FLUOXETINE

Fluoxetine hydrochloride
dl-N-methyl-3-phenyl-3-(alpha,alpha,alpha-trifluoro-p-tolyl) oxy)propylamine hydrochloride
Fontex
LILLY-103472
LILLY-110140
LY-110140
CAS 54910-89-3

IDENTIFIERS

CAS REGISTRY NUMBER

54910-89-3(Fluoxetine)

NIOSH/RTECS NUMBER

DA 8326855

MOLECULAR FORMULA

C17-H18-F3-N-O
C17H18F3NO-HCl

ERG GUIDE NUMBER

Editor's Note: An ERG guide with information appropriate to this material does not exist.

USES/FORMS/SOURCES

USES

Fluoxetine is used in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, depressive episodes associated with bipolar I disorder, and bulimia nervosa (Prod Info PROZAC(R) oral capsules, oral delayed release capsules, 2014). It is also used in the treatment of premenstrual dysphoric disorder (Prod Info SARAFEM(R) oral tablets, 2008).

FORMS

Fluoxetine is available as 10 mg, 20 mg, and 40 mg capsules, 90 mg delayed-release capsules, 10 mg, 20 mg, and 60 mg tablets, 20 mg/5 mL oral solution, and 20 mg/5 mL oral syrup (Prod Info PROZAC(R) oral capsules, oral delayed release capsules, 2014; Prod Info SARAFEM(R) oral tablets, 2008).
Fluoxetine is also available in combination with olanzapine as 25 mg-3 mg, 25 mg-6 mg, 25 mg-12 mg, 50 mg-6 mg, 50 mg-12 mg capsules (Prod Info SYMBYAX(R) oral capsules, 2015).

-CLINICAL EFFECTS

GENERAL CLINICAL EFFECTS

USES: Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and is used for depressive disorder, obsessive-compulsive disorder, panic attack, and bulimia nervosa.

PHARMACOLOGY: Fluoxetine and its active metabolite norfluoxetine inhibit reuptake of serotonin from the synaptic cleft, therefore increasing serotonergic neurotransmission.

TOXICOLOGY: Severe toxicity is not common, but may develop from excessive serotonergic effects, particularly when fluoxetine is ingested with another agent that increases CNS serotonin.

EPIDEMIOLOGY: Poisoning with fluoxetine and other SSRIs are common. Life threatening toxicity is rare, and patients usually recover without sequelae.

WITH POISONING/EXPOSURE

MILD TO MODERATE POISONING: Somnolence, dizziness, nausea, and vomiting are common; QTc prolongation may occur even in therapeutic or mild overdose.
SEVERE POISONING: Significant CNS depression, seizures, and QTc prolongation. Ventricular dysrhythmias have rarely been reported. Serotonin toxicity (autonomic instability, altered mental status, seizures, muscle rigidity, hyperreflexia, and hyperthermia) may occur; however, most reported cases involve patients using multiple serotonergic agents.

WITH THERAPEUTIC USE

ADVERSE EFFECTS: Somnolence, dizziness, insomnia, nervousness, headache, nausea, vomiting, and diarrhea are often reported. Hyponatremia, due to inappropriate secretion of antidiuretic hormone (SIADH), may be observed.

Editor's Note: An ERG guide with information appropriate to this material does not exist.

ACUTE CLINICAL EFFECTS

SUMMARY

PHARMACOLOGY: Fluoxetine and its active metabolite norfluoxetine inhibit reuptake of serotonin from the synaptic cleft, therefore increasing serotonergic neurotransmission.
TOXICOLOGY: Severe toxicity is not common, but may develop from excessive serotonergic effects, particularly when fluoxetine is ingested with another agent that increases CNS serotonin.
EPIDEMIOLOGY: Poisoning with fluoxetine and other SSRIs are common. Life threatening toxicity is rare, and patients usually recover without sequelae.
THERAPEUTIC: ADVERSE EFFECTS: Somnolence, dizziness, insomnia, nervousness, headache, nausea, vomiting, and diarrhea are often reported. Hyponatremia, due to inappropriate secretion of antidiuretic hormone (SIADH), may be observed.
MILD TO MODERATE POISONING: Somnolence, dizziness, nausea, and vomiting are common; QTc prolongation may occur even in therapeutic or mild overdose.
SEVERE POISONING: Significant CNS depression, seizures, and QTc prolongation. Ventricular dysrhythmias have rarely been reported. Serotonin toxicity (autonomic instability, altered mental status, seizures, muscle rigidity, hyperreflexia, and hyperthermia) may occur; however, most reported cases involve patients using multiple serotonergic agents.

