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DUTASTERIDE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and 2 isoforms of steroid 5 alpha-reductase.

Specific Substances

    1) GI-198745
    2) GI-198745X
    3) GG-745
    4) CAS 164656-23-9
    5) Molecular Formula: C(27)H(30)F(6)N(2)O(2)
    1.2.1) MOLECULAR FORMULA
    1) C27H30F6N2O2

Available Forms Sources

    A) FORMS
    1) Dutasteride is available as 0.5 mg capsules(Prod Info AVODART(R) oral capsules, 2014).
    B) USES
    1) Dutasteride is used in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men to help improve urinary symptoms, and to reduce both the risk of acute urinary retention and the potential need for BPH-related surgery (Prod Info AVODART(R) oral capsules, 2014).
    2) Dutasteride in combination with tamsulosin is used in the treatment of symptomatic BPH in men who have an enlarged prostate (Prod Info JALYN(TM) oral capsules, 2013).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
    B) PHARMACOLOGY: Dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5-alpha-reductase.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: COMMON: Impotence, decreased libido, and ejaculation disorders. LESS COMMON: Dizziness and breast disorders.
    E) WITH POISONING/EXPOSURE
    1) TOXICITY: There are no reports of toxicity following acute overdose. In volunteer studies, single doses of up to 40 mg (80 times the therapeutic dose) for 7 days have been administered with no significant effects reported.
    0.2.20) REPRODUCTIVE
    A) Dutasteride and dutasteride/tamsulosin combination are categorized as FDA pregnancy category X. Dutasteride can be absorbed through the skin, and pregnant women are warned to avoid handling the soft gelatin capsules to prevent possible absorption due to the potential risk of a fetal anomaly to a male fetus. Dutasteride should not be used or handled by breastfeeding women.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, the manufacturer does not report any carcinogenic potential of dutasteride in humans.

Laboratory Monitoring

    A) Obtain a pregnancy test in any woman of child bearing potential who is exposed to dutasteride.
    B) Monitoring after overdose is based on symptoms observed, no other specific laboratory evaluation is indicated.
    C) Obtain an ECG in patients who exhibit signs of an anaphylactic reaction.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Dutasteride has a low toxicity profile. Treatment of overdose is symptomatic and supportive.
    C) DECONTAMINATION
    1) PREHOSPITAL: Gastric decontamination is unlikely to be necessary unless a coingestant is involved.
    2) HOSPITAL: Gastric decontamination is unlikely to be necessary unless a coingestant is involved. If dutasteride exposure occurs in a woman who might be pregnant, activated charcoal should be administered as soon as possible to minimize potential exposure to the developing fetus.
    D) ANTIDOTE
    1) None.
    E) ACUTE ALLERGIC REACTION
    1) Mild to moderate allergic reactions may be treated with antihistamines with or without inhaled beta agonists, corticosteroids or epinephrine. Treatment of severe anaphylaxis also includes oxygen supplementation, aggressive airway management, epinephrine, ECG monitoring, and IV fluids.
    F) ENHANCED ELIMINATION
    1) Due to large volume of distribution and high protein binding, dialysis is unlikely to be beneficial.
    G) PATIENT DISPOSITION
    1) HOME CRITERIA: Asymptomatic children and adults with inadvertent overdose can be managed at home.
    2) OBSERVATION CRITERIA: All patients with deliberate overdose should be evaluated in a healthcare facility.
    3) ADMISSION CRITERIA: Patients demonstrating significant toxicity should be hospitalized.
    4) CONSULT CRITERIA: If a pregnant woman is exposed to dutasteride, consultation with a toxicologist and neonatologist is recommended to assess the risk to the developing male fetus. Due to the long elimination half life of dutasteride (5 weeks), any woman exposed to it should avoid pregnancy because of the risk to the developing male fetus. Consultation with a toxicologist and neonatologist is advised to determine when attempting to become pregnant might be safe.
    H) PITFALLS
    1) When managing duasteride overdose, the possibility of coingestion of other agents should be considered. Failure to recognize treatment of exposure differs for women who might be pregnant.
    I) PHARMACOKINETICS
    1) The absolute bioavailability is approximately 60%. Volume of distribution is 300 to 500 L. Metabolism occurs extensively in the liver and excretion is primarily in the feces. Terminal elimination half-life is approximately 5 weeks at steady state and serum concentrations can remain detectable (greater than 0.1 ng/mL) for up to 4 to 6 months after the cessation of therapy.
    J) DIFFERENTIAL DIAGNOSIS
    1) Includes other agents that may cause hypersensitivity reactions.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) Dutasteride is produced as a soft gelatin capsule and can be absorbed cutaneously. Pregnant women should avoid contact with dutasteride to decrease any potential risk to a developing male fetus. If contact should occur, immediate hand washing with soap and water is recommended (Prod Info AVODART(R) oral capsules, 2011).

