GlaxoSmithKline (919) 483-2100
PO Box 13398 (919) 483-2700 (24 hour contact)
5 Moore Drive
RTP, NC 27709 Effective Date: 06/22/98
MATERIAL SAFETY DATA SHEET
SECTION 1: CHEMICAL SUBSTANCE
PRODUCT NAME: FloventĀ® Inhalation Aerosol
FloventĀ® RotadiskĀ®
COMMON NAME: fluticasone propionate
CHEMICAL NAME: S-(fluoromethyl)6Ī±,9-difluoro-11Ī²,17-dihydroxy-16Ī±-methyl-3-oxoandrosta-1,4-diene-
17Ī² -carbothioate, 17-propionate
SYNONYMS: FloventĀ® 44 mcg Inhalation Aerosol; FloventĀ® 110 mcg Inhalation Aerosol; FloventĀ® 220
mcg Inhalation Aerosol; Flovent Inhalation Aerosol; FloventĀ® Rotadisk 50 mcg; FloventĀ®
RotadiskĀ® 100 mcg; FloventĀ® RotadiskĀ® 250 mcg; Flovent Rotadisk; FloventĀ® ; fluticasone
propionate inhalation powder; fluticasone propionate inhalation aerosol
SUBSTANCE CLASS: Anti-inflammatory corticosteroid
SECTION 2: HAZARDOUS INGREDIENTS
NAME CAS/EINECS/ELINCS # % GW LIMITS OTHER LIMITS
(mcg/m3)
w/v or w/w (ppm)
3 mcg/m3
fluticasone propionate 80474-14-2 (pure substance) Not Established
(OEL)
1000 ppm
*fluorotrichloromethane 75-69-4 Not Established OSHA PEL
(Freon 11) ACGIH TLV
1000 ppm
*dichlorodifluoromethane 75-71-8 Not Established OSHA PEL
(Freon 12) ACGIH TLV
*FloventĀ® Inhalation Aerosol Component
SECTION 3: HAZARDS IDENTIFICATION
THE RISK OF HEALTH HAZARDS MAY BE REDUCED WHEN FLOVENTĀ® INHALATION AEROSOL AND FLOVENTĀ® ROTADISKĀ® ARE
HANDLED IN UNIT DOSAGE FORM.
May cause sensitization (allergy) by skin contact or inhalation.
Possible risk of birth defects to the unborn child.
See also Section 11: āToxicological Informationā?.
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. PLEASE REFER TO THE PRODUCT PACKAGE INSERT FOR
INFORMATION REGARDING THE USE OF THE PRODUCT FOR MEDICAL PURPOSES.
FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 4: FIRST AID MEASURES
If in Eyes: Flush thoroughly with large amounts of cool water for at least 15 minutes. Obtain medical
attention.
If on Skin: Wash affected areas with soap and water after removing contaminated clothing. Obtain
medical attention if contamination is significant and/or a skin reaction is evident.
If Inhaled: If not breathing, give artifical respiration or CPR. If breathing is difficult, give oxygen. Obtain
medical attention. For resuscitation following significant exposure to the propellants,
epinephrine and related drugs may be contraindicated (see "Notes to Physician").
If Ingested: If awake and able to swallow, rinse mouth with water. Never give anything by mouth if
unconscious or having convulsions. Obtain medical attention.
Notes to Physician: The propellants dichlorodifluoromethane and fluorotrichloromethane can cause or aggravate an
irregular heartbeat. In the setting of a resuscitation effort, epinephrine and similar drugs
should be used with caution. The active component in FloventĀ® is fluticasone propionate, a
synthetic corticosteroid. Because of the possibility of systemic absorption of inhaled
corticosteroids, patients treated with these drugs should be observed carefully for any evidence
of systemic corticosteroid effects.
SECTION 5: FIRE / EXPLOSION HAZARDS & FIRE-FIGHTING MEASURES
FLASHPOINT/TEST METHOD: Not determined
LEL / UEL: Not determined
SPECIAL PROPERTIES RELATED TO FIRE HAZARD: Not determined
STORAGE OR HANDLING CONDITIONS TO BE AVOIDED: The contents of FloventĀ® Inhalation Aerosol are under
pressure. Do not puncture. Canisters exposed to
temperatures above 120Ā°F may rupture.
