Material Safety Data Sheet
1. PRODUCT IDENTIFICATION
Product Name Methylprednisolone Acetate Sterile Aqueous Suspension 鈥? Multi-Dose
Acetate Sterile
Product Use Medical Treatment; Corticosteroid (anti-inflammatory)
Manufacturer Teva Parenteral Medicines, Inc.
Address 11 Hughes
Irvine, CA 92618-1902
Chemtrec Emergency No. 1-800-424-9300 (United States)
1-202-483-7617 (International Collect)
Business Phone 1-800-729-9991
Website Addres http://www.sicorinc.com
Aqueous Suspension
Depo-Medrol鈩?
Common Names
RU 3533
Chemical Name pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-
methyl-,(6伪,11尾)-
Chemical Formula C24H32O6
Chemical Family Glucocorticoid (corticosteroid)
How Supplied 40mg/ml: 5 ml in 5ml vial
40 mg/ml: 10 ml in 10ml vial
,Methylprednisolone
80mg/ml: 5 ml in 5 ml vial
Date of Preparation: November 27, 2000
2. COMPOSITION AND INGREDIENTS
EXPOSURE LIMITS IN AIR
CHEMICAL NAME CAS# 40 mg/ml 80 mg/ml
% % ACGIH OSHA Other
TWA*
by weight by weight TLV CEIL PEL CEIL
4ug/m3
Methylprednisolone acetate 53-36-1 4 8 NE NE NE NE
Polyethylene glycol 3350 None 2.91 2.82 NE NE NE NE NE
Polysorbate 80 2748-88-1 0.194 0.188 NE NE NE NE NE
Monobasic Sodium Phosphate 7558-80-7 0.68 0.659 NE NE NE NE NE
Dibasic Sodium Phosphate 7558-79-4 0.142 0.137 NE NE NE NE NE
Benzyl Alcohol 100-51-6 0.916 0.888 NE NE NE NE NE
Water for Injection 7732-18-5 Balance Balance NE NE NE NE NE
Sodium Chloride (to adj. tonicity) 7647-14-5 Trace Trace NE NE NE NE NE
2mg/m3 2mg/m3
Sodium hydroxide and/or 1310-73-2 Trace Trace NE NE NE
Hydrochloric acid (for pH adjustment) 7647-01-0 Trace Trace NE 5ppm NE 5ppm NE
NE - Not Established C - Ceiling Limit * Pharmacia and Upjohn Derived Limit
NOTE: All WHMIS required information is included. It is located in appropriate sections based on the ANSI Z400.1 鈥? 1998 format
CHEMTREC NUMBER: Use only in the event of a chemical emergency involving a spill, leak, fire, exposure or accident involving this
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Material Safety Data Sheet
3. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Material is a white suspension. May cause allergic reactions.
Overexposure may cause damage to the kidneys, pituitary, cardiovascular, immune and nervous
systems. Avoid breathing vapor. Avoid contact with eyes, skin and clothing. Do not taste or swallow.
Methylprednisolone Acetate Sterile
Wash thoroughly after handling.
Symptoms of Overexposure by Route of Exposure: This material is intended for intravenous injection
under the supervision of physicians.
Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the
small size of individual containers.
Contact with Skin or Eyes: Contact may cause mild irritation. Effects may include stinging, watering,
Aqueous Suspension
and redness of the eyes and redness and a burning sensation on the skin. Hypersensitive (allergic)
reactions have been observed following clinical use of the product.
Ingestion: Although ingestion is not an anticipated route of occupational exposure, this material has a
low degree of toxicity. Harmful effects from swallowing are not expected. Symptoms similar to those
identified under injection may occur.
Injection: Local redness and pain are the primary symptoms of accidental injection in an occupational
setting. Medical personnel are not anticipated to experience over-exposures to the therapeutic doses of
this product. See package insert for adverse reactions associated with therapeutic doses of this
product.
Health Effects or Risks From Exposure (An explanation in lay terms):
Acute: The primary health effects anticipated in an occupational setting include irritation of eyes and skin
as well as redness and local swelling after accidental injection. In case of over-exposure by injection,
effects such as hypertension, headaches, abdominal pain, pancreatitis, visual disturbances (including
cataracts, glaucoma and blindness), muscle weakness and fatigue, acne, menstrual disorders, peptic
ulcers, fluid retention, heart failure, susceptibility to infection, and fluctuation in electrolyte levels may
occur.
Cancer: Methylprednisolone acetate was negative in the DNA-cell-binding (DCB) assay. Ingredients
are not listed as carcinogenic by NTP, IARC or OSHA.
Chronic: Corticosteroids are generally teratogenic in laboratory animals (see Section 11).