Range Of Toxicity

    A) TOXICITY: A maximum toxic dose has not been established for dutasteride. In volunteers, single doses of up to 40 mg (80 times the therapeutic dose) for 7 days have been given with no significant adverse events.
    B) THERAPEUTIC DOSE: The recommended dose is 0.5 mg (1 capsule) orally once daily, and may be prescribed alone or in combination with tamsulosin.

Clinical Effects

Summary Of Exposure

    A) USES: Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
    B) PHARMACOLOGY: Dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5-alpha-reductase.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: COMMON: Impotence, decreased libido, and ejaculation disorders. LESS COMMON: Dizziness and breast disorders.
    E) WITH POISONING/EXPOSURE
    1) TOXICITY: There are no reports of toxicity following acute overdose. In volunteer studies, single doses of up to 40 mg (80 times the therapeutic dose) for 7 days have been administered with no significant effects reported.

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) ABNORMAL SEXUAL FUNCTION
    1) WITH THERAPEUTIC USE
    a) ANDROGENIC SUPPRESSION - Sexual dysfunction has been frequently reported following dutasteride therapy (Prod Info Avodart, 2003). Impotence is the most common adverse event reported.
    b) INCIDENCE - Ejaculation disorder (0.1% to 2.2%), impotence (0.8% to 7.3%), and decreased libido (0.3% to 4.2%) have been reported with dutasteride use (n=2167) (Prod Info Avodart, 2003; Roehrborn et al, 2002).
    c) SYMPTOMS - The incidence in dutasteride-induced sexual dysfunction decreased with the duration of therapy (Prod Info Avodart, 2003). Most symptoms were rated as mild to moderate.
    B) PROSTATE SPECIFIC ANTIGEN ABNORMAL
    1) WITH THERAPEUTIC USE
    a) Dutasteride therapy can cause a decrease in serum prostate specific antigen (PSA) levels by approximately 40% in the first three months of therapy, and by approximately 50% by 6, 12, or 24 months of treatment (Prod Info Avodart, 2003).
    1) This is a known and somewhat predictable consequence of therapy. In order to obtain an accurate PSA value for a man treated (> than 6 months of therapy) with dutasteride, it is recommended that the value obtained be multiplied by 2 to achieve an accurate PSA level (Prod Info Avodart, 2003; Roehrborn et al, 2002).

Endocrine

    3.16.2) CLINICAL EFFECTS
    A) GYNECOMASTIA
    1) WITH THERAPEUTIC USE
    a) Gynecomastia has been reported during dutasteride treatment of benign prostatic hyperplasia (1.1% or less of patients; n=2167) (Prod Info Avodart, 2003).

