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DORZOLAMIDE/TIMOLOL is a brand name for Timolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative-Free, Eye drops, solution in single-dose containeris indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative 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 Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative- Free, Eye drops, solution in single-dose container in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic agent is being used, Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative-Free, Eye drops, solution in single-dose container and the other agent should be administered at least ten minutes apart.
This medicinal product is a sterile solution that does not contain a preservative. The solution from one individual single-dose container is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single-dose container is opened, any remaining contents must be discarded immediately after administration.
Patients should be instructed to wash their hands before use and avoid allowing the container to come into contact with the eye or surrounding structures as this could cause injury to the eye (see instructions for use). 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. Method of administration 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. Instructions for use Patients should be informed of the correct handling of the single-dose container. 6 for specific diagrams and instructions for use.
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.
Summary of the safety profile In a clinical study for Dorzolamide/Timolol Eye drops, Preservative-Free the observed adverse reactions have been consistent with those that were reported previously with Dorzolamide/ Timolol eye drops (preserved formulation), dorzolamide hydrochloride and/or timolol maleate.
During clinical studies, 1035 patients were treated with Dorzolamide/Timolol Eye drops (preserved formulation). 2% of all patients discontinued because of local adverse reactions suggestive of allergy or hypersensitivity (such as lid inflammation and conjunctivitis).
Dorzolamide/Timolol Eye drops, Preservative-Free has been shown to have a similar safety profile to that Dorzolamide/Timolol Eye drops (preservative containing formulation) in a repeat dose double-masked, comparative study. Like other topically applied ophthalmic medicines, 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* Cardiac disorders Timolol maleate eye drops, solution bradycardia * chest pain*, palpitation*, oedema*, arrhythmia*, congestive heart failure*, cardiac arrest*, heart block atrioventricular block, cardiac failure.
Dorzolamide hydrochloride eye drops, solution Palpitations, Tachycardia Dorzolamide hydrochloride eye drops, solution HypertensionVascular disorders Timolol maleate eye drops, solution hypotension*, claudication, Raynaud’s phenomenon*, cold hands and feet* Respiratory , thoracic, and mediastinal disorders Dorzolamide/ Timolol Eye drops, Solution Preservative- Free sinusitis shortness of breath, respiratory failure, rhinitis, rarely bronchospasm Dorzolamide hydrochloride eye drops, solution Epistaxis* dyspnoea Timolol maleate eye drops, solution Dyspnoea* bronchospasm (predominantly in patients with pre- System Organ Class (MedDRA) Formulation Very Common Common Uncommon Rare Not Known** existing bronchospastic disease)*, respiratory failure, cough* Gastrointest inal disorders Dorzolamide/ Timolol Eye drops, Solution Preservative- Free dysgeusia Dorzolamide hydrochloride eye drops, solution nausea* throat irritation, dry mouth* Timolol maleate eye drops, solution nausea*, dyspepsia* diarrhoea, dry mouth* dysgeusia, abdominal pain, vomiting Skin and subcutaneo us tissue disorders Dorzolamide/ Timolol Eye drops, Preservative- Free contact dermatitis, Stevens- Johnson syndrome, toxic epidermal necrolysis Dorzolamide hydrochloride eye drops, solution rash* Timolol maleate eye drops, solution alopecia*, psoriasiform rash or exacerbation of psoriasis* skin rash Musculoske letal and connective tissue disorders Timolol maleate eye drops, solution systemic lupus erythematosus myalgia Renal and urinary disorders Dorzolamide/ Timolol Eye drops, Solution Preservative- Free urolithiasis 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 administrati on site conditions Timolol maleate eye drops, solution asthenia/ fatigue* *These adverse reactions were also observed with Dorzolamide/Timolol Eye drops (preserved formulation) during […]
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. Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative-Free, Eye drops, solution in single-dose container 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 This medicinal product has not been studied in patients with hepatic impairment and should therefore 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 sulfonamides. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides 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.
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If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation. Local ocular adverse effects, similar to those observed with dorzolamide hydrochloride eye drops, have been seen with this medicinal product.
If such reactions occur, discontinuation of Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative-Free, Eye drops, solution in single-dose container 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 may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.
Concomitant Therapy The effect on intra-ocular 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 (preserved formulation), urolithiasis has been reported infrequently. Because Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative-Free, Eye drops, solution in single-dose container 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 this medicinal product.
Other The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. This medicinal product 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 Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative- Free, Eye drops, solution in single-dose container to these groups of patients. g. timolol, acetazolamide) after filtration procedures.
As with the use of other antiglaucoma […]