SDS Number 110432 Approved/Revised 17-Dec-2004 Version 11
Material AUGMENTIN XR
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material AUGMENTIN XR
AUGMENTIN XR 1 GRAM EXTENDED RELEASE TABLETS * AUGMENTIN
Synonyms
XR EXTENDED RELEASE TABLETS * AUGMENTIN SR * AUGMENTIN SR
1000 MG/62.5 MG SUSTAINED RELEASE TABLETS * AUGMENTIN RETARD
* AUGMENTIN 16:1 TABLETS * NDC NO. 0029-6096-28 * NDC NO.
0029-6096-40 * NDC NO. 0029-6096-62 * NDC NO. 0029-6096-63 * NDC NO.
0029-6096-64 * NDC NO. 0029-6096-65 * POTASSIUM CLAVULANATE,
AMOXYCILLIN TRIHYDRATE AND SODIUM AMOXYCILLIN, 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
POTASSIUM CLAVULANATE 4.7
61177-45-5
AMOXICILLIN TRIHYDRATE 40
61336-70-7
AMOXYCILLIN SODIUM 29.3
34642-77-8
NON-HAZARDOUS INGREDIENTS 26
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
Fire and Explosion
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SDS Number 110432 Approved/Revised 17-Dec-2004 Version 11
Material AUGMENTIN XR
Health Exposure might occur via skin; eyes; ingestion.
May produce allergic skin reactions.
Respiratory allergen.
Possible effects of overexposure in the workplace include: symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing);
nausea; vomiting; diarrhoea.
Health effects information is based on hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
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 Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre. Medical treatment in cases of overexposure should be
treated as an overdose of penicillin antibiotic. In allergic individuals,
exposure to this material may require treatment for initial or delayed allergic
symptoms and signs. This may include immediate and/or delayed treatment
of anaphylactic reactions.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product. Ocular
Caused or Aggravated
symptoms may be indicative of allergic reaction. Pulmonary symptoms may
by Exposure
indicate allergic reaction or asthma. This material may cause or aggravate
allergy to penicillin antibiotics.
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, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
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
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SDS Number 110432 Approved/Revised 17-Dec-2004 Version 11
Material AUGMENTIN XR
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 No specific decontamination or detoxification procedures have been
identified for this product. Water can be used for clean-up and
Procedures
decontamination operations.
7. HANDLING AND STORAGE
HANDLING
General Requirements Avoid breaking or crushing tablets.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
POTASSIUM CLAVULANATE
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 5000 MCG/M3 (8 HR TWA)
Exposure Limit
AMOXICILLIN TRIHYDRATE
INGREDIENT
3
GSK Occupational
Hazard Category
RESPIRATORY SENSITISER, SKIN
GSK Occupational 100 MCG/M3 (15 MIN STEL)
SENSITISER
Exposure Limit
AMOXYCILLIN SODIUM
INGREDIENT
3
GSK Occupational
Hazard Category
RESPIRATORY SENSITISER, SKIN
GSK Occupational 100 mcg/m3 (15 MIN STEL)
SENSITISER
Exposure Limit
Occupational Hygiene Air For advice on suitable monitoring methods, consult your local occupational
or industrial hygiene specialist, health and safety department, or the health
Monitoring Methods
and safety group identified in section 1.
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material based upon the OEL/Occupational Hazard Category
and the outcome of a site- or operation-specific risk assessment. Refer to
the Exposure Control Matrix for more information about how ECA's are
assigned and how to interpret them.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
Respirators If respiratory protective equipment (RPE) is used, the type of RPE will
depend upon air concentrations present, required protection factor as well
as hazards, physical properties and warning properties of substances
present.
Other Equipment or Wear appropriate clothing to avoid skin contact. Wash hands and arms
thoroughly after handling.
Procedures
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SDS Number 110432 Approved/Revised 17-Dec-2004 Version 11
Material AUGMENTIN XR
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
White.
Colour
Tablet.
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 Adverse effects might occur following inhalation.
Skin Effects Irritation might occur following direct contact.
Eye Effects Minor irritation might occur following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment
based upon effects of structurally similar substances.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Assessment based upon effects of structurally similar substances.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. 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. No adverse effects have been reported
following extensive use or exposure in humans.
Pharmacological Effects This material is a penicillin; an antibiotic.
12. ECOLOGICAL INFORMATION
* Summary This material contains two or more active pharmaceutical ingredients that
have been tested, one of which may be harmful if released directly to the
environment. Specific information on that active pharmaceutical ingredient
is provided below. 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.
ECOTOXICITY
Aquatic
* Algal This material contains an active pharmaceutical ingredient that is harmful to
algae.
IC50: 56 mg/L, 72 Hours, Selenastrum capricornutum,
green algae
NOEL: 9.4 mg/L, 72 Hours, Selenastrum capricornutum,
green algae
* Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphids.
EC50: 1610 mg/L, 48 Hours, Daphnia magna, Static test
NOEL: 530 mg/L, 48 Hours, Daphnia magna, Static test
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SDS Number 110432 Approved/Revised 17-Dec-2004 Version 11
Material AUGMENTIN XR
* Fish This material contains an active pharmaceutical ingredient that is not toxic
to fish.
Adult Lepomis macrochirus, bluegill sunfish
EC50: > 790 mg/L, 96 Hours, Static test
Adult Lepomis macrochirus, bluegill sunfish
NOEL: 790 mg/L, 96 Hours, Static test
Adult Oncorhyncus mykiss, rainbow trout
EC50: > 960 mg/L, 96 Hours, Static test
Adult Oncorhyncus mykiss, rainbow trout
NOEL: 960 mg/L, 96 Hours, Static test
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
* 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
* Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral: 28.3 Hours, Measured
Half-Life, Acidic: 11.9 Hours, Measured
Half-Life, Basic: 9.92 Hours, Measured
* Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Inherent
Percent Degradation: 90 %, 28 days, Zahn-Wellens, Activated sludge
* BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
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 material.
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.
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SDS Number 110432 Approved/Revised 17-Dec-2004 Version 11
Material AUGMENTIN XR
* 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 dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 17-Dec-2004 SDS Version Number 11
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION European Union Classification and Labelling
Requirements
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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