Dutasteride, sold under the brand name Avodart among others, is a medication primarily used to treat the symptoms of a
benign prostatic hyperplasia
Benign prostatic hyperplasia (BPH), also called prostate enlargement, is a noncancerous increase in size of the prostate gland. Symptoms may include frequent urination, trouble starting to urinate, weak stream, inability to urinate, or loss o ...
(BPH), an enlarged prostate not associated with cancer. A few months may be required before benefits occur.
[ It is also used for scalp hair loss in men and as a part of hormone therapy in ]transgender women
A trans woman or a transgender woman is a woman who was assigned male at birth. Trans women have a female gender identity, may experience gender dysphoria, and may transition; this process commonly includes hormone replacement therapy and ...
. It is usually taken by mouth.
The most commonly reported side effects of dutasteride, although rare, include sexual dysfunction and depression.[ In the largest available study of 6,729 men with BPH, 9% experienced erectile dysfunction (compared to 5.7% treated with a ]placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.
In general, placebos can af ...
), 3.3% experienced decreased sex drive
Libido (; colloquial: sex drive) is a person's overall sexual drive or desire for sexual activity. Libido is influenced by biological, psychological, and social factors. Biologically, the sex hormones and associated neurotransmitters that act up ...
(vs 1.6% of placebo), and 1.9% had enlarged breasts (vs 1% of placebo). Exposure during pregnancy
Pregnancy is the time during which one or more offspring develops (gestation, gestates) inside a woman, woman's uterus (womb). A multiple birth, multiple pregnancy involves more than one offspring, such as with twins.
Pregnancy usually occur ...
is specifically contraindicated because antiandrogen
Antiandrogens, also known as androgen antagonists or testosterone blockers, are a class of drugs that prevent androgens like testosterone and dihydrotestosterone (DHT) from mediating their biological effects in the body. They act by blocking the ...
s such as dutasteride have been shown to interfere with the sexual development of male fetuses.[
Dutasteride was patented in 1993 by GlaxoSmithKline and was approved for medical use in 2001.][ In the United States and elsewhere, it is available as a generic medication.][ In 2018, it was the 291st-most commonly prescribed medication in the US with more than 1million prescriptions.
]
Medical uses
Benign prostatic hyperplasia and prostate cancer
Dutasteride is used for treating BPH, colloquially known as an "enlarged prostate". It is approved by the Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) in the U.S. for this indication. A 2010 Cochrane review
Cochrane (previously known as the Cochrane Collaboration) is a British international charitable organisation formed to organise medical research findings to facilitate evidence-based choices about health interventions involving health profes ...
found a 25–26% reduction in the risk of developing prostate cancer with 5α-reductase inhibitor chemoprevention
Chemoprevention (also chemoprophylaxis) refers to the administration of a medication for the purpose of preventing disease or infection. Antibiotics, for example, may be administered to patients with disorders of immune system function to preven ...
.
Scalp hair loss and excessive hair growth
Dutasteride is approved for the treatment of male androgenetic alopecia in South Korea
South Korea, officially the Republic of Korea (ROK), is a country in East Asia, constituting the southern part of the Korean Peninsula and sharing a land border with North Korea. Its western border is formed by the Yellow Sea, while its eas ...
and Japan at a dosage of 0.5 mg per day. Several studies have found it to induce hair regrowth in men more rapidly and to a greater extent than even the highest approved dosage of finasteride. The superior effectiveness of dutasteride relative to finasteride for this indication is because the inhibition of 5α-reductase and consequent reduction of DHT production within the hair follicles is more complete with dutasteride. Dutasteride is also used off-label in the treatment of female pattern hair loss.
Other 5α-reductase inhibitors such as finasteride (a type 2 inhibitor) have been used off-label
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although ...
to treat excessive hair growth in women with hirsutism
Hirsutism is excessive body hair on parts of the body where hair is normally absent or minimal. The word is from early 17th century: from Latin ''hirsutus'' meaning "hairy". It usually refers to a "male" pattern of hair growth in a female that ...
