Brimonidine

Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. ( 1 )

• Apply a pea-sized amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek
• Brimonidine topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips
• Wash hands after applying brimonidine topical gel
• Brimonidine topical gel is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount once daily to each of the five areas of the face (forehead, chin, nose, each cheek) avoiding the eyes and lips. • Hands should be washed immediately after applying brimonidine topical gel. • For topical use only • Not for oral, ophthalmic, or intravaginal use

Brimonidine Topical Gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. Gel, 0.33%; Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. ( 3 )

• Keep brimonidine topical gel out of reach of children
• Serious adverse reactions were experienced by two children of a subject in a clinical trial who accidentally ingested brimonidine topical gel [ see Warnings and Precautions ]
• Safety and effectiveness
• In pediatric patients have not been established

One hundred and five subjects aged 65 and older were included in clinical trials with brimonidine topical gel. No overall differences in safety or effectiveness were observed between subjects ≥ 65 years of age and younger adult subjects. Clinical studies of brimonidine topical gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

• See FDA-approved patient labeling (Patient Information and Instructions for Use)
• Patients using brimonidine topical gel should receive the following information and instructions: • This medication is to be used as directed by the physician. • It is for external use only. • Brimonidine Topical Gel should not be applied to irritated skin or open wounds. • Avoid contact with the eyes and lips. • Patients should wash their hands immediately after applying the medication. • Some patients using Brimonidine Topical Gel may experience erythema, flushing or excessive whitening. • Patients should report any adverse reactions to their physician. • Keep out of reach of children. …

• Brimonidine topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to any component
• Reactions have included angioedema, urticarial, and contact dermatitis [ see Warnings and Precautions and Adverse Reactions ]
• Known hypersensitivity to any component of brimonidine topical gel

7.1 Anti-hypertensives/Cardiac Glycosides Alpha-2 agonists, as a class, may reduce blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised. 7.2 CNS Depressants Although specific drug-drug interactions studies have not been conducted with brimonidine topical gel, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. 7.3 Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. …

• Potentiation of Vascular Insufficiency ( 5.1 ) • Severe Cardiovascular Disease ( 5.2 ) • Serious Adverse Reactions Following Ingestion of brimonidine topical gel ( 5.3 ) • Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists ( 5.4 ) • Local Vasomotor Adverse Reactions ( 5.5 ) • Hypersensitivity ( 5.6 ) 5.1 Potentiation of Vascular Insufficiency Brimonidine topical gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome. 5.2 Severe Cardiovascular Disease Alpha-2 adrenergic agonists can lower blood pressure. …

The following adverse drug reactions are discussed in greater detail in other sections of the label: • Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists [ see Warnings and Precautions ( 5.4 ) ] • Local Vasomotor Adverse Reactions [ see Warnings and Precautions ( 5.5 ) ] • Hypersensitivity [ see Warnings and Precautions ( 5.6 ) ] In controlled clinical trials with brimonidine topical gel the most common adverse reactions (incidence ≥ 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies of brimonidine topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. …

No information is available on overdose in adults with brimonidine topical gel. Oral overdoses of other alpha-2 adrenergic agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression, and seizure. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.