Atropine Sulfate Ophthalmic Ointment USP, 1%

SECTION 2: Hazards identification

EMERGENCY OVERVIEW Tube packed in a cardboard box. Translucent, colorless to light yellow ointment. Contains highly potent, active ingredient, atropine. Atropine is an intense poison. Do not engage in hazardous activity while under the influence. May cause temporary light sensitivity. Avoid mouth and skin contact. Toxic by ingestion and skin contact. *************************************************************************************************

Health hazards

Carcinogenicity: (NTP) No (IARC) No (OSHA) No Eye: May cause irritation and hypersensitivity (anaphylactic) in some individuals. May cause temporary light sensitivity. Overdosage (systemic toxicity) is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, mental aberration (hallucinations) unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastric motility and decreased secretion in salivary and sweat glands, pharynx, bronchi, nasal passages and loss of neuromuscular coordination. Severe reactions are manifested by low blood pressure (hypotension) with progressive respiratory depression. Coma and death have been reported in the very young. The main symptoms are drowsiness leading to coma. Atropine poisoning is rarely fatal. Once the drug is withdrawn, the mechanism of overdosage is self limiting. Skin: May cause irritation and hypersensitivity in some individuals. Toxic systemic effects may be induced by skin contact. Ingestion: May cause irritation, vomiting, diarrhea and hypersensitivity in some individuals. Ingestion atropine sulfate may induce systemic toxicity effects. Inhalation: May cause irritation and hypersensitivity in some individuals.

Potential chronic health

May cause irritation and hypersensitivity. Prolonged application may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young. Target Organs: Eyes, central nervous system, respiratory, and digestive tract.

Medical Conditions Generally Aggravated by Exposure

Hypersensitivity to any of the components of the product. Persons with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. Animal reproduction studies have not been performed with atropine. It is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atropine should be given to pregnant woman only if clearly needed.