. Since dutasteride is an inhibitor of both type 1 and 2 5α-reductases, it could theoretically be a more effective therapy for hirsutism. However, dutasteride is not recommended for this indication due to a lack of supportive clinical evidence and a substantial risk of birth defects in female patients who inadvertently become pregnant.
Transgender hormone therapy
Dutasteride is sometimes used as a component of hormone therapy for transgender women in combination with an estrogen
Estrogen or oestrogen is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three major endogenous estrogens that have estrogenic hormonal ac ...
and/or another antiandrogen
Antiandrogens, also known as androgen antagonists or testosterone blockers, are a class of drugs that prevent androgens like testosterone and dihydrotestosterone (DHT) from mediating their biological effects in the body. They act by blocking the ...
such as spironolactone
Spironolactone, sold under the brand name Aldactone among others, is a medication that is primarily used to treat fluid build-up due to heart failure, liver scarring, or kidney disease. It is also used in the treatment of high blood press ...
. It may be useful for treating scalp hair loss or in those who have issues tolerating spironolactone.
Available forms
Dutasteride is provided in the form of soft, oil
An oil is any nonpolar chemical substance that is composed primarily of hydrocarbons and is hydrophobic (does not mix with water) & lipophilic (mixes with other oils). Oils are usually flammable and surface active. Most oils are unsaturated ...
-filled gelatin capsules containing 0.5 mg dutasteride each.
Contraindications
Women who are or who may become pregnant should not handle the drug. Dutasteride can cause birth defect
A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities ca ...
s in male fetus
A fetus or foetus (; plural fetuses, feti, foetuses, or foeti) is the unborn offspring that develops from an animal embryo. Following embryonic development the fetal stage of development takes place. In human prenatal development, fetal dev ...
es, specifically ambiguous genitalia
Intersex people are individuals born with any of several sex characteristics including chromosome patterns, gonads, or genitals that, according to the Office of the United Nations High Commissioner for Human Rights, "do not fit typical bin ...
and undermasculinization. This is due to its antiandrogenic effects similar to what is seen in 5α-reductase deficiency
5α-Reductases, also known as 3-oxo-5α-steroid 4-dehydrogenases, are enzymes involved in steroid metabolism. They participate in three metabolic pathways: bile acid biosynthesis, androgen and estrogen metabolism. There are three isozymes of ...
. For the same reason, women who are currently pregnant should never take dutasteride. People taking dutasteride should not donate blood
A blood donation occurs when a person voluntarily has blood drawn and used for blood transfusion, transfusions and/or made into biopharmaceutical medications by a process called Blood fractionation, fractionation (separation of whole blood com ...
to prevent birth defects if a pregnant woman receives blood and should also not donate blood for at least 6 months after the cessation of treatment due to the drug's long elimination half-life
Biological half-life (also known as elimination half-life, pharmacologic half-life) is the time taken for concentration of a biological substance (such as a medication) to decrease from its maximum concentration ( Cmax) to half of Cmax in the bl ...
.
Children and people with known significant hypersensitivity
Hypersensitivity (also called hypersensitivity reaction or intolerance) refers to undesirable reactions produced by the normal immune system, including allergies and autoimmunity. They are usually referred to as an over-reaction of the immune ...
(e.g., serious skin reaction
A skin condition, also known as cutaneous condition, is any medical condition that affects the integumentary system—the organ system that encloses the body and includes skin, nails, and related muscle and glands. The major function of this ...
s, angioedema
Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. The swelling may occur in the face, tongue, larynx, abdomen, or arms and legs. Often it is associated with hives, which are ...
) to dutasteride should not take it.
Adverse effects
Dutasteride has overall been found to be well tolerated in studies of both men and women, producing minimal side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
s. Adverse effects include headache and gastrointestinal discomfort. Isolated reports of menstrual
The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that make pregnancy possible. The ovarian cycle controls the production and release of eggs a ...
changes, acne
Acne, also known as ''acne vulgaris'', is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles. Typical features of the condition include blackheads or whiteheads, pimples, oily skin, and ...
, and dizziness
Dizziness is an imprecise term that can refer to a sense of disorientation in space, vertigo, or lightheadedness. It can also refer to disequilibrium or a non-specific feeling, such as giddiness or foolishness.