CARDIOVASCULAR

CONDUCTION DISORDER OF THE HEART: ACUTE EXPOSURE: Cardiovascular side effects associated with fluoxetine overdose include hypertension, ECG abnormalities, and syncope (Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008).
TACHYARRHYTHMIA: ACUTE EXPOSURE: Tachycardia is common after overdose (Braitberg & Curry, 1995).
QTc PROLONGATION: Prolonged QTc has been reported with fluoxetine overdose (Graudins et al, 1997; Hofman & Liu, 1994).

FLUID ELECTROLYTE

HYPONATREMIA: Hyponatremia secondary to SIADH has been reported in patients taking therapeutic doses of fluoxetine (Jackson et al, 1995; Flint et al, 1996; Girault et al, 1997; Anon, 1994; Wilkinson et al, 1999).

GASTROINTESTINAL

NAUSEA : Nausea is a common side effect seen with therapeutic(Wernicke, 1985) or with excessive dosing (Borys et al, 1992).
DIARRHEA: Diarrhea developed in 38% of patients receiving therapeutic doses of fluoxetine for panic attacks (Gorman et al, 1987).

HEENT

EYES

BLURRED VISION: After overdose, blurred vision has been reported (Technical Information, 1987).

IMMUNOLOGIC

ANAPHYLACTOID REACTION: Urticaria, angioedema, bronchospasm, and other anaphylactoid events have been reported (Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008).

NEUROLOGIC

CNS EFFECTS: CNS effects associated with fluoxetine overdose include: abnormal gait, confusion, mania, movement disorders, seizures, somnolence, and vertigo (Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008).
SEROTONIN SYNDROME: Serotonin syndrome has been described in fluoxetine interactions with irreversible MAOIs, moclobemide, tryptophan, selegiline, nefazodone, tramadol, and lithium (Mitchell, 1997; Smith & Wenegrat, 2000; Kesavan & Sobala, 1999). SIGNS may include hyperreflexia, hyperthermia, restlessness, diaphoresis, unsteady gait, and myoclonic jerking (Perse et al, 1991).
SYNCOPE: Syncope has been reported at dosages of 20 to 80 mg/day, (Ellison et al, 1990).
EXTRAPYRAMIDAL DISEASE: : Extrapyramidal symptoms have been reported in patients taking fluoxetine but they are not common (Arya, 1994).
ATAXIA: Ataxia and tremor were side effects observed frequently with fluoxetine therapy (Wernicke, 1985) and with overdose (Borys et al, 1992).
INSOMNIA: Insomnia as well as nervousness and anxiety are common, mild to moderately severe side effects seen with therapeutic dosing (Wernicke, 1985) and with higher than recommended doses (140 to 220 mg/day) (Technical Information, 1987).

RESPIRATORY

DISORDER OF RESPIRATORY SYSTEM: Pulmonary dysfunction has been reported with fluoxetine overdose (Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008).

CHRONIC CLINICAL EFFECTS

WITH POISONING/EXPOSURE

There is some potential for misuse of fluoxetine by patients with mood disorders.

WITH THERAPEUTIC USE

The usual fluoxetine dose is 20 mg to 80 mg/day (Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008).
Super-therapeutic doses, in the range of 90 mg to 120 mg/day, can produce anorexia and weight loss (HSDB , 1996).
Approximately 1% of patients receiving fluoxetine therapy experience allergic reactions, including contact dermatitis, acne, cysts, facial edema, alopecia, and exacerbation of herpes simplex (HSDB , 1996). Cutaneous pseudolymphomas with features of delayed hypersensitivity reactions were seen in 8 patients after initiation of fluoxetine and/or amitriptyline hydrochloride therapy; resolution or improvement was seen after such therapy was discontinued (Crowson & Magro, 1995).
Rare complications of fluoxetine therapy include hepatitis, exacerbation of preexisting restless legs syndrome, pulmonary granulomatosis, complex movement disorders, and bruising (Friedenberg & Rothstein, 1996; Bakshi, 1996; Dekerviler et al, 1996; Bharucha & Sethi, 1996; Pai & Kelly, 1996).
Progressive development of dyspnea, lung infiltrates, and restrictive lung disease consistent with hypersensitivity pneumonitis was reported in 1 patient receiving fluoxetine therapy for depression (Gonzalez-Rothi et al, 1995).
Withdrawal symptoms are less frequent with fluoxetine than with other SSRI drugs (0.002%) and may consist of dizziness, paraesthesia, tremor, anxiety, nausea, and palpitations. Withdrawal usually commences after 2 days and lasts an average of 10 days. This is stated not to be a physical drug-dependency syndrome (Price et al, 1996).

