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. | ||
|
Indapamide | 26807-65-8 | ||
| Corn Starch | 9005-25-8 | ||
| Stearates | NA | ||
| Microcrystalline Cellulose | 9004-34-6 | ||
| Hydroxypropyl Methylcellulose | 9004-65-3 | ||
| Magnesium Stearate | 557-04-0 | ||
| Polyethylene Glycol | 25322-68-3 | ||
| Asbestos-Free Talc | 14807-96-6 | ||
| Coloring Agent | NA | ||
| Lactose | 63-42-3 | ||
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.