MATERIAL SAFETY DATA SHEET
Issued: 10/19/94 Prepared by: Gary Wong
Revised: 01/29/02 Manager EHS
Revision: 01 Core No. 315
1. PRODUCT AND COMPANY IDENTIFICATION
Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
Product Name:
Same
Generic Name:
24208-315-10 (10 ml)
NDC No.
Prescription only medication, filled inside bottle suitable for
Legal Category:
dispensing, and overpacked inside a cardboard carton.
Drug Composition: Antimicrobial\Antibiotic combination
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
3 3
Description CAS # TLV (mg/m ) PEL(mg/m ) % Content
Trimethoprim 738-70-5 NE NE <1
Polymyxin B Sulfate 1405-20-5 NE NE <1
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Sodium Chloride, Benzalkonium Chloride
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MSDS: Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle in a cardboard box. Clear, colorless aqueous solution.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: When used topically Polymyxin B Sulfate is rarely irritating and absorption from
the intact skin or mucous membrane is insignificant. Can also cause local irritation
on installation and hypersensitivity (anaphylactic) in some individuals. The most
frequent adverse reactions are localized irritation consisting of transient burning or
stinging or increased redness on installation. Trimethoprim Sulfate and Polymyxin B
Sulfate has a low incidence of hypersensitivity (less than 2 of 100 patients)
consisting of lid edema, itching, increased redness of the eye (conjunctival
erythema), tearing (lacrimation) and/or a rash around the eye (circumocular rash).
Although sensitivity reactions are rare, an isolated incident of photosensitivity was
reported in a patient who received the drug orally.
Skin: May cause hypersensitivity in some individuals. Possible hypersensitivity
responses include rash, pruritus (itching) and exfoliative dermatitis (sheading skin).
Although sensitivity reactions are rare, an isolated incident of photosensitivity was
reported in a patient who received the drug orally.
Ingestion: May cause irritation and hypersensitivity in some individuals. Ingestion of
very large quantities can induce gastric disturbances including nausea, vomiting,
headaches, dizziness.
Inhalation: May cause irritation and hypersensitivity in some individuals.
Chronic Effects: May cause irritation and hypersensitivity. As with other antibiotic
preparations, prolonged use may result in the overgrowth of non-susceptible
organisms, including fungi. Appropriate measures should be taken if this occurs.
Target Organs: Eyes, skin and digestive tract.
Medical Conditions Aggravated by Long Term Exposure:
?Hypersensitivity to antibiotics or any of the component of the product.
?Impairment of fertility: Polymyxin B Sulfate has been reported to impair the motility
of equine sperm, but its effects on male or female fertility are unknown. No
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MSDS: Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
adverse effects on fertility or general reproductive performance were observed in
rats given trimethoprim in oral doses as high as 70 mg/kg/day for males and 14
mg/kg/day for females.
?Pregnancy:Teratogenic effects: Pregnancy Category C. Animal reproduction
studies have not been conducted with Polymyxin B Sulfate. It is not known whether
polymyxin B sulfate can cause fetal harm when administered to a pregnant
woman or can affect reproductive capacity. Teratogenic tests of trimethoprim in
rats show 40 times the human dose can cause birth defects. Fetal loss (dead and
resorbed and malformed fetuses) were shown in rabbits given six times the human
dose. Trimethoprim may inhibit folic acid metabolism and should only be used
during pregnancy if the potential benefit outweighs the risk to the fetus.
While there are no large well-controlled studies of the use of trimethoprim in
pregnant women, Brumfitt and Pursell, in a retrospective study reported the
outcome of 186 pregnancies during which the mother received either a placebo or
oral trimethoprim in combination with sulfamethoxazole. The incidence of
congenital abnormalities was 4.5% (3 of 66) in those who received placebo and
3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole. There were
no abnormalities in the 10 children whose mothers received the drug during the
first trimester. In a separate survey, Brumfitt and Pursell also found no congenital
abnormalities in 35 children whose mothers had received oral trimethoprim and
sulfamethoxazole at the time of conception or shortly thereafter.
The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day
commencing with the last third of gestation and continuing through parturition
and lactation caused no deleterious effects on gestation or pup growth and
survival.
4. FIRST AID MEASURES
Eyes: If not prescribed this medication, 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 give plenty of water and bland fluids. Seek
professional assistance.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician immediately.
Note to Physicians: None.
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MSDS: Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Emits SOx, NOx and toxic fumes.
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
0 0 0 0
controlled room temperature 15 -30 C (59 - 86 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
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.
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MSDS: Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
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
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, colorless solution.
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: Strong oxidizers and flame.
Hazardous Decomposition Products: Emits SOx, NOx and toxic fumes.
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
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 #
1404-26-8 Polymyxin B Sulfate
May cause irritation to skin, mucous membranes and respiratory tract. Prolonged
and repeated contact can produce hypersensitivity (anaphylactic) in some
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MSDS: Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
individuals. Overexposure may produce dizziness, diminished muscular
coordination, kidney damage (nephrotoxicity), and sensory disturbances. This
material is not readily absorbed into the gut and does not present a toxicological
hazard. IV- mouse LD50 5.4 mg/kg, IP- mouse 20.5 mg/kg, Oral- mouse 790 mg/kg,
SC- mouse LD50 59.5 mg/kg.
738-70-5 Trimethoprim
May cause irritation to the mucous membranes of the eyes, skin, digestive and
respiratory tract. Overexposure symptoms due to ingestion of more than one gram
include nausea, vomiting, headaches, confusion, mental depression, dizziness, and
bone marrow depression. Possible hypersensitivity responses include rash, pruritus
(itching), exfoliative dermatitis (sheading skin). Teratogenic tests in rats show 40
times the human dose can cause birth defects. Fetal loss (dead and resorbed and
malformed fetuses) were shown in rabbits given six times the human dose.
Trimethoprim may inhibit folic acid metabolism and should only be used during
pregnancy if the potential benefit outweighs the risk to the fetus. Oral-rat LD50 200
mg/Kg, Intraperitoneal-rat LD50 1460 mg/Kg, Oral-mouse LD50 3960 mg/Kg,
Intraperitoneal-mouse LD50 3500 mg/Kg.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOSAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The
method typically used is incineration.
RCRA Hazardous Waste: Not Listed
EPA Designations:
Not Listed
SARA Title III:
14. TRANSPORTATION INFORMATION
Not classified as hazardous by DOT regulations.
Transportation Data:
15. REGULATORY INFORMATION
Not classified as hazardous by DOT regulations.
DOT Designations:
RCRA Hazardous Waste
EPA Designations:
(40 CFR 261.33) Not Listed
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Polymyxin B Sulfate & Trimethoprim Ophthalmic Solution USP
Prescription only medication.
FDA Designations:
NDC No. 24208-315-10 (10 ml)
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
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 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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