-FIRST AID

FIRST AID AND PREHOSPITAL TREATMENT

PREHOSPITAL: GI decontamination is not recommended because of potential for somnolence and seizures.

-RANGE OF TOXICITY

MINIMUM LETHAL EXPOSURE

ACUTE

An adult died after an ingestion of 520 mg of fluoxetine alone; causality could not be established (Prod Info PROZAC(R) oral pulvules, delayed-release capsules, 2011).

In a retrospective review of data reported to the FDA and Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers, ingestions of 260 mg of fluoxetine alone were reported to be associated with deaths; direct causality could not be determined (Nelson et al, 2007).

The estimated human lethal dose of fluoxetine is 1200 to 2000 mg (60 to 100 capsules of 20 mg) (Kincaid et al, 1990).
Two deaths have been reported following fluoxetine overdose; however, both patients had other contributory causes (Technical Information, 1987).

A 42-year-old woman reported to ingest 1600 mg of fluoxetine along with maprotiline was found dead; postmortem concentrations were fluoxetine 4570 nanograms(ng)/mL and maprotiline 4180 ng/mL (Technical Information, 1987).
In the second case, a 24-year-old woman was found dead with a piece of plastic wrap on her face and a partially empty bottle of fluoxetine. The estimated amount ingested was 1580 mg. A preliminary autopsy report showed some signs of asphyxia and a fluoxetine level of 1934 ng/mL (Technical Information, 1987).

ANIMAL DATA

Lethal seizures were seen in 50% of various animals given 200 to 700 mg/kg. The exact dose needed is species-dependent (Wernicke, 1985).

MAXIMUM TOLERATED EXPOSURE

SUMMARY

Based on manufacturer data, an adult survived an ingestion of 8 g of fluoxetine and recovered (Prod Info PROZAC(R) oral pulvules, delayed-release capsules, 2011).

ADULT

Acute ingestions in adults of 300 to 440 mg, with no coingestants, resulted in no reported signs or symptoms in 2 patients. Coma was reported in 1 patient with a questionable history of ingestion of 340 mg. Ingestion of 900 to 1200 mg resulted in minor ECG changes (Technical Information, 1987).
CASE REPORT: A woman with a history of epilepsy experienced generalized seizures, ECG changes and tachycardia, dizziness, and blurred vision after ingesting approximately 3 grams of fluoxetine (Perse et al, 1991).
CASE REPORT: A 33-year-old man coingested 120 fluoxetine 20 mg capsules (2400 mg total) and 100 acetaminophen 500 mg tablets and developed QRS prolongation that was responsive to sodium bicarbonate IV(Graudins et al, 1997).
CASE REPORT: A 37-year-old woman developed a single, generalized tonic-clonic seizure approximately 3 hours after ingesting 1400 mg fluoxetine along with alcohol. Fluoxetine and norfluoxetine serum levels were 922 ng/mL and 379 ng/mL, respectively, 6 hours postingestion (Suchard, 2008).

PEDIATRIC

In a retrospective study with telephone follow-up of 126 children younger than 6 years of age with acute ingestion of at least 20 mg of fluoxetine only, 116 patients did not develop any signs or symptoms of toxicity. Of these, 7 patients who had received ipecac vomited, 3 patients vomited without receiving ipecac, and 1 patient developed sedation. The dose ingested ranged from 20 mg to 400 mg, with 90% of children ingesting 20 to 60 mg. Children who ingest up to 60 mg of fluoxetine (or 5 mg/kg) do not require gastric decontamination or medical treatment. These children can be monitored at home for rare adverse effects (Baker & Morgan, 2004).
CASE REPORT: A 12-year-old boy who ingested 1880 mg of fluoxetine (26 mg/kg) had a single seizure, depressed sinus tachycardia segments on ECG, nausea, dizziness, blurred vision, and headache (Riddle et al, 1989).
Acute ingestion of up to 100 mg is not expected to cause toxicity (Nelson et al, 2007).

