Dosing and uses of Mirvaso (brimonidine topical)
Adult dosage forms and strengths
topical geL
- 0.33%
Rosacea
Indicated for persistent facial erythema of rosacea
Apply topically to face qDay
Pediatric dosage forms and strengths
<18 years: Safety and efficacy not established
Mirvaso (brimonidine topical) adverse (side) effects
1-10%
Flushing (10%)
Erythema (8%)
Nasopharyngitis (5%)
Skin-burning sensation (4%)
Increased intraocular pressure (4%)
Headache (4%)
Postmarketing Reports
Cardiovascular disorders: Bradycardia, hypotension (including orthostatic hypotension)
Immune system disorders: Angioedema, hypersensitivity, lip swelling, swollen tongue, throat tightness, urticaria
Nervous system disorders: Dizziness
Skin and subcutaneous disorders: Pallor
Warnings
Contraindications
Hypersensitivity
Cautions
Caution with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome
Alpha-2 adrenergic agents can lower blood pressure; caution with severe or unstable/uncontrolled cardiovascular disease
Serious adverse reactions may occur following accidental ingestion of alpha-2 agonists by children; keep out of reach of children
Not for oral, ophthalmic, or intravaginal use
Erythema involving areas of face previously not affected by erythema and areas (e.g., neck and chest) outside of treatment sites reported
Treatment effect of topical gel may begin to diminish hours after application
Increased frequency of flushing and/or erythema with flushing following gel application reported
Pallor or excessive whitening at or outside application site, following treatment with topical gel.reported
Allergic contact dermatitis reported
Hypersensitivity reactions following gel application include angioedema, throat tightening, tongue swelling, and urticaria; Institute appropriate therapy and discontinue therapy, if clinically significant hypersensitivity reaction occurs
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Mirvaso (brimonidine topical)
Mechanism of action
Alpha-2 adrenergic agonist
Absorption
Onset: Rapid onset
Duration: Up to 12 hr
