MATERIAL SAFETY DATA SHEET

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1 MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY Material Manufacturer Distributor Pravastatin Sodium Tablets USP 10 mg, 20 mg, 40 mg & 80 mg Lupin Limited Goa INDIA. Lupin Pharmaceuticals, Inc. Harborplace Tower, 21 st Floor 111, South Calvert Street Baltimore, MD United States Tel Fax COMPOSITION / INFORMATION ON INGREDIENTS Ingredients CAS Quantity Pravastatin Sodium USP mg, 20 mg, 40 mg and 80 mg Tabs 3. HAZARD IDENTIFICATION Fire and Explosion Health Assume that this product is capable of sustaining combustion. Hypersensitivity to any component of this medication Active liver disease or unexplained, persistent elevations of serum transaminases. Pregnancy and Lactation. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. Pravastatin sodium tablets should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the MSDS : 020/02 Page 1 of 6

2 potential hazards. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus. Environment No information is available about the potential of this product to produce adverse environmental effects. 4. FIRST AID MEASURES Ingestion Inhalation Skin Contact Eye Contact If conscious, give water to drink and 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. Move individual to fresh air. Obtain medical attention if breathing difficulty occurs. If not breathing, provide artificial respiration assistance. 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. Flush eyes with plenty of water. Get medical attention. NOTES TO HEALTH PROFESSIONALS OVERDOSAGE To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required. 5. FIRE FIGHTING MEASURES Fire and Explosion Hazards Extinguishing Media Special Firefighting Procedures Hazardous Combustion Products Assume that this product is capable of sustaining combustion. Water spray, carbon dioxide, dry chemical powder or appropriate foam. 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 or decomposition products are expected when the product is exposed to fire. MSDS : 020/02 Page 2 of 6

3 6. ACCIDENTAL RELEASE MEASURES Personal Precautions Environmental Precautions Clean-up Methods Wear protective clothing and equipment consistent with the degree of hazard. For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage systems. Collect and place it in a suitable, properly labeled container for recovery or disposal. 7. HANDLING AND STORAGE Handling Storage No special precautions are necessary when handling packed product. In case of accident, avoid breathing dust from crushed tablets. Avoid contact with skin and eyes. Wash hands after use. Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling. 9. PHYSICAL AND CHEMICALS PROPERTIES Physical Form Pravastatin sodium tablets are supplied as: 10 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets, debossed with LU on one side and N01 on the other side.they are supplied in bottles of 90 (NDC ), bottles of 500 (NDC ) and bottles of 1000 (NDC ). Bottles contain a desiccant sachet. 20 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets, debossed with LU on one side and N02 on the other side. They are supplied in bottles of 90 (NDC ), bottles of 500 (NDC ) and bottles of 1000 (NDC ). Bottles contain a desiccant sachet. MSDS : 020/02 Page 3 of 6

4 40 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets, debossed with LU on one side and N03 on the other side. They are supplied in bottles of 90 (NDC ), bottles of 500 (NDC ) and bottles of 1000 (NDC ). Bottles contain a desiccant sachet. 80 mg tablets: Yellow coloured, oval shaped, biconvex, film-coated tablets, debossed with LU on one side and N04 on the other side. They are supplied in bottles of 90 (NDC ), bottles of 500 (NDC ) and bottles of 1000 (NDC ). Bottles contain a desiccant sachet. 10. STABILITY AND REACTIVITY Stable under recommended storage conditions. 11. TOXICOLOGICAL INFORMATION Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year study in rats fed pravastatin at doses of 10, 30, or 100 mg/kg body weight, there was an increased incidence of hepatocellular carcinomas in males at the highest dose (p <0.01). These effects in rats were observed at approximately 12 times the human dose (HD) of 80 mg based on body surface area mg/m2 and at approximately 4 times the human dose, based on AUC. In a 2-year study in mice fed pravastatin at doses of 250 and 500 mg/kg/day, there was an increased incidence of hepatocellular carcinomas in males and females at both 250 and 500 mg/kg/day (p<0.0001). At these doses, lung adenomas in females were increased (p=0.013). These effects in mice were observed at approximately 15 times (250 mg/kg/day) and 23 times (500 mg/kg/day) the human dose of 80 mg, based on AUC. In another 2-year study in mice with doses up to 100 mg/kg/day (producing drug exposures approximately 2 times the human dose of 80 mg, based on AUC), there were no drug-induced tumors. No evidence of mutagenicity was observed in vitro, with or without ratliver metabolic activation, in the following studies: microbial mutagen tests, using mutant strains of Salmonella typhimurium or Escherichia coli; a forward mutation assay in L5178Y TK +/- mouse lymphoma cells; a chromosomal aberration test in hamster cells; and a gene conversion assay using Saccharomyces cerevisiae. In addition, there was no evidence of mutagenicity in either a dominant lethal test in mice or a micronucleus test in mice. In a study in rats, with daily doses up to 500 mg/kg, pravastatin did not produce any adverse effects on fertility or general reproductive performance. However, in a study with another HMG-CoA reductase inhibitor, there was decreased fertility in male rats treated for 34 weeks at 25 mg/kg body weight, although this effect was not observed in a MSDS : 020/02 Page 4 of 6

5 subsequent fertility study when this same dose was administered for 11 weeks (the entire cycle of spermatogenesis, including epididymal maturation). In rats treated with this same reductase inhibitor at 180 mg/kg/day, seminiferous tubule degeneration (necrosis and loss of spermatogenic epithelium) was observed. Although not seen with pravastatin, two similar drugs in this class caused drug-related testicular atrophy, decreased spermatogenesis, spermatocytic degeneration, and giant cell formation in dogs. The clinical significance of these findings is unclear. 12. ECOLOGICAL INFORMATION No information available. 13. DISPOSAL CONSIDERATION Incinerate in an approved facility. Follow all federal state and local environmental regulations. 14. TRANSPORT INFORMATION IATA/ICAO - Not Regulated IATA Proper shipping Name : N/A IATA UN/ID No : N/A IATA Hazard Class : N/A IATA Packaging Group : N/A IATA Label : N/A IMDG - Not Regulated IMDG Proper shipping Name : N/A IMDG UN/ID No : N/A IMDG Hazard Class : N/A IMDG Flash Point : N/A IMDG Label : N/A DOT - Not Regulated DOT Proper shipping Name : N/A DOT UN/ID No : N/A DOT Hazard Class : N/A DOT Flash Point : N/A DOT Packing Group : N/A DOT Label : N/A MSDS : 020/02 Page 5 of 6

6 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. MSDS : 020/02 Page 6 of 6

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