Target Organs: This product may produce adverse effects on the kidneys, pituitary, cardiovascular,
immune and nervous systems. (see Section 11).
Other: This product contains benzyl alcohol which is potentially toxic when administered locally to
neural tissues.
Multi-dose use from a single vial requires special care to avoid contamination.
See package insert for additional information.
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Material Safety Data Sheet
3. HAZARD IDENTIFICATION cont.
Pre-Existing Medical Conditions: Conditions aggravated by exposure may include kidney, pituitary,
cardiovascular, immune and nervous systems disorders. Corticosteroids may increase susceptibility to
Methylprednisolone Acetate Sterile
infection (including reactivation of latent tuberculosis and enhancement of secondary eye infections due
to fungi or viruses) or mask some signs of infection. Recent immunization procedures may result in a
lack of antibody response and neurological disorders. This material is contraindicated for intrathecal
administration, systemic fungal infections and in patients with clinically significant hypersensitivity to it.
Corticosteroids exhibit enhanced effects on persons with hypothyroidism or cirrhosis.
4. FIRST-AID MEASURES
Aqueous Suspension
Skin Exposure: Remove contaminated shoes and clothing and cleanse affected area(s) thoroughly by
washing with mild soap and water. If irritation or redness develops and persists, seek medical attention.
Eye Exposure: If irritation or redness develops, move victim away from exposure and into fresh air.
Flush eyes with clean water and seek medical attention.
Inhalation: If respiratory symptoms develop, move victim away from source of exposure and into fresh
air. If symptoms persist, seek medical attention. If victim is not breathing, clear airway and immediately
begin artificial respiration. If breathing difficulties develop, oxygen should be administered by qualified
personnel. Seek immediate medical attention.
Ingestion: If swallowed, seek emergency medical attention. If victim is drowsy or unconscious and
vomiting, place on the left side with the head down and DO NOT give anything by mouth. If not vomiting
and professional advice is not available, DO NOT induce vomiting. If possible, do not leave victim
unattended and observe closely for adequacy of breathing.
Victims of chemical exposure must be taken for medical attention. Take a copy of the MSDS to the
physician or health professional with victim. Physicians should refer to Section 11 (Toxicological
Information) as well as the Physicians Desk Reference for additional treatment information.
5. FIRE-FIGHTING MEASURES
Flash Point: Non-flammable Autoignition Temperature: Not applicable
Flammable Limits (in air by volume, %): Lower: Not applicable Upper: Not applicable
Fire Extinguishing Equipment: Use extinguishing agent suitable for type of surrounding fire.
Water Spray: OK Carbon Dioxide: OK Halon: OK
Foam: OK Dry Chemical: OK Other: Any "ABC" Class
Unusual Fire and Explosion Hazards: No unusual fire or explosion hazards are expected.
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
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Material Safety Data Sheet
5. FIRE-FIGHTING MEASURES cont.
Special Fire Fighting Procedures.: For fires beyond the incipient stage, emergency responders in the
immediate hazard area should wear bunker gear. When the potential chemical hazard is unknown, in
enclosed or confined spaces, or when explicitly required by DOT, a self-contained breathing apparatus
Methylprednisolone Acetate Sterile
should be worn. In addition, wear other appropriate protective equipment as conditions warrant (see
Section 8). Isolate immediate hazard area and keep unauthorized personnel out. Contain spill if it can
be done with minimal risk. Move undamaged containers from immediate hazard area if it can be done
with minimal risk. Cool equipment exposed to fire with water, if it can be done with minimal risk.
NFPA HAZARD CLASS: Health: 1 (Slight)
Flammability: 0 (Least)
Reactivity: 0 (Least)
Aqueous Suspension
6. ACCIDENTAL RELEASE MEASURES
Spill and Leak Response:
For small releases of this product, wear latex or nitrile gloves and safety glasses. Absorb spilled liquid
and rinse area thoroughly with soap and water.
For large or uncontrolled releases, stay away from spill. Isolate immediate hazard area and keep
unauthorized personnel out. Contain spill if it can be done with minimal risk. Wear appropriate
protective equipment including respiratory protection as conditions warrant (see Section 8). Prevent
spilled material from entering sewers, storm drains, other unauthorized treatment drainage systems, and
natural waterways. Dike far ahead of spill for later recovery or disposal. Spilled material may be
absorbed into an appropriate absorbent material. Notify appropriate federal, state, and local agencies.
Immediate cleanup of any spill is recommended.
7. HANDLING and STORAGE
Work and Hygiene Practices: As with all chemicals, avoid getting this product ON YOU or IN YOU. Do
not eat, drink, smoke or apply cosmetics while handling the product. Wash hands thoroughly after
handling.
Particular care in working with this product must be practiced in pharmacies and other preparation
areas, during manufacture of this product, and during patient administration. Precautions should be
taken during the following activities:
Withdrawal of needles from drug vials.
