Note: Ingredients listed on restricted chemical lists
EC/CAS
7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
General Information
Revision date
2003-05-29
Product name
Brimonidine Tartrate Ophthalmic Solution 0.2%
1.2.1 Relevant identified uses
Pharmaceutical preparation, filled inside plastic bottle suitable
Emergency telephone
(800) 227-1427
Icons in SDS
Company Information
company name
BAUSCH & LOMB PHARMACEUTICALS, INC
Section 2
SECTION 2: Hazards identification
EMERGENCY OVERVIEW Presents little or no hazards if spilled and no unusual hazard if involved in fire. **********************************************************************************************
Health hazards
Carcinogenicity: (NTP) No (IARC) No (OSHA) No No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved ~77 and 118 times, respectively, the plasma drug concentration estimated in humans treated with one drop brimonidine tartrate ophthalmic solution 0.2% into both eyes 3 times per day. Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies including the Ames test, chromosomal aberation assay in Chinese Hamster Ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice, and dominant lethal assay. Reproductive studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to brimonidine tartrate ophthalmic solution 0.2%. Eye: Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The preservative in brimonidine tartrate ophthalmic solution 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling brimonidine tartrate ophthalmic solution 0.2% to insert soft contact lenses. Skin: Irritant Ingestion: Harmful if swallowed Inhalation: Harmful if inhaled
Potential chronic health
Not known Target Organs: Liver
Medical Conditions Generally Aggravated by Exposure
No information is available on overdosage in humans. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