EXTINGUISHING MEDIA: Water Spray, Multipurpose Dry Chemical.
FIRE-FIGHTING PROCEDURES: Wear full protective clothing and use self-contained
breathing apparatus (SCBA).
SECTION 6: SPILL AND LEAK PROCEDURES
SPILL RESPONSE PROCEDURES (Liquid, Solid, Gas/Vapor):
Protective equipment may be necessary for spills. (See Section 8, āExposure Controls / Personal Protectionā? for
guidance).
For small quantities associated with normal therapeutic use, collect spillage and transfer to a closed waste container
for disposal. For large or bulk quantities, collect spillage by carefully wet wiping or HEPA vacuuming and place in a
labeled, sealed container for disposal. Wash spill area (floor or other contact surfaces) with a suitable cleaning
solvent, like ethanol.
In the event of canister leakage, Freon-12 and Freon-11 will evaporate. These substances are known to harm the
environment by depleting ozone in the upper atmosphere.
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FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 7: HANDLING AND STORAGE
HANDLING: Avoid contact with eyes, skin, and clothing.
FloventĀ® RotadiskĀ® is intended for use with the DiskhalerĀ® Inhalation Device. Use the FloventĀ®
RotadiskĀ® blisters within 2 months after opening of the moisture-protective foil overwrap or before
the expiration date, whichever comes first. Do not puncture any fluticasone propionate RotadiskĀ®
blister until taking a dose using the DiskhalerĀ® .
STORAGE: Store FloventĀ® Inhalation Aerosol between 2Ā°and 30Ā°C (39Ā°and 86Ā°F). Store canister with nozzle
end down. Protect from freezing temperatures and direct sunlight.
NOTE: The contents of FloventĀ® Inhalation Aerosol are under pressure. Do not puncture or incinerate. Do
not store at temperatures above 120Ā° near heat or open flame. Canisters exposed to temperatures
,
above 120Ā°F may rupture. (See Section 5 ā? / Explosion Hazards & Fire-Fighting Measuresā?
Fire ).
Store FloventĀ® RotadiskĀ® at controlled room temperature, 20Ā°and 25Ā°C, (68Ā°and 77Ā°F) in a dry
place.
SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
ENGINEERING CONTROLS: Use good general exhaust ventilation to keep airborne concentrations below the
Occupational Exposure Limit (OEL), OSHA Permissible Exposure Limit (PEL), and ACGIH
Threshold Limit Value (TLV).
PERSONAL PROTECTION:
Respiratory: Not required under normal conditions of therapeutic use and storage. See Section 5 -
ā? / Explosion Hazards & Fire-Fighting Measuresā? for respiratory protection in the
Fire
event of a fire.
Eye: Not required for recommended dosage and administration. Workers should wear
adequate eye protection to prevent eye contact.
Clothing: Adequate protective clothing should be worn to prevent occupational skin contact.
Gloves: When routine handling or spill cleanup may result in skin contact, impermeable gloves
should be worn.
WORK PRACTICES: Special care should be taken to ensure that contaminated clothing, equipment and
work surfaces are properly cleaned or disposed of after use. Wash hands and other
areas of skin contact thoroughly after handling this material. Contaminated clothing
should be disposed of or cleaned. A suitable solvent, such as ethanol, should be used
for cleaning equipment and work surfaces, unless other standard operating procedures
supersede these recommendations.
SECTION 9: PHYSICAL / CHEMICAL PROPERTIES
APPEARANCE AND ODOR: Fluticasone propionate, the active ingredient in FloventĀ® Inhalation Aerosol is an
odorless white to off-white powder. Freon-12 is a colorless gas with an ether-
like odor at high concentrations. Freon-11 is a colorless, odorless gas.
Page 3 of 8
FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 9: PHYSICAL / CHEMICAL PROPERTIES (contā?
d)
APPEARANCE AND ODOR (contā? FloventĀ® 44 mcg, 110 mcg, and 220 mcg Inhalation Aerosols are supplied in
d):
7.9 g and/or 13 g canisters. Each canister is supplied with a dark orange-
colored oral actuator with a peach-colored strapcap.
