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Procter & Gamble
MATERIAL SAFETY DATA SHEET
Macrobid®
Page 1 of 5
SECTION 1 – CHEMICAL / PRODUCT AND COMPANY IDENTIFICATION
PROCTER & GAMBLE PHARMACEUTICALS, INC.
Hazard Rating
PO BOX 191
NORWICH, NY 13815
EMERGENCY PHONE:
24 HOUR SPILL RESPONSE PHONE: 800-424-9300 CHEMTREC
Chemical
Nitrofurantoin monohydrate: 1-[[(5-
Macrobid® Capsules
Nitro-2-furanyl)methylene]amino]-2,4-
Marketed Drug Product
imidazolidinedione monohydrate
Intended
Pharmaceutical
Nitrofurantoin macrocrystals: 1-[[(5-
Nitro-2-furanyl)methylene]amino]-2,4-
imidazolidinedione

Chemical
Nitrofuran
Formula:
Monohydrate: C
8H6N4O5 H2O
Macrocrystals: C
SECTION II - HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW: Macrobid® is a 100 mg opaque black and yellow gelatin capsule. It contains
2 plugs, one yellow, the second a mottled off-white to light yellow in color. Material is intended for use as a
human pharmaceutical. Accidental excessive ingestion may cause gastrointestinal effects, skin,
hypersensitivity reactions, hematological , neurological, liver and pulmonary effects. Hazard and
Toxicological information is based on the active pharmaceutical ingredients.

Eye: As a capsule, unlikely to come into contact with eye. If powder from crushed or pulverized
capsule cores contacts eyes, unknown effect from direct contact by material.
Skin: As a capsule, unlikely to come into prolonged contact with skin. Prolonged contact with
powder from crushed or pulverized capsule cores may cause skin irritation.
Ingestion: Accidental excessive ingestion may cause gastrointestinal effects, skin, hypersensitivity
reactions, hematological , neurological, liver and pulmonary effects.
Inhalation: As a capsule, unlikely to be inhaled. If powder from crushed or pulverized capsule core is
inhaled, may be irritating to upper respiratory tract.
Reproductive Hazard? Reversible alterations in spermatogenesis in male rats. Refer to
Toxicological Section XI.
Carcinogenic Hazard? IARC classifies nitrofurantoin as a Group 3 carcinogen (not
classifiable as to its carcinogenicity in humans) based on
“inadequate” data in humans and “limited” data in animals (IARC,
1990). See Section XI for additional carcinogenicity information.

Medical Conditions Aggravated by Gastrointestinal, pulmonary, hypersensitivity reaction, skin,
Exposure or Target Organ Systems: hemolytic anemia. Cases of hemolytic anemia of the primaquine-
sensitivity type have been induced by nitrofurantoin. Hemolysis
appears to be linked to a glucose-6-phosphate dehydrogenase
deficiency in the red blood cells of the affected patients. Hemolysis
is an indication for discontinuing nitrofurantoin; hemolysis ceases
when the drug is withdrawn.
Target Organ Systems: Liver, lungs, nervous system.

Procter & Gamble

PROCTER & GAMBLE Page 2 of 5
MSDS Identifier:
Macrobid®
SECTION III – COMPOSITION AND INGREDIENTS
Principal Hazardous Components CAS
1-[[[5-Nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione
1-[[[5-Nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate
17140-81-7
Excipients: carbomer 934P, corn starch, compressible sugar, D&C yellow No.
Various 77.2%
10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose,
magnesium stearate, povidone, talc, and titanium dioxide.
NOTE: This MSDS is written to address potential worker health and safety issues associated with the
handling of the formulated final product which is a capsule, e.g., during the transportation, distribution, and
use by medical personnel. For worker health and safety information during the manufacture of Macrobid®,
please refer to the MSDS on each component.