Dizziness is a common medical c ...
also exist. A small risk of sexual side effects has been documented in men taking the drug during the first few months of therapy.
The FDA added a black-box warning to dutasteride in 2011 describing an increased risk of high-grade prostate cancer in those who take the drug. No direct mechanistic link between 5α-reductase inhibitors and prostate cancer has been established. This is not due to a direct link between dutasteride or other 5α-reductase inhibitors and cancer ''per se'', but rather that those who take 5α-reductase inhibitors may have a decrease in prostate-specific antigen
Prostate-specific antigen (PSA), also known as gamma-seminoprotein or kallikrein-3 (KLK3), P-30 antigen, is a glycoprotein enzyme encoded in humans by the ''KLK3'' gene. PSA is a member of the kallikrein-related peptidase family and is secreted b ...
(PSA) levels, and therefore increases in PSA (which are an indicator of possible cancer) may be masked in those who take the drug. This is thought to delay cancer diagnosis so that patients taking 5α-reductase inhibitors present with a higher-grade tumor at the time of diagnosis. The American Urological Association
The American Urological Association (AUA) is a professional association in the United States for urology professionals. It has its headquarters at the William P. Didusch Center for Urologic History in Maryland.
AUA works with many international o ...
advises that increased risk for patients taking these drugs leads to higher prostate cancer-specific and all-cause mortality
Mortality rate, or death rate, is a measure of the number of deaths (in general, or due to a specific cause) in a particular population, scaled to the size of that population, per unit of time. Mortality rate is typically expressed in units of de ...
. The AUA also advises that this affect can be alleviated with more frequent screening and lower PSA cutoffs for diagnostic biopsies in men taking dutasteride or other 5α-reductase inhibitors. Dutasteride is known to reduce the growth and prevalence of benign prostate tumors.A 2018 meta-analysis
A meta-analysis is a statistical analysis that combines the results of multiple scientific studies. Meta-analyses can be performed when there are multiple scientific studies addressing the same question, with each individual study reporting me ...
found no higher risk of breast cancer
Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a r ...
with 5α-reductase inhibitors.
Sexual
Sex is the biological distinction of an organism between male and female.
Sex or SEX may also refer to:
Biology and behaviour
*Animal sexual behaviour
**Copulation (zoology)
**Human sexual activity
**Non-penetrative sex, or sexual outercourse
** ...
and mood side effects, such as erectile dysfunction, loss of libido, depression, and reduced semen volume occur in as many as 4.8% of patients taking 5α-reductase inhibitors including dutasteride. In affected men, semen volume is decreased an average of 30%, with a smaller subgroup of patients also experiencing a decrease of sperm motility of 6-12%. Sperm shape and function are unaffected and the impact on male fertility is unknown. These negative effects reverse by 3-4 months after discontinuation of the drug.
In a study of 6,729 men with benign prostatic hyperplasia
Benign prostatic hyperplasia (BPH), also called prostate enlargement, is a noncancerous increase in size of the prostate gland. Symptoms may include frequent urination, trouble starting to urinate, weak stream, inability to urinate, or loss o ...
(BPH, a condition where the prostate grows unnassociated with cancer
Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...
), 9% had erectile dysfunction (compared to 5.7% treated with a placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.
In general, placebos can af ...
), 3.3% experienced decreased sex drive
Libido (; colloquial: sex drive) is a person's overall sexual drive or desire for sexual activity. Libido is influenced by biological, psychological, and social factors. Biologically, the sex hormones and associated neurotransmitters that act up ...
(vs 1.6% of placebo), and 1.9% had enlarged breasts (vs 1% of placebo). These effects were noted to resolve over time, with many fewer men reporting any adverse effects by the end of the 4 year study. The rate of discontinuation of the drug due to adverse effects was less than 5%.
