300 Northfield Road
MATERIAL SAFETY DATA SHEET
Bedford, OH 44146
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Amidodarone Hydrochloride Injection (3, 9 and 18 mL)
Chemical Names: Amiodarone Hydrochloride
Synonyms: 2-butyl-3-benzofuranyl 4-(2-(diethylamino) ethoxy)-3,5-diiodophenyl ketone hydrochloride;
amiodaronum hydrochloride; Methanone, (2-butyl-3-benzofuranyl) (4-(2-(diethylamino)ethoxy)-3,5-
diiodophenyl-, hydrochloride; Amiodarone HCl; SKF 331314 A, Trangorex, L 3424, L 3438 labaz,
Cordarone?br>
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: 1(800)424-9300
Telephone Number for Info.: (440)232-3320 -or- (800)562-4797
Medical Emergency: Professional Services 1(800)521-5169
Date Prepared: July 30, 2002
Date Revised: August 23, 2005
Date Revised: June 26, 2007
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
Amiodarone
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Hydrochloride 5 19774-82-4 NONE NONE 20 ug/m 3
(BVL OEL)
Benzyl Alcohol 2 100-51-6 NONE NONE NONE
Polysorbate 80 10 9005-65-6 NONE NONE NONE
Water for Injection 83 7732-18-5 NONE NONE NONE
Amiodarone is a sterile injectable liquid drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Under normal use, Amiodarone presents little hazard. It may be absorbed through the
skin or via inhalation of aerosols or accidentally ingested.
Health Hazard (Acute & Chronic): Amiodarone is a drug generally considered a class III
antiarrhythmic used in treating heart beat irregularities. Minimal adverse health effect should
occur from routine use under care of a physician with this product. Accidental ingestion may
result nausea, vomiting, irregular heart beat, headache, lung damage. Short-term contact may
cause dermal irritation.
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Carcinogenicity: NTP? NO IARC Monographs? NONE OSHA Regulated? NO
Signs & Symptoms of Exposure: Possible irritation to skin and respiratory tract.
Medical Conditions Generally Aggravated by Exposure: Hypotension may occur with use.
BVL Hazard Category: 3
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BVL Occupational Exposure limit (OEL): 20 ug/m
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 or more minutes.
Skin Exposure: Wash skin with cool, soapy water for 15 minutes.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
If person is conscious, induce vomiting. Never induce vomiting on an unconscious person.
Inhalation: If difficulty breathing, administer oxygen. Seek attention of a physician immediately.
When appropriate and trained in CPR, provide artificial respiration.
Section V - FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): Not Applicable LEL: Not Applicable UEL: Not Applicable
Flammable Limits: Not Applicable
Extinguishing Media: Use water or an ABC multi-purpose extinguisher.
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters
should wear self-contained breathing apparatus to avoid inhalation of smoke. Product is aqueous-
based and is not expected to present a fire hazard concern.
Unusual Fire/Explosion Hazards: NONE
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Amiodarone with absorbent materials and dispose according to local, state,
and federal guidelines.
Release to Air: If aerosolized, reduce exposures by ventilating area; clean up spill immediately to
prevent evaporation
Release to Water: Refer to local water authority. Drain disposal is not recommended; however,
refer to local, state, and federal disposal guidelines.
Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE
Steps to be taken in case material is released or spilled: See Section VI above.
Wear latex or nitrile gloves and safety glasses when cleaning spills. A dust/mist respirator (N95)
may be necessary if excessive aerosols are generated.
Waste Disposal Method: Incineration in an approved incinerator is recommended. Refer to local, state,
and federal rules.
Precautions to be taken in handling and storing: Store between 15-25 癈. Protect from excessive
light and heat. Follow instructions provided in packaging.
Other Precautions: NONE
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Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Under normal use, respirators are not required. If aerosols are generated, a
disposable dust/mist respirator (N95) may be used. Personnel wearing respirators should be fit
tested and approved for respirator use under the OSHA Respiratory Protection Standard 29 CFR
1910.134.
Ventilation: Handle product in a well-ventilated area.
