MATERIAL SAFETY DATA SHEET
Issued: 02/26/99 Prepared by: Gary Wong
Revised: NA Manager EHS
Revision: Original Core No. 402
1. PRODUCT AND COMPANY IDENTIFICATION
Metipranolol Ophthalmic Solution 0.3%
Product Name:
Same
Generic Name:
24208-402-05 ( 5 ml)
NDC No.
24208-402-10 (10 ml)
Prescription only medicine, filled inside plastic dropper bottle
Legal Category:
suitable for dispensing, and overpacked inside a cardboard
carton.
Drug Composition: Beta-adrenoceptor blocker (Reduces intraocular pressure in
the eye)
BAUSCH & LOMB PHARMACEUTICALS, INC.
8500 Hidden River Parkway
Tampa, FL 33637
Information: (800) 323-0000 (M-F) 8am-5pm EST
Emergency: (800) 227-1427 24 hrs
2. COMPOSITION/INFORMATION ON INGREDIENTS
3 3
Description CAS # TLV (mg/m ) PEL(mg/m ) % Content
Metipranolol 22664-55-7 NE NE 0.3
Povidone 9003-39-8 10 15 >1
Purified Water NA NE NE >1
Hydrochloric Acid 7647-01-0 5 ppm Ceiling: ACGH/OSHA >1
Ingredients <1% - Glycerin, Sodium Chloride, Edetate Disodium, Benzalkonium
Chloride
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle in a cardboard box. Clear, colorless to light yellow, odorless solution.
Potent medication. Individuals with asthma, cardiac disease and diabetes may be
more susceptible to systemic effects. Patients taking phenothiazine and beta-
adrenergic compounds can experience additive low blood pressure effects.
Persons with various strong allergies can have an anaphylactic reaction to this
preparation. Toxic by ingestion. May cause drowsiness. Avoid hazardous activities.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: May cause irritation, slight burning sensation on application and
hypersensitivity (anaphylactic), especially in individuals subject to allergies. Adverse
reactions in small numbers of individuals include headache, conjunctivitus, eyelid
dermatitis, blepharitis, blurred vision, tearing, browache, photophobia, and edema.
Because topically administered beta-adrenergic compounds may be absorbed
systemically, (whole body) effects may include acute toxicity. Acute toxicity effects
include severe respiratory distress (especially asthma sufferers), cardiac effects and
rarely heart failure. Symptoms of thyroid overactivity (thyrotoxicosis), and low blood
sugar (hypoglycemia) may be masked by the effects of metipranolol.
Skin: May cause irritation and hypersensitivity, including localized and generalized
rash. Systemic absorption is possible with repeated or prolonged contact.
Ingestion: May cause irritation and hypersensitivity, especially in individuals with
other allergies. Toxic by ingestion due to systemic absorption. Can also cause
nausea and diarrhea.
Inhalation: May cause irritation and hypersensitivity. May cause systemic effects.
Chronic Effects: As with other topically administered ophthalmic drugs,
metipranolol may be absorbed systemically. The same adverse reactions found with
systemic administration of beta-adrenergic blocking agents may occur with topical
administration, such as severe respiratory reactions and cardiac reactions, including
death due to bronchospasm in patients with asthma, and death associated with
cardiac failure. These have been reported with topical application of beta-adrenergic
blocking agents. Metipranolol may mask signs (e.g. rapid heart beat) of
thyrotoxicosis.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
Target Organs: Eye, heart, skin, digestive and respiratory tract, brain and thyroid.
Medical Conditions Aggravated by Long Term Exposure:
路 Patients with hypersensitivity to other beta-adrenergic agents may have reactions
to metipranolol. Persons with a hypersensitivity to any component of this product.
Patients conditions which may be affected include bronchial asthma, severe
chronic pulmonary disease and cardiac disease.
路 Beta adrenergic agents can mask the symptoms of hypoglycemia in diabetic
patients. Metipranolol can mask signs (e.g. tachycardia) of thyrotoxicosis.
路 It is not known if metipranolol is excreted in the milk of nursing mothers.
Systemically administered beta-blockers are known to be excreted in human milk.
Optipranolol has been shown to increase fetal resorption, fetal death, and delayed
development when administered orally to rats at 50 mg/Kg during organogenesis.
