MATERIAL SAFETY DATA SHEET
Issued: 02/07/03 Prepared by: Gary Wong
Revised: N/A Manager EHS
Revision: Original Core No. 399
1. PRODUCT AND COMPANY INFORMATION
Product Name: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
Generic Name: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
NDC No. 24208-399-15 (15ml)
Legal Category: Prescription only medicine filled in 15 ml bottle with spray
attachment and overpacked inside a cardboard carton.
Drug Composition: Anticholinergic agent
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
TLV (mg/m3) PEL (mg/m3)
Description CAS # %
Content
Ipratropium Bromide 66985-17-9 NE NE 0.06%
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Sodium Chloride, Edetate Disodium Dihydrate, Benzalkonium
Chloride
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MSDS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Clear colorless solution in plastic bottle with spray attachment. Presents little or no
hazards if spilled and no unusual hazard if involved in fire.
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POTENTIAL HEALTH HAZARDS
Carcinogenicity: (NTP) No (IARC) No (OSHA) No
Eye: Do not spray Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) in
your eyes. Patients should be advised that temporary blurring of vision,
precipitation or worsening of narrow-angle glaucoma or eye pain may result if
Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) comes into direct contact
with the eyes.
Skin: May cause irritation.
Ingestion: Ipratropium Bromide is not well absorbed systemically after intranasal
or oral administration. Following administration of a 20 mg oral dose (equivalent to
ingesting more than two bottles of Ipratropium Bromide Nasal Solution 0.06%
Nasal Spray) to 10 male volunteers, no change in heart rate or blood pressure was
noted.
Inhalation: The most frequently reported nasal adverse events were transient
episodes of nasal dryness or epistaxis.
Chronic Effects: Oral median lethal doses of Ipratropium Bromide were greater
than: 1,000 mg/kg in mice (approximately 6,000 and 3,800 times the maximum
recommended daily intranasal dose in adults and children, respectively, on a
mg/m2 basis) 1,700 mg/kg in rats (approximately 21,000 and 13,000 times the
maximum recommended daily intranasal dose in adults and children, respectively,
on a mg/m2 basis) and 400 mg/kg in dogs (approximately 16,000 and 10,000 times
the maximum recommended daily intranasal dose in adults and children,
respectively, on a mg/m2 basis).
Target Organs: Target organs of toxicity (0.06%) at repeated doses were liver, GI
tract adrenals (rat), male reproductive organs and eyes (dog).
Medical Conditions Aggravated by Long Term Exposure: Ipratropium Bromide
Nasal Solution 0.06% (Nasal Spray) was well tolerated by most patients. The most
frequently reported adverse events were transient episodes of nasal dryness or
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MSDS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
epistaxis. The majority of these adverse events (96%) were mild or moderate in
nature, none was considered serious, and none resulted in hospitalization. No
patient required treatment for nasal dryness, and only three patients (<1%)
required treatment for epistaxis, which consisted of local application of pressure or
a moisturizing agent (e.g., petroleum jelly). No patient receiving Ipratropium
Bromide Nasal Solution 0.06% (Nasal Spray) was discontinued from the trial due
to either nasal dryness or bleeding. Adverse events reported by less than 1% of
the patients receiving Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
during the controlled clinical trials which are potentially related to Ipratropium
Bromide's local effects or systemic anticholinergic effects include: taste perversion,
nasal burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation,
pharyngitis, tachycardia, thirst, tinnitus and blurred vision. Additional anticholinergic
effects noted with other Ipratropium Bromide dosage forms (Ipratropium Bromide
inhalation solution, Ipratropium Bromide inhalation aerosol, and Ipratropium
Bromide Nasal Solution 0.06% Nasal Spray include: precipitation or worsening of
narrow-angle glaucoma, urinary retention, prostate disorders, constipation, and
bowel obstruction. There were no reports of allergic-type reactions in the
controlled clinical trials. Allergic-type reactions such as skin rash, angioedema of
the tongue, lips and face, urticaria, laryngospasm and anaphylactic reactions have
been reported with other Ipratropium Bromide products. No controlled trial was
conducted to address the relative incidence of adverse events for three times daily
versus four times daily therapy.
