\nOn August 26, 2013, the United States Food and Drug Administration (FDA) approved brimonidine (Mirvaso\u00ae) current<\/span> gel<\/span>, 0.33% * (Galderma Laboratories, Texas, USA) For Topical Treatment of Persistent Facial Treatment erythema<\/span> Rosacea (redness) in adults over 18 years of age. It is not indicated for the treatment of inflammatory<\/span> injuries (papules<\/span> and pustules<\/span>) of rosacea.<\/p>\nAlthough several medications are approved for the treatment of inflammatory rosacea, there is currently no approved medication that directly targets rosacea erythema, making it a key unmet medical need.<\/p>\n
Brimonidine is the first and only FDA approved topical treatment specifically developed and indicated for facial erythema in rosacea.<\/p>\n
Applied once a day, brimonidine works quickly to reduce rosacea redness and the beneficial effects last up to 12 hours.<\/p>\n
Brimonidine is also available as eye drops to treat ocular<\/span> hypertension<\/span> or glaucoma<\/span>.<\/p>\n<\/span>How does brimonidine work?<\/span><\/h2>\n\n- While the exact cause of rosacea erythema is not known, the erythema is presumed to result from deregulation<\/span> at cutaneous<\/span> vasomotor responses, leading to abnormal dilation of the face blood vessels<\/span> about various stimuli.<\/li>\n
- Research studies suggest the involvement of adrenergic receptors in the neurovascular regulatory pathway.<\/li>\n
- Brimonidine is a relatively selective alpha-2 adrenergic agonist.<\/li>\n
- Topical application of brimonidine gel can reduce erythema by constricting dilated facial blood vessels to reduce rosacea redness.<\/li>\n<\/ul>\n
Link to key evidence from clinical trials on brimonidine<\/p>\n
<\/span>Dosage and administration<\/span><\/h2>\n\n- Brimonidine is supplied as a gel for topical administration.<\/li>\n
- It is recommended that you apply a pea-sized amount of the medication once a day to each of the five areas of the face: center forehead, chin, nose, and cheeks.<\/li>\n
- The gel should be applied smoothly and evenly as a thin layer over the entire face, avoiding the eyes and lips.<\/li>\n
- The gel should not be applied to irritated skin or open wounds.<\/li>\n
- Hands should be thoroughly washed after applying topical gel.<\/li>\n<\/ul>\n
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<\/span>What are the side effects of brimonidine?<\/span><\/h2>\nIn clinical trials, the most common Adverse reactions<\/span> (occurring at a frequency \u22651%) including:<\/p>\n\n- erythema<\/li>\n
- blush<\/li>\n
- burning sensation on the skin<\/li>\n
- Contact dermatitis<\/span>\n<\/li>\n<\/ul>\n
In the long-term study, where patients used topical brimonidine gel for up to 12 months, the most common adverse events<\/span> including redness (10%), erythema (8%), rosacea (5%), nasopharyngitis<\/span> (5%), burning sensation on the skin (4%), increased intraocular pressure (4%) and headache (4%).<\/p>\nPost-marketing reports suggest that flare-up of redness and rebound discomfort may be more common than clinical trials predicted.<\/p>\n
<\/span>Warnings and precautions<\/span><\/h2>\n<\/span>Worsening vascular<\/span> insufficiency<\/span><\/h3>\nBrimonidine topical gel should be used with caution in patients with depression, cerebral<\/span> or coronary insufficiency, Raynaud's phenomenon<\/span>orthostatic hypotension<\/span>thrombangiitis obliterans scleroderma<\/span>\/ \/systemic<\/span> sclerosis<\/span>or Sj\u00f6gren syndrome<\/span>.<\/p>\n<\/span>Severe heart disease<\/span><\/h3>\nAlpha-2 adrenergic agonists can lower blood pressure. Brimonidine topical gel should be used with caution in patients with severe, unstable or uncontrolled cardiovascular disease.<\/p>\n
<\/span>Serious adverse reactions after oral intake.<\/span><\/h3>\nTwo young children experienced serious adverse reactions after an accident ingestion<\/span> brimonidine topical gel. Adverse reactions experienced included lethargy, respiratory distress with apneic episodes (requiring intubation), breast<\/span> bradycardia<\/span>confusion psychomotor<\/span> hyperactivity and diaphoresis. Both children were hospitalized overnight and discharged the next day without aftermath<\/span>.<\/p>\n<\/span>The pregnancy<\/span><\/h3>\nThere are no adequate and well-controlled studies on the use of topical brimonidine gel in pregnant women. It is not known if brimonidine is safe for breastfeeding mothers. In animal studies, brimonidine tartrate has been shown to be excreted in breast milk.<\/p>\n
<\/span>Children<\/span><\/h3>\nSafety and effectiveness in pediatric<\/span> patients have not been studied.<\/p>\n<\/span>The elders<\/span><\/h3>\nClinical studies of the topical brimonidine gel did not include a sufficient number of subjects age 65 and older to determine whether they respond differently to younger subjects. One hundred and five subjects older than 65 years were included in clinical trials with topical brimonidine gel. No overall differences in safety or effectiveness were observed between subjects 65 years of age and younger adult subjects.<\/p>\n
<\/span>Drug interactions<\/span><\/h2>\n<\/span>Blood pressure and heart medications.<\/span><\/h3>\nAlpha-2 agonists, as a class, can lower blood pressure. Patients in concomitant<\/span> beta-blockers, antihypertensives and \/ or cardiac glycosides must be carefully monitored.<\/p>\n<\/span>Central nervous system depressants<\/span><\/h3>\nAlthough no specific drug interaction studies have been conducted with topical brimonidine gel, the possibility of an additive or potentiating effect with CNS<\/span> Depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.<\/p>\n<\/span>Monoamine oxidase inhibitors<\/span><\/h3>\nMonoamine oxidase (MAO) inhibitors may theoretically interfere with metabolism<\/span> of brimonidine and can lead to increased systemic side effects, such as hypotension.<\/p>\nNew Zealand approved data sheets are the official source of information for these prescription drugs, including approved uses and risk information. See the New Zealand individual data sheet on the Medsafe website.<\/span><\/em><\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"El 26 de agosto de 2013, la Administraci\u00f3n de Drogas y Alimentos de los Estados Unidos (FDA) aprob\u00f3 la brimonidina (Mirvaso\u00ae) actual gel, 0.33% * (Galderma Laboratories, Texas, EE. UU.)…<\/p>","protected":false},"author":8,"featured_media":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","format":"standard","meta":{"footnotes":""},"categories":[204],"tags":[],"class_list":["post-7558","wiki","type-wiki","status-publish","format-standard","category-glosario-definiciones"],"_links":{"self":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki\/7558","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki"}],"about":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/types\/wiki"}],"author":[{"embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/comments?post=7558"}],"version-history":[{"count":0,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki\/7558\/revisions"}],"wp:attachment":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/media?parent=7558"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/categories?post=7558"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/tags?post=7558"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}