Protective Gloves: Latex or nitrile
Eye Protection: Safety glasses
Other Protective Clothing or Equipment: Lab Coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking while
handling this product.
Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS
Physical State: Liquid Specific Gravity: Approx. to water
Appearance and Odor: Pale-yellow solution Melting Point: Approx. 0癈
Boiling Point: Approx. 100癈 Evaporation Rate: Approx. to water
Vapor Pressure: Not available Solubility in Water: Soluble
Vapor Density: Not available pH: Not Available
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): Strong oxidizers or water-reactive materials.
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts of nitrogen oxides, carbon monoxide, carbon dioxide, and
sulfur oxides.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Storage near oxidizers and water reactive materials
Section XI - TOXICOLOGICAL INFORMATION
For Amiodarone Hydrochloride (active ingredient) RTECS Number OB1361000
LD50 rat, intravenous = 170 mg/kg
LD50 rat, oral = >3 gm/kg
LD50 rat, intraperitoneal = 610 mg/kg
LD50 mouse, oral = >3 gm/kg
LD50 dog, oral = >5 gm/kg
LD50 dog, intravenous = 5 gm/kg
Additional reproductive health data is available from the National Institute for Occupational Safety and
Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS).
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Amiodarone. Handle in a manner
to prevent spills or releases to the environment.
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Section XIII - DISPOSAL INFORMATION
Dispose of by incineration at an approved/permitted incinerator.
Review local, state, and federal regulations for your regulatory area.
Section XIV - TRANSPORTATION INFORMATION
Amiodarone solution USP is not a DOT hazardous material.
Amiodarone is not a DOT Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
Listed on the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65).
CODE - DFM
Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address the therapeutic use of this material
2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and
other sharps used in the administration. All needle sticks must be reported to your company
Management.
3. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories):
1 = Low Toxicity
2 = Moderate Toxicity
3 = Potent or Toxic
4 = Highly Potent or Toxic
5 = Extremely Potent or Toxic
4. OEL=Occupational Exposure Limit. An internal limit set by Ben Venue Laboratories for the
recommended limit of employee exposure to airborne dusts or aerosols that should not be
exceeded over an eight-hour time-weighted average.
5. Amiodarone Hydrochloride may be considered a Hazardous Drug as described in the NIOSH
Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in
Health Care Settings. Employees who prepare or administer hazardous drugs or who work in
areas where these drugs are used should follow specific handling guidelines in order to prevent
exposure to these agents in the air or on work surfaces, clothing, or equipment.
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6. The Following Guidance Information is excerpted from the NIOSH Alert:
Elements of a Hazardous Drug Handling Program include:
?Establishment and implementation of written policies and protocols to ensure the safe
handling of oncolytic and/or potent drugs, including receipt of product.
?Training and education of employees on the recognition, evaluation and control of
Hazardous Drugs
?Effective Planning and design of the workplace
?Use of best practice control measures and specialized equipment such as ventilated
cabinets or isolators designed for worker protection
?Wearing recommended personal protective equipment
?An integrated health surveillance program that: includes the assessment and counseling of
prospective employees before they commence any work involving oncolytic and/or potent
drugs and related waste
7. Published guidance on the handling and transport of cytotoxic drugs:
NIOSH Alert ?Preventing occupational exposures to antineoplastic and other hazardous drugs in
health care settings
http://www.cdc.gov/niosh/docs/2004-165/
National Study Commission on Cytotoxic Exposure: Recommendation for handling Cytotoxic
Agents:
http://www.nih.gov/od/ors/ds/pubs/cyto/index.htm
This document is generated to distribute health, safety and environmental data. It is not a specification sheet and none of the
displayed data should be construed as a specification. Information on this MSDS sheet was obtained from sources which we
believe are reliable, and we believe that the information is complete and accurate. However, the information is provided without
any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn are from
sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of the product
are beyond our control and may also be beyond our knowledge. It is the user's responsibility to determine the suitability of any
material for a specific purpose and to adopt such safety precautions as may be necessary. If the product is used as a component in
another product, this MSDS information may not be applicable. For these reasons, we do not assume any responsibility and
expressly disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling, storage, use
or disposal of this product.
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