300 Northfield Road
MATERIAL SAFETY DATA SHEET
Bedford, OH 44146
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Fenoldapam Mesylate Injection (10ml/vial, 2 cc and 3 cc vials)
Chemical Names: 6-chloro-2,3,4,5-tetrahhydr-1-hydroxyphenyl)-[1H]-3-benzazepine-7,8-diol
methanesulfonate
Synonyms: CORLOPAM.
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: March 31, 2004
Date Revised: July 13, 2007
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
Fenoldapam Mesylate 1.0 66227-57-0 NONE NONE NONE KNOWN
Citric Acid 0.34 77-92-9 NONE NONE NONE KNOWN
Sodium Citrate
Dihydrate 0.06 6132-04-3 NONE NONE NONE KNOWN
10 mg/m3 (AIHA)
Propylene Glycol 51.8 57-55-6 NONE NONE
5 mg/m3 5 mg/m3 5 mg/m3
Sodium Metabisulfite 0.1 7681-57-4
Water for Injection 46.7 7732-18-5 NONE NONE NONE KNOWN
Fenoldapam Mesylate Injection is a sterile injectable liquid drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Contact with skin/eyes; inhalation of aerosols or accidentally ingested. Under normal
use with supervision of a physician, Fenoldapam Mesylate Injection presents little hazard.
Health Hazard (Acute & Chronic): Fenoldapam Mesylate Injection is a rapid-acting vasodilator for
individuals with mild to moderate hypertension or hypertensive emergencies. Minimal adverse health
effect should occur from use under care of a physician with this product. Adverse effects may include
intra-ocular pressure, tachycardia, hyptension and hypkalemia. Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less
severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the
general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic
than in non-asthmatic people.
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Medical Conditions Generally Aggravated by Exposure: Hypersensitivity, cardiac disease and
glaucoma.
Carcinogenicity: NTP? NO IARC Monographs? NONE OSHA Regulated? NO
Signs & Symptoms of Exposure: Possible irritation to skin, eyes, and respiratory tract.
BVL Hazard Category: 2
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 or more minutes. Get medical attention if
irritation or signs of exposure are noted.
Skin Exposure: Remove contaminated clothing, wash skin with water and soap for 15 minutes. Get
medical attention if irritation or signs of exposure are noted.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
Never give anything by mouth to an unconscious person.
Injection: In cases of accidental injection, wash and disinfect area, get medical attention.
Inhalation: If difficulty with breathing, remove from exposure, 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: Heat of the fire could cause ampules, vials or syringes to burst.
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Fenoldapam Mesylate 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 2-30癈. Follow instructions
provided in packaging.
Other Precautions: None Known
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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: Not available
Appearance and Odor: Clear to whitish solution. Melting Point: 271 ?273 癈
Boiling Point: Not available Evaporation Rate: Not available
Vapor Pressure: Not available Solubility in Water: Soluble
Vapor Density: Not available pH: 2.8 ?3.8
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): None identified.
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts such as oxides of carbon, nitrogen, and sulfur and HCl gases.
Hazardous Polymerization: Will not occur
Conditions to Avoid: None identified.
Section XI - TOXICOLOGICAL INFORMATION
For Fenoldapam Mesylate (active ingredient) RTECS CX7185050
TDLo (dog), = intravenous:Dose: 20 ug/kg
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Fenoldapam Mesylate. Handle in a
manner to prevent spills or releases to the environment.
Section XIII - DISPOSAL INFORMATION
Dispose of by incineration at an approved/permitted incinerator.
Review local, state, and federal regulations for your regulatory area.
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Section XIV - TRANSPORTATION INFORMATION
Fenoldapam Mesylate Injection is not a DOT hazardous material.
Fenoldapam Mesylate Injection is not a DOT Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
TSCA Listed?: Unknown
Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address 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.
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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