product may be absorbed systemically. Dorzolamide contains a sulfonamido group, which also occurs in sulphonamides. Therefore, the same types of adverse reactions found with systemic administration of sulphonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
1. The above are based on the components and are not unique to the combination.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dorzolamide in United Kingdom.
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**Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with Tidomat. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation. Local ocular adverse reactions, similar to those observed with dorzolamide hydrochloride eye drops, have been seen with dorzolamide/timolol eye drops, solution.
If such reactions occur, discontinuation of Tidomat should be considered. While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Concomitant therapy The effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed.
5). The use of dorzolamide and oral carbonic anhydrase inhibitors is not recommended. Withdrawal of therapy As with systemic beta-blockers, if discontinuation of ophthalmic timolol is needed in patients with coronary heart disease, therapy should be withdrawn gradually.
Additional effects of beta-blockade Hypoglycaemia/diabetes Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia.
Beta-blockers may also mask the signs of hyperthyroidism. Abrupt withdrawal of beta-blocker therapy may precipitate a worsening of symptoms. Corneal diseases Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.
g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol. Therapy with beta-blockers may aggravate symptoms of myasthenia gravis. Additional effects of carbonic anhydrase inhibition 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/timolol eye drops, solution, urolithiasis has been reported infrequently. Because Tidomat contains 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 Tidomat.
Other The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Dorzolamide/timolol eye drops, solution has not been studied in patients with acute angle-closure glaucoma.
Corneal oedema and irreversible corneal decompensation have been reported in patients with pre- existing chronic corneal defects and/or a history of intraocular surgery while using dorzolamide. There is an increased potential for developing corneal oedema in patients with low endothelial cell counts.
Precautions should be used when prescribing Tidomat to these groups of patients. g. timolol, acetazolamide) after filtration procedures. As with the use of other antiglaucoma medicinal products, diminished responsiveness to ophthalmic timolol maleate after prolonged therapy has been reported in some patients.
However, in clinical studies in which 164 patients have been followed for at least three years, no significant difference in mean intraocular pressure has been observed after initial stabilisation. Contact lens use Tidomat contains the […]