MATERIAL SAFETY DATA SHEET
Dihydroergotamine Mesylate Injection 1 mg/mL
Paddock Laboratories, Inc. Emergency Assistance:
CHEMTREC庐 (24-hour)
3940 Quebec Avenue North 1-800-424-9300
Minneapolis, MN 55427
Tel: (763) 546-4676 Paddock Technical Assistance: 1-800-328-5113
Creation Date: Revision Date:
28 May 2004 28 May 2004
SECTION 1: PRODUCT IDENTIFICATION
PRODUCT: Dihydroergotamine Mesylate Injectables 1 mg/mL (DHE)
COMMON NAME: Dihydroergotamine Mesylate
CHEMICAL NAME: Ergotaman-3, 6, 18-trione,9,10-dihydro-12-hydroxy-2-methyl-5-(phenylmethyl)-,(5a)-
monomethanesulfonate
SYNONYMS: DHE Mesylate, Ergotamine, 9,10-dihydro-Mesylate
CHEMICAL FORMULA: C33H37N5O5 鈥? CH4O3S
CHEMICAL FAMILY: Ergot Alkaloids
SECTION 2: COMPOSITION AND INGREDIENTS
CHEMICAL NAME CAS# % w/w OSHA PEL ACGIH TLV IDLH
Dihydroergotamine Mesylate 6910-39-2 <10 NE NE NE
Alcohol, USP 64-17-5 <10 by volume 1000 PPM 1000 PPM 1000 PPM
Glycerin 56-81-4 <50 NE 10mg/cum NE
(vapor)
Water 7732-18-5 >50 NE NE NE
Methane Sulfonic Acid 75-75-2 For pH adj.
Sodium Hydroxide 1310-73-2 For pH adj.
NE = Not Established
SECTION 3: HAZARDS INDENTIFICATION
EMERGENCY OVERVIEW: Material is a clear, colorless solution. Avoid breathing vapor. Avoid contact with eyes,
skin and clothing. Do not taste or swallow. Wash thoroughly after handling. Pregnancy category X.
Symptoms of Overexposure by Route of Exposure: This material is intended for the acute treatment of migraine
headaches or the acute treatment of cluster headache episodes. Signs of overexposure include numbness and
tingling of fingers and toes, extremity muscle pains, nausea, vomiting, localized edema and itching.
TO THE BEST OF OUR KNOWLEDGE THE INFORMATION CONTAINED HEREIN IS ACCURATE AS OF THE DATE HEREOF.
ANY DETERMINATION AS TO THE SUITABILITY OF THE PRODUCT FOR ANY PARTICULAR PURPOSE, ITS SAFE USE OR
DISPOSAL SHALL BE THE RESPONSIBILITY OF THE USER. THE INFORMATION CONTAINED HEREIN IS IN NO WAY
INTENDED TO SUPPLEMENT, MODIFY OR SUPERSEDE THE INFORMATION PROVIDED IN THE PRODUCT PACKAGE
INSERT WITH RESPECT TO THE USE OF THE PRODUCT FOR MEDICAL PURPOSES.
MSDS 鈥? Dihydroergotamine Mesylate Injection, USP Page 2 of 6
Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the small size of
individual containers.
Contact With Eyes: Under normal use, D H E presents little hazard.
Contact with Skin: Remove contaminated clothing. Wash shin with soap and water for 15 minutes. Get medical
attention if signs of exposure are noted.
Ingestion: Ingestion is not an anticipated route of occupational exposure. If this occurs, flush mouth with water and
seek medical attention.
Injection: If accidental injection occurs in an occupational setting, seek medical attention. 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 :
Health Hazards (Acute and Chronic): D H E is an alpha adrenergic blocking agent with a stimulating effect on
smooth muscle peripheral and cranial blood vessels and produces depression of central vasomotor centers. Adverse
acute effects are irritation to mucous membranes and respiratory tract, nausea, vomiting, headache, diarrhea, thirst,
coldness of skin, weak pulse numbness.
Pregnancy: D H E is listed as pregnancy category X. If you are pregnant and exposed to D H E, seek medical
attention immediately.
Target Organs: This product has not been identified as producing permanent adverse effects on organ systems.
Pre-Existing Medical Conditions: Conditions aggravated by exposure may include peripheral vascular disease,
coronary heart disease, hypertension, impaired hepatic/renal function, sepsis, pregnancy.
SECTION 4: FIRST AID MEASURES
Skin Exposure: Remove contaminated shoes and clothing and cleanse affected area(s) thoroughly by
washing with mild soap and water for 15 minutes. If irritation or redness develops and
persists, seek medical attention.
Eye Exposure: Immediately flush eyes with clean water. For direct contact, hold eyelids apart and flush the
affected eye(s) with clean water for at least 20 minutes. Seek immediate medical attention.
Inhalation: If 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, wash mouth and 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.
MSDS 鈥? Dihydroergotamine Mesylate Injection, USP Page 3 of 6
SECTION 5: FIRE / EXPLOSION HAZARDS & FIRE-FIGHTING MEASURES
Flash Point: No data Autoignition Temperature: No data
Flammable Limits (in air by volume, %): Lower: No data Upper: No data
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 鈥淎BC鈥? 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.
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 the DOT Emergency Response Guidebook, a self-contained breathing
apparatus 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.
