SDS Number 3124 Approved/Revised 21-Jul-2008 Version 15
PAXIL TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material PAXIL TABLETS
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AROXAT 20 MG TABLETS * DEROXAT 20 MG TABLETS * NDC NO. 0029-3210-13 * NDC
Synonym(s)
NO. 0029-3211-13 * NDC NO. 0029-3211-21 * NDC NO. 0029-3211-59 * NDC NO.
0029-3212-13 * NDC NO. 0029-3213-13 * PAXIL 10 MG TABLETS * PAXIL 20 MG TABLETS
* PAXIL 30 MG TABLETS * PAXIL 40 MG TABLETS * AROPAX 20 MG TABLETS * AROPAX
30 MG TABLETS * TAGONIS 20 MG TABLETS * SEROXAT TABLETS * PAXIL DC *
PAROXETINE HYDROCHLORIDE, FORMULATED PRODUCT
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
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2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
NON-HAZARDOUS INGREDIENTS Unassigned 93.6
PAROXETINE HYDROCHLORIDE 110429-35-1 6.4
HEMIHYDRATE
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Potent pharmaceutical agent. Exposure might occur via ingestion; skin; eyes.
Health
Possible effects of overexposure in the workplace include: dry mouth; nausea; diarrhoea;
constipation; drowsiness; dizziness; weakness; insomnia sexual dysfunction;. Health effects
information is based on hazards of components. Not expected to be a health hazard during
normal handling.
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Harmful to aquatic organisms. May cause long-term adverse effects in the aquatic
Environment
environment.
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SDS Number 3124 Approved/Revised 21-Jul-2008 Version 15
PAXIL TABLETS
Material
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the
exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.
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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
Medical treatment in cases of overexposure should be treated as an overdose of paroxetine.
Medical Treatment
Treat according to locally accepted protocols. For additional guidance, refer to the local
poison control information centre.
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Refer to prescribing information for detailed description of medical conditions caused by or
Medical Conditions
aggravated by overexposure to this product.
Caused or Aggravated by
Exposure
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Pre-placement and periodic health surveillance is not usually indicated. The final
Health Surveillance
determination of the need for health surveillance should be determined by local risk
Procedures
assessment.
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No specific antidotes are recommended.
Antidotes
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5. FIRE-FIGHTING MEASURES
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Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
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Water or foam extinguishers are recommended.
Extinguishing Media
Carbon dioxide or dry powder extinguishers may be ineffective.
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For single units (packages): No special requirements needed.
Special Firefighting
For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
flammable vapours might be evolved from fires involving this product and associated
packaging, self contained breathing apparatus and full protective equipment are
recommended for firefighters.
If possible, contain and collect firefighting water for later disposal.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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Water can be used for clean-up and decontamination operations. No specific
Decontamination Procedures
decontamination or detoxification procedures have been identified for this product.
7. HANDLING AND STORAGE
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HANDLING
Avoid breaking or crushing tablets.
General Requirements
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
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SDS Number 3124 Approved/Revised 21-Jul-2008 Version 15
PAXIL TABLETS
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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PAROXETINE HYDROCHLORIDE HEMIHYDRATE
INGREDIENT
3
GSK Occupational Hazard
Category
REPRODUCTIVE HAZARD
GSK Occupational 40 mcg/m3 (8 HR TWA)
Exposure Limit
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None required for normal handling. Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
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This product is expected to be stable.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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This preparation contains ingredient(s) with the following activity: a selective serotonin
Pharmacological Effects
re-uptake inhibitor. Adverse effects of overexposure might include: drowsiness; dizziness; dry
mouth; diarrhoea; constipation; nausea; weakness; insomnia; sexual dysfunction; damage to
mucosa.
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Adverse effects might occur in the following organ(s) following overexposure: central nervous
Target Organ Effects
system.
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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No studies have been conducted.
Inhalation Toxicity
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Irritation is not expected following direct contact.
