Tobramycin Ophthalmic Solution USP, 0.3%

Contains

Tobramycin 32986-56-4 NE NE 0.3 Boric Acid 10043-35-3 NE NE >1 Purified Water 7732-18-5 NE >1 Ingredients <1% - Sodium Chloride, Sodium Sulfate Decahydrate, Tyloxapol, Benzalkonium Chloride 3. HAZARDS IDENTIFICATION ************************************************************************************************* EMERGENCY OVERVIEW Plastic bottle packed in a cardboard carton. Clear, colorless to pale yellow, solution. ************************************************************************************************* POTENTIAL HEALTH HAZARDS Carcinogenicity: (NTP) No (IARC) No (OSHA) No Eye: This is an ophthalmic preparation. May cause irritation and hypersensitivity in some individuals. Adverse reactions include localized ocular toxicity, lid itch and swelling and redness of the mucous membrane of the eye (conjunctival erythema). These reactions occur in less than 3% of patients. Signs of overdose of Tobramycin Ophthalmic Solution include inflammation of the cornea (punctate keratitis), erythema, increased tearing (lacrimation), swelling (edema) and lid itching. Skin: May cause irritation. Repeated or prolonged contact can induce hypersensitivity (anaphylactic) in some individuals. Ingestion: May cause irritation and hypersensitivity in some individuals. Ingestion of large quantities can cause nausea and vomiting. Inhalation: May cause irritation to the respiratory tract and hypersensitivity in some individuals. Chronic Effects: May cause irritation and hypersensitivity (anaphylactic) in some individuals. Prolonged use of topical antibiotics can give rise to overgrowth of nonsusceptible organisms, including fungi. Bacterial resistance to tobramicin may also develop. Target Organs: Eyes, skin and digestive tract. Medical Conditions Aggravated by Long Term Exposure: Allergies to aminoglycoside antibiotics or any component of the product. As with other antibiotic preparations, prolonged use may result in overgrowth of other nonsusceptible organisms, including fungi. ppropriate measures should be taken if this occurs. Reproduction studies, in three different types of animals, at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are no adequate and well controlled studies in pregnant women. Tobramycin should be used in pregnancy only if the potential benefits justify the risk to the fetus. Because of the potential for adverse reactions in nursing infants from Tobramycin Ophthalmic Solution, a decision should be made whether to discontinue nursing the infant or discontinue taking the drug, taking into account the importance of the drug to the mother.