Microsoft word - furosemide injection usp.doc

Product: Furosemide Injection, USP Revision: 1

Luitpold Pharmaceuticals, Inc.
Chemtrec 24/7 Emergency Telephone Number (800) 645-1706
(631) 924-4000
Furosemide Injection, USP

10 mg/mL: 0517-5702-25, 0517-5704-25, 0517-5710-25

Appearance / Odor Clear, colorless to slightly yellow, odorless solution. WARNING!
Skin, eye and respiratory irritant Causes slight irritation of the eyes, skin and respiratory tract. Toxicity to fish/aquatic organisms Product is not known to be toxic to fish. Likely Routes of Exposure Eye contact, inhalation and ingestion. Inhalation May cause irritation of the upper and lower respiratory tract. Ingestion May cause irritation of the gastrointestinal tract. Skin Absorption Not absorbed through the skin. Medical Conditions Aggravated by Workers with impaired cardiovascular, kidney or liver functions Exposure should minimize their exposure to this product. It is strongly recommended that pregnant workers not be exposed to this product. Target Organs Kidney, liver, cardiovascular systems. Luitpold Pharmaceuticals, Inc. – American Regent Product: Furosemide Injection, USP Revision: 1
Section 2: HAZARDS IDENTIFICATION (continued)
Potential Environmental Effects: This product is not known to be toxic to fish. See Section 12 for more information This product does not contain any carcinogens or potential carcinogens as listed by OSHA, IARC or NTP. This material is considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200). Section 3: COMPOSITION AND INFORMATION ON INGREDIENTS
Eye Contact Causes irritation. Flush for 15 minutes with copious quantities Skin Contact May cause irritation. Remove contaminated clothing. Flush area with copious quantities of water for 15 minutes. Seek medical attention. Inhalation May cause irritation of respiratory tract. Remove person to fresh air. Remove contaminated clothing. Seek medical attention. Ingestion May cause nausea, vomiting and irritation of the gastrointestinal tract. Flush mouth out with water. Seek medical attention. Note to Physicians Exposure to this product may result in headache, tinnitus, electrolyte imbalance, dry mouth, weakness, lethargy, drowsiness and muscle pains. Dermatitis, urticaria, rash and photosensitivity could be observed. Tachycardia, arrhythmia, hypotension, hypocalemia, hypochloremic alkalosis, nausea and vomiting may be observed as well. See prescribing information. Luitpold Pharmaceuticals, Inc. – American Regent Product: Furosemide Injection, USP Revision: 1
Suitable Extinguishing Media Water spray, foam, dry chemical or Carbon Dioxide (CO2). Caution: CO2 will displace air in confined spaces and may
cause an Oxygen deficient atmosphere.
Hazardous Combustion Products When heated, Furosemide solution thermally decomposes to form toxic vapors. (i.e. Carbon Monoxide, Carbon Dioxide and Nitrogen Oxides) Protection for Firefighters: Furosemide solution thermally decomposes to form toxic vapors. Vapors may be irritating to eyes and skin and toxic to respiratory tract. Firefighters are to wear self-contained breathing apparatus (SCBA) and full turn out gear (Bunker gear). Cool containers with water spray and use caution when approaching. Section 6: ACCIDENTAL RELEASE MEASURES
Personnel Precautions Use personal protective equipment recommended in Section 8 of this document and isolate the hazard area. Environmental Precautions This material is not considered a water pollutant. However, it is recommended to prevent spilled or leaking material from entering waterways. Minimize the use of water to prevent environmental contamination. Methods of Containment Absorb material with suitable materials such as clay absorbent or absorbent pads for aqueous solutions. Methods of Clean Up Vacuum spillage with a vacuum cleaner having a high efficiency particulate (HEPA) filter, or absorb liquid with clay absorbent, absorbent pads or paper towels. Use plastic tools to scoop up, sweep or containerize spilled material. Use plastic drums to contain spilled materials. Wipe working surfaces to dryness, and then wash with soap and water. Other Information A spill of this material does not need to be reported to the Luitpold Pharmaceuticals, Inc. – American Regent Product: Furosemide Injection, USP Revision: 1
As a general rule, when handling pharmaceutical products, avoid all contact and inhalation of mists or
vapors associated with the product. Avoid contact with skin, eyes or clothing. Do not mix with other
Use in a well ventilated area. Wash thoroughly after handling.
Store in a well ventilated area. Keep containers closed when not in use. Product residue may remain in
empty containers. Observe all label precautions until container is cleaned, discarded or destroyed.
Exposure Guidelines
Ventilation Local exhaust or general ventilation is recommended. Respiratory Protection Under normal conditions of product use, respiratory protection is not required. When required, use a NIOSH approved air purifying respirator with combination P-100 / organic vapor cartridges. Eye Protection Wear ANSI approved chemical splash goggles or safety glasses. Skin Protection When administering this product to patients, use nitrile or latex gloves. Use Tyvek™ SL or equivalent coveralls, PVC booties and nitrile gloves for clean up activities. Section 9: PHYSICAL AND CHEMICAL PROPERTIES
Color Clear, colorless to slightly yellow solution. Freezing Point Approximately 32 degrees Fahrenheit Boiling Point Approximately 212 degrees Fahrenheit Flammability Nonflammable, noncombustible Luitpold Pharmaceuticals, Inc. – American Regent Product: Furosemide Injection, USP Revision: 1
Solubility (water) Slightly soluble in water Auto-ignition Temperature Not applicable Volatile Organic Compounds (%) 0 percent Section 10: STABILITY AND REACTIVITY
Conditions to Avoid Do not mix with other drugs. Avoid heat, light and humidity. Keep away from flames, thermally decomposes to form toxic vapors. Incompatible Materials Reactive with oxidizers, metals and acids. Hazardous Decomposition Products Carbon Monoxide, Carbon Dioxide and Nitrogen Oxides may be Possibility of Hazardous Reactions Hazardous polymerization will not occur. Section 11: TOXICOLOGY INFORMATION
Acute Effects