A subset of men affected by sexual and mood side effects report persistent loss of libido, depression, and erectile dysfunction for several years after discontinuing treatment. This remains a highly contested topic in the academic literature due to disagreements about whether the nocebo
A nocebo effect is said to occur when negative expectations of the patient regarding a treatment cause the treatment to have a more negative effect than it otherwise would have. For example, when a patient anticipates a side effect of a medicatio ...
effect may play a role, whether self-report questionnaires are reliable for this data, and whether enough objective evidence exists to conclude these effects are persistent after discontinuation of the drug. The Post-Finasteride Syndrome Foundation (PFSF) was created with a medical advisory board to study the topic (finasteride is a similar 5α-reductase inhibitor) and lawsuits alleging harm from the drug are ongoing. Concerns from the PFSF and other patient advocates led the FDA to add a black-box warning to Finasteride for possible risks of suicide in June 2022. Some experts have questioned the basis of the black-box warning, given that it relies on anecdotal patient-reported outcomes rather than prospective trials.
Overdose
No specific antidote
An antidote is a substance that can counteract a form of poisoning. The term ultimately derives from the Greek term φάρμακον ἀντίδοτον ''(pharmakon) antidoton'', "(medicine) given as a remedy". Antidotes for anticoagulants are s ...
for overdose
A drug overdose (overdose or OD) is the ingestion or application of a drug or other substance in quantities much greater than are recommended. of dutasteride is known, since the drug is extremely safe and well tolerated. Research studies show that even at 100 times the normal dose, dutasteride is not lethal. Treatment of dutasteride overdose should be based on symptoms and should be with supportive therapies. The long elimination half-life of dutasteride should be taken into consideration in the event of an overdose of the medication. Dutasteride has been used in clinical studies at doses of up to 40 mg/day for a week (80 times the therapeutic dosage) and 5 mg/day for 6 months (10 times the therapeutic dosage) with no significant safety
Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to the control of recognized hazards in order to achieve an acceptable level of risk.
Meanings
There are two slightly dif ...
concerns or additional side effects.
Current investigations
Dutasteride has been studied in combination with bicalutamide
Bicalutamide, sold under the brand name Casodex among others, is an antiandrogen medication that is primarily used to treat prostate cancer. It is typically used together with a gonadotropin-releasing hormone (GnRH) analogue or surgical remo ...
in the treatment of prostate cancer.
Ongoing clinical trials are investigating whether dutasteride may be an effective treatment for premenstrual dysphoric disorder
Premenstrual dysphoric disorder (PMDD) is a mood disorder characterized by emotional, cognitive, and physical symptoms that cause significant distress or impairment in menstruating women during the luteal phase of the menstrual cycle. The symptom ...
(PMDD), because dutasteride may inhibit the conversion of progesterone to allopregnanolone, a neurosteroid metabolite, which may be responsible for some of the debilitating symptoms of PMDD.
Pharmacology
Pharmacodynamics
Dutasteride belongs to a class of drugs called 5α-reductase inhibitors, which block the action of the 5α-reductase enzymes that convert testosterone into DHT. It inhibit
Inhibitor or inhibition may refer to:
In biology
* Enzyme inhibitor, a substance that binds to an enzyme and decreases the enzyme's activity
* Reuptake inhibitor, a substance that increases neurotransmission by blocking the reuptake of a neurotr ...
s all three form
Form is the shape, visual appearance, or configuration of an object. In a wider sense, the form is the way something happens.
Form also refers to:
*Form (document), a document (printed or electronic) with spaces in which to write or enter data
...
s of 5α-reductase, and can decrease DHT levels in the blood by up to 98%. Specifically it is a competitive
Competition is a rivalry where two or more parties strive for a common goal which cannot be shared: where one's gain is the other's loss (an example of which is a zero-sum game). Competition can arise between entities such as organisms, indivi ...
