Product Information
Registration Status: ActiveSIN14828P
MIRVASO GEL 3MG/G is approved to be sold in Singapore with effective from 2015-08-17. It is marketed by GALDERMA SINGAPORE PTE LTD, with the registration number of SIN14828P.
This product contains Brimonidine 3.3MG/G in the form of GEL. It is approved for CUTANEOUS use.
This product is manufactured by Laboratoires GALDERMA in FRANCE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Brimonidine is a drug used to treat glaucoma. It acts via decreasing aqueous humor synthesis. A topical gel formulation, marketed under the name Mirvaso, was FDA approved on August 2013 for the treatment of rosacea.
Indication
The ophthalmic solution is indicated for patients with open-angle glaucoma or ocular hypertension to lower intraocular pressure. The topical gel is indicated for the treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years or older.
Mechanism of Action
Brimonidine is an alpha adrenergic receptor agonist (primarily alpha-2). It has a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that Brimonidine has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. The topical gel reduces erythema through direct vasocontriction.
Pharmacokinetics
- Absorption
- Minimal systemic absorption occurs after ocular insertion. When the topical gel was applied to adult patients with facial erythema associated with rosacea, the plasma maximum concentration (Cmax) and area under the concentration-time curve (AUC) were 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL, respectively. These values were reached on Day 15 of treatment.
- Distribution
- Metabolism
- Metabolized primarily by the liver.
- Elimination
Toxicity
Oral LD50 is 50 mg/kg in mice and 100 mg/kg in rats. Common adverse reactions of the topical gel formulation include erythema, flushing, skin burning sensation, and contact dermatitis.
Active Ingredient/Synonyms
5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline | Brimonidina | Brimonidine | Brimonidinum | Bromoxidine | Brimonidine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.