LOTEMAX

BAUSCH & LOMB PHARMACEUTICALS, INC

Revision date : 2002-02-05

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

56-81-5

Name of the chemical

glycerol

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Revision date

2002-02-05

Product name

LOTEMAX

Product Synonyms

Loteprednol Etabonate Ophthalmic Suspension, 0.5%

1.2.1 Relevant identified uses

for dispensing, and overpacked inside a cardboard carton

Emergency telephone

(800) 227-1427

Icons in SDS

Company Information

company name

BAUSCH & LOMB PHARMACEUTICALS, INC

Section 2

SECTION 2: Hazards identification

EMERGENCY OVERVIEW Plastic bottle in cardboard box. White suspension. Toxic by ingestion. *************************************************************************************************

Health hazards

Carcinogenicity: (NTP) No (IARC) No (OSHA) No Eye: May cause irritation, burning sensation on installation and hypersensitivity (anaphylactic) in some individuals. Studies in animals indicate that topical adrenocoids, when used in large amounts, can be systemically absorbed and can cause fetal abnormalities. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Systemic toxicity reactions include reversible hypothalamic-pituitary-adrenal axis gland suppression, manifestations of Cushing's syndrome, intercranial hypertension, hyperglycemia and glycosuria in some patients. Skin: May cause irritation and localized hypersensitivity in some individuals with itching, swelling and diffused redness of the skin. Ingestion: May cause irritation and hypersensitivity in some individuals. Large doses can induce vomiting, diarrhea, adrenal gland suppression, Cushing's syndrome, water retention, electrolyte imbalance and hyper-glycemia. Inhalation: May cause irritation and hypersensitivity in some individuals.

Potential chronic health

May cause hypersensitivity. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Prolonged use can result in elevation of intraocular pressure, with damage to the optic nerve, defects in visual acuity and fields of vision and/or in posterior subcapsular cataract formation. It may also aid in the establishment of secondary ocular infections from fungi or viruses liberated from ocular tissues. Target Organs: Eyes, skin, digestive tract, kidney and brain.

Medical Conditions Generally Aggravated by Exposure

Anaphylactic cross-reactions may occur for glucocorticoids. Preexisting conjunctival or systemic fungal infections may be aggravated. Appropriate measures should be taken if this occurs. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral diseases of the cornea and conjunctiva. Tuberculosis of the eye. Fungal diseases of the ocular structures. Hypersensitivity to any of the ingredients of the medication. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent untreated infection of the eye can be masked or activity enhanced by the presence of corticosteroid medication.

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