SECTION IV - FIRST AID MEASURES
Eye: If powder contacts eye, flush with plenty of water for at least 15 minutes. Do not put oil or
oinment in eyes. Get immediate medical attention.
Skin: If powder contacts skin, flush with plenty of water for at least 15 minutes.
Get immediate medical attention.
Inhalation: As a capsule, not expected. If powder from crushed or pulverized capsule core is inhaled,
remove to fresh air. Call a physician. Provide supportive symptomatic care.
Ingestion: If swallowed, wash out mouth with water provided person is conscious. Do not induce
vomiting. Call a physician. Provide supportive symptomatic care.
Additional First Aid Measures: Not available

SECTION V - FIRE FIGHTING MEASURES
Flash Point:
Not applicable
Not available
Flash Point test
Not Available
Auto-ignition
Not applicable
Not available
Flammable Limits
Not applicable
Temperature:
(% by volume in air)
LEL %
UEL %

Extinguishing Media This material is assumed to be combustible, and should be treated as such. Water
spray, CO2, dry chemical or appropriate foam.
Explosion Hazards This material is assumed to be combustible and may emit toxic fumes, under fire
conditions.
Special Instructions As with all fires, evacuate personnel to safe area. Firefighters should use self-
contained breathing apparatus and protective clothing to prevent contact with
skin and eyes.

SECTION VI - ACCIDENTAL RELEASE MEASURES
Personnel Safeguards: Wear gloves to avoid contact with skin and eyes when handling/counting
large amounts of capsules. Wash thoroughly after handling.
Environmental Precautions: Dispose of all collected material in accordance with applicable local, state
and federal waste disposal regulations (see Section XIII).
Spill Clean-up Procedures: If capsules are broken and the core is crushed or pulverized, cordon off
the area. Take proper precautions to minimize exposure by using
appropriate personal protective equipment. Wet material with water to
reduce potential for dust generation and soak up material with
absorbent, e.g., paper towels. Wash spill area thoroughly with soap and
water.

Procter & Gamble
PROCTER & GAMBLE Page 3 of 5
MSDS Identifier:
Macrobid®
SECTION VII - HANDLING AND STORAGE
Recommended Storage Temperature
Not available
None 59-86
Personnel Precautions: Avoid contact with skin and eyes.
Conditions for Safe Storage: Store in dry location, minimize exposure to light.
Other Precautions: N/A
SECTION VIII - EXPOSURE CONTROLS, PERSONAL PROTECTION
Engineering Controls: Not applicable for capsules.
Eye Protection: Not applicable for capsules.
Respiratory Protection: Not applicable for capsules.
Skin Protection: Rubber gloves are recommended to minimize potential for skin contact when
handling/counting large amounts of capsules.
Exposure Limits: Active Ingredient Exposure Limit: 0.5 mg/m3 (Active Pharmaceutical
Ingredient) P&GP Internal OEL
SECTION IX - PHYSICAL AND CHEMICAL PROPERTIES
Appearance / Color:
Not available
Solubility in
Not available
Opaque black and yellow
Water: <0.1 mg/ml at 19oC
gelatin capsule. 2 plugs: one
yellow, the second a mottled
off-white to light yellow in
color.

