MATERIAL SAFETY DATA SHEET

1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY

Material Pravastatin Sodium Tablets USP

10 mg, 20 mg, 40 mg & 80 mg

Manufacturer Lupin Limited

Goa 403 722
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

Pravastatin Sodium USP 81093-37-0 10 mg, 20 mg, 40 mg and 80 mg Tabs

3. HAZARD IDENTIFICATION

Fire and Explosion Assume that this product is capable of sustaining combustion.

Health 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
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 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 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.

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

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 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 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.

Storage 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 68180-485-09), bottles of
500 (NDC 68180-485-02) and bottles of 1000 (NDC 68180-485-03).
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 68180-486-09), bottles of 500
(NDC 68180-486-02) and bottles of 1000 (NDC 68180-486-03). Bottles
contain a desiccant sachet.
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 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 68180-487-09), bottles of 500
(NDC 68180-487-02) and bottles of 1000 (NDC 68180-487-03). 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 68180-488-09), bottles of 500
(NDC 68180-488-02) and bottles of 1000 (NDC 68180-488-03). 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 rat-
liver 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
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 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

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 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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Effective Date : 29/01/2014