Buspirone Hydrochloride Tablets USP

SECTION 2: Hazards identification

EMERGENCY OVERVIEW:

Product definition

Buspirone Hydrochloride Tablets, USP are available as Buspirone Hydrochloride Tablets, USP 5 mg are White to off white ovoid- rectangular uncoated tablet with score line on one side and engraved ‘5’ on the other side. Tablets are packed in the bottles of 100 having NDC 64380-741-06. Buspirone Hydrochloride Tablets, USP 10 mg are White to off white ovoid - rectangular uncoated tablet with score line on one side and engraved ‘10’ on the other side. Tablets are packed in the bottles of 100 having NDC 64380-742-06. Buspirone Hydrochloride Tablets, USP 15 mg are White to off white rectangular uncoated tablet with trisected score lines on one side and trisected score line with engraved ‘5’ on each trisection of other 1 side. The 15 mg tablet is in xx tablet design and scored so that it can be either bisected or trisected. Tablets are packed in bottles of 60 having NDC 64380-743-03, 100 having NDC 64380-743-06 and 180 having NDC 64380-743-18. Buspirone Hydrochloride Tablets, USP 30 mg are White to off white rectangular uncoated tablet with trisected score lines on one side and trisected score line with engraved ‘10’ on each trisection of other side. Tablets are packed in bottles of 60 having NDC 64380-744-03. Store at 20 °C to 25 °C (68 ° to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USPcontrolled room temperature].

Health hazards

The chief health hazard associated with overexposures during normal use and handling is the potential for irritation of contaminated skin. Individuals who have had allergic reactions to products containing Buspirone Hydrochloride or any of the other ingredients in this product may experience allergic reactions to this product. Therapeutic use of Buspirone Hydrochloride can cause adverse symptoms of the central nervous system, gastrointestinal system, and skin. Flammability Hazards: If heated to high temperatures for a prolonged period, the product may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon oxides, nitrogen oxides, sodium oxides, magnesium oxides, sodium oxides, and Reactivity Hazards: This product is not reactive.

Environmental hazards

Large quantities released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for the situation to which they respond. SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The health hazard information provided below is pertinent to medical employees using this product in an occupational setting. The following paragraphs describe the symptoms of exposure by route of exposure. INHALATION: Inhalation of airborne dusts generated by this product may slightly irritate the nose, throat, and lungs. Symptoms may include coughing, sneezing, and difficulty breathing. CONTACT WITH SKIN or EYES: Contact with the skin may cause mild irritation, which is alleviated upon rinsing. Prolonged or reaped skin contact may cause dermatitis (dry, red skin). Contact with the eyes of airborne dusts generated by this product may cause mild eye irritation. 2 SKIN ABSORPTION: This product and its components are not known to be absorbed through intact skin. INGESTION: Ingestion is not a significant route of occupational overexposure. Acute ingestion of large quantities of this product caused by poor hygiene practices can cause nausea, vomiting, dizziness, drowsiness, pupil constriction, and gastric distress. Symptoms of prolonged or repeated ingestion, as may occur when poor industrial hygiene is practiced, may include those described for ―Other Potential Health Effects‖. Individuals who have had allergic reactions to products containing Buspirone Hydrochloride or any of the other ingredients in this product may experience allergic reactions to this product. INJECTION: Though not anticipated to be a significant route of overexposure for this product, injection (via punctures or lacerations by contaminated objects) may cause redness at the site of injection. OTHER POTENTIAL HEALTH EFFECTS-Therapeutic Doses: Employees administering the product should not experience adverse effects if handled properly. Adverse effects from therapeutic doses have included the following: Dizziness, drowsiness, nervousness, insomnia, lightheadedness, difficulty concentrating, excitement, anger, hostility, confusion, and depression. Rapid heartbeat and palpitations. Blurred vision. Nausea, dry mouth, gastric distress, diarrhea, constipation, and vomiting. Muscle and joint pain. Numbness, incoordination, tremor, and burning, prickling, itching, or tingling of the skin. Rash. Headache, fatigue, weakness, sweating, and clamminess.

Potential health effects

OR RISKS FROM EXPOSURE An Explanation in Lay Terms. Overexposure to this product may cause the following health effects: ACUTE: The primary health effects that may be experienced by medical personnel exposed to this product is mild irritation of contaminated skin. CHRONIC: Repeated skin contact may cause dermatitis (dry, red skin). In the event of acute or chronic exposures to therapeutic doses of this product, effects described in ―Other Potential Health Effects‖ may result. See Section 11 (Toxicological Information, for additional information). 3 TARGET ORGANS ACUTE Industrial Exposure Skin, eyes. Therapeutic Doses Central nervous system and gastrointestinal system. CHRONIC Industrial Exposure Skin. Therapeutic Doses Central nervous system, gastrointestinal system, and skin.