There are no well controlled studies in pregnant women. Optipranolol Ophthalmic
Solution should be used in pregnant women if the potential benefit justifies the risk
to the fetus.
4. FIRST AID MEASURES
Eyes: If not prescribed this medication, rinse immediately with copious amounts of
water for at least 20 minutes. Contact a physician.
Skin: Remove all contaminated clothing and wash skin with copious amounts of
water for at least 20 minutes. Contact physician if skin becomes irritated.
Ingestion: Wash out mouth and give plenty of water and bland fluids. Contact a
physician.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician immediately.
Note to Physicians:
路 Non-cardioselective beta-adrenoceptor blockers reduce cardiac output.
路 Patients conditions which may be affected include bronchial asthma, severe
chronic pulmonary disease, sinus bradycardia, second and third degree
atrioventricular block, overt cardiac failure, cardiogenic shock or hypersensitivity to
any component of this product.
路 Beta adrenergic agents can mask the symptoms of hypoglycemia in diabetic
patients.
路 Metipranolol can mask signs (e.g. tachycardia) of thyrotoxicosis.
路 Persons with a history of serious anaphylactic reactions may be more reactive to
repeated contact to metipranolol, either accidental, diagnostic, or therapeutic.
Patients with hypersensitivity reactions may be unresponsive to the usual doses of
epinephrine used to treat allergic reactions.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
Additional details are available on the package insert or in the Physicians Desk
Reference.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash Point: NE Method: NE
Flammable Limits: Lower Flammable Limit: NE Upper Flammable Limit: NE
Autoignition Temperature: NE
Hazardous Products: Acetaldehyde, Crotonaldehyde, Acetone, Sulfur Dioxide
(SO2) and toxic fumes.
Extinguishing Media: Dry chemical, carbon dioxide, halon, water spray or fog, and
foam on surrounding materials.
Fire Fighting Instructions: Wear self-contained breathing apparatus and protective
clothing. Use water spray to keep fire-exposed containers cool. Do not spray water
into the burning material.
6. ACCIDENTAL RELEASE MEASURES
Large/Small Spills: Notify your supervisor immediately. Minimize contact with
spilled material. Keep other personnel away from the clean up area. Wear
appropriate respiratory protection. Wear approved respirator and chemically
compatible gloves. Use personal protective equipment. (Refer to Section 8)
Squeegee, scoop, absorb or use a vacuum to clean up spill. Clean area with an
alkaline cleaner/detergent. Dispose of waste material in accordance with Federal,
State and Local regulations.
While not a RCRA hazardous waste, material should be disposed of according to
Federal, State and Local regulations. Incineration is the preferred disposal method.
7. HANDLING AND STORAGE
This material should be handled and stored per label and other instructions to
ensure product integrity.
Handling: Avoid contact with product and use caution to prevent puncturing
containers. No special protective equipment or procedures are required in the
clinical or home environment.
Storage: Store product upright in original containers with the cap tightly closed at a
0 0 0 0
controlled room temperature 15 -30 C (59 - 86 F). KEEP THIS AND ALL DRUGS
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
OUT OF THE REACH OF CHILDREN.
8. EXPOSURE CONTROL/PERSONAL PROTECTION
Engineering Controls: In the manufacturing plant, provide adequate ventilation for
the raw material handling and compounding process which will maintain the dust
and vapor levels below the TLV, STEL, and PEL values for the ingredients.
Ventilation fans should be explosion proof. Use adequate personal protective
equipment e.g. NIOSH-approved respirators, goggles or safety glasses, gloves and
protective clothing. Ensure training in the handling of chemical material and use
current Material Safety Data Sheets.
Eye Protection: (29 CFR 1910.133) Recommend goggles or chemical safety
glasses.
Skin Protection: Thick impermeable gloves and protective clothing.
Respiratory Protection: (29 CFR 1910.134) NIOSH approved respirator, with
organic vapor, acid gas and HEPA filter recommended for handling raw materials.
Warning: Do not use air purifying respirators in oxygen depleted
environments. No respiratory protection is required in the clinical or home
environment.
Other: None
Ventilation: Recommended. Provide adequate local exhaust ventilation.