Skin Effects
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Irritation is not expected following direct contact with eyes.
Eye Effects
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Sensitisation (allergic skin reaction) is not expected.
Sensitisation
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Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
Carcinogenicity
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
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None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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This material contains an active pharmaceutical ingredient that has been tested, and which
Summary
may be toxic to aquatic organisms if released directly to the environment. Consult the MSDS
of the active ingredient for specific information about potential environmental effects.
Appropriate precautions should be taken to limit release of this material to the environment.
Local regulations and procedures should be consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided below.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is
Activated Sludge
harmful to activated sludge microorganisms.
Respiration
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IC50: 25 mg/L, 3 Hours, Residential sludge
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SDS Number 3124 Approved/Revised 21-Jul-2008 Version 15
PAXIL TABLETS
Material
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Microtox is a general toxicity test which utilizes a sensitive marine
Microtox
photo bacteria as the test species. This material contains an active
pharmaceutical ingredient that is harmful to these microorganisms.
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EC50: 8.2 mg/L, 15 Minutes
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This material contains an active pharmaceutical ingredient that is toxic
Daphnid
to daphnids.
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EC50: 2.5 mg/L, 48 Hours, Daphnia magna, Static test
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NOEC: 0.49 mg/L, 48 Hours, Daphnia magna, Static
test
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This material contains an active pharmaceutical ingredient that is toxic
Fish
to fish.
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Adult Lepomis macrochirus, bluegill sunfish
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EC50: 1.6 mg/L, 96 Hours, Static test
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Adult Lepomis macrochirus, bluegill sunfish
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NOEC: 0.18 mg/L, 96 Hours, Static test
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has solubility in water.
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This material contains an active pharmaceutical ingredient that will not readily enter into air
Volatility
from water. This material contains an active pharmaceutical ingredient that will not readily
enter into the air from hard surfaces or from a container of the pure substance.
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Henrys Law Constant 3.39E-10 atm m3/mol, Calculated
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This material contains an active pharmaceutical ingredient that is not likely to adsorb to
Adsorption
sludge or biomass if released directly to the environment. This material contains an active
pharmaceutical ingredient that is not likely to adsorb to soil or sediment if released directly to
the environment.
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Soil Sediment Sorption 0.8, Estimated
(log Koc):
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Sludge Biomass 2.94 Measured
Distribution Coefficient
(log Kd):
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This material contains an active pharmaceutical ingredient with octanol/water partition
Partitioning
coefficient data that suggests that for environmental fate predictions the active
pharmaceutical ingredient will not have the tendency to distribute into fats.
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PERSISTENCE/DEGRADATION
This material contains an active pharmaceutical ingredient that has been shown to be
Hydrolysis
chemically stable in water. Hydrolysis is unlikely to be a significant depletion mechanism.
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Half-Life, Neutral: > 1 Years, Measured, Deionized Water
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This material contains an active pharmaceutical ingredient that has been shown to be
Photolysis
chemically unstable in water when exposed to light. Aqueous photolysis may be a significant
depletion mechanism.
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Half-Life, Aqueous: 2.4 Hours, Measured, Deionized Water
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UV/Visible Spectrum: 292 nm at pH 5 to 9
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
(as defined by 1993 OECD Testing Guidelines). It may persist in the environment.
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be re-sold or re-used.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
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SDS Number 3124 Approved/Revised 21-Jul-2008 Version 15
PAXIL TABLETS
Material
14. TRANSPORT INFORMATION
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The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons
trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous
goods for transport.
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UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US or
European ground transport purposes.
15. REGULATORY INFORMATION
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The information included below is an overview of the major regulatory requirements. It should not be considered to be an
exhaustive summary. Local regulations should be consulted for additional requirements.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
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US OSHA Standard (29 CFR Part 1910.1200)
This dosage form is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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15
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
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The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of
issue. 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.
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