FloventĀ® RotadisksĀ® 50 mcg, 100 mcg, and 250 mcg are circular double-foil
packs containing four blisters of the drug. Fifteen (15) RotadisksĀ® are packaged
in a white polypropylene tube, and the tube is packaged in a plastic-coated,
moisture-protective foil pouch. A carton contains the foil pouch of 15
RotadisksĀ® and one dark orange- and peach-colored DiskhalerĀ® inhalation
device.
PHYSICAL STATE (liquid/solid/gas): Fluticasone propionate, the active ingredient in FloventĀ® Inhalation Aerosol and
FloventĀ® RotadiskĀ® is a solid. Freon-11 and Freon-12 are gases.
MELTING POINT (deg. C): Not determined
BOILING POINT (deg. C): Not determined
SOLUBILITY/MISCIBILITY (% w/v): Not determined for FloventĀ® Inhalation Aerosol or FloventĀ® RotadiskĀ® .
Fluticasone propionate, the active ingredient in FloventĀ® , is practically insoluble
in water, slightly soluble in 95% ethanol and methanol, and freely soluble in
dimethyl sulfoxide and dimethyl formamide.
SECTION 10: STABILITY AND REACTIVITY
CHEMICAL STABILITY: Stable
CONDITIONS TO AVOID: Not determined
INCOMPATIBILITY WITH OTHER MATERIALS: Not determined for FloventĀ® Inhalation Aerosol or FloventĀ® RotadiskĀ® .
No known incompatibilities have been identified for fluticasone
propionate, the active ingredient in FloventĀ® .
HAZARDOUS DECOMPOSITION PRODUCTS: Hazardous decomposition products of FloventĀ® Inhalation Aerosol and
FloventĀ® RotadiskĀ® have not been determined. Thermal decomposition
products of fluticasone propionate, the active ingredient in FloventĀ® ,
include toxic and/or corrosive oxides of nitrogen, hydrogen fluoride,
and sulfur.
HAZARDOUS POLYMERIZATION: Will not occur.
SECTION 11: TOXICOLOGICAL INFORMATION
THE RISK OF HEALTH HAZARDS MAY BE REDUCED WHEN FLOVENTĀ® INHALATION AEROSOL AND FLOVENTĀ® ROTADISKĀ® ARE
HANDLED IN UNIT DOSAGE FORM.
PHARMACOLOGICAL ACTIVITY: The active component in FloventĀ® is fluticasone propionate, a synthetic
corticosteroid. FloventĀ® Inhalation Aerosol and FloventĀ® RotadiskĀ® are indicated
for the maintenance treatment of asthma as prophylactic therapy. They are also
indicated for patients requiring oral corticosteroid therapy for asthma.
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FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 11: TOXICOLOGICAL INFORMATION (contā?
d)
OCCUPATIONAL EXPOSURE LIMITS: For fluticasone propionate, the active ingredient in FloventĀ® , the Glaxo Wellcome
estimated safe working level is an eight hour time-weighted average (TWA) of 3
mcg/m3 (includes a skin notation -- skin contact can lead to substantial
absorption of fluticasone).
For the FloventĀ® Inhalation Aerosol propellant dichlorodifluoromethane (Freon-
12), the ACGIH TLV (threshold limit value) and the OSHA PEL (permissable
exposure limit) is 1000 ppm as an eight hour time-weighted average (TWA). For
the propellant flurotrichloromethane (Freon-11), the ACGIH TLV (threshold limit
value) is 1000 ppm as an eight hour time-weight average (TWA) and the OSHA
PEL (permissible exposure limit) is a maximum concentration of 1000 ppm.
ACUTE TOXICITY: Overexposure to fluticasone propionate in the occupational setting may result in
the same adverse effects which have been observed when this substance is used
medically. (see Clinical Safety for "Signs and Symptoms of Occupational
Exposure ".) Potential for allergic hypersensitivity (including itching, rashes,
hives, chest tightness, and wheezing) to the formulated product in the
occupational setting may exist. Inhalation of high concentrations of the
propellants in FloventĀ® Inhalation Aerosol may cause dizziness, disorientation,
uncoordination, nausea, vomiting, irregular heartbeat or loss of consciousness.
