SDS Number 127295 Approved/Revised 15-Oct-2004 Version 05
Material LANOXICAPS
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material LANOXICAPS
LANOXICAPS 0.05MG * LANOXICAPS 0.1MG * LANOXICAPS 0.2MG * NDC
Synonyms
NO 0173-0270-55 * NDC NO 0173-0272-55 * NDC NO 0173-0274-55 *
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
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
DIGOXIN 0.03 to 0.05
20830-75-5
ETHANOL 2.6 to 4.04
64-17-5
NON-HAZARDOUS INGREDIENTS 95.91 to 97.37
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
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.
4. FIRST-AID MEASURES
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SDS Number 127295 Approved/Revised 15-Oct-2004 Version 05
Material LANOXICAPS
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 Carbon dioxide, dry powder or foam extinguishers are recommended. Do
not use water extinguishers. Water jets may intensify the fire or be
ineffective.
Special Firefighting For larger amounts (multiple packages/pallets) of product: Since toxic,
corrosive or flammable vapours might be evolved from fires involving this
Procedures
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. Move containers
from the fire area if possible without increased personal risk. For single
units (packages): No special requirements needed.
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 No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
7. HANDLING AND STORAGE
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SDS Number 127295 Approved/Revised 15-Oct-2004 Version 05
Material LANOXICAPS
HANDLING
General Requirements 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
DIGOXIN
INGREDIENT
4
GSK Occupational
Hazard Category
GSK Occupational 1 mcg/m3 (8 HR TWA)
Exposure Limit
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. Special considerations apply in the
planning, design, review and implementation of controls - seek specialist
assistance from local occupational hygienist or safety department.
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, it should provide full face
protection. Follow local regulations for respirator use in the workplace.
Other Equipment or Wash hands and arms thoroughly after handling. Wear appropriate clothing
to avoid skin contact.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Soft capsule containing 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 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.
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Material LANOXICAPS
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
daphids.
EC50: 24.2 mg/l, 24 Hours, Daphnia magna, Static test
* 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
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Material LANOXICAPS
* 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.
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
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SDS Number 127295 Approved/Revised 15-Oct-2004 Version 05
Material LANOXICAPS
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-Oct-2004 SDS Version Number 5
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION
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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