Drug transfers using syringes and needles or filter straws.
Expulsion of air from drug-filled syringes.
Storage and Handling Practices: Employees must be trained to properly use the product. Ensure vials
are properly labeled. Store only in approved containers. Keep away from sources of ignition and any
incompatible materials or conditions (see Section 10).
Protective Practices During Maintenance of Contaminated Equipment: When cleaning non-disposable
equipment, wear latex or nitrile gloves (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. All needles, syringes, vials and other disposable items contaminated
with this product should be disposed of properly.
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Material Safety Data Sheet
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
Ventilation and Engineering Controls: Use with adequate ventilation. Follow standard medical product
handling procedures.
Methylprednisolone Acetate Sterile
Respiratory Protection: Not normally required for routine, medical administration of this product. A
NIOSH certified air-purifying respirator with a type 95 filter may be used under conditions where airborne
concentrations are expected to be excessive. Protection provided by air purifying respirators is limited
(see manufacturer鈥檚 respirator selection guide). Use a positive pressure air supplied respirator if there is
potential for uncontrolled release, exposure levels are not known, or any other circumstances where air-
purifying respirators may not provide adequate protection. A respiratory protection program that meets
OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements must be followed whenever workplace
conditions warrant a respirator's use.
Aqueous Suspension
Eye Protection: Approved eye protection to safeguard against potential eye contact, irritation or injury is
recommended. Depending on conditions of use, a face shield may be necessary.
Hand Protection: Use latex, nitrile, or rubber gloves. Check gloves for leaks. Wash hands before and
after using gloves.
Body Protection: No special body protection required for routine, medical administration of this product.
Wear lab coat, gown, or smock, as appropriate for procedure.
Product Preparation Instructions for Medical Personnel: Follow standard procedure for handling
pharmaceutical materials and recommendations presented on the Package Insert.
9. PHYSICAL and CHEMICAL PROPERTIES
Relative Vapor Density (air = 1): ND Evaporation Rate (n-BuAc=1): ND
Specific Gravity (water = 1): ~1 Melting/Freezing Point: ND
Solubility in Water: insoluble Boiling Point: ND
ND pH: 3.5-7.0
Vapor Pressure, mm Hg @ 25掳C.
. Odor Threshold: Odorless
Appearance and Color: White suspension
ND = No Data
10. STABILITY and REACTIVITY
Stability: Stable under normal conditions of storage and handling. The recommended storage
temperature is 20o 鈥? 25oC (68o 鈥? 77oF)
Materials With Which Substance is Incompatible: This product is generally compatible with other
common materials in a medical facility.
Hazardous Polymerization: Will not occur.
Hazardous Combustion Products: Carbon monoxide and carbon dioxide.
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Materials Safety Data Sheet
11. TOXICOLOGICAL INFORMATION
Toxicity Data: The following information is for Methylprednisolone Acetate
Oral LD50(rat) =10 g/kg
Methylprednisolone Acetate Sterile
IP LD50(mouse) >1409 mg/kg
SubQ LD50(rat) =265 mg/kg
SubQ LD50(mouse) =1320 mg/kg
Suspected Cancer Agent: This product as well as all components of this product have NOT been identified
as carcinogens by NTP, IARC or OSHA. Methylprednisolone Acetate was negative in the DNA-cell-
binding (DCB) assay.
Aqueous Suspension
Irritancy of Product: This product is not expected to be irritating to contaminated skin, eyes and other
tissues. The active ingredient is non-irritating to the eyes and the skin.
Sensitization to the Product: Hypersensitive reactions have been observed following clinical use of this
product.
Target Organ(s): The active ingredient, Methylprednisolone Acetate, is a glucocorticoid. Glucocorticoids
affect carbohydrate, protein and fat metabolism; functions of the cardiovascular system, kidney, skeletal
muscle, nervous system and other organ and tissues. It may modify the body鈥檚 immune response to
diverse stimuli. Chronic overexposure to glucocorticoids may produce pituitary-adrenal suppression,
Cushing鈥檚 syndrome (redistribution of body fat to face, and back of the neck and trunk, causing 鈥渕oon
face鈥?), increased susceptibility to infections with suppression of inflammatory response, osteoporosis,
cataracts, glaucoma with possible damage to the optic nerve, mental symptoms, hyperglycemia and
glycosuria.
Reproductive Toxicity Information: Listed below is information concerning the effects of
Methylprednisolone Acetate on human and animal reproductive systems. This material is classified as
a Pregnancy Category C: Risk cannot be ruled out.
Mutagenicity: Methylprednisolone Acetate was negative in the DNA damage/alkaline elution assay.