Skin contact with propellant vapors could cause skin irritation and/or frostbite.
REPEAT DOSE TOXICITY: Repeated exposure to fluticasone propionate in the occupational setting may
result in the same adverse effects which have been observed when this substance
is used medically. (see Clinical Safety for "Signs and Symptoms of Repeated
Occupational Exposure".)
IRRITATION: Repeated skin contact with fluticasone propionate may result in itching, burning,
irritation, dryness or redness of the skin.
The propellants in FloventĀ® Inhalation Aerosol can cause skin irritation or
frostbite. Avoid contact with the eyes.
SENSITIZATION: Repeated and frequent skin contact with fluticasone propionate at work may
lead to a rash which appears when exposure to this steroid ceases (for example,
while on vacation) and disappears upon return to work and re-exposure to
fluticasone. The occurrence of such symptoms indicates that work practices
require review and possible modification to reduce steroid contact with skin.
REPRODUCTIVE EFFECTS: Fluticasone propinate has no effect on fertility and mating performance in
standard tests with rats. Corticosteroids have been shown to cause birth defects
in studies with animals when administered systemically and topically.
Fluticasone propionate caused cleft palate and fetal growth retardation in mice,
rats and rabbits when administered by subcutaneous injection. There are no
adequate and well-controlled studies of fluticasone propionate in pregnant
women. FloventĀ® Inhalation Aerosol and FloventĀ® RotadiskĀ® should be used
during pregnancy only if the potential benefit justifies the potential risk to the
fetus. For recommended dosage and administration, FloventĀ® Inhalation Aerosol
and FloventĀ® RotadiskĀ® are classified as "Pregnancy Category C". Systemically
administered corticosteroids are excreted in human milk. It is not known
whether fluticasone propionate is excreted in human breast milk, but caution
should be exercised when FloventĀ® is administered to a nursing woman.
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FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 11: TOXICOLOGICAL INFORMATION (contā?
d)
REPRODUCTIVE EFFECTS (contā?
d): Precautions should be taken to limit exposure to FloventĀ® while pregnant or
nursing; medical evaluation of exposure and attention to compliance with
standard operating procedures and/or other workplace health and safety
directives is advised.
GENOTOXICITY: Fluticasone propionate was not mutagenic (causing change in the genetic
material) in standard tests with bacteria and did not cause chromosome breakage
in human cell cultures or mice.
CARCINOGENICITY: Animal studies conducted to date give no indication that fluticasone has cancer-
causing potential.
CLINICAL SAFETY: In clinical trials, pharyngitis, nasal congestion, upper respiratory infection, and
headache were observed more frequently in patients using FloventĀ® . Eye
irritation, nausea/vomiting, dizziness, dermatitis, oral infections, malaise or
fatigue, and insomnia were also more somewhat more frequent. Rare instances
of hypersensitivity reactions, including urticaria, rash, angioedema, and
bronchospasm have been reported. Fluticasone propionate can be absorbed
during skin contact and may be absorbed following ingestion or inhalation.
Repeated skin contact may result in itching, burning, irritation, dryness, redness,
and, less frequently, thinning of the skin.
Chronic exposure is normally required for systemic (affecting the whole body)
reactions. Although it has not been observed, systemic effects of FloventĀ® could
include suppression of the adrenal cortex, a serious medical condition, which
results in decreased ability to respond to stress (such as serious illness, surgery,
and infections). Depressed adrenal function may also result in high blood sugar,
sugar in the urine, fluid and salt retention with swelling, abnormal fat
deposition, weight gain, increased appetite, and diabetes. Fluticasone may slow
wound healing, increase susceptibility to certain infectious diseases, and
contribute to development of cataracts and glaucoma. Thinning of the skin and
increased ease of bruising may also result from repeated contact with fluticasone
propionate.
