MATERIAL SAFETY DATA SHEET
Issued: 01/05/05 Prepared by: Gary Wong
Revised: N/A Manager EHS
Revision: Original Core No. 358
1. PRODUCT AND COMPANY INFORMATION
Product Name: Zylet鈩?
Generic Name: Loteprednol Etabonate 0.5% and Tobramycin 0.3%
Ophthalmic Suspension
NDC No. 24208-358-25 (2.5 ml)
24208-358-05 ( 5 ml)
24208-358-10 ( 10 ml)
Legal Category: Prescription only medicine, filled in dropper-tipped plastic
bottle suitable for dispensing, and overpacked inside a
cardboard carton.
Drug Composition: Glucocorticoid and Aminoglycoside Antibiotic
BAUSCH & LOMB INCORPORATED
8500 Hidden River Parkway
Tampa, FL 33637
Information: (800) 323-0000 (M-F) 8am-5pm EST
Emergency: (800) 227-1427 24 hrs
2. PRODUCT AND COMPANY INFORMATION
TLV (mg/m3) PEL (mg/m3) % Content
Description CAS #
Loteprednol 82034-46-6 NE NE 0.5
Etabonate
Tobramycin 32986-56-4 NE NE 0.3
Glycerin 56-81-5 10 NE >1
Povidone 9003-39-8 NE NE >1
Purified Water NA NE NE >1
Ingredients <1%: Tyloxapol, Edetate Disodium, Benzalkonium Chloride
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle with dropper tip in cardboard box. Milky white to off white
suspension, toxic by ingestion. Presents little or no hazard if spilled and no
unusual hazard if involved in fire.
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POTENTIAL HEALTH HAZARDS
Carcinogenicity: (NTP) No (IARC) No (OSHA) No
Eye: This is an ophthalmic preparation. May cause irritation and hypersensitivity in
some individuals. Adverse reactions include localized ocular toxicity, lid itch and
swelling and redness of the mucous membrane of the eye (conjunctival erythema).
These reactions occur in less than 3% of patients. Signs of overdose of Tobramycin
Ophthalmic Solution include inflammation of the cornea, erythema, increased tearing
(lacrimation), swelling (edema) and lid itching.
Skin: May cause irritation and localized hypersensitivity in some individuals with
itching, swelling and diffused redness of the skin. Repeated or prolonged contact
can induce hypersensitivity in some individuals.
Ingestion: May cause irritation and hypersensitivity in some individuals. Large doses
can induce vomiting, diarrhea, adrenal gland suppression, Cushing's syndrome,
water retention, electrolyte imbalance and hyperglycemia.
Inhalation: May cause irritation to the respiratory tract and hypersensitivity in some
individuals.
Chronic Effects: May cause irritation and hypersensitivity in some individuals.
Prolonged use of topical antibiotics can give rise to overgrowth of nonsusceptible
organisms, including fungi. Bacterial resistance to tobramycin may also develop. In
the presence of dermatological infections, the use of an appropriate antifungal or
antibacterial agent should be administered. Manifestations of adrenal suppression in
children include linear growth retardation, delayed weight gain, low plasma cortisol
levels and absence of response to ACTH stimulation. Prolonged use can result in
elevation of intraocular pressure, with damage to the optic nerve, defects in visual
acuity and fields of vision and/or posterior subcapsular cataract formation. It may also
contribute to secondary ocular infections from fungi or viruses liberated from ocular
tissues derived from nonsusceptable organisms.
Target Organs: Eyes, skin, digestive tract, kidney and brain.
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
Medical Conditions Aggravated by Long Term Exposure: Allergies to
aminoglycoside antibiotics or any component of the product. As with other antibiotic
preparations, prolonged use may result in overgrowth of other nonsusceptible
organisms, including fungi. Appropriate measures should be taken if this occurs.
Reproduction studies, in three different types of animals, at doses up to thirty-three
times the normal human systemic dose have revealed no evidence of impaired
fertility or harm to the fetus due to tobramycin. There are no adequate and well
controlled studies in pregnant women. Tobramycin should be used in pregnancy only
if the potential benefits justify the risk to the fetus. Because of the potential for
adverse reactions in nursing infants from Tobramycin Ophthalmic Solution, a decision
should be made whether to discontinue nursing the infant or discontinue taking the
drug, taking into account the importance of the drug to the mother.
鈥? Anaphylactic cross-reactions may occur for glucocorticoids.
鈥? Preexisting conjunctival or systemic fungal infections may be aggravated.
Appropriate measures should be taken if this occurs.
鈥? Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other
viral diseases of the cornea and conjunctiva.
鈥? Tuberculosis of the eye.
鈥? Fungal diseases of the ocular structures.
鈥? Hypersensitivity to any of the ingredients of the medication.
鈥? Various ocular diseases and long-term use of topical corticosteroids have been
known to cause corneal and scleral thinning. Use of topical corticosteroids in the
presence of thin corneal or scleral tissue may lead to perforation.
