MATERIAL SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY
Material Meloxicam Tablets
7.5 mg or 15 mg
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
Meloxicam 71125-38-7 7.5 mg /Tablet or 15 mg/ Tablet
Non-hazardous ingredients -------------- q.s.
3. HAZARDOUS IDENTIFICATION
Statement of Hazard/Risk Phrase May cause skin, eye, or respiratory tract irritation.
Precautionary Measures Do not get in eyes, on skin, on clothing. Avoid breathing dust,
vapor, mist or gas. Use with adequate ventilation. Wash
thoroughly after handling.
Primary route(s) of Exposure Inhalation, ingestion and eye or skin contact.
Effects of Overexposure Acute:
Gastrointestinal irritation, ulceration or bleeding. Headache.
Dizziness. See Package Insert for additional information on
overdose.
Chronic:
Liver effects such as jaundice, hepatitis and hepatic failure
have occurred with NSAIDs. Long term administration of
NSAIDs has caused renal papillary necrosis and other renal
changes.
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Medical Conditions Aggravated by Meloxicam Tablets are contraindicated for individuals with
Exposure known hypersensitivity to Meloxicam or those who have
experienced asthma, urticaria or allergic type reactions to
NSAIDs, including aspirin. Caution should be exercised for
patients with a history of gastrointestinal disease or those
receiving treatment with anticoagulants. See the package
insert for more information.
4. FIRST AID MEASURES
Ingestion Get medical attention to determine whether vomiting or
evacuation of stomach is necessary. Do not give anything by
mouth to an unconscious or convulsing person.
Inhalation Remove from area to fresh air. Seek medical attention if
respiratory irritation develops or if breathing becomes difficult.
Skin Contact Remove contaminated clothing. Wash affected areas with
plenty of water and soap if available, for several minutes. Seek
medical attention if irritation or rash develops and persists.
Eye Contact Flush eyes with large amounts of running water for 15 minutes.
Hold eyelids open. Get immediate medical attention
Antidotes No specific antidote exists.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Hazards Not expected for the product, although the packaging is
combustible
Extinguishing Media Water, carbon dioxide, or dry chemical.
Special Firefighting Procedures Although material will not ignite, if heated strongly in a fire
situation product may decompose forming carbon dioxide,
carbon monoxide, oxides of nitrogen and sulfur. NIOSH
approved SCBA and full protective gear for firefighters is
recommended if product is involved in a major fire. If possible,
contain and collect firefighting water for later disposal.
Hazardous Combustion Products Carbon monoxide. Carbon dioxide. Nitrogen oxides. Sulfur
oxides.
Unusual Fire and Explosion Hazards As with all finely divided organic powders, it is advisable to
eliminate explosion hazards by methods such as grounding
mechanical equipment in contact with the material to prevent
the buildup of static electricity, inerting the atmosphere or
controlling dust levels.
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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.
Decontamination Procedure No specific decontamination or detoxification procedures have
been identified for this product. Water can be used for clean-
up and decontamination operations.
7. HANDLING AND STORAGE
Precautions for Safe Handling and Use Avoid generating dust or mist and contact with skin, eyes and
clothing. Use with adequate ventilation. Wash thoroughly after
handling. Launder contaminated clothing before reuse. Do not
get in eyes, on skin or clothing. Avoid breathing dust or mist.
Use adequate dust/vapor control
Storage Store at 20°-25°C (68°-77°F) [See USP Controlled Room
Temperature]. Keep in a dry place.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Safety glasses with side shields.
Respirators In operations where mists or aerosols are generated, wear a
NIOSH approved respirator that has been selected by a
technically qualified person for the specific conditions.
Other Equipment or Procedures Wear appropriate clothing to avoid skin contact. Wash hands
and arms thoroughly after handling.
Work/Hygienic Practices Do not permit eating, drinking or smoking near this material.
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9. PHYSICAL & CHEMICAL PROPERTIES
Physical Form Tablet.
Appearance 7.5 mg Tablets: Light yellow, round, biconvex tablets.
15 mg Tablets: Light yellow, oval, biconvex tablets.
10. STABILITY AND REACTIVITY
Stable under recommended storage conditions.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity (RAT) In an oral toxicity study, the LD 50 was 84mg/kg. Main signs of
toxicity included reduced motor activity, anemia and cyanosis.
(Rabbit): LD 50 320 mg/kg
(Mouse): LD 50 470 mg/kg
Genotoxicity Meloxicam showed no mutagenic or clastogenic activity in the
Ames, the host mediated, the micronucleus, the HGPRT and
the chromosomal aberration tests in cultured Chinese hamster
ovary cells.
Carcinogenicity IARC, NTP or OSHA does not list Ingredient(s) as
carcinogenic. Studies showed no tumorigenic or carcinogenic
potential up to a dose of 0.8mg/kg in rats and 8mg/kg in mice.
Repeated dose studies Repeated dose studies showed characteristic changes
reported with other NSAIDs (gastrointestinal ulceration and
erosion). Long term studies showed renal papillary necrosis.
Teratogenicity Doses up to 4mg/kg in rats and 80mg/kg in rabbits showed no
signs of teratogenicity. Doses of 0.125 mglkg in rats caused
elevations still births. 20mg/kg and higher in rabbits was
embryotoxic.
12. ECOLOGICAL INFORMATION
No information available.
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13. DISPOSAL CONSIDERATION
Waste Disposal Method Dispose of by incineration in accordance with applicable
international, national, state, and/or local waste disposal
regulations.
14. TRANSPORT INFORMATION
Not regulated for transportation by the United States Department of Transportation (DOT), International
Maritime Organization (IMO), or International Air Transport Association (lATA). May be subject to state and/or
local transportation requirements.
15. REGULATORY INFORMATION
No information available.
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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