Individuals known to be hypersensitive to corticosteroids should not be exposed.
The immunosuppressive effects of fluticasone propionate may increase
susceptibility to viral diseases (such as chickenpox and measles) and other
infectious diseases. Use of FloventĀ® has been associated with localized fungal
infections of the mouth and pharynx.
For recommended dosage and administration, propellant concentrations are
nonhazardous, however, high propellant concentrations in the air may cause
suffocation.
SECTION 12: ECOLOGICAL INFORMATION
ENVIRONMENTAL FATE: Fluticasone propionate compartmentalizes into the terrestrial environment.
ENVIRONMENTAL EFFECTS: Fluticasone propionate is not readily biodegradable in soils other than clay and is
unlikely to bioaccumulate. It is potentially toxicity to receptors in the terrestrial
environment at levels greater than 1000 mg/L.
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FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 12: ECOLOGICAL INFORMATION (contā?
d)
Note: The following statement is required by the Federal Governmentā? Clean Air Act for all products containing or
s
manufactured with chlorofluorocarbons (CFCs).
WARNING: FloventĀ® Inhalation Aerosol contains trichlorofluoromethane and dichlorodifluoromethane, substances
which harm public health and environment
by destroying ozone in the upper atmosphere.
ENVIRONMENTAL TEST RESULTS:
STUDY NAME RESULTS COMMENTS
Water Solubility: 69.5Āµg/L at 25Ā°C
Hydrolysis Rate: Does not hydrolyze. Half life greater than one year
at 25Ā°C
Vapor Pressure: 1.47X10-5 Torr at 25Ā°C
n-Octanol/Water Partition Coefficient: 2.78 at pH 7
UV/Visible Spectrum: No absorbance
Aerobic Biodegradation (water) Not readily biodegradable <44% in 28 days
Aerobic Biodegradation (soil) Readily biodegradable in sandy loam
and silty clay >50%
Soil Absorption/Desorption: Very strong adsorption >25%
Subacute Toxicity to Earthworms >1000 mg/kg
Activated sludge respiration inhibition test >1000 mg/L
Acute toxicity to Daphnia EC50>0.55 mg/L at 48 hours No-effect at 0.19Āµg/L
SECTION 13: WASTE DISPOSAL
ROUTINE: Propellants should be removed from canisters and recycled. Unused product should be
disposed of at an approved facility in accordance with federal, state and local regulations.
ACCIDENTAL RELEASE: Clean up spills immediately, observing precautions in Section 8 - āPersonal Protectionā?.
Remove or decontaminate all residues in accordance with federal, state and local
regulations.
SECTION 14 TRANSPORTATION INFORMATION
Component 1 or Formulation 1: FloventĀ® Inhalation Aerosol
US Department of Transportation
Proper Shipping Name: Aerosols
Hazard Class/Division: 2.2 Identification #: UN1950
NOTE: (This product may also be transported under the provision of 49CFR, 173.4. Contact Glaxo Wellcomeā?
s
Dangerous Goods Safety, (919) 483-6595 to obtain a copy of DOT Approval CA-9702012.)
IATA/ICAO
Proper Shipping Name: Aerosols, non-flammable, n.o.s.
Hazard Class/Division: 2.2 Identification #: UN1950
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FloventĀ® Inhalation Aerosol Effective Date: 06/22/98
FloventĀ® RotadiskĀ®
SECTION 14 TRANSPORTATION INFORMATION (contā?
d)
IMDG
Proper Shipping Name: Not Regulated
RQ: None Marine Pollutant: No
Component 2 or Formulation 2: FloventĀ® RotadiskĀ®
US Department of Transportation
Proper Shipping Name: Not Regulated
IATA/ICAO
Proper Shipping Name: Not Regulated
IMDG
Proper Shipping Name: Not Regulated
RQ: None Marine Pollutant: No
SECTION 15: REGULATORY INFORMATION
EC PACKAGING AND LABELING FOR SUPPLY: Not determined.
OTHER LEGISLATION: Not determined.
SECTION 16: OTHER INFORMATION
REVISION DATE: 06/22/98 SUPERSEDES: 06/02/97
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