SDS Number 3119 Approved/Revised 14-Apr-2005 Version 10
PAXIL ORAL SUSPENSION
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material PAXIL ORAL SUSPENSION
SEROXAT LIQUID * SEROXAT SUSPENSION * DEROXAT SUSPENSION *
Synonyms
FORMULA CODE B046 * NDC NO. 0029-3215-48 * PAROXETINE
HYDROCHLORIDE, FORMULATED PRODUCT
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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
GlaxoSmithKline, Corporate Environment, Health & Safety
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 0.2
110429-35-1
NON-HAZARDOUS INGREDIENTS 99.8
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
Fire and Explosion
Health Caution - Potent pharmaceutical agent. Exposure might occur via ingestion;
skin; eyes.
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.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
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SDS Number 3119 Approved/Revised 14-Apr-2005 Version 10
PAXIL ORAL SUSPENSION
Material
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. If the exposed subject is fully conscious, give
plenty of water to drink. Obtain medical attention.
Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Medical treatment in cases of overexposure should be treated as an
overdose of paroxetine. Treat according to locally accepted protocols. For
additional guidance, refer to the local poison control information centre.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
Caused or Aggravated
by Exposure
Health Surveillance Pre-placement and periodic health surveillance is not usually indicated. The
final determination of the need for health surveillance should be determined
Procedures
by local risk assessment.
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water is recommended for fires involving packaging.
Special Firefighting For single units (packages): No special requirements needed. 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.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
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 labelled container for recovery or
disposal.
Decontamination Water can be used for clean-up and decontamination operations. No
specific decontamination or detoxification procedures have been identified
Procedures
for this product.
7. HANDLING AND STORAGE
HANDLING
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SDS Number 3119 Approved/Revised 14-Apr-2005 Version 10
PAXIL ORAL SUSPENSION
Material
General Requirements 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 No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
INGREDIENT
3
GSK Occupational
Hazard Category
GSK Occupational 40 mcg/m3 (8 HR TWA)
Exposure Limit
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Orange.
Colour
Liquid.
Physical Form
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Minor irritation might occur following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: central nervous system.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
selective serotonin re-uptake inhibitor.
Adverse effects of overexposure might include: drowsiness; diarrhoea;
constipation; nausea; irritation; weakness; insomnia; sexual dysfunction;
damage to mucosa.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
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SDS Number 3119 Approved/Revised 14-Apr-2005 Version 10
PAXIL ORAL SUSPENSION
Material
Summary This material contains an active pharmaceutical ingredient that has been
tested, and which 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.
ECOTOXICITY
Aquatic
Activated Sludge This material contains an active pharmaceutical ingredient that is harmful to
activated sludge microorganisms.
Respiration
IC50: 25 mg/L, 3 Hours, Residential sludge
Microtox Microtox is a general toxicity test which utilizes a sensitive marine photo
bacteria as the test species. This material contains an active
pharmaceutical ingredient that is harmful to these microorganisms.
EC50: 8.2 mg/L, 15 Minutes
Daphnid This material contains an active pharmaceutical ingredient that is toxic to
daphids.
EC50: 2.5 mg/L, 48 Hours, Daphnia magna, Static test
NOEL: 0.49 mg/L, 48 Hours, Daphnia magna, Static test
Fish This material contains an active pharmaceutical ingredient that is toxic to
fish.
Adult Lepomis macrochirus, bluegill sunfish
EC50: 1.6 mg/L, 96 Hours, Static test
Adult Lepomis macrochirus, bluegill sunfish
NOEL: 0.18 mg/L, 96 Hours, Static test
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air 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.
Henry's Law Constant 3.39E-10 atm m^3/mol, Calculated
Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to 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.
Soil Sediment Sorption 0.8, Estimated
(log Koc):
Sludge Biomass 2.94 Measured
Distribution Coefficient
(log Kd):
Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
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SDS Number 3119 Approved/Revised 14-Apr-2005 Version 10
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Material
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water. Hydrolysis is unlikely to be a
significant depletion mechanism.
Half-Life, Neutral: > 1 Years, Measured, Deionized Water
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 2.4 Hours, Measured, Deionized Water
UV/Visible Spectrum: 292 nm at pH 5 to 9
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable (as defined by 1993 OECD Testing Guidelines). It
may persist in the environment.
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
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.
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
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.
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This product is classified as hazardous according to the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 14-Apr-2005 SDS Version Number 10
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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SDS Number 3119 Approved/Revised 14-Apr-2005 Version 10
PAXIL ORAL SUSPENSION
Material
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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