鈥? Acute purulent untreated infection of the eye can be masked or activity enhanced
by the presence of corticosteroid medication.
Chronic Effects: Long-term animal studies have not been conducted to evaluate
the carcinogenic potential of loteprednol etabonate or tobramycin. Loteprednol
etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk
assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the
single dose mouse micronucleus assay. Oral treatment of male and female rats
with up to 50 mg/kg/day and 25mg/kg/day of loteprednol etabonate, respectively,
(500 and 250 times the maximum clinical dose, respectively) prior to and during
mating did not impair fertility in either gender. No impairment of fertility was noted
in studies of subcutaneous tobramycin in rats at doses of 100 mg/kg/day (1700
times the maximum daily clinical dose).
4. FIRST AID MEASURES
Remove from exposure and in the event of any untoward events, obtain
appropriate medical attention. Persons developing serious hypersensitivity
reactions must receive immediate medical attention.
Eyes: May cause irritation. Flush immediately with copious amounts of water
for at least 20 minutes. Contact a physician.
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
Skin: May cause irritation. Remove all contaminated clothing and wash skin
with copious quantities of water for at least 20 minutes. Contact physician if
skin becomes irritated.
Ingestion: May cause irritation. Flush out mouth with water. Give plenty of
water and bland fluids. Do not give anything to an unconscious person. Contact
physician.
Inhalation: May cause irritation of respiratory tract. Avoid inhalation. Remove
person to fresh air, and if breathing stops, use artificial respiration. Contact
physician.
Note to Physicians:
Pregnancy: Teratogenic effects: Pregnancy Category C. Loteprednol
etabonate was shown to be teratogenic when administered orally to rats and
rabbits during organogenesis at 5 and 3 mg/kg/day, respectively (50 and 30
times the maximum daily clinical dose in rats and rabbits, respectively). An oral
dose of loteprednol etabonate in rats at 50 mg/kg/day (500 times the maximum
daily clinical dose) during late pregnancy through the weaning period showed a
decrease in the growth and survival of pups without dystocia. However, no
adverse effect in the pups was observed at 5 mg/kg/day (50 times the maximum
daily clinical dose).
Parenteral doses of tobramycin did not show any harm to fetuses up to 100
mg/kg/day (1700 times the daily clinical dose) in rats and rabbits.
There are no adequate and well controlled studies in pregnant women. Zylet鈩?
should be used during pregnancy only if potential benefits justifies the potential
risks to the fetus.
Nursing Mothers: It is not known whether topical ophthalmic administration of
corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in human milk. Systemic steroids appear in human milk
and could suppress growth, interfere with endogenous corticosteroid production,
or cause other untoward effects. Caution should be exercised when Loteprednol
Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension is administered
to a nursing woman.
Additional details are available in the package insert or in the Physicians Desk
Reference.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
Hazardous Products: Emits 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
controlled room temperature 15掳-25掳 C (59掳- 77掳 F). PROTECT FROM FREEZING.
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.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
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: Milky white to off-white suspension, odorless.
Boiling Point: N/A Evaporation Rate: NE
Specific Gravity 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: 4 cps
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold. Avoid freezing.
Incompatibility: This product has the incompatibilities of water e.g. strong acids,
bases, alkali metals, alkali hydrides and silver preparations.
Hazardous Decomposition Products: Emits toxic fumes.
Hazardous Polymerization: Should not occur.
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 #
82034-46-6 Loteprednol Etabonate
May cause irritation to the eyes, skin and respiratory tract. Can cause
hypersensitivity in some individuals. Adverse reactions to corticosteroids include
suppression of adrenal gland secretion, Cushing鈥檚 syndrome, water retention,
electrolyte imbalance and hyperglycemia. Studies in animals indicate that topical
adrenocorticoids, when used in large amounts, can be systemically absorbed and
can cause fetal abnormalities. Immune suppression may result from chronic high
doses.
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
32986-56-4 Tobramycin
Topical or parenteral contact with high concentrations of some of the components
of this ophthalmic formulation are known to produce hypersensitivity reactions in a
small number of persons. The most adverse reactions are localized ocular toxicity
and hypersensitivity, including conjunctiva erythema, itching, swelling. Material
may be irritating to mucous membranes and respiratory tract. As a general rule,
individuals working with chemicals should consider all chemicals to be potentially
hazardous even if their individual hazards may be unknown or uncharacterized.
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. PRODUCT AND COMPANY 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. 24208-358-25 (2.5 ml)
NDC No. 24208-358-05 ( 5 ml)
NDC No. 24208-358-10 ( 10 ml)
OSHA Designations: (29 CFR 1910.1000, Table Z)
Not Listed
SARA Title III: Not listed under Section 313 of Toxic Release Reporting.
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BAUSCH & LOMB INCORPORATED
MSDS: Zylet 鈩?
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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