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1,2,4-Triazolo[4,3-a]pyridine,5,6,7,8-tetrahydro-3-[2-[4-(2-methylphenyl)-1-piperazinyl]ethyl]-,hydrochloride (1:1)

MATERIAL SAFETY DATA SHEET

Issued: 12/20/01 Prepared by: Gary Wong
Revised: NA Manager EHS
Revision: Original Core No. 394

1. PRODUCT AND COMPANY IDENTIFICATION

REV??EYES??
Product Name:
Dapiprazole Hydrochloride Ophthmalic Solution 0.5%
Generic Name:
24208-394-07 (25 mg)
NDC No.

Prescription only medicine, filled in bottle supplied with vial
Legal Category:
of diluent, dropper for dispensing, and overpacked inside a
cardboard carton.

Drug Composition: Antiglaucoma; miotic

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
3
Dapiprazole 72822-13-0 35 mcg/m eye, (REL, Abbott) 0.5
Hydrochloride
3 3
Mannitol 10 mg/m total 15 mg/m total 2.0
3 3
5 mg/m respirable 5 mg/m respirable

Ingredients <1% - Sodium Chloride, Hydroxypropyl Methylcellulose, Edetate Sodium,
Sodium Phosphate dibasic, Sodium Phosphate monobasic, Water, Benzalkonium
Chloride
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3. HAZARDS IDENTIFICATION

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EMERGENCY OVERVIEW

Contact with eyes may cause pupil constriction. Target organs are eyes and
cardiovascular system.

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POTENTIAL HEALTH HAZARDS

(NTP) No No No
Carcinogenicity: (IARC) (OSHA)

Eye: No data

Skin: No data

Ingestion: No data

Inhalation: No data

Chronic Effects:

Target Organs:

Medical Conditions Aggravated by Long Term Exposure: Data suggest
hypersensitivity to dapiprazole, ocular lesions, such as acute iritis, and
cardiovascular disease.

Contraindications: Miotics are contraindicated where constriction is undesirable;
such as acute iritis, and in those subjects showing hypersensitivity to any
component of this preparation.

4. FIRST AID MEASURES

Eyes: Remove from source of exposure. Flush with copious amounts of water for
at least 20 minutes. If irritation persists or signs of toxicity occur, seek medical
attention. No known antidote. Provide symptomatic/supportive care as necessary.
Contact a physician.

Skin: Remove from source of exposure. Flush with copious amounts of water for
at least 20 minutes. If irritation persists or signs of toxicity occur, seek medical
attention. No known antidote. Provide symptomatic/supportive care as necessary.
Contact physician if skin becomes irritated.

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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: Carcinogenesis, Mutagenesis, Impairment of Fertility:
Dapiprazole hydrochloride has been shown to significantly increase the incidence
of liver tumors in rats after continuous dietary administration for 104 weeks. This
effect was found only in male rats treated with the highest dose administered in
the study, i.e., 300 mg/kg/day, (80,000 times the human dose) and was not
observed in male and female rats at doses of 30 and 100 mg/kg/day and female
rats at doses of 300 mg/kg/day. Negative results have been reported on the
mutagenicity and impairment of fertility studies with dapiprazole hydrochloride.
Pregnancy Category B. Reproduction studies have been performed in rats and
rabbits at doses up to 128,000 (rat) and 27,000 (rabbit) times the human
ophthalmic dose and revealed no evidence of impaired fertility or harm to the fetus
due to dapiprazole hydrochloride. There are, however, no adequate and well
controlled studies in pregnant women. Because animal reproduction studies are
not always predictive of human response, this drug should be used during
pregnancy only if clearly needed.

Nursing mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when dapiprazole hydrochloride ophthalmic solution is administered to a nursing
woman.

For Topical Ophthalmic Use Only. NOT FOR INJECTION.

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: Emits 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
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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
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.
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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:
Boiling Point: NE Evaporation Rate: NE
Melting Point: NE Vapor Density: NE
Vapor Pressure: NE Specific Gravity: NE
Water Solubility: Soluble Percent Volatile by Volume: <1

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: Emits 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 #

72822-13-0 Dappiprazole Hydrochloride
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In controlled studies the most frequent reaction to dapiprazole was conjunctival
injection lasting 20 minutes in over 80% of patients. Burning on instillation of
dapiprazole hydrochloride ophthalmic solution was reported in approximately half
of all patients. Reactions occurring in 10% to 40% of patients included ptosis, lid
erythema, lid edema, chemosis, itching, punctate keratitis, corneal edema,
browache, photophobia and headaches. Other reactions reported less frequently
included dryness of eyes, tearing and blurring of vision.

TOXICITY:
Oral toxicity: N/D. LD50 for Dapiprazole HCl = 1189??2100 mg/kg in mice, rats and
rabbits.

Dermal toxicity: N/
Inhalation toxicity: N/
Corrosiveness:N/
Dermal irritation: N/
Ocular irritation: N/
Dermal sensitization: N/
Special target organ effects: N/D. In clinical use dapiprazole hydrochloride is an
alpha??adrenergic blocking drug that causes the pupil of the eye to become
smaller, can reduce blood pressure and can reverse the effects of opiate and
alcohol withdrawal.

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:

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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. 24208-07 (25 mg)

(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

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
N/D ?? Not Determined
< - Less Than
> - Greater Than

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