NITAZOXANIDE
HAZARDTEXT ®
Information to help in the initial response for evaluating chemical incidents
-IDENTIFICATION
SYNONYMS
IDENTIFIERS
USES/FORMS/SOURCES
Nitazoxanide is indicated for the treatment of diarrhea, caused by Cryptosporidium parvum and Giardia lamblia, in pediatric patients 1 to 11 years of age (Prod Info Alinia, 2002).
Nitazoxanide is manufactured, in the United States, by Romark Pharmaceuticals (Prod Info Alinia, 2002).
-CLINICAL EFFECTS
GENERAL CLINICAL EFFECTS
- USES: Nitazoxanide oral suspension is used to treat diarrhea caused by Cryptosporidium parvum and Giardia lamblia in pediatric patients 1 to 11 years of age. Nitazoxanide oral tablets are used for the same indications in patients 12 years of age and older.
- PHARMACOLOGY: Nitazoxanide is an antiparasitic agent (nitrothiazole derivative) with antiprotozoal activity that appears to interfere with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction required for anaerobic energy metabolism.
- EPIDEMIOLOGY: Overdose is rare.
COMMON: The most common adverse effects include abdominal pain, diarrhea, headache, nausea, vomiting. LESS FREQUENT: Although causality has not been established, other adverse effects that have been reported less frequently (less than 1%) include dizziness, somnolence, insomnia, tremor, hypesthesia, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst, discolored urine, dysuria, amenorrhea, menorrhagia, renal pain, labial edema, elevated SGPT, elevated creatinine (oral suspension), anemia, leukocytosis, rash, pruritus, eye discoloration, ear ache, epistaxis, lung disease, pharyngitis, tachycardia, syncope, hypertension, myalgia, leg cramps.
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
-FIRST AID
FIRST AID AND PREHOSPITAL TREATMENT
- Toxicity after acute ingestion is unlikely. Gastrointestinal decontamination is generally unnecessary.
-RANGE OF TOXICITY
MAXIMUM TOLERATED EXPOSURE
- Single oral doses of up to 4 grams have been administered to healthy volunteers without the occurrence of significant adverse effects (Prod Info ALINIA(R) oral tablets, oral suspension, 2005).
- Carcinogenicity Ratings for CAS55981-09-4 :
ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed EPA (U.S. Environmental Protection Agency, 2011): Not Listed IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed MAK (DFG, 2002): Not Listed NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed
TOXICITY AND RISK ASSESSMENT VALUES
- EPA Risk Assessment Values for CAS55981-09-4 (U.S. Environmental Protection Agency, 2011):
LD50- (ORAL)CAT: LD50- (ORAL)DOG: LD50- (ORAL)MOUSE: LD50- (ORAL)RAT:
-STANDARDS AND LABELS
WORKPLACE STANDARDS
- ACGIH TLV Values for CAS55981-09-4 (American Conference of Governmental Industrial Hygienists, 2010):
- AIHA WEEL Values for CAS55981-09-4 (AIHA, 2006):
- NIOSH REL and IDLH Values for CAS55981-09-4 (National Institute for Occupational Safety and Health, 2007):
- OSHA PEL Values for CAS55981-09-4 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
- OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS55981-09-4 (U.S. Occupational Safety and Health Administration, 2010):
ENVIRONMENTAL STANDARDS
- EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS55981-09-4 (U.S. Environmental Protection Agency, 2010):
- EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS55981-09-4 (U.S. Environmental Protection Agency, 2010):
- EPA RCRA Hazardous Waste Number for CAS55981-09-4 (U.S. Environmental Protection Agency, 2010b):
- EPA SARA Title III, Extremely Hazardous Substance List for CAS55981-09-4 (U.S. Environmental Protection Agency, 2010):
- EPA SARA Title III, Community Right-to-Know for CAS55981-09-4 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):
- DOT List of Marine Pollutants for CAS55981-09-4 (49 CFR 172.101 - App. B, 2005):
- EPA TSCA Inventory for CAS55981-09-4 (EPA, 2005):
LABELS
- NFPA Hazard Ratings for CAS55981-09-4 (NFPA, 2002):
-PERSONAL PROTECTION
SUMMARY
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
PROTECTIVE CLOTHING
- CHEMICAL PROTECTIVE CLOTHING. Search results for CAS 55981-09-4.
-PHYSICAL HAZARDS
FIRE HAZARD
- FLAMMABILITY CLASSIFICATION
- NFPA Flammability Rating for CAS55981-09-4 (NFPA, 2002):
- FIRE CONTROL/EXTINGUISHING AGENTS
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
- NFPA Extinguishing Methods for CAS55981-09-4 (NFPA, 2002):
EVACUATION PROCEDURES
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
- AIHA ERPG Values for CAS55981-09-4 (AIHA, 2006):
- DOE TEEL Values for CAS55981-09-4 (U.S. Department of Energy, Office of Emergency Management, 2010):
- AEGL Values for CAS55981-09-4 (National Research Council, 2010; National Research Council, 2009; National Research Council, 2008; National Research Council, 2007; NRC, 2001; NRC, 2002; NRC, 2003; NRC, 2004; NRC, 2004; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 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62 FR 58840, 1997; 65 FR 14186, 2000; 65 FR 39264, 2000; 65 FR 77866, 2000; 66 FR 21940, 2001; 67 FR 7164, 2002; 68 FR 42710, 2003; 69 FR 54144, 2004):
- NIOSH IDLH Values for CAS55981-09-4 (National Institute for Occupational Safety and Health, 2007):
CONTAINMENT/WASTE TREATMENT OPTIONS
-PHYSICAL/CHEMICAL PROPERTIES
MOLECULAR WEIGHT
DESCRIPTION/PHYSICAL STATE
- Nitazoxanide is a light yellow crystalline powder that is poorly soluble in ethanol and practically insoluble in water (Prod Info Alinia, 2002).
-REFERENCES
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