Hygienic Practices: Train employees concerning hazards and precautions.
Wash hands and forearms after each use and use recommended personal
protective equipment while handling.
Contaminated Equipment: Wash contaminated clothing separately. Wash
equipment with soap and water. Release rinse water into an approved wastewater
system or according to Federal, State and Local regulations.
9. CHEMICAL & PHYSICAL PROPERTIES
Appearance & Odor: Clear, colorless to light yellowish.
Boiling Point: NE Evaporation Rate: NE
Melting Point: NE Vapor Density: NE
Specific Gravity: 1.0 Vapor Pressure: NE
Water Solubility: Miscible Percent Volatile by Volume: <1
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
Incompatibility: This product has the incompatibilities of water e.g. strong acids,
bases, alkali metals, alkali hydrides and silver preparations.
Hazardous Decomposition Products: Acetaldehyde, crotonaldehyde, acetone,
sulfur dioxide (SO2) and toxic fumes.
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
Summary of Risks: Toxicological information refers to raw materials product.
Concentrations and toxicological effects are substantially reduced in the product. For
more detailed information see MSDS on chemical material.
CAS #
22664-55-7 Metipranolol
May cause irritation to eyes, skin, respiratory and digestive tract. Can cause
hypersensitivity (anaphylactic) especially in individuals with a history of various
strong allergic reactions. Systemic toxicity effects include inflammation and irritation
of the eye, skin rash, itching or hives, headaches, vomiting, diarrhea, lethargy, lack
of coordination and chest pain. Topical application of beta-adrenergic blocking
agents have been reported to cause severe respiratory reactions and cardiac
reactions, including death due to bronchospasm in patients with asthma, and death
in association with cardiac failure. Symptoms of thyroid over activity (thyrotoxicosis)
and low blood sugar (hypoglycemia) can be masked by the effects of metipranolol.
7647-01-0 Hydrochloric Acid
Hydrochloric acid is a severe irritant to eyes, skin, respiratory and digestive tract.
Corrosive to all tissues. Ingestion effects include burns of the digestive tract,
vomiting, chills and shock. Exposure to gas or fumes may cause immediate
coughing, burning of the nose and throat, choking, dizziness, weakness and difficulty
swallowing. Exposure to concentrations above 5 ppm can cause inflammation and
ulcerations, headache and palpitations. Exposure to concentrations of 100 ppm or
above is immediately hazardous to health. Effects after 6-8 hour latency period
include tightness in the chest, air hunger, dizziness, frothing at the mouth,
pulmonary edema (fluid in the lungs) and cyanosis. Severe exposure may cause
circulatory shock, asphyxiation and death. Chronic exposure can cause dermatitis,
respiratory or gastric disturbances e.g. pneumonia, asphyxia, ulceration or kidney,
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
liver or heart failure. Inhalation - Mouse LC50 2124 ppm/30 minutes; Oral-rabbit 900
Mg/Kg.
9003-39-8 Povidone, USP
Testing results indicated this chemical is not a skin sensitizer, primary irritant of the
eyes, skin or respiratory tract. No symptoms of exposure recorded or expected.
Oral-rat LD50 >100,000 mg/kg.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOSAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The
method typically used is incineration.
RCRA Hazardous Waste: Not Listed
EPA Designations:
Not Listed
SARA Title III:
14. TRANSPORTATION INFORMATION
Not classified as hazardous by DOT regulations.
Transportation Data:
15. REGULATORY INFORMATION
Not classified as hazardous by DOT regulations.
DOT Designations:
RCRA Hazardous Waste
EPA Designations:
(40 CFR 261.33) Not Listed
Prescription only medication.
FDA Designations:
NDC No. 24208-402-05 ( 5 ml)
NDC No. 24208-402-10 (10 ml)
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
CALIFORNIA PROPOSITION 65: Not Listed
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Metipranolol Ophthalmic Solution 0.3%
16. OTHER INFORMATION
None
The information contained herein is furnished without warranty of any kind. The
above information is believed to be correct but does not purport to be all-inclusive
and should be used only as a guide. Users should make independent
determinations of the suitability and completeness of information from all sources to
assure proper use and disposal of these materials and the safety and health of
employees and customers.
NE - Not Established
< - Less Than
> - Greater Than
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