Reproductive

    3.20.1) SUMMARY
    A) Dutasteride and dutasteride/tamsulosin combination are categorized as FDA pregnancy category X. Dutasteride can be absorbed through the skin, and pregnant women are warned to avoid handling the soft gelatin capsules to prevent possible absorption due to the potential risk of a fetal anomaly to a male fetus. Dutasteride should not be used or handled by breastfeeding women.
    3.20.2) TERATOGENICITY
    A) ANIMAL STUDIES
    1) Dutasteride has demonstrated teratogenicity in developmental toxicity and animal reproduction studies (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(R) oral capsules, 2010).
    2) RATS: There are no adequate and well-controlled studies of dutasteride/tamsulosin combination use during pregnancy in humans. Preclinical data suggest that the suppression of circulating levels of dihydrotestosterone may adversely affect the development of external genital organs in the male fetus of a woman exposed to dutasteride. In an embryo-fetal development study of dutasteride in rats, fetal male genitalia abnormalities, nipple development, hypospadias, and distended preputial glands in male offspring were observed at doses 10 times less than the maximum recommended human dose (MRHD). In several studies conducted in female rats also have shown dutasteride to be a developmental teratogen. At doses of 111 times the MRHD, there was an increase of stillborn pups. Reductions in fetal body weight were observed at doses of greater than or equal to 15 times the MRHD, and increased incidences of skeletal variations were observed at doses of greater than or equal to 56 times the MRHD (Prod Info JALYN(R) oral capsules, 2010).
    3) RABBITS: In 2 embryo-fetal studies in rabbits, male genitalia abnormalities were observed at doses of one-third the maximum recommended human dose (MRHD) (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(R) oral capsules, 2010).
    4) MONKEYS: In embryo-fetal development studies of pregnant rhesus monkeys intravenously exposed to dutasteride, a reduction in fetal adrenal and prostate weights, and increases in testis and fetal ovarian weights were observed (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(R) oral capsules, 2010).
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    1) Dutasteride and dutasteride/tamsulosin combination are categorized as FDA pregnancy category X. Based on preclinical studies, dutasteride appears to suppress circulating levels of dihydrotestosterone, which may inhibit the normal development of external genital organs in a male fetus whose mother has been exposed (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(R) oral capsules, 2010).
    B) DERMAL ABSORPTION
    1) Dutasteride can be absorbed through the skin, and pregnant women are warned to avoid handling the soft gelatin capsules to prevent possible absorption due to the potential risk of a fetal anomaly to a male fetus (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(R) oral capsules, 2010). It is recommended that women wash their hands immediately with soap and water after coming in contact with a leaking capsule(Prod Info JALYN(R) oral capsules, 2010).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) SUMMARY
    1) It is not known if dutasteride or dutasteride/tamsulosin is excreted in human milk, and the potential for adverse effects in the nursing infant from exposure to the drug are unknown. Dutasteride or dutasteride/tamsulosin should not be used or handled by breastfeeding women (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(R) oral capsules, 2010).
    3.20.5) FERTILITY
    A) ANIMAL STUDIES
    1) MALE RATS: In rat studies, mature males treated with dutasteride at doses 0.05, 10, 50 and 500 mg/kg/day (0.1 to 110-fold the expected clinical exposure of parent drug) for up to 31 weeks had dose- and time-dependent decreases in fertility. Other findings included: reduced cauda epididymal (absolute) sperm counts, but not sperm concentration (at 50 and 500 mg/kg/day), reduced weights of the epididymis, prostate and seminal vesicles, and microscopic changes in male reproductive organs. The fertility effects were reversible 6 weeks after drug cessation, and sperm counts returned to normal at 14 weeks. Studies in rats receiving tamsulosin in single or multiple daily doses of 300 mg/kg/day (AUC exposure in rats approximately 50 times the maximum human exposure using the maximum therapeutic dose) found a significant reduction in fertility in males. This reduction is thought to be due to an effect of the compound on the vaginal plug formation in female rats, possibly due to changes of semen content or impairment of ejaculation. These effects were reversible, showing improvement by 3 days after a single dose and by 4 weeks after multiple dosing; the effects were completely reversed 9 weeks after discontinuation of multiple dosing. Multiple doses of 10 and 100 mg/kg a day (1/5 and 16 times the anticipated human AUC exposure, respectively) produced no significant effects on fertility in male rats (Prod Info JALYN(R) oral capsules, 2010; Prod Info AVODART(R) soft gelatin oral capsules, 2010).
    2) FEMALE RATS: In fertility studies, female rats given oral doses of dutasteride at 0.05, 2.5, 12.5, and 30 mg/kg/day had reduced litter size, increased embryo resorption and feminization of male fetuses (decreased anogenital distance, increased incidence of hypospadias, nipple development) at doses of greater than 2.5 mg/kg/day (14 to 90-fold the expected clinical exposure in men). A reduction in fetal body weights was also observed at equal or greater than 0.05 mg/kg/day in rats (less than 0.02-fold the human exposure). Studies in female rats found a significant reduction in fertility after single or multiple dosing using 300 mg/kg/day of the R-isomer or a racemic mixture of tamsulosin, respectively. In female rats, the reductions in fertility after single doses of tamsulosin were considered to be associated with impairments in fertilization. Multiple dosing with 10 or 100 mg/kg/day of the racemic mixture of tamsulosin did not significantly alter fertility in female rats (Prod Info JALYN(R) oral capsules, 2010; Prod Info AVODART(R) soft gelatin oral capsules, 2010).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS164656-23-9 (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):
    1) Not Listed
    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, the manufacturer does not report any carcinogenic potential of dutasteride in humans.
    3.21.4) ANIMAL STUDIES
    A) NEOPLASM
    1) MICE: In a 2-year carcinogenicity study involving B6C3F1 mice, an increased incidence of benign hepatocellular adenomas was reported in females only at a dutasteride dose of 250 mg/kg/day (290-fold the expected exposure to a 0.5-mg daily dose). Dutasteride was administered to male mice at doses of 3, 35, 250, and 500 mg/kg/day and to female mice at doses of 3, 35, and 250 mg/kg/day. Of the 3 major human metabolites, 2 have been detected in mice. In mice, dutasteride exposure to these metabolites is either lower compared with exposure in humans or is unknown (Prod Info AVODART(R) soft gelatin oral capsules, 2010).
    2) RATS: In a 2-year carcinogenicity study involving Han Wistar rats, males developed Leydig cell adenomas at doses of 53 mg/kg/day (135-fold the expected clinical exposure). Leydig cell hyperplasia was also observed at 7.5 mg/kg/day (52-fold the expected clinical exposure) and 53 mg/kg/day. A positive correlation between proliferative changes in the Leydig cells and an increase in circulating luteinizing hormone (LH) levels was found (at tumorigenic doses LH levels were increased by 167% in rats) (Prod Info AVODART(R) soft gelatin oral capsules, 2010).

