Alphagan/Alphagan P 0.1% Special Precautions

ALPHAGAN/ALPHAGAN P 0.1% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. Patients prescribed IOP-lowering medication should be routinely monitored for IOP.
Effects on Ability to Drive and Use Machines: As with other similar medications, ALPHAGAN/ALPHAGAN P 0.1% may cause fatigue and/or drowsiness in some patients. Patients who engage in activities such as driving and operating machinery should be cautioned of the potential for a decrease in mental alertness. ALPHAGAN/ALPHAGAN P 0.1% may also cause blurred vision or visual disturbance in some patients. The patient should wait until these symptoms have cleared before driving or using machinery.
ALPHAGAN/ALPHAGAN P 0.1% has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
Alphagan: Although ALPHAGAN 0.2% had minimal effect on the blood pressure and heart rate of patients in clinical studies, caution should be exercised in treating patients receiving ALPHAGAN with severe cardiovascular disease.
Delayed ocular hypersensitivity reactions have been reported with ALPHAGAN 0.2%, with some reported to be associated with an increase in IOP.
During the studies there was a loss of effect in some patients. The IOP-lowering efficacy observed with ALPHAGAN 0.2% ophthalmic solution during the first month of therapy may not always reflect the long-term level of IOP reduction. For those patients whose IOP is not adequately controlled with twice-daily dosing, an additional drop of brimonidine in the afternoon can be added. Patients prescribed IOP-lowering medication should be routinely monitored for IOP.
The preservative in ALPHAGAN 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to wait at least 15 minutes after instilling ALPHAGAN to insert soft contact lenses.
Use in Children: Children 2 years of age and above, especially those weighing ≤20 kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence. Refer to information as follows.
In a 3-month, Phase 3 study in children aged 2-7 years with glaucoma inadequately controlled by beta-blockers, a high prevalence of somnolence (55%) was reported with ALPHAGAN/ALPHAGAN P 0.1% as adjunctive treatment. This was severe in 8% of the children and led to discontinuation of treatment in 13%. The incidence of somnolence decreased with increasing age, the least being in the 7-year-old age group (25%), but was more affected by weight, occurring more frequently in children weighing ≤20 kg (63%) compared to those weighing >20 kg (25%).
Safety and effectiveness of ALPHAGAN/ALPHAGAN P 0.1% in children under the age of 2 years have not been established. During post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in neonates, infants and children receiving brimonidine either for congenital glaucoma or by accidental ingestion.
Use in the Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients. The C_max and apparent half-life of brimonidine were similar in elderly subjects (65 years or older) and younger adults, indicating that its systemic absorption and elimination were not significantly affected by age.