Brimolol

Brimolol Special Precautions

brimonidine + timolol

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Special Precautions
Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing <20 kg, should be treated with caution and closely monitored due to the high incidence of somnolence. The safety and effectiveness of YSP BRIMOLOL EYE DROP in children and adolescents (2 to 7 years of age) have not been established. Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate ophthalmic solution 0.2% is associated with an increase in IOP.
If allergic reactions are observed, treatment with YSP BRIMOLOL EYE DROP should be discontinued.
Like other topically applied ophthalmic agents, YSP BRIMOLOL EYE DROP may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed. Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see Dosage & Administration.
Cardiac disorders: In patients with cardiovascular diseases (e.g., coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed with 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.
As with systemic beta-blockers, if discontinuation of treatment is needed in patients with coronary heart disease, therapy should be withdrawn gradually to avoid rhythm disorders, myocardial infarct or sudden death.
Respiratory disorders: Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta-blockers. YSP BRIMOLOL EYE DROP 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.
Surgical anaesthesia: Beta-blocking ophthalmological preparations may block beta-agonist effects e.g. of adrenaline. The anaesthetist must be informed if the patient is using YSP BRIMOLOL EYE DROP.
In patients with severe renal impairment on dialysis, treatment with timolol has been associated with pronounced hypotension.
Other beta-blocking agents: The effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patient already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended (see Interactions).
Hyperthyroidism: Beta-blockers may also mask the signs of hyperthyroidism.
YSP BRIMOLOL EYE DROP must be used with caution in patients with metabolic acidosis and untreated phaeochromocytoma.
Corneal diseases: Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.
Hypoglycemia/diabetes: Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to uncontrolled diabetic patients (especially those with labile diabetes) as beta-blockers may mask the signs and symptoms of acute hypoglycaemia. The indicatory signs of acute hypoglycaemia may be masked, in particular tachycardia, palpitation and sweating.
Vascular disorders: Patients with severe peripheral circulatory disturbance/disorders (i.e. Raynaud's phenomenon) should be treated with caution.
Anaphylactic reactions: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual dose of adrenaline used to treat anaphylactic reaction.
Choroidal detachment: Choroidal detachment after filtration procedures has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide).
The preservative in YSP BRIMOLOL EYE DROP, benzalkonium chloride, may cause eye irritation. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to application and wait at least 15 minutes after instilling YSP BRIMOLOL EYE DROP before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops.
YSP BRIMOLOL EYE DROP has not been studied in patients with closed-angle glaucoma.
YSP BRIMOLOL EYE DROP has not been studied in patients with hepatic or renal impairment. Therefore, caution should be used in treating such patients.
Effects on Ability to Drive and Use Machine: YSP BRIMOLOL EYE DROP has minor influence on the ability to drive and use machines.
YSP BRIMOLOL EYE DROP may cause transient blurring of vision, visual disturbance, fatigue and/or drowsiness which may impair the ability to drive or operate machines. Patients who engage in activities such as driving and operating machinery should be cautioned of the potential for a decrease in mental alertness. The patient should wait until these symptoms have cleared before driving or using machinery.
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