4. FIRST AID MEASURES
Eyes: 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 drink plenty of water and bland fluids. The use
of an emetic drug and/or gastric lavage is advisable. Do not give anything to an
unconscious person. Contact physician.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician.
Note to Physicians:
Pregnancy: TERATOGENIC EFFECTS Pregnancy Category B. Oral reproduction
studies were performed at doses of 10 mg/kg in mice, 1,000 mg/kg in rats and 125
mg/kg in rabbits. These doses correspond, in each species respectively, to
approximately 60, 12,000, and 3,000 times the maximum recommended daily
intranasal dose in adults on a mg/m2 basis. Inhalation reproduction studies were
conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg, respectively
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MSDS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
(approximately 20 and 45 times, respectively, the maximum recommended daily
intranasal dose in adults on a mg/m2 basis). These studies demonstrated no
evidence of teratogenic effects as a result of Ipratropium Bromide. At oral doses
above 90 mg/kg in rats (approximately 1,100 times the maximum recommended
daily intranasal dose in adults on a mg/m2 basis) embryotoxicity was observed as
increased resorption. This effect is not considered relevant to human use due to
the large doses at which it was observed and the difference in route of
administration. However, no adequate or well controlled studies have been
conducted in pregnant women. Because animal reproduction studies are not
always predictive of human response, Ipratropium Bromide should be used during
pregnancy only if clearly needed.
Nursing Mothers: It is known that some Ipratropium Bromide is systemically
absorbed following nasal administration; however the portion which may be
excreted in human milk is unknown. Although lipid-insoluble quaternary bases
pass into breast milk, the minimal systemic absorption makes it unlikely that
Ipratropium Bromide would reach the infant in an amount sufficient to cause a
clinical effect. However, because many drugs are excreted in human milk, caution
should be exercised when Ipratropium Bromide Nasal Solution 0.06% Nasal Spray
is administered to a nursing woman.
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
Hazardous Products: CO, CO2, NOX , HBr
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: Use personal protective equipment. Contain the spill to
prevent drainage into sewers, drains or streams. Use absorbent material to solidify
the spill. Shovel or scoop up solidified waste. Dispose of material according to
Federal, State and Local regulations.
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MSDS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
7. HANDLING AND STORAGE
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
controlled room temperature 150-300 C (590- 860 F). KEEP THIS AND ALL DRUGS
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
Contaminated Equipment: Wash contaminated clothing separately. Wash
contaminated 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 solution
Boiling Point: NE Evaporation Rate: NE
Specific Gravity: 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Miscible Percent Volatile by Volume: <1
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MSDS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
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: CO, CO2, NOX , HBr
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY
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 # 66985-17-9 Ipratropium Bromide
Oral median lethal doses of Ipratropium Bromide were greater than 1,000 mg/kg in
mice (approximately 16,000 and 9,500 times the maximum recommended daily
intranasal dose in adults and children, respectively, on a mg/m2 basis), 1,700
mg/kg in rats (approximately 55,000 and 32,000 times the maximum
recommended daily intranasal dose in adults and children, respectively, on a
mg/m2 basis), and 400 mg/kg in dogs (approximately 43,000 and 25,000 times the
maximum recommended daily intranasal dose in adults and children, respectively,
on a mg/m2 basis).
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The
method typically used is incineration.
EPA Designations: RCRA Hazardous Waste: Not Listed
SARA Title III: Not Listed
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MSDS: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)
14. TRANSPORTATION INFORMATION
Transportation Data: Not classified as hazardous by DOT regulations.
15. REGULATORY INFORMATION
DOT Designations: Not classified as hazardous by DOT regulations.
EPA Designations: RCRA Hazardous Waste
(40 CFR 261.33) Not Listed
FDA Designations: Prescription only medication.
NDC No. 24208-399-15 (15ml)
OSHA Designations: (29 CFR 1910.1000, Table Z)
Not Listed
SARA Title III: Not listed under Section 313 of Toxic Release Reporting.
CALIFORNIA PROPOSITION 65: Not Listed
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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