, mechanism-based ( irreversible) inhibitor of all three isoform
A protein isoform, or "protein variant", is a member of a set of highly similar proteins that originate from a single gene or gene family and are the result of genetic differences. While many perform the same or similar biological roles, some iso ...
s of 5α-reductase, types I, II, and III ( values are 3.9 nM for type I and 1.8 nM for type II). This is in contrast to finasteride, which is similarly an irreversible inhibitor of 5α-reductase but only inhibits the type II and III isoenzyme In biochemistry, isozymes (also known as isoenzymes or more generally as multiple forms of enzymes) are enzymes that differ in amino acid sequence but catalyze the same chemical reaction. Isozymes usually have different kinetic parameters (e.g. dif ...
s. As a result of this difference, dutasteride is able to achieve a reduction in circulating DHT levels of up to 98%, whereas finasteride is able to achieve a reduction of only 65 to 70%. In spite of the differential reduction in circulating DHT levels, the two drugs decrease levels of DHT to a similar extent of approximately 85 to 90% in the prostate gland
The prostate is both an accessory gland of the male reproductive system and a muscle-driven mechanical switch between urination and ejaculation. It is found only in some mammals. It differs between species anatomically, chemically, and physio ...
, where the type II isoform predominates.
Since 5α-reductases degrade testosterone to DHT, the inhibition of these enzymes could theoretically cause an increase in testosterone. A 2018 review found that initiation of 5α-reductase inhibitors did not result in a consistent increase in testosterone levels. Among the studies analyzed, there was no statistically significant change in testosterone levels from 5α-reductase inhibitors overall, though men with lower baseline testosterone levels did show an increase.
In addition to inhibition of DHT production, 5α-reductase inhibitors such as dutasteride are also neurosteroidogenesis inhibitors, preventing the 5α-reductase-mediated biosynthesis of various neurosteroids, including allopregnanolone (from progesterone), (from deoxycorticosterone Deoxycorticosterone (DOC), or desoxycorticosterone, may refer to:
* 11-Deoxycorticosterone (21-hydroxyprogesterone)
* 21-Deoxycorticosterone (11β-hydroxyprogesterone)
See also
* Deoxycortisol
* Deoxycortisone
* 11-Hydroxyprogesterone
{{Che ...
), and 3α-androstanediol (from testosterone). These neurosteroids are potent positive allosteric modulator
In pharmacology and biochemistry, allosteric modulators are a group of substances that bind to a receptor to change that receptor's response to stimulus. Some of them, like benzodiazepines, are drugs. The site that an allosteric modulator binds to ...
s of the GABAA receptor and have shown antidepressant, anxiolytic
An anxiolytic (; also antipanic or antianxiety agent) is a medication or other intervention that reduces anxiety. This effect is in contrast to anxiogenic agents which increase anxiety. Anxiolytic medications are used for the treatment of anxiet ...
, and pro-sexual effects in animal research
Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This ...
. For this reason, decreased neurosteroid production is one hypothesized mechanism for sexual dysfunction and depression associated with 5α-reductase inhibitors such as dutasteride.
Pharmacokinetics
The oral bioavailability
In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation.
By definition, when a medication is administered intravenously, its bioavailability is 100%. Ho ...
of dutasteride is about 60%. Consumption with food does not adversely affect its absorption. Peak plasma levels occur 2 to 3 hours after administration. Dutasteride is present in semen
Semen, also known as seminal fluid, is an organic bodily fluid created to contain spermatozoa. It is secreted by the gonads (sexual glands) and other sexual organs of male or hermaphroditic animals and can fertilize the female ovum. Sem ...
at levels up to 3 ng/ml, with no significant effects on DHT levels of sexual partners. The drug is extensively metabolized
Metabolism (, from el, μεταβολή ''metabolē'', "change") is the set of life-sustaining chemical reactions in organisms. The three main functions of metabolism are: the conversion of the energy in food to energy available to run cell ...
in the liver
The liver is a major organ only found in vertebrates which performs many essential biological functions such as detoxification of the organism, and the synthesis of proteins and biochemicals necessary for digestion and growth. In humans, it ...
by '' CYP3A4''. It has three major metabolites: 6'-hydroxydutasteride, 4'-hydroxydutasteride, and 1,2-dihydrodutasteride. The former two are formed by ''CYP3A4'', while the latter is not. All three metabolites are active; 6'-hydroxydutasteride has similar 5α-reductase inhibitor potency
Potency may refer to:
* Potency (pharmacology), a measure of the activity of a drug in a biological system
* Virility
* Cell potency, a measure of the differentiation potential of stem cells
* In homeopathic dilutions, potency is a measure of how ...
