MATERIAL SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY
Material Cefadroxil for Oral Suspension USP
250 mg/5 mL and 500 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
Ingredients CAS Quantity
Cefadroxil monohydrate
equivalent to Cefadoxil 50370-12-2 250 mg/5 mL; 500 mg/5 mL
Non-hazardous ingredients -------------- q.s.
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 Move individual to fresh air. Obtain medical attention if breathing
difficulty occurs. If not breathing, provide artificial respiration
assistance.
Skin Contact Remove contaminated clothing and flush exposed area with large
amounts of water. Wash all exposed areas of skin with plenty of soap
and water. Obtain medical attention if skin reaction occurs.
Eye Contact Flush eyes with plenty of water. Get medical attention.
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. Protect the patient's airway and support ventilation
and perfusion. Meticulously monitor and maintain, within acceptable
limits, the patient's vital signs, blood gases, serum electrolytes, etc.
A study of children under six years of age suggested that ingestion of
less than 250 mg/kg of cephalosporins is not associated with
significant outcomes. No action is required other than general support
and observation. For amounts greater than 250 mg/kg, induce gastric
emptying.
In five anuric patients, it was demonstrated that an average of 63% of a
1 g oral dose is extracted from the body during a 6? hour
hemodialysis session.
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 at 25癈 (77癋); excursions permitted to 15?30?C (59?86?F); [see USP
Controlled Room Temperature].After reconstitution: store in refrigerator.
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 Light orange coloured powder.
10. STABILITY AND REACTIVITY
Stable under recommended storage conditions.
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11. TOXICOLOGICAL INFORMATION
The following adverse events and altered laboratory tests have been reported for cephalosporin-class
antibiotics in general:
Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic
anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs' test, increased BUN,
increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated
alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal
impairment when the dosage was not reduced.
If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can
be given if clinically indicated.
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: Clostridium difficile associated diarrhea (CDAD) has been reported
with use of nearly all antibacterial agents, including cefadroxil
monohydrate, and may range in severity from mild diarrhea to fatal
colitis. Therefore, it is important to consider this diagnosis in
patients who present with diarrhea subsequent to the administration
of antibacterial agents. Careful medical history is necessary since
CDAD has been reported to occur over two months after the
administration of antibacterial agents.
Hypersensitivity Reactions: Before therapy with cefadroxil is instituted, careful inquiry should
be made to determine whether the patient has had previous
hypersensitivity reactions to cefadroxil, other cephalosporins,
penicillins, or other drugs. If cefadroxil is to be given to penicillin-
sensitive patients, caution should be exercised because cross-
hypersensitivity among ?lactam antibiotics has been clearly
documented and may occur in up to 10% of patients with a history
of penicillin allergy. If an allergic reaction to cefadroxil occurs, the
drug should be discontinued. Serious acute hypersensitivi ty
reactions may require treatment with epinephrine and other
emergency measures, including oxygen, intravenous fluids,
intravenous antihistamines, corticosteroids, pressor amines, and
airway management, as clinically indicated.
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.
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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.
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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