HAZARD CLASS: Health: 2 (Least)
Flammability: 0 (Least)
Reactivity: 0 (Least)
SECTION 6: SPILL AND LEAK PROCEDURES
Spill and Leak Response:
For small releases of this product, wear nitrile or other suitable gloves and safety glasses. Absorb spilled liquid and
rinse area thoroughly with soap and water.
For large or uncontrolled releases, stay upwind and 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.
SECTION 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.
Storage and Handling Practices: Employees must be trained to properly use the product. Ensure ampules are
properly labeled. Store only in approved containers. Keep away from any incompatible materials or conditions (see
Section 10). Store below 25掳C (77掳F). Protect from light. Product must not be used if it is discolored or contains a
precipitate.
MSDS 鈥? Dihydroergotamine Mesylate Injection, USP Page 4 of 6
Protective Practices During Maintenance of Contaminated Equipment: When cleaning non-disposable equipment,
wear nitrile or other suitable gloves, 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.
SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
Ventilation and Engineering Controls: Use with adequate ventilation. Follow standard medical product handling
procedures.
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 29 CFR 1910.134 and ANSI Z88.2 requirements must be followed
whenever workplace conditions warrant a respirator鈥檚 use.
Eye Protection: The use of a face shield and/or chemical goggles to safeguard against potential eye contact,
irritation, or injury is recommended.
Hand Protection: Use nitrile, rubber, or other suitable 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.
SECTION 9: PHYSICAL / CHEMICAL PROPERTIES
Boiling Point: Not Available Vapor Pressure: Not Available
Melting/Freezing Point: Not Available pH: 3.4 鈥? 4.9
Water Solubility: Slight Water Reactive: No
Specific Gravity (Water =1): Not Available Evaporation Rate (Butyl acetate = 1): Not Available
Appearance/Odor: Clear, colorless solution / odorless
ND = No Data
SECTION 10: STABILITY AND REACTIVITY
Stability: Stable under labeled storage conditions.
Incompatible Materials: ND.
Hazardous Polymerization: Will not occur.
Conditions to Avoid: Protect from light and excessive heat.
SECTION 11: TOXICOLOGICAL INFORMATION
Toxicity Data: Not Available
Suspected Cancer Agent: This product has NOT been identified as a carcinogen by NTP, IARC or OSHA.
MSDS 鈥? Dihydroergotamine Mesylate Injection, USP Page 5 of 6
Irritancy of Product: This product may be irritating to eyes and other tissues.
Sensitization to the Product: This material may produce hypersensitization, irritating to mucous membranes and
respiratory tract. May be hypersensitive to other Ergot derivatives.
Reproductive Toxicity Information: Listed below is information concerning the effects of Dihydroergotamine Mesylate
on human and animal reproductive systems. This material is classified as a Pregnancy
Category X (May cause fetal harm).
Mutagenicitv: Negative in the Ames test and the in vitro Chinese hamster V79/HGPRT assay.
Embryotoxicitv/Teratogenicity/Reproductive Toxicity: DHE may cause fetal harm if taken while pregnant.
ACGIH Biological Exposure Indices: Currently there are no Biological Exposure Indices (BEIs) associated with the
components of this product.
SECTION 12: ECOLOGICAL INFORMATION
All work practices must be aimed at eliminating environmental contamination.
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 DHE on plants or
animals in the environment.
Effect of Chemicals on Aquatic Life: No specific information is available on the effect of DHE on aquatic life.
SECTION 13: WASTE DISPOSAL
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
SECTION 14: TRANSPORTATION INFORMATION
This Material 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
MSDS 鈥? Dihydroergotamine Mesylate Injection, USP Page 6 of 6
SECTION 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
U.S. TSCA Inventory Status: DHE 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.
ANSI Labeling (Based on 129.1. Provided to Summarize Occupational Exposure Hazards):
WARNING! Serious AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN ASSOCIATED WITH
THE COADMINISTRATION OF DHE WITH POTENT CYP3A4 INHIBITORS INCLUDING PROTEASE INHIBITORS
AND MACROLIDE ANTIBIOTICS. BECAUSE CYP3A4 INHIBITION ELEVATES THE SERUM LEVELS OF DHE,
THE RISK FOR VASOSPASM LEADING TO CEREBERAL ISCHEMIA AND/OR ISCHEMIA OF THE EXTREMITIES
IS INCREASED. HENCE, CONCOMITANT USE OF THESE MEDICATIONS IS CONTRAINDICATED. DHE 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 DHE. Do not taste or swallow.
Wash thoroughly after handling. Clean up spills promptly.
CANADIAN REGULATIONS:
Canadian DSL/NDSL Status: DHE is regulated by the Food and Drug Administration of Health Canada and is
therefore exempt from the requirements of CEPA.
SECTION 16: OTHER INFORMATION
DEFINITIONS OF ABBREVIATIONS USED:
ACGIH: American Conference of Governmental Industrial Hygienists
CAS: Chemical Abstract Service
IARC: Internal Agency for Research on Cancer
IDLH: Immediately Dangerous to Life or Health Level
LC50: Median Lethal Concentration
LD50: Median Lethal Dose
MSHA: Mine Safety and Health Administration
N/A: Not Available
NIOSH: National Institute for Occupational Safety and Health
NTP: National Toxicology Program
OSHA: Occupational Safety and Health Administration
PEL: Permissible Exposure Limit
STEL: Short Term Exposure Limit
TLV: Threshold Limit Value
TWA: Time Weighted Average
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