MATERIAL SAFETY DATA SHEET
Issued: 05/29/03 Prepared by: Gary Wong
Revised: N/A Manager EHS
Revision: Original Core No. 411
1. PRODUCT AND COMPANY INFORMATION
Product Name: Brimonidine Tartrate Ophthalmic Solution 0.2%
Generic Name: Brimonidine Tartrate Ophthalmic Solution 0.2%
NDC No. 24208-411-05 ( 5 ml)
24208-411-10 (10 ml)
24208-411-15 (15 ml)
Legal Category: Pharmaceutical preparation, filled inside plastic bottle suitable
for dispensing, and overpacked inside a cardboard carton.
Drug Composition: Alpha-2 adrenergic agonist
BAUSCH & LOMB PHARMACEUTICALS, INC.
8500 Hidden River Parkway
Tampa, FL 33637
Information: (800) 323-0000 (M-F) 8am-5pm EST
Emergency: (800) 227-1427 24 hrs
2. COMPOSITION/INFORMATION ON INGREDIENTS
TLV (mg/m3) PEL (mg/m3)
Description CAS # % Content
Brimonidine Tartrate 59803-94-4 NE NE 0.2
Polyvinyl Alcohol 9002-89-5 NE NE >1
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Sodium Chloride, Sodium Citrate, Citric Acid, Benzalkonium
Chloride
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Presents little or no hazards if spilled and no unusual hazard if involved in fire.
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POTENTIAL 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
Chronic Effects: Not known
Target Organs: Liver
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
Medical Conditions Aggravated by Long Term 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.
4. FIRST AID MEASURES
Eyes: Rinse immediately with copious amounts of water for at least 20 minutes.
Contact a physician.
Skin: Remove all contaminated clothing and wash skin with copious amounts of
water for at least 20 minutes. Contact physician if skin becomes irritated.
Ingestion: Wash out mouth and drink plenty of water and bland fluids. The use
of an emetic drug and/or gastric lavage is advisable. Do not give anything to an
unconscious person. Contact physician.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician.
Note to Physicians: Although brimonidine tartrate ophthalmic solution 0.2% had
minimal effect on blood pressure of patients in clinical studies, caution should be
exercised in treating patients with severe cardiovascular disease.
Brimonidine tartrate ophthalmic solution 0.2% has not been studied in patients with
hepatic or renal impairment; caution should be used in treating such patients.
Brimonidine tartrate ophthalmic solution 0.2% should be used with caution in
patients with depression, cerebral or coronary insufficiency, Raynaud鈥檚
phenomenon, orthostatic hypotension or thromboangiitis obliterans.
During the studies there was a loss of effect in some patients. The IOP-lowering
efficacy observed with brimonidine tartrate ophthalmic solution 0.2% during the first
month of therapy may not always reflect the long-term level of IOP reduction.
Patients prescribed IOP-lowering medication should be routinely monitored for
IOP.
Pregnancy: Teratogenic Effects: Pregnancy Category B.
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%. Dosing at this level produced 100 times the plasma drug
concentration level seen in humans following multiple ophthalmic doses.
There are no adequate and well-controlled studies in pregnant women. In animal
studies, brimonidine crossed the placenta and entered into the fetal circulation to a
limited extent. Brimonidine tartrate ophthalmic solution 0.2% should be used during
pregnancy only if the potential benefit to the mother justifies the potential risk to the
fetus.
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
Nursing Mothers: It is not known whether this drug is excreted in human milk; in
animal studies brimonidine tartrate was excreted in breast milk. A decision should
be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother.
Additional details are available on the package insert or in the Physicians Desk
Reference.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Hydrogen Bromide and Nitrogen Oxides
Extinguishing Media: Dry chemical, carbon dioxide, halon, water spray or fog, and
foam on surrounding materials.
Fire Fighting Instructions: Wear self-contained breathing apparatus and protective
clothing. Use water spray to keep fire-exposed containers cool. Do not spray water
into the burning material.
6. ACCIDENTAL RELEASE MEASURES
Large/Small Spills: Use personal protective equipment. Contain the spill to
prevent drainage into sewers, drains or streams. Use absorbent material to solidify
the spill. Shovel or scoop up solidified waste. Dispose of material according to
Federal, State and Local regulations.
7. HANDLING AND STORAGE
Handling: Avoid contact with product and use caution to prevent puncturing
containers. No special protective equipment or procedures are required in the clinical
or home environment.
Storage: Store product upright in original containers with the cap tightly closed at a
controlled room temperature 150-300 C (590- 860 F). KEEP THIS AND ALL DRUGS
OUT OF THE REACH OF CHILDREN.
8. EXPOSURE CONTROL/PERSONAL PROTECTION
Engineering Controls: In the manufacturing plant, provide adequate ventilation for
the raw material handling and compounding process, which will maintain the dust
and vapor, levels below the TLV, STEL, and PEL values for the ingredients.
Ventilation fans should be explosion proof. Use adequate personal protective
equipment e.g. NIOSH-approved respirators, goggles or safety glasses, gloves and
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
protective clothing. Ensure training in the handling of chemical material and use
current Material Safety Data Sheets.