as dutasteride, while the other two are less potent. Dutasteride has an extremely long terminal
Terminal may refer to:
Computing Hardware
* Terminal (electronics), a device for joining electrical circuits together
* Terminal (telecommunication), a device communicating over a line
* Computer terminal, a set of primary input and output dev ...
or elimination half-life of about 4 to 5 weeks. Its elimination half-life is increased in the elderly (170 hours for men aged 20–49 years, 300 hours for men aged >70 years). No dosage adjustment is necessary in the elderly nor in patients with renal impairment
Kidney failure, also known as end-stage kidney disease, is a medical condition in which the kidneys can no longer adequately filter waste products from the blood, functioning at less than 15% of normal levels. Kidney failure is classified as eit ...
. Because of its long elimination half-life, dutasteride requires 5 to 6 months to reach steady-state concentrations. It also remains in the body for a long time after discontinuation and can be detected up to 4 to 6 months. In contrast to dutasteride, finasteride has a short terminal half-life of only 5 to 8 hours. Dutasteride is eliminated mainly in the feces (40%) as metabolites. A smaller portion (5%) is eliminated unchanged in the urine
Urine is a liquid by-product of metabolism in humans and in many other animals. Urine flows from the kidneys through the ureters to the urinary bladder. Urination results in urine being excreted from the body through the urethra.
Cellular ...
.
Chemistry
Dutasteride, also known as ''N''- ,5-bis(trifluoromethyl)phenyl3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide, is a synthetic androstane
Androstane is a C19 steroidal hydrocarbon with a gonane core. Androstane can exist as either of two isomers, known as 5α-androstane and 5β-androstane.
File:androstane.png, 5α-Androstane
File:androstane 5beta.png, 5β-Androstane
Pharmacology ...
steroid and a 4-azasteroid. It is an analogue of finasteride in which the ''tert''-butyl amide moiety
Moiety may refer to:
Chemistry
* Moiety (chemistry), a part or functional group of a molecule
** Moiety conservation, conservation of a subgroup in a chemical species
Anthropology
* Moiety (kinship), either of two groups into which a society is ...
has been replaced with a 2,5-''bis''(trifluoromethyl)phenyl group
A group is a number of persons or things that are located, gathered, or classed together.
Groups of people
* Cultural group, a group whose members share the same cultural identity
* Ethnic group, a group whose members share the same ethnic ide ...
.
History
Dutasteride was patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A ...
ed in 1996 and was first described in the scientific literature
: ''For a broader class of literature, see Academic publishing.''
Scientific literature comprises scholarly publications that report original empirical and theoretical work in the natural and social sciences. Within an academic field, scie ...
in 1997. It was approved by the FDA for the treatment of BPH in November 2001, and was introduced on the United States market the following year under the brand name Avodart. Dutasteride has subsequently been introduced in many other countries, including throughout Europe and South America. The patent protection of dutasteride expired in November 2015, so the drug has since become available in the United States in a variety of low-cost generic formulations.
It was approved for the treatment of scalp hair loss in South Korea in 2009 and in Japan in 2015. It has not been approved for this indication in the United States, though it is often used off-label
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although ...
.
Society and culture
Generic names
Dutasteride is the generic name of the drug Avodart and its , , , and .
Brand names
Dutasteride is sold primarily under the brand name Avodart, but also in combination with tamsulosin under the brand names Combodart and Duodart. Dutasteride is also available in India in combination with alfuzosin under the brand names Alfusin-D and Dutalfa.
Availability
Dutasteride is available widely throughout the world, including in the United States, Canada
Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tot ...
, the United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the European mainland, continental mainland. It comprises England, Scotlan ...
, Ireland
Ireland ( ; ga, Éire ; Ulster Scots dialect, Ulster-Scots: ) is an island in the Atlantic Ocean, North Atlantic Ocean, in Northwestern Europe, north-western Europe. It is separated from Great Britain to its east by the North Channel (Grea ...
, many other European countries, Australia, and South Africa
South Africa, officially the Republic of South Africa (RSA), