Pressural [as hemihydrate]

Indapamide®


1. PRODUCT IDENTIFICATION

Product Name(s): Indapamide®

Arcola Laboratories, Inc.

500 Arcola Road

Collegeville, PA 19426-0107

24-Hour Emergency Phone: (610)454-8181

2. COMPOSITION / INFORMATION ON INGREDIENTS

Common Name CAS No.
Exposure Limits

Indapamide

26807-65-8

NA
Corn Starch9005-25-8
NA
Stearates NA
NA
Microcrystalline Cellulose9004-34-6
NA
Hydroxypropyl Methylcellulose9004-65-3
NA
Magnesium Stearate557-04-0
10 mg/m3 ACGIH TLV-TWA
Polyethylene Glycol25322-68-3
NA
Asbestos-Free Talc14807-96-6
2 mg/m3 (respirable) ACGIH TLV-TWA
Coloring Agent NA
NA
Lactose63-42-3
NA

3. HAZARDS IDENTIFICATION

Potential Health Effects

Eye

As a film-coated tablet, not expected to be irritating to the eyes.

Skin Contact

None expected.

Skin Absorption

None expected.

Ingestion

Indapamide is an antihypertensive and a diuretic. Adverse effects have been reported in patients using this product. If inadvertently ingested in significant quantities, indapamide may alter the body's electrolyte balance or cause an allergic reaction.

Inhalation

As a film-coated tablet, not expected.

Chronic Effects/Carcinogenicity

Because thiazide diuretics have been associated with a decrease in uteroplacental perfusion, there is concern about exposure to these substances during pregnancy however, there are no data indicating such an effect would occur with indapamide exposures.

4. FIRST AID MEASURES

Eyes

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice if irritation occurs.

Skin

If inadvertently exposed to crushed tablets, wash with soap and water. Seek medical attention if any symptoms appear.

Ingestion

If inadvertently swallowed, seek medical advice immediately and show this container or label.

Inhalation

If inadvertently exposed to crushed tablets, get fresh air. Should symptoms develop, get medical attention immediately

Note to Physician

Additional details are available in section 11, on the package insert or in the Physicians' Desk Reference.


5. FIRE FIGHTING MEASURES

FLAMMABLE LIMITS
Flash Pt:Unspecified
Flammable Limits in Air-Lower:Unspecified
Flammable Limits in Air-Upper:Unspecified
Auto-Ignition Temperature:Unspecified

General Hazards

S41 In case of fire and/or explosion do not breathe fumes. CO, CO2, phosgene and oxides of nitrogen and sulfur may be generated in a fire.

Fire Fighting Extinguishing Media

S43 In case of fire use waterspray, foam or dry chemical.

Fire Fighting Instructions

S43 In case of fire, use full firefighting turnout (bunker) gear and self-contained breathing apparatus (SCBA). Keep personnel upwind and away from fire. Move container from fire area if you can do it without risk. Do not scatter spilled material with high-pressure water streams. Dike fire-control water for later disposal.

Hazardous Combustion Products

CO, CO2 and oxides of nitrogen and sulfur may be generated in a fire.

6. ACCIDENTAL RELEASE MEASURES

Large Spill

Scoop up, place in suitable container for disposal and mop area.

Small Spill

Same as for large spills.

7. HANDLING AND STORAGE

Special Handling

Protect product from physical damage.

Special Storage

Store at controlled room temperatures 59-86 degrees F (15-30 degrees C).

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Eye Protection

For intact tablets, none required.

Skin Protection

For intact tablets, none required.

Respiratory Protection

For intact tablets, none required.

Engineering Controls

Manufacturing and packaging operations should be designed so as to offer no significant exposure to this material.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical Form: Octagon-shaped coated tablets
Color:White
Boiling Point:Unspecified
Melting Point:Unspecified
Freezing Point:Unspecified
pH:Unspecified
Solubility in Water:Limited
Specific Gravity:Unspecified
Decomposition Temperature:Unspecified
Evaporation Rate:Unspecified
Vapor Pressure:Unspecified
Vapor Density:Unspecified


10. STABILITY AND REACTIVITY

Incompatibility

Heat and strong oxidizers.

Hazardous Decomposition Products

No Data.

Hazardous Polymerization

Will not occur.

General Information

No additional information.


11. TOXICOLOGICAL INFORMATION

Toxicology Text

Indapamide is rapidly and completely absorbed from the gastro-intestinal tract. It is extensively detoxified and metabolized in the liver. Elimination is biphasic with a half-life of 14 hours. Indapamide bears a structural similarity to the triazide diuretics which are known to decrease vascular smooth muscle reactivity. Indapamide appears to cause vasodilation, probably by inhibiting the passage of calcium and other ions (sodium, potassium) across membranes. This same effect may cause hypokalcemia in susceptible individuals. Indapamide has also been shown to cause uterine myometrial relaxation in experimental animals; however, this effect has not been of any human clinical significance. Lifetime feeding studies in laboratory animals were negative indicating no increase in cancer among animals treated with indapamide. Exposures to more than 6,000 times the recommended human dose of indapamide did not cause any birth defects among experimental animals.

RAT LD50; ROUTE: Oral; DOSE: >3 gm/kg; REFERENCE: Arzneimittel-Forschung. Drug Research 25:1491, 1975.

MOUSE LD50; ROUTE: Oral; DOSE: >3 gm/kg; REFERENCE: Arzneimittel-Forschung. Drug Research 25:1491, 1975.

12. ECOLOGICAL INFORMATION

No information for determination of unusual environmental fate or toxicity is available at this time.

13. DISPOSAL CONSIDERATIONS

Disposal Information

Waste must be disposed of in accordance with federal, state and local environmental regulations. Waste may be placed in a leakproof, puncture resistant container which is then placed in disposable wire-tie or sealable 4-mil-thick polyethylene or 2-mil-thick propylethylene bags.

Waste Disposal Methods

Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state and local environmental regulations.


14. TRANSPORT INFORMATION

Proper Shipping Name:Not regulated.

Transportation of Hazardous Material Description

Domestic DOT Label: ORM-D; International (IMO) label: Drugs/Medicines

Not a regulated material. Ship according to DOT and/or IATA regulations.

15. REGULATORY INFORMATION

TSCA

This material is a pharmaceutical agent and as such is regulated by the United States Food and Drug Administration (FDA).

CERCLA

Not listed.

SARA Title III

Not listed.

SARA 313

Not listed.

16. OTHER INFORMATION

Prepared By:David Eherts CIH
Approved By:ITAC
Approved Date:07/25/96
Supersedes Date:08/21/92

Other Information

The information contained herein is based upon data considered true and accurate. Arcola Laboratories Inc. makes no warranties, express or implied, as to the adequacy of the information contained herein. This information is offered solely for the user's consideration, investigation and verification. Report to the manufacturer any allegations of health effects resulting from handling or accidental contact with this material.

Revision Summary

First revision.