SDS Number 110565 Approved/Revised 03-Aug-2006 Version 9
LANOXIN TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material LANOXIN TABLETS
LANOXIN TABLETS 0.125 MG * LANOXIN TABLETS 0.25 MG *
Synonyms
LANACORDIN COMPRIMIDOS * LENOXIN MITE TABLETS 125 MG *
LENOXIN TABLETS 250 MG * NDC NO 0173-0242-55 * NDC NO
0173-0242-56 * NDC NO 0173-0242-75 * NDC NO 0173-0249-55 * NDC NO
0173-0249-56 * NDC NO 0173-0249-75 * NDC NO 0173-0249-80 * DIGOXIN,
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
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 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
DIGOXIN 0.13
20830-75-5
NON-HAZARDOUS INGREDIENTS 99.87
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Potent pharmaceutical agent.
Exposure might occur via skin; ingestion; eyes.
Possible effects of overexposure in the workplace include: cardiovascular
effects.
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.
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SDS Number 110565 Approved/Revised 03-Aug-2006 Version 9
LANOXIN TABLETS
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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 Medical treatment in cases of overexposure should be treated as an
overdose of a cardiac glycoside. Treat according to locally accepted
protocols. For additional guidance, refer to the local poison control
information centre.
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 For medical treatment in cases of overexposure, a recommended antidote
would be Digibind. The decision as to whether the severity of poisoning
requires administration of any antidote and actual dose required should be
made by qualified medical personnel. For the latest information, refer to the
local poison control information centres.
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
Personal Precautions Use protective clothing during clean-up prior to disposal of spilled product.
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
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SDS Number 110565 Approved/Revised 03-Aug-2006 Version 9
LANOXIN TABLETS
Material
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
DIGOXIN
INGREDIENT
5
GSK Occupational
Hazard Category
GSK Occupational 1 mcg/m3 (8 HR TWA)
Exposure Limit
ENGINEERING CONTROLS
* Exposure Controls The active ingredient was formerly assigned to OHC 4 with the Highly
Potent notation. 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. Special considerations apply in the
planning, design, review and implementation of controls - seek specialist
assistance from local occupational hygienist or safety department.
* Containment Open handling may result in overexposure. It is strongly advised that
dedicated areas and containment, such as glove boxes, isolators, and
enclosed material transfer systems be used to prevent personnel exposure
and spread of contamination.
* Ventilation Local exhaust ventilation (LEV) is not appropriate at this level, since total
containment should usually be used.
* Administrative Strict control of access to the working area is essential. Only trained
personnel should enter the area during operations. Adopt procedures to
prevent contamination of working materials and adjacent areas.
PERSONAL PROTECTIVE EQUIPMENT
* Eye Protection When isolation is not possible, chemical splash goggles or equivalent eye
protection must be used with other applicable protective equipment.
* Gloves Care must be exercised if insufficient data are available and further
guidance should be sought from your local EHS department. Glove
selection must take into account any solvents and other hazards present.
The selection of gloves for a specific activity must be based on the
material's properties and on possible permeation and degradation that may
occur under the circumstances of use. Potential allergic reactions can occur
with certain glove materials (e.g. Latex) and therefore these should be
avoided.
* Respirators When isolation is not possible, respiratory protective equipment (RPE)
should be combined with applicable protective equipment.
* Other Equipment or Follow all local regulations if personal protective equipment (PPE) is used
in the workplace. When isolation is not possible in production areas,
Procedures
applicable protective equipment must be used. Consider additional control
procedures for maintenance, cleaning and emergencies.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Tablet.
Physical Form
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Material
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 Irritation is not expected following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: heart.
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 material is a cardiac glycoside.
Other Adverse Effects The following adverse effects have been noted with therapeutic use of this
material: symptoms of hypersensitivity (such as skin rash, hives, itching,
and/or difficulty breathing).
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested and which may be harmful 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 mixture 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 not toxic
to activated sludge microorganisms.
Respiration
IC50: > 100 mg/l, 3 Hours, Activated sludge
NOEC: 100 , 3 Hours, Activated sludge
Algal No toxicity to algae was observed for the active pharmaceutical ingredient
in this mixture, but the upper range of the test was limited by the low water
solubility of the compound.
IC50: > 10 mg/l, 72 Hours, Selenastrum capricornutum,
green algae
NOEL: 10 mg/l, 72 Hours, Selenastrum capricornutum,
green algae
* Daphnid This material contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 24.2 mg/l, 24 Hours, Daphnia magna, Static test
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SDS Number 110565 Approved/Revised 03-Aug-2006 Version 9
LANOXIN TABLETS
Material
Fish This material contains an active pharmaceutical ingredient that is toxic to
fish.
Adult Oncorhyncus mykiss, rainbow trout
EC50: 2.9 mg/l, 96 Hours, Static test
Adult Oncorhyncus mykiss, rainbow trout
NOEL: 0.56 mg/l, 96 Hours, Static test
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has limited solubility in water.
Volatility 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.
This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant < 1.00E-16 atm m^3/mol, Estimated
Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to soil or sediment if released directly to the environment. This
material contains an active pharmaceutical ingredient that is not likely to
adsorb to sludge or biomass if released directly to the environment.
Sludge Biomass 1.78 Measured Measured at pH 7
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
Photolysis This mixture contains an active pharmaceutical ingredient that is likely to
undergo photodegradation.
UV/Visible Spectrum: 220 nm
Biodegradation This mixture 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: > 99 %, 14 days, Zahn-Wellens, Activated sludge
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. Wherever possible, disposal should be in an on-site licenced
chemical incinerator, if allowed by the incinerator licence or permit. If no
on-site incinerator is available, dispose of material in a licenced commercial
chemical incinerator.
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.
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SDS Number 110565 Approved/Revised 03-Aug-2006 Version 9
LANOXIN TABLETS
Material
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 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 03-Aug-2006 SDS Version Number 9
SDS Sections Updated
Sections Subsections
EXPOSURE CONTROLS / PERSONAL PROTECTION Administrative
Containment
Exposure Controls
Eye Protection
Gloves
Occupational Hygiene Air Monitoring Methods
Occupational Hygiene Surface Monitoring Method
Other Equipment or Procedures
Other Exposure Limits
Other Information
Other Protective Equipment
Respirators
Surface Exposure Target
Ventilation
HAZARDS IDENTIFICATION
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION
Australian Classification according to Hazardous
Substance and Dangerous Goods Regulatory
Framework
European Union Classification and Labelling
Requirements
Other Regulations
Other US Regulations - California Proposition 65
Other US Regulations - TSCA Status
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SDS Number 110565 Approved/Revised 03-Aug-2006 Version 9
LANOXIN TABLETS
Material
SDS Sections Updated
Sections Subsections
REGULATORY INFORMATION State Regulations
Summary
US Environmental (EPA) Requirements
US OSHA Standard (29 CFR Part 1910.1200) -
Classification
US OSHA Standard (29 CFR Part 1910.1200) -
Target Organ Stat
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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