Genotoxicity

    A) There was no evidence of genotoxicity or mutagenicity in the following tests: a bacterial mutagenesis assay (Ames test), a chromosomal aberration assay in CHO cells, and a micronucleus assay in rats. In addition, 2 major human metabolites were not mutagenic in either the Ames or abbreviated Ames tests (Prod Info AVODART(R) soft gelatin oral capsules, 2010).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Obtain a pregnancy test in any woman of child bearing potential who is exposed to dutasteride.
    B) Monitoring after overdose is based on symptoms observed, no other specific laboratory evaluation is indicated.
    C) Obtain an ECG in patients who exhibit signs of an anaphylactic reaction.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients demonstration toxicity should be hospitalized.
    6.3.1.2) HOME CRITERIA/ORAL
    A) Asymptomatic children and adults with inadvertent overdose can be managed at home.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) If a pregnant woman is exposed to dutasteride, consultation with a toxicologist and neonatologist is recommended to assess the risk to the developing male fetus.
    B) Due to the long elimination half life of dutasteride (5 weeks), any woman exposed to it should avoid pregnancy because of the risk to the developing male fetus. Consultation with a toxicologist and neonatologist is advised to determine when attempting to become pregnant might be safe.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) All patients with deliberate overdose should be evaluated in a healthcare facility.

