Page 1 of 4 ?Fluconazole for Oral Suspension
IN CASE OF EMERGENCY
Emergency Phone: (614) 276-4000
Material Safety Data Sheet
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Common/Trade Name: Fluconazole for Oral Suspension
Chemical Name: 2,4-difluoro-alpha,alpha1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol
Synonyms: None
Molecular Formula: C13H12F2N6O
Molecular Weight: 306.3
CAS No: 86386-73-4
Chemical Family: Synthetic triazole antifungal agents
Product Use: Treatment of fungal infections
Boehringer Ingelheim Roxane Inc.
Manufacturer's Name:
1809 Wilson Road
Address:
Columbus, Ohio 43228
2. COMPOSITION / INFORMATION ON INGREDIENTS
Composition CAS# Exposure Limit
Fluconazole (active ingredient) 86386-73-4 None established
REFER to PHYSICIAN'S DESK REFERENCE for common components present as <1%
3. HAZARDS IDENTIFICATION
Emergency Physical State: White, powder used for oral suspension
Overview White, orange-flavored powder that provides 350 mg or 1400 mg doses of Fluconazole per
bottle.
Odor: None
WARNING!
May be harmful if swallowed.
Accidental ingestion of large amounts may be fatal.
Primary Route(s)
of Entry Ingestion
Potential Health Inhalation: Not expected to be an inhalation hazard in final pharmaceutical form.
Effects:
Eye Contact: Not expected to be a hazard to the eye. Contact with eye may cause irritation,
burning and redness.
Skin Contact: Not expected to be a hazard to the skin. Can cause hypersensitive reactions
resulting in rash, redness, itching and inflammation.
Ingestion: May be harmful if ingested. Ingestion may cause nausea, vomiting, diarrhea and
other systemic effects.
Toxicity Data: See Section 11
Effects of The potential for exposure is reduced in finished pharmaceutical form.
Overexposure: Overexposure by ingestion may cause decreased motility and respiration, salivation, urinary
incontinence, cyanosis, and loss of righting reflex.
Target Organs: Gastrointestinal tract
4. FIRST AID MEASURES
Page 2 of 4 ?Fluconazole for Oral Suspension
Eye Exposure Any material that contacts the eye should be washed out immediately with water. If easy to do,
remove contact lenses if worn. Get medical attention if symptoms persist.
Skin Exposure Wash with soap and water. Get medical attention if symptoms occur.
Ingestion Call a physician or poison control center immediately.
Inhalation Move to fresh air and treat symptomatically. If breathing is difficult, move to fresh air. Get
medical attention immediately.
5. FIRE AND EXPLOSION HAZARDS
Flammability N/A Upper: N/A
Lower:
Flash Point Not available
Extinguishing Media Use water spray, carbon dioxide, dry chemical or material appropriate for fire in
surrounding area.
Special Fire Fighting
Procedures Wear full protective clothing and self-contained breathing apparatus.
Unusual Fire/Explosion
Hazards Not Applicable
Hazardous Combustion
Products Carbon dioxide, carbon monoxide, oxides of nitrogen, hydrogen fluoride
6. ACCIDENTAL RELEASE INFORMATION
STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF PRODUCT IS SPILLED:
Use appropriate personal protective equipment (see Section 8). Sweep up and containerize spill material in a
compatible container. Dispose according to applicable regulations. Incineration of the waste at an approved facility
is recommended.
7. PRECAUTIONS FOR SAFE HANDLING AND USE
Precautions Handling Observe good industrial hygiene practices.
Significant Quantities
of Product:
Storage Before Reconstitution: Store at 20?and 25癈 (68?to 77癋).
After Reconstitution: Store suspension at 5?to 25癈 (41?to 77癋). Discard unused portion
after 2 weeks. Protect from freezing.
Keep container closed tightly. Protect from light and moisture. Store away from foodstuffs.
8. CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Exposure Limits None
Engineering Controls Not required when handling containers. Good ventilation should be used. Ventilation should
be matched to conditions.
Respiratory Not required when handling containers. NIOSH/MSHA approved respirators for protection
Protection should be used if respirators are found to be necessary. Ventilation should be matched to
conditions.
Personal Protection Not required when handling final product. If containers are compromised or exposure is
likely wear: Goggles, Lab Coat, Gloves
Recommended
Facilities Eye wash, washing facilities
9. PHYSICAL / CHEMICAL CHARACTERISTICS
Appearance White powder Melting point Not available Solubility in Soluble
water
Odor None Boiling point Not available Specific Gravity Not available
Taste Orange Vapor Pressure Not available Flashpoint Not available
pH Not available Density Not available Flammability Not available
Limits
10. STABILITY AND REACTIVITY DATA
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Stability Stable
Incompatibility Oxidizing material
Hazardous
Decomposition Oxides of carbon, oxides of nitrogen, hydrogen fluoride
Conditions to
Avoid Excessive heat and light
Hazardous
Polymerization Will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity:
Active Ingredient:
LD50 Oral (rat): 1271 mg/kg
LD50 Oral (mouse): 1408 mg/kg
Carcinogenicity: Not listed as a carcinogen by NTP, IARC Monographs or OSHA.
12. ENVIRONMENTAL IMPACT INFORMATION
No information is currently available on the environmental impact of this product.
13. DISPOSAL INFORMATION
Waste Disposal Considerations: Dispose of material according to federal, state and local disposal regulations or
company operating procedures. Disposal by incineration is recommended.
At home: Discard away from children's reach.
14. TRANSPORTATION INFORMATION
This product is not subject to the regulations for the safe transport of hazardous chemicals.
DOT: Not regulated
TDG: Not regulated
IATA: Not regulated
IMDG: Not regulated
15. REGULATORY INFORMATION
DEA: Fluconazole is not a controlled substance.
FDA: Fluconazole is an approved prescription medication.
Inventory Status:
This material is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exempt purposes such
as R&D or drug use.
This material is not listed on the DSL Inventory but is exempt.
16. OTHER DATA
ABBEVIATIONS:
N/A ?not applicable
Prepared by: Boehringer Ingelheim Roxane Inc.
References:
1. Fluconazole for Oral Suspension, Package Insert, Boehringer Ingelheim Roxane Inc., Columbus, Ohio
2. RTECS No. XZ4810000 for 1H-1,2,4-Triazole-1-ethanol, alpha-(2,4-difluorophenyl)-alpha-(1H-1,2,4-triazol-1-
ylmethyl)-
3. Ariel Webinsight. Regulatory and ChemExpert Database.
4. PDR ?Physicians Desk Reference
Date: 09/13/2008 - New MSDS
SEE CURRENT PACKAGE INSERT FOR FURTHER INFORMATION
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The information provided is believed to be complete and accurate. If this product is combined with other materials, deteriorates or
becomes contaminated, it may pose hazards not mentioned in this MSDS. It is the users' responsibility to use the information
according to the application. Boehringer Ingelheim Roxane Inc. assumes no responsibility or liability resulting from the use of this
information.
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