Embryotoxicity/Teratogenicity/Reproductive Toxicity: Corticosteroids are generally teratogenic in
laboratory animals; there are no well-controlled studies in women. The safety of their use in
pregnant women has not been absolutely established. Infants born of mothers who have received
substantial doses of corticosteroids during pregnancy should be carefully observed for signs of
hypoadrenalism.
ACGIH Biological Exposure Indices: Currently there are no Biological Exposure Indices (BEIs)
associated with the components of this product.
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Materials Safety Data Sheet
12. ECOLOGICAL INFORMATION
All work practices must be aimed at eliminating environmental contamination.
Methylprednisolone Acetate Sterile
Environmental Stability: This product will be relatively stable under ambient environmental conditions.
Effect of Materials on Plants or Animals: No specific information is available on the effect of
Methylprednisolone Acetate on plants or animals in the environment.
Effect of Chemicals on Aquatic Life: No specific information is available on the effect of
Methylprednisolone Acetate on plants or animals in the aquatic environment.
13. DISPOSAL CONSIDERATIONS
Aqueous Suspension
Preparing Wastes for Disposal: This material, if discarded as produced, is not a RCRA 鈥渓isted鈥? or
鈥渃haracteristic鈥? hazardous waste. Use resulting in chemical or physical change or contamination may
subject it to regulation as a hazardous waste. Along with properly characterizing all waste materials
consult state and local regulations regarding the proper disposal of this material.
U.S. EPA Waste Number: None
14. TRANSPORTATION INFORMATION
This Materials is not Hazardous as Defined by 49 CFR 172.101 by the U. S. Department of
Transportation
Proper Shipping Name: Not applicable
Hazard Class Number and Description: Not applicable
UN Identification Number: Not applicable
Packing Group: Not applicable
DOT Label(s) Required: Not applicable
North American Emergency Response Guidebook Number (1996): Not applicable.
MARINE POLLUTANT: No component of this product is listed as a Marine Pollutant (49 CFR 172.101,
Appendix B)
Transport Canada Transportation of Dangerous Goods Regulations: Not applicable
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Materials Safety Data Sheet
15. REGULATORY INFORMATION
U.S. REGULATIONS:
U.S. SARA Reporting Requirements: The components of this product are not subject to the reporting
requirements of Sections 302, 304 and 313 of Title II of the Superfund Amendments and
Reauthorization Act.
U.S. SARA Threshold Planning Quantity: Not applicable
U.S. CERCLA Reportable Quantities (RQ): Not applicable
Methylprednisolone Acetate Sterile
U.S. TSCA Inventory Status: Methylprednisolone Acetate is a 鈥渄rug鈥? as defined by the Federal Food,
Drug and Cosmetic Act and is therefore not a chemical substance under TSCA.
California Safe Drinking Water and Toxic Enforcement Act (Proposition 65): This product does NOT
contain a chemical known to the State of California to cause developmental and reproductive effects.
Other U.S. Federal Regulations: Based on this product鈥檚 use, the requirements of the OSHA
Bloodborne pathogen Standard (29 CFR 1910.1030) are applicable.
Aqueous Suspension
ANSI Labeling (Based on 129.1, Provided to Summarize Occupational Exposure Hazards):
WARNING! MAY CAUSE ALLERGIC REACTIONS. OVEREXPOSURE MAY CAUSE DAMAGE TO
THE KIDNEYS, PITUITARY, CARDIVASCULAR, IMMUNE and NERVOUS SYSTEMS.
Methylprednisolone Acetate should be administered under the supervision of a qualified physician.
Avoid over-exposure. Avoid breathing vapor. Avoid contact with eyes, skin and clothing. Do not eat,
drink or smoke when handling Methylprednisolone Acetate. Do not taste or swallow. Wash thoroughly
after handling. Clean up spills promptly.
CANADIAN REGULATIONS:
Canadian DSL/NDSL Status: Methylprednisolone Acetate is regulated by the Food and Drug
Administration of Health Canada and is therefore exempt from the requirements of CEPA.
16. OTHER INFORMATION
Issue Date: 11/27/00
Previous Issue Date: None
The information in this document is believed to be correct as of the date issued. HOWEVER, NO
WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY
OTHER WARRANTY IS EXPRESSED OR IS TO BE IMPLIED REGARDING THE ACCURACY OR
COMPLETENESS OF THIS INFORMATION, THE RESULTS TO BE OBTAINED FROM THE USE OF
THIS INFORMATION OR THE PRODUCT, THE SAFETY OF THIS PRODUCT, OR THE HAZARDS
RELATED TO ITS USE. This information and product are furnished on the condition that the person
receiving them shall make his own determination as to the suitability of the product for his particular
purpose and on the condition that he assume the risk of his use thereof.
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