Monitoring

    A) Obtain a pregnancy test in any woman of child bearing potential who is exposed to dutasteride.
    B) Monitoring after overdose is based on symptoms observed, no other specific laboratory evaluation is indicated.
    C) Obtain an ECG in patients who exhibit signs of an anaphylactic reaction.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY
    1) Gastric decontamination is unlikely to be necessary unless a coingestant is involved. If exposure occurs in a woman who might be pregnant, GI decontamination should be performed to minimize exposure to the fetus.
    B) ACTIVATED CHARCOAL
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) Single doses up to 40 milligrams (80 times the therapeutic dose) of dutasteride for 7 days have been well tolerated. Gastrointestinal decontamination is generally not indicated, but should be considered if there are more toxic coingestants involved. If dutasteride exposure occurs in a woman who might be pregnant, activated charcoal should be administered as soon as possible to minimize potential exposure to the developing fetus.
    B) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment is SYMPTOMATIC and SUPPORTIVE as indicated along with the consideration of the long half-life of dutasteride (serum concentrations of greater than 0.1 ng/mL have remained detectable for up to 4 to 6 months after discontinuation of therapy) .
    B) MONITORING OF PATIENT
    1) Obtain a pregnancy test in any woman of child bearing potential who is exposed to dutasteride.
    2) Monitoring after overdose is based on symptoms observed, no other specific laboratory evaluation is indicated.
    3) Obtain an ECG in patients who exhibit signs of an anaphylactic reaction.

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) Dutasteride is produced as a soft gelatin capsule and can be absorbed cutaneously. Pregnant women should avoid contact with dutasteride to decrease any potential risk to a developing male fetus (dutasteride may inhibit the normal development of external genital organs). If contact should occur, immediate hand washing with soap and water is recommended (Prod Info Avodart, 2003).

Enhanced Elimination

    A) HEMODIALYSIS
    1) Due to large volume of distribution and high protein binding, dialysis is unlikely to be beneficial.

Range Of Toxicity

Summary

    A) TOXICITY: A maximum toxic dose has not been established for dutasteride. In volunteers, single doses of up to 40 mg (80 times the therapeutic dose) for 7 days have been given with no significant adverse events.
    B) THERAPEUTIC DOSE: The recommended dose is 0.5 mg (1 capsule) orally once daily, and may be prescribed alone or in combination with tamsulosin.

Therapeutic Dose

    7.2.1) ADULT
    A) DUTASTERIDE OR DUTASTERIDE/TAMSULOSIN
    1) ORAL CAPSULE: 0.5 mg dutasteride (1 capsule) once daily (Prod Info AVODART(R) oral capsules, 2014; Prod Info JALYN(TM) oral capsules, 2013)
    2) ADMINISTRATION: Swallow whole; DO NOT chew or open (Prod Info AVODART(R) oral capsules, 2014; Prod Info JALYN(TM) oral capsules, 2013).
    3) Not indicated for use in women and CONTRAINDICATED in women who are pregnant or of childbearing potential(Prod Info AVODART(R) oral capsules, 2014; Prod Info JALYN(TM) oral capsules, 2013)
    7.2.2) PEDIATRIC
    A) DUTASTERIDE OR DUTASTERIDE/TAMSULOSIN
    1) Dutasteride is CONTRAINDICATED for use in pediatric patients. Safety and effectiveness have not been established (Prod Info AVODART(R) soft gelatin oral capsules, 2010; Prod Info JALYN(TM) oral capsules, 2013).

Maximum Tolerated Exposure

    A) GENERAL/SUMMARY
    1) In volunteers, single doses of up to 40 milligrams (80 times the therapeutic dose) for 7 days have been given with no significant adverse events (Prod Info Avodart, 2003).
    2) In a clinical study (n=60), daily doses of 5 milligrams (10 times the therapeutic dose) were given for 6 months without any additional adverse events reported as those at therapeutic dose (Prod Info Avodart, 2003).

Workplace Standards

    A) ACGIH TLV Values for CAS164656-23-9 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS164656-23-9 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS164656-23-9 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) 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
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS164656-23-9 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5-alpha-reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT) (Prod Info AVODART(R) oral capsules, 2014).

Physicochemical

Physical Characteristics

    A) Dutasteride is a white to pale yellow powder that is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL) and insoluble in water. Dutasteride has a melting point of 242 to 250 degrees C (Prod Info AVODART(R) soft gelatin oral capsules, 2010).

Molecular Weight

    A) 528.5 (Prod Info AVODART(R) soft gelatin oral capsules, 2010)

References

General Bibliography

    1) 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.
    2) 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.
    3) 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.
    4) 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.
    5) 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.
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