Inhalation Respiratory irritation is possible. Eye Irritation Eye irritation is possible. Skin Irritation Skin irritation may be possible. Sensitization Repeated exposures may lead to sensitivity to this product. Luitpold Pharmaceuticals, Inc. – American Regent Product: Furosemide Injection, USP Revision: 1
Section 11: TOXICOLOGY INFORMATION (continued)
Chronic Effects
Organ Systems Prolonged or repeated exposure may lead to damage to the kidneys, liver and cardiovascular system. Carcinogenicity At high doses, two animal studies illustrated that Furosemide is carcinogenic. No adequate and well controlled studies in humans have been conducted. Mutagenicity One animal cell study illustrated Furosemide is mutagenic in somatic mammalian cells. No adequate and well controlled studies in humans regarding the mutagenic effects of Furosemide. Sodium Chloride is considered mutagenic for mammalian somatic cells, bacteria and yeast. Reproductive Effects Animal studies have demonstrated that Furosemide is embryotoxic. No adequate and well controlled studies in humans have been conducted. Furosemide passes into breast milk of nursing mothers. Developmental Effects Above prescribed doses, Furosemide was found to be teratogenic in animal studies. No adequate and well controlled studies in humans. Classified as Pregnancy Category C. Section 12: ECOLOGICAL INFORMATION
Persistence / Degradability Short term products of biodegradation are not likely. Long term Bioaccumulation / Accumulation No applicable bioaccumulation is expected in the environment. Mobility in Environment Appreciable volatilization is not expected into the air. Section 13: DISPOSAL CONDITIONS
Disposal Do not mix with other substances. Dispose of in accordance with Federal, state and local regulations. Contact your state or local government environmental and / or sanitation department for guidance on disposal. Section 14: TRANSPORTATION INFORMATION
Regulatory Agency Shipping Description
US DOT (ground) Not considered a DOT regulated material - Non hazardous for IATA (air) Not considered a DOT regulated material - Non hazardous for Luitpold Pharmaceuticals, Inc. – American Regent Product: Furosemide Injection, USP Revision: 1
STATE RIGHT TO KNOW Refer to the applicable state to determine applicability. California Safe Drinking Water & This material is not known to contain any chemicals currently Toxic Enforcement Act (Prop 65) listed as carcinogens or reproductive toxins under California NFPA Rating Health - 2, Fire - 1, Reactivity - 0 Section 16: OTHER INFORMATION
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in
emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the
treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease,
including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater
diuretic potential is desired.
Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous
administration of Furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute
pulmonary edema.
If gastrointestinal absorption is impaired or oral medication is not practical for any reason, Furosemide
is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral
Furosemide as soon as practical.
Refer to Luitpold / American Regent’s prescribing information for further information at
Prepared By: Christopher Seniuk CIH CSP
The information above is believed to be accurate and represents the best information currently available to American Regent. The information has not been verified and we cannot, therefore, guarantee its accuracy or completeness or adequacy for all persons and situations or as to the results to be obtained by use of the information. It is the user’s obligation to evaluate and use this product safely and to comply with all applicable laws and regulations. WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, WITH RESPECT TO SUCH INFORMATION AND WE ASSUME NO LIABILITY RESULTING FROM ITS USE. Users should make their own investigations to determine the suitability of the information for their own particular purposes. The user assumes all risks from use of the product. In no event shall Luitpold, its subsidiaries, its affiliates and its contractors be liable for any claims, losses or damages of any third party, or for lost profits, or for any special, indirect, incidental, consequential or exemplary damages however arising, even if Luitpold has been advised of the possibility of such damages. Luitpold Pharmaceuticals, Inc. – American Regent


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