Brizagan Special Precautions

Cardiac disorders: Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease.
Eye disorders: Some (12.7%) patients in clinical trials experienced an ocular allergic type reaction with Brizagan (see Adverse Reactions for details). If allergic reactions are observed, treatment with Brizagan should be discontinued.
Delayed ocular hypersensitivity reactions have been reported with Brizagan 0.2%, with some reported to be associated with an increase in IOP.
Vascular disorders: Brizagan should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Hepatic and renal insufficiency: Brizagan has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
Benzalkonium chloride: The preservative in Brizagan, benzalkonium chloride, may cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface. Patients should remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Patients should avoid contact with soft contact lenses.
Brizagan should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
Effects on ability to drive and use machine: Brizagan may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. Brizagan may cause blurred and/or abnormal vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. The patient should wait until these symptoms have cleared before driving or using machinery.
Use in Children: 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 and severity of somnolence (see Adverse Reactions).