Carcinogenicity Ratings for CAS54910-89-3 :

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 IRIS

EPA Risk Assessment Values for CAS54910-89-3 (U.S. Environmental Protection Agency, 2011):

Not Listed

TOXICITY VALUES

References: Stark et al, 1985
- LD50- (ORAL)MOUSE:
- LD50- (ORAL)RAT:

-STANDARDS AND LABELS

WORKPLACE STANDARDS

ACGIH TLV Values for CAS54910-89-3 (American Conference of Governmental Industrial Hygienists, 2010):

Not Listed

AIHA WEEL Values for CAS54910-89-3 (AIHA, 2006):

Not Listed

NIOSH REL and IDLH Values for CAS54910-89-3 (National Institute for Occupational Safety and Health, 2007):

Not Listed

OSHA PEL Values for CAS54910-89-3 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):

Not Listed

OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS54910-89-3 (U.S. Occupational Safety and Health Administration, 2010):

Not Listed

ENVIRONMENTAL STANDARDS

EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS54910-89-3 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS54910-89-3 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA RCRA Hazardous Waste Number for CAS54910-89-3 (U.S. Environmental Protection Agency, 2010b):

Not Listed
Editor's Note: The D, F, and K series waste numbers and Appendix VIII to Part 261 -- Hazardous Constituents were not included. Please refer to 40 CFR Part 261.

EPA SARA Title III, Extremely Hazardous Substance List for CAS54910-89-3 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA SARA Title III, Community Right-to-Know for CAS54910-89-3 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):

Not Listed

DOT List of Marine Pollutants for CAS54910-89-3 (49 CFR 172.101 - App. B, 2005):

Not Listed

EPA TSCA Inventory for CAS54910-89-3 (EPA, 2005):

Not Listed

LABELS

NFPA

NFPA Hazard Ratings for CAS54910-89-3 (NFPA, 2002):

Not Listed

-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 54910-89-3.

Specific recommendations and test data for this chemical were not found in the available manufacturers' product literature. A complete list of consulted manufacturers and references is presented below.

-PHYSICAL HAZARDS

FIRE HAZARD

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

FLAMMABILITY CLASSIFICATION

NFPA Flammability Rating for CAS54910-89-3 (NFPA, 2002):

Not Listed

FIRE CONTROL/EXTINGUISHING AGENTS

Editor's Note: An ERG guide with information appropriate to this material does not exist.

NFPA Extinguishing Methods for CAS54910-89-3 (NFPA, 2002):

Not Listed

EVACUATION PROCEDURES

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

AIHA ERPG Values for CAS54910-89-3 (AIHA, 2006):

Not Listed

DOE TEEL Values for CAS54910-89-3 (U.S. Department of Energy, Office of Emergency Management, 2010):

Not Listed

AEGL Values for CAS54910-89-3 (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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National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; 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, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; 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, 2005; 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, 2005; 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, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 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):

Not Listed

NIOSH IDLH Values for CAS54910-89-3 (National Institute for Occupational Safety and Health, 2007):

Not Listed

CONTAINMENT/WASTE TREATMENT OPTIONS

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

SMALL LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

LARGE LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

-PHYSICAL/CHEMICAL PROPERTIES

MOLECULAR WEIGHT

309.33 (Canada, 1997)

345.79 (hydrochloride) (Prod Info SARAFEM(R) oral tablets, 2009; Prod Info PROZAC(R) oral pulvules, solution, delayed-release capsules, 2009)

DESCRIPTION/PHYSICAL STATE

Fluoxetine is a white to off-white crystalline solid that has a solubility in water of 14 mg/mL (Prod Info SARAFEM(R) oral tablets, 2009; Prod Info PROZAC(R) oral pulvules, solution, delayed-release capsules, 2009).

-REFERENCES

GENERAL BIBLIOGRAPHY

40 CFR 372.28: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Lower thresholds for chemicals of special concern. National Archives and Records Administration (NARA) and the Government Printing Office (GPO). Washington, DC. Final rules current as of Apr 3, 2006.

40 CFR 372.65: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Chemicals and Chemical Categories to which this part applies. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Apr 3, 2006.

49 CFR 172.101 - App. B: Department of Transportation - Table of Hazardous Materials, Appendix B: List of Marine Pollutants. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Aug 29, 2005.

62 FR 58840: 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, 1997.

65 FR 14186: 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, 2000.

65 FR 39264: 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, 2000.

65 FR 77866: 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, 2000.

66 FR 21940: 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, 2001.

67 FR 7164: 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, 2002.

68 FR 42710: 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, 2003.

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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National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances: Acute Exposure Guideline Levels (AEGLs) for Mercury Vapor (Proposed). United States Environmental Protection Agency. Washington, DC. 2009b. Available from URL: http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a8a087&disposition=attachment&contentType=pdf. As accessed 2010-08-12.

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FLUOXETINE

Classification | Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents