MATERIAL SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY
Suprax餂?
Material
Cefixime for Oral Suspension, USP
100 mg/5 mL
Manufacturer Lupin Limited
Mumbai 400 098 INDIA
Distributor Lupin Pharmaceuticals, Inc.
Harborplace Tower, 21st Floor
111, South Calvert Street
Baltimore, MD 21202
United States
Tel. 001-410-576-2000
Fax. 001-410-576-2221
2. COMPOSITION / INFORMATION ON INGREDIENTS
Label Claim: When reconstituted, each teaspoonful (5 mL) contains 100 mg of cefixime as the trihydrate
Ingredients CAS Quantity (% w/w)
Cefixime (as trihydrate) 79350-37-1 4.82
Non-hazardous ingredients -------------- 95.18
3. HAZARDOUS IDENTIFICATION
Fire and Explosion Assume that this product is capable of sustaining combustion.
Health Exposure might occur via skin; eyes; ingestion; inhalation.
May cause sensitisation by inhalation or skin contact.
Environment No information is available about the potential of this product to
produce adverse environmental effects.
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4. FIRST AID MEASURES
Ingestion Never attempt to induce vomiting. Do not attempt to give any
solid or liquid by mouth if the exposed subject is unconscious or
semi-conscious. Wash out the mouth with water. Obtain medical
attention.
Inhalation Physical form suggests that risk of inhalation exposure is
negligible.
Skin Contact Using appropriate personal protective equipment, remove
contaminated clothing and flush exposed area with large
amounts of water. Obtain medical attention if skin reaction
occurs.
Eye contact Wash immediately with clean and gently flowing water. Continue
for at least 15 minutes. Obtain medical attention if required.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Treat according to locally accepted protocols. For additional
guidance, refer to the current prescribing information or to the
local poison control information center. Medical treatment in
cases of overexposure should be treated as an overdose of a
cephalosporin antibiotic. Gastric lavage may be indicated;
otherwise no specific antidote exists. Cefixime is not removed in
significant quantities from the circulation by hemodialysis or
peritoneal dialysis. In allergic individuals, exposure to this
material may require treatment for initial or delayed allergic
symptoms and signs. This may include immediate and/or
delayed treatment of anaphylactic reactions.
Antidotes No specific antidote exists.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Hazards Assume that this product is capable of sustaining combustion.
Extinguishing Media Water spray, carbon dioxide, dry chemical powder or appropriate
foam.
Special Firefighting Procedures For single units (packages): No special requirements needed.
For larger amounts (multiple packages/pallets) of product: Since
toxic, corrosive or flammable vapors might be evolved from fires
involving this product and associated packaging, self contained
breathing apparatus and full protective equipment are
recommended for firefighters.
Hazardous Combustion Products Hazardous combustion or decomposition products are expected
when the product is exposed to fire.
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6. ACCIDENTAL RELEASE MEASURES
Personal precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways,
sewers, or surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labeled container for recovery
or disposal.
7. HANDLING AND STORAGE
Handling No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
Storage Store drug powder at 20-25掳 C (68 鈥? 77掳F) [See USP Controlled Room
Temperature]. The reconstituted product may be stored at room
temperature or under refrigeration.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling.
9. PHYSICAL & CHEMICAL PROPERTIES
Physical Form Powder (Granules).
10. STABILITY AND REACTIVITY
Stable under recommended storage conditions.
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11. TOXICOLOGICAL INFORMATION
Oral Toxicity: Not expected to be toxic following ingestion.
Inhalation Toxicity: Can produce respiratory irritation. Adverse effects might occur following
inhalation.
Skin Effects: Irritation might occur following direct contact.
Eye Effects: Irritation might occur following direct contact with eyes.
Gastrointestinal Reactions: Diarrhea, loose or frequent stools, abdominal pain, nausea, dyspepsia
and flatulence.
Hypersensitivity Reactions: Incidence rates below 2% reported.
Genetic Toxicity: Not expected to be genotoxic based on animal studies.
Carcinogenicity: Not expected to be carcinogenic based on animal studies.
Reproductive Effects: Not expected to produce adverse effects on fertility or development
based on animal studies. No adequate and well-controlled studies in
pregnant women. No studies during labor and delivery. Should be used
during pregnancy only if clearly needed.
Pharmacological Effects: This material is an antibiotic; a cephalosporin. It is an agent intended for
the treatment of bacterial infections.
12. ECOLOGICAL INFORMATION
No relevant studies identified.
13. DISPOSAL CONSIDERATION
Incinerate in an approved facility. Follow all federal state and local environmental regulations.
14. TRANSPORT INFORMATION
The Material Safety Data Sheet (MSDS) should accompany all shipments for reference in the event of
spillage or accidental release. Transportation and shipping of this product is not restricted. It has no
known, significant hazards requiring special packaging or labeling for air, maritime, or ground transport
purposes.
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15. REGULATORY INFORMATION
No information found.
16. OTHER INFORMATION
The above information is believed to be correct but does not purport to be all-inclusive and shall be used
only as a guide. Nothing herein shall be deemed to create any warranty, express or implied. It is the
responsibility of the user to determine the applicability of this information and the suitability of the material
or product for any particular purpose.
Lupin shall not be held liable for any damage resulting from handling or from contact with the above
product. Lupin reserves the right to revise this MSDS.
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Effective Date : 03.03.2004 Page 5 of 5
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