Brimonidine precautions

List of precautions
General Patients with severe cardiovascular disease Patients with hepatic or renal impairment Loss of effect Carcinogenesis Mutagenesis Impairment of fertility Pregnancy Nursing mothers Pediatric use Geriatric use

General
Brimonidine tartrate ophthalmic solution 0.2% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangiitis obliterans. Return to top

Patients with severe cardiovascular disease
Although Brimonidine tartrate ophthalmic solution 0.2% had minimal effect on blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Return to top

Patients with hepatic or renal impairment
Brimonidine tartrate ophthalmic solution 0.2% has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients. Return to top

Loss of effect
During the studies there was a loss of effect in some patients. The IOP-lowering efficacy observed with Brimonidine tartrate ophthalmic solution 0.2% during the first month of therapy may not always reflect the long-term level of IOP reduction. Patients prescribed IOP-lowering medication should be routinely monitored for IOP. Return to top

Carcinogenesis
No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of Brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved ~77 and 118 times, respectively, the plasma drug concentration estimated in humans treated with one drop Brimonidine tartrate ophthalmic solution 0.2% into both eyes 3 times per day. Return to top

Mutagenesis
Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies including the Ames test, chromosomal aberation assay in Chinese Hamster Ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice, and dominant lethal assay. Return to top

Impairment of fertility
Reproductive studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine tartrate ophthalmic solution 0.2%. Return to top

Pregnancy
Pregnancy category B Teratogenic Effects Reproductive studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine tartrate ophthalmic solution 0.2%. Dosing at this level produced 100 times the plasma drug concentration level seen in humans following multiple ophthalmic doses. There are no adequate and well-controlled studies in pregnant women. In animal studies, Brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine tartrate ophthalmic solution 0.2% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Return to top

Nursing mothers
It is not known whether this drug is excreted in human milk; in animal studies Brimonidine tartrate was excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Return to top

Pediatric use
In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse events with Brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% - 83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age or older (>20kg), somnolence appears to occur less frequently (25%). The most commonly observed adverse event was somnolence. Approximately 16% of patients on Brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence. The safety and effectiveness of Brimonidine tartrate ophthalmic solution 0.2% have not been studied in pediatric patients below the age of 2 years. Brimonidine tartrate ophthalmic solution 0.2% is not recommended for use in pediatric patients under the age of 2 years. (Also refer to Adverse Reactions section). Return to top

Geriatric use
No overall differences in safety or effectiveness have been observed between elderly and other adult patients. Return to top