Product Name: Levophed Bitartrate
Synonyms: Norepinephrine bitartrate, L-Arterenol bitartrate
Manufacturer: Multiple pharmaceutical producers worldwide
Emergency Contact: Refer to local Poison Control Center or supplier-specific emergency hotline
Recommended Use: Treatment of acute hypotensive states
Restrictions on Use: Prescription medication only, hospital settings under direct supervision by medical professionals
CAS Number: 55-31-2
UN Number: Not classified as hazardous for transport under normal pharmaceutical shipment
GHS Classification: Acute toxicity (Oral, Dermal, Inhalation), Category 4
Pictogram: Exclamation mark (Warning)
Signal Word: Warning
Hazard Statements: May cause allergic reactions, cardiovascular disturbances, serious eye irritation, respiratory distress, and skin sensitization. Risk of hypertension, arrhythmias, and tissue necrosis if extravasation occurs.
Precautionary Statements: Avoid contact with skin and eyes. Use appropriate personal protective equipment in clinical and laboratory settings. Prevent release to the environment by ensuring containment procedures.
Chemical Name: Norepinephrine bitartrate
Common Name: Levophed
Formula: C8H11NO3.C4H6O6
Content: Typically supplied as 1 mg/mL solution for injection
Impurities: Water for injection, sodium chloride (in buffered solutions), sulfuric acid for pH adjustment, minor inactive stabilizers
Inhalation: Move person to fresh air, support breathing, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, rinse skin immediately with copious amounts of water, wash with soap thoroughly, get medical help for persistent irritation
Eye Contact: Flush eyes with plenty of clean, lukewarm water for at least 15 minutes, do not allow patient to rub eyes, consult healthcare professional urgently
Ingestion: Do not induce vomiting, rinse mouth thoroughly, seek immediate medical advice due to risk of systemic cardiovascular effects
Most Important Symptoms/Effects: Hypertensive crisis, arrhythmia, tissue necrosis at injection site, severe headache, shortness of breath, vision changes
Suitable Extinguishing Media: Use dry chemical powder, CO2, water spray, or foam for surrounding fire
Specific Hazards: Product does not burn readily; toxic fumes may form under combustion, including oxides of nitrogen and carbon
Protective Equipment for Firefighters: Wear full protective gear including self-contained breathing apparatus to prevent inhalation of combustion products
Special Procedures: Evacuate area, cool containers exposed to flames with water spray; avoid run-off contamination
Personal Precautions: Use gloves, protective clothing, and eye protection to avoid direct contact
Environmental Precautions: Avoid dispersal into sewers, soil, and waterways by using absorbent material to contain spills
Clean-Up Methods: Dilute small spills with water, mop up, dispose of material in accordance with institutional and governmental regulations. Place absorbed material in sealed chemical waste container for proper disposal.
Handling: Avoid inhaling vapors, mist, or direct contact with skin and eyes during preparation and administration. Only trained personnel should handle this medication in a proscribed clinical environment, utilizing safe syringe techniques and proper needle sticks protocols. Implement standard precautions to prevent accidental exposure.
Storage: Store protected from light in original packaging at 20°C to 25°C (68°F to 77°F). Do not freeze; keep ampules or vials tightly closed. Keep away from incompatible substances such as strong oxidants. Segregate from food and beverage areas. Secure storage against unauthorized access or accidental misuse.
Engineering Controls: Work in a well-ventilated area, preferably with local exhaust hoods in compounding pharmacies. Ensure emergency eyewash stations and safety showers are readily accessible.
Personal Protective Equipment: Laboratory coat, disposable nitrile gloves, splash-proof goggles, face shield in case of splashes. Respiratory protection is not necessary under normal controlled use but keep NIOSH-certified respirators available for spill response or situations with high aerosol generation.
Hygiene Measures: Avoid hand-to-mouth contact, never eat or drink in preparation area, wash hands thoroughly post-handling, double-glove if risk of puncture or exposure increases.
Physical State: Clear, colorless to slightly yellow aqueous solution
Odor: Slight, not distinctive
pH: Typically in the range of 3.0 to 4.0
Boiling Point: Not applicable for aqueous solution
Melting Point: Not directly applicable (solution form)
Solubility: Freely soluble in water
Vapor Pressure: Not significant
Density: Approximately 1.0 g/mL (based on water content)
Partition Coefficient: Low, as it is highly polar and water-soluble
Chemical Stability: Stable under recommended storage conditions
Reactivity: Avoid strong acids, bases, and oxidizers as degradation may occur
Decomposition Products: With heat or under fire, decomposition may release carbon monoxide, carbon dioxide, and nitrogen oxides
Conditions to Avoid: Exposure to direct sunlight, excessive heat, and freezing temperatures. Avoid storing in unsealed containers due to potential for product degradation.
Acute Toxicity: Can cause fatal cardiovascular effects at high doses; symptoms include severe hypertension, tachycardia, bradycardia, headache, anxiety
Skin/Eye Irritation: May cause significant irritation on direct contact with skin or mucous membranes
Respiratory Sensitization: Rare but possible in susceptible individuals
Chronic Effects: Repeated or prolonged exposure may lead to hypersensitivity or cardiovascular events, especially in healthcare workers handling large quantities
Carcinogenicity: Not listed as a carcinogen by IARC, NTP, OSHA
Reproductive Toxicity: No definitive human data; animal studies limited
Ecotoxicity: Pharmaceutical active ingredients such as norepinephrine have demonstrated toxicity to aquatic organisms at relatively low concentrations
Persistence and Degradability: Not readily biodegradable in groundwater; may persist in aquatic environments
Bioaccumulation: Low potential for bioaccumulation due to high water solubility
Mobility in Soil: Likely to be mobile in soil and groundwater, increasing risk of environmental exposure if not properly contained during spills
Other Adverse Effects: Discharge to environment should be avoided, residues require responsible disposal.
Disposal Recommendations: Dispose of in accordance with local, regional, national, and international regulations for controlled substances and pharmaceutical waste. Do not flush down the drain. Employ authorized chemical waste contractors for incineration or approved chemical destruction.
Container Handling: Empty vials and ampules should be triple rinsed, then disposed of as pharmaceutical waste. Sharps (needles, syringes) must be placed in puncture-resistant containers before final disposal.
UN Number: Not assigned for shipment in ready-to-use pharmaceutical quantities
Transport Hazard Class: Not regulated as dangerous goods by DOT, IATA, IMDG in finished dosage form
Packaging Requirements: Secure, leak-proof outer packaging, temperature-controlled during shipping
Special Transport Precautions: Protect from physical damage, extreme temperatures, and direct sunlight to preserve medication efficacy during transit
US Federal Regulation: Included on US FDA approved drug list; not subject to OSHA Hazard Communication Standard when in final form for patient use
EU Regulation: Classified as prescription medicinal product; not regarded as hazardous substance under REACH or CLP in finished medicinal form
Other National Regulation: Follows local country legislation governing hospital-controlled drugs and waste disposal protocols
Inventory Status: Listed in applicable national drug and chemical inventories
Safety Reports: Subject to pharmacovigilance reporting systems; healthcare facilities must maintain records of use and waste
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