Ezetimibe Tablets USP 10 mg

SECTION 2: Hazards identification

Not considered hazardous when handled under normal conditions. EMERGENCY OVERVIEW Caution Statement: Each Ezetimibe Tablet intended for oral administration contains Ezetimibe, USP and excipients generally considered to be non-toxic and non-hazardous in small quantities and under conditions of normal occupational exposure. SWALLOWED Although ingestion is not thought to produce harmful effects, the material may still be damaging to the health of the individual following ingestion, especially where pre-existing organ EYE Although the material is not thought to be an irritant, direct contact with the eye may cause transient discomfort characterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. SKIN The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting. Open cuts, abraded or irritated skin should not be exposed to this material. Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected. INHALED The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting. Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.

Potential chronic health

Long-term exposure to the product is not thought to produce chronic effects adverse to the health (as classified using animal models); nevertheless exposure by all routes should be minimized as a matter of course. Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particles less than 0.5 micron penetrating and remaining in the lung. Ezetimibe did not produce adverse effects on fertility in male or female rabbits, was not teratogenic in rabbits and rats, nor was it genotoxic in a bacterial mutagenicity study (Ames test) or the chromosomal aberration assay (HPBL) assay.ection 3 - COMPOSITIO Routes of Entry Oral Effects of Tablets are intended for human consumption under guidance of a Overexposure physician. Intact Tablets are not considered hazardous under normal handling procedures.

Medical Conditions Generally Aggravated by Exposure

Carcinogenicity