MEGESTROL
HAZARDTEXT ®
Information to help in the initial response for evaluating chemical incidents
-IDENTIFICATION
SYNONYMS
Megestrol acetate Megestrol 6-Methyl-3,20-dioxopregna-4,6-dien-17alpha-yl acetate BDH-1298 Compound 5071 NSC-71423 SC-10363 CAS 3562-63-8 (megestrol) CAS 595-33-5 (megestrol acetate)
IDENTIFIERS
USES/FORMS/SOURCES
Megestrol acetate is indicated, in patients with acquired immunodeficiency syndrome (AIDS), for the treatment of anorexia, cachexia, or significant weight loss that is unexplained (Prod Info Megace(R) oral suspension, 2012; Prod Info MEGACE(R)ES oral suspension, 2008). Megestrol acetate is also indicated, as palliative therapy, for the treatment of advanced carcinoma of the breast or endometrium (Prod Info MEGACE(R)ES oral suspension, 2008).
Megestrol acetate is available as 20 mg and 40 mg tablets, and as 40 mg/mL oral suspension (Prod Info Megace(R) oral suspension, 2012; Prod Info megestrol acetate oral suspension, 2007; Prod Info megestrol acetate oral tablets, 2007). Megestrol acetate is also available as an oral suspension in a concentrated formula of 625 mg/5 mL (Prod Info MEGACE(R) ES oral suspension, 2006).
-CLINICAL EFFECTS
GENERAL CLINICAL EFFECTS
- USES: Megestrol acetate is indicated, in patients with acquired immunodeficiency syndrome (AIDS), for the treatment of anorexia, cachexia, or significant weight loss that is unexplained. It is also indicated, as palliative therapy, for the treatment of advanced carcinoma of the breast or endometrium.
- PHARMACOLOGY: Megestrol acetate, a synthetic derivative of progesterone, is suggested to reduce estrogen secretion by inhibiting the production of pituitary gonadotropin in endometrial carcinoma. As an antineoplastic, it is suggested that megestrol acetate exerts direct cytotoxic effects on breast cancer cells by either interfering with availability, stability and turnover of estrogen and the interaction with genes at the estrogen receptor complex or at the progestin receptor complex by interacting directly to turn of the specific estrogen-responsive genes. The exact mechanism of action for its clinical use in endometrial cancer and as appetite-enhancing agent in cachexia remains unknown.
- EPIDEMIOLOGY: Overdose is rare.
In several overdose cases during postmarketing period, diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain were reported.
Most adverse effects are related to chronic or high-dose therapy. CHRONIC: Hyperglycemia, impotence, decreased libido, deep venous thrombosis, and tachypnea may occur with chronic therapy. Other adverse effects that have been reported include: hypertension, nausea and vomiting, diarrhea, insomnia, asthenia, hot flashes, thrombophlebitis, and pulmonary embolism. HIGH-DOSE THERAPY: Cushing syndrome and cholestatic hepatitis were reported following high-dose megestrol therapy (800 to 1200 mg/day). Mild blood pressure elevation, weight gain, increased appetite, hyperglycemia, edema, dyspnea, and congestive heart failure have been reported in patients receiving high-dose regimens (480 to 1600 mg/day) for the treatment of advanced breast cancer. RARE: Alopecia and skin rashes have been rarely reported.
- 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, and is generally only expected with chronic use. Gastrointestinal decontamination is generally unnecessary.
-RANGE OF TOXICITY
MAXIMUM TOLERATED EXPOSURE
- In studies, megestrol doses up to 1200 mg/day did not result in serious unexpected side effects. In several overdose cases during postmarketing period, diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain were reported (Prod Info Megace(R) oral suspension, 2012).
- High-dose regimens (480 to 1600 mg/day) used for the treatment of advanced breast cancer were associated with mild blood pressure elevation, weight gain, increased appetite, hyperglycemia, edema, dyspnea, and congestive heart failure (Aisner et al, 1987).
- Cushing syndrome and cholestatic hepatitis were reported following high-dose megestrol therapy (800 to 1200 mg/day) (Capparros et al, 2001; Foitl et al, 1989).
- Carcinogenicity Ratings for CAS3562-63-8 :
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 CAS3562-63-8 (U.S. Environmental Protection Agency, 2011):
-STANDARDS AND LABELS
WORKPLACE STANDARDS
- ACGIH TLV Values for CAS3562-63-8 (American Conference of Governmental Industrial Hygienists, 2010):
- AIHA WEEL Values for CAS3562-63-8 (AIHA, 2006):
- NIOSH REL and IDLH Values for CAS3562-63-8 (National Institute for Occupational Safety and Health, 2007):
- OSHA PEL Values for CAS3562-63-8 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
- OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS3562-63-8 (U.S. Occupational Safety and Health Administration, 2010):
ENVIRONMENTAL STANDARDS
- EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS3562-63-8 (U.S. Environmental Protection Agency, 2010):
- EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS3562-63-8 (U.S. Environmental Protection Agency, 2010):
- EPA RCRA Hazardous Waste Number for CAS3562-63-8 (U.S. Environmental Protection Agency, 2010b):
- EPA SARA Title III, Extremely Hazardous Substance List for CAS3562-63-8 (U.S. Environmental Protection Agency, 2010):
- EPA SARA Title III, Community Right-to-Know for CAS3562-63-8 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):
- DOT List of Marine Pollutants for CAS3562-63-8 (49 CFR 172.101 - App. B, 2005):
- EPA TSCA Inventory for CAS3562-63-8 (EPA, 2005):
LABELS
- NFPA Hazard Ratings for CAS3562-63-8 (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 3562-63-8.
-PHYSICAL HAZARDS
FIRE HAZARD
- FLAMMABILITY CLASSIFICATION
- NFPA Flammability Rating for CAS3562-63-8 (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 CAS3562-63-8 (NFPA, 2002):
EVACUATION PROCEDURES
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
- AIHA ERPG Values for CAS3562-63-8 (AIHA, 2006):
- DOE TEEL Values for CAS3562-63-8 (U.S. Department of Energy, Office of Emergency Management, 2010):
- AEGL Values for CAS3562-63-8 (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 CAS3562-63-8 (National Institute for Occupational Safety and Health, 2007):
CONTAINMENT/WASTE TREATMENT OPTIONS
-PHYSICAL/CHEMICAL PROPERTIES
MOLECULAR WEIGHT
DESCRIPTION/PHYSICAL STATE
- Megestrol acetate is a white or almost white crystalline powder, that is practically insoluble in water, sparingly soluble in alcohol, and soluble in acetone (Sweetman, 2007).
-REFERENCES
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- 69 FR 54144: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2004.
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