Brimonidine
Generic Name: brimonidine
Brand Names:
Brimonidine
11 DESCRIPTION Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11 H 10 BrN 5 • C 4 H 6 O 6 . It has the following structural formula: Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder.
Overview
11 DESCRIPTION Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11 H 10 BrN 5 • C 4 H 6 O 6 . It has the following structural formula: Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder.
Uses
1 INDICATIONS AND USAGE 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 )
Dosage
2 DOSAGE AND ADMINISTRATION 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. ( 2 ) • Hands should be washed immediately after applying brimonidine topical gel. ( 2 ) • For topical use only ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )
Side Effects
6 ADVERSE REACTIONS 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.
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS 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 ( 5.6 ) and Adverse Reactions ( 6.1 , 6.2 ) ]. Known hypersensitivity to any component of brimonidine topical gel ( 4 )
Pregnancy
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. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine Topical Gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube or pump with a child resistant cap in the following sizes: 30 gram tube NDC 45802- 078 -94 45 gram tube NDC 45802- 078 -84 30 gram pump NDC 45802- 078 -30 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Con...
Frequently Asked Questions
What is Brimonidine used for?▼
1 INDICATIONS AND USAGE 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 )
What are the side effects of Brimonidine?▼
6 ADVERSE REACTIONS 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.
Can I take Brimonidine during pregnancy?▼
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. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18.
What are the important warnings for Brimonidine?▼
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS 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 ( 5.6 ) and Adverse Reactions ( 6.1 , 6.2 ) ]. Known hypersensitivity to any component of brimonidine topical gel ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.