Eye Protection: (29 CFR 1910.133) Recommend goggles or chemical safety
glasses.
Skin Protection: Thick impermeable gloves and protective clothing.
Respiratory Protection: (29 CFR 1910.134) NIOSH approved respirator, with
organic vapor, acid gas and HEPA filter recommended for handling raw materials.
Warning: Do not use air-purifying respirators in oxygen-depleted
environments. No respiratory protection is required in the clinical or home
environment.
Other: None
Ventilation: Recommended
Contaminated Equipment: Wash contaminated clothing separately. Wash
contaminated equipment with soap and water. Release rinse water into an approved
wastewater system or according to Federal, State and Local regulations.
9. CHEMICAL & PHYSICAL PROPERTIES
Appearance & Odor: Clear, greenish-yellow color
Boiling Point: NE Evaporation Rate: NE
Specific Gravity: 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Miscible Percent Volatile by Volume: <1
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
Incompatibility: This product has the incompatibilities of water e.g. strong acids,
bases, alkali metals, alkali hydrides and silver preparations.
Hazardous Decomposition Products: Hydrogen Bromide and Nitrogen Oxides
Hazardous Polymerization: Should not occur.
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
11. TOXICOLOGY
Summary of Risks: Toxicological information refers to raw materials product.
Concentrations and toxicological effects are substantially reduced in the product. For
more detailed information see MSDS on chemical material
CAS# 70359-46-5 Brimonidine Tartrate
May cause irritation to the eyes and skin. May be harmful to the digestive and
respiratory tract.
CAS# 77-92-9 Citric Acid
May cause irritation to the eyes and respiratory tract. Mild irritant to the skin.
Naturally occurring compound in plant and animal tissues. Generally recognized as
safe in foods. Chronic oral over exposure can cause tooth enamel damage. Oral-rat
LD50 11,700 mg/kg. Severe irritation eye 750 mg/24 hr.
CAS # 9002-89-5 Polyvinyl Alcohol
Dust may cause irritation to eyes and respiratory tract. No known effects by skin
contact or ingestion. Inhalation of dust can induce bronchitis or asthma attacks in
some individuals. No known dermal effects due to acute exposure. Degradation
products of stored material are methanol (PEL=260 mg/M3) and methyl acetate
(TLV=200 ppm). Decomposition products are acetaldehyde, crotonaldehyde and
acetone. Oral-rat LD50 >10 mg/kg. Acetaldehyde: CAS# 75-07-0; TLV=100 ppm;
Suspected Carcinogen. Crotonaldyhyde: CAS# 4170-30-3; PEL=2 ppm; Suspected
Carcinogen. Acetone: CAS# 67-64-1; TLV= 750 ppm.
CAS # 7647-14-5 Sodium Chloride
May cause irritation to eyes, skin, nerves, respiratory, and digestive tract. Eyes and
respiratory tract can be irritated by solid or dust. Prolonged skin contact can cause
irritation. Ingestion of large amounts can cause high blood pressure (hypertension)
and congestion of the internal organs (esp. the meninges and brain), cramps,
vomiting, prostration, coma and death.
CAS # 54-64-8 Sodium Citrate Dihydrate
May cause irritation to eyes, skin, respiratory, and digestive tract. Target organs are
the central nervous system, kidneys and bones. Increased risk persons have
impaired renal function, dehydration, sodium restricted diets or hypertension. This
information may be based on general information regarding sodium salts. Ingestion
of large doses can cause nausea, vomiting, convulsions, diarrhea, and hypernoia
(hyper mental activity or imagination). Chronic exposure can cause urolithiasis
(build-up of calcium deposits in the urinary tract) due to increased extraction of
calcium from the bones.
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The
method typically used is incineration.
EPA Designations: RCRA Hazardous Waste: Not Listed
SARA Title III: Not Listed
14. TRANSPORTATION INFORMATION
Transportation Data: Not classified as hazardous by DOT regulations.
15. REGULATORY INFORMATION
DOT Designations: Not classified as hazardous by DOT regulations.
EPA Designations: RCRA Hazardous Waste
(40 CFR 261.33) Not Listed
FDA Designations: Prescription only medication.
NDC No. 24208-411-05 ( 5 ml)
24208-411-10 (10 ml)
24208-411-15 (15 ml)
OSHA Designations: (29 CFR 1910.1000, Table Z)
Not Listed
SARA Title III: Not listed under Section 313 of Toxic Release Reporting.
CALIFORNIA PROPOSITION 65: Not Listed
16. OTHER INFORMATION
None
The information contained herein is furnished without warranty of any kind. The
above information is believed to be correct but does not purport to be all-inclusive
and should be used only as a guide. Users should make independent determinations
of the suitability and completeness of information from all sources to assure proper
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MSDS: Brimonidine Tartrate Ophthalmic Solution 0.2%
use and disposal of these materials and the safety and health of employees and
customers.
NE- Not Established
< - Less Than
> - Greater Than
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