Not available
Vapor Pressure
Not available
Odor Threshold:
Not available
Vapor Density:
Not available
Physical State:
Not available
Specific Gravity
Not available
(H2O=1):
Molecular Weight:
Not available
Percent Volatile by
Not available
Macrocrystals: 238.16
Volume (%):
Monohydrate: 256.17
Not available
Evaporation Rate:
Not available
Boiling or Melting
Not available
Other Not Available
Point of Active 270-272
Miscellaneous
Pharmaceutical Melting Point
Properties
Ingredient:
SECTION X – STABILITY AND REACTIVITY
Stability:
Unstable
Hazardous
Will Not Occur
May Occur
Polymerization:
Polymerization: Not Available
Incompatibility:
Oxidizing agents
(Materials to avoid)
Hazardous CO2, CO, nitrogen oxides
Decomposition Products:
Procter & Gamble
PROCTER & GAMBLE Page 4 of 5
MSDS Identifier:
Macrobid®
SECTION XI - TOXICOLOGICAL INFORMATION
Eye Effects: Not available
Acute Oral Effects: The oral LD50 of nitrofurantoin in rats and mice was reported to be 604 and
360 mg/kg, respectively.
Acute Inhalation Effects: Not available
Chronic Effects: Pulmonary, liver, and nervous system.
Sub-Chronic Effects: Pulmonary, liver, and nervous system.
Reproductive and Doses of 10 mg/kg/day or greater, higher than therapeutic doses, in
Birth Effects: healthy human males may produce a slight to moderate decrease
in sperm count. The administration of high doses (10 mg/kg/day)
of nitrofurantoin to rats causes reversible spermatogenic arrest.
Several reproduction studies have been performed in rabbits and
rats at doses up to six times the human dose and have revealed no
evidence of impaired fertility or harm to the fetus due to
nitrofurantoin. In a single published study conducted in mice at 68
times the human dose, growth retardation and a low incidence of
minor and common malformations were observed. However, at 25
times the human dose, fetal malformations were not observed; the
relevance of these findings to humans is uncertain.

Genetic Toxicity: Nitrofurantoin has produced positive results in Ames Assay in the presence and
absence of a liver activating system. Nitrofurantoin induced increased
numbers of sister chromatid exchanges and chromosomal aberrations in
Chinese hamster ovary cells but not in human cells in culture. Results of the
sex-linked recessive lethal assay in Drosphila were negative after
administration of nitrofurantoin by feeding or by injection. Nitrofurantoin did
not induce heritable mutation in the rodent models examined.

Carcinogenicity: Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F1
mice as shown by increased incidences of tubular adenomas, benign mixed
tumors, and granulose cell tumors of the ovary. In male F344/N rats, there
were increased incidences of uncommon kidney tubular cell neoplasms,
osteosarcomas of the bone, and neoplasms of the subcutaneous tissue. In one
study involving subcutaneous administration of 75 mg/kg nitrofurantoin to
pregnant female mice, lung papillary adenomas of unknown significance were
observed in the F1 generation.

SECTION XII -ECOLOGICAL INFORMATION
No environmental fate studies have been conducted to date.
Agency Agency Requirement
N/A

SECTION XIII - DISPOSAL CONSIDERATIONS
All wastes containing the material should be properly labeled. Dispose of any waste residues according to
prescribed federal, state and local guidelines, e.g., appropriately permitted chemical waste incinerator.
Rinse waters resulting from spill cleanups should be discharged in an environmentally safe manner, e.g.,
appropriately permitted municipal or on-site wastewater treatment facility.

Procter & Gamble
PROCTER & GAMBLE Page 5 of 5
MSDS Identifier:
Macrobid®
SECTION XIV – TRANSPORTATION
Transport according to all local, state and federal regulations.
Agency Parameter

Requirement
Proper Shipping Name
Not applicable/not regulated
Hazard Class or Division
Not applicable/not regulated
UN or NA Number
Not applicable/not regulated
Packing Group
Not applicable/not regulated
Hazardous Waste Number
Not regulated under RCRA
SECTION XV - ADDITIONAL REGULATORY INFORMATION
Observe all federal, state and local environmental regulations.
Not covered by WHMIS – cosmetics, drugs, food or devices (as defined by the FDA).
SECTION XVI - OTHER INFORMATION
DISCLAIMER: This MSDS is intended to provide a brief summary of our knowledge and guidance
regarding the use of this material. It is not meant to be an all-inclusive document on worldwide hazard
communication regulations. All P&G operations must comply with applicable local and national
MSDS/Hazard Communication Regulations. This information is offered in good faith. Each user of this
material needs to evaluate the conditions of use and design the appropriate protective mechanisms to
prevent employee exposures, property damage or release to the environment.

Source: http://www.alvogen.us.com/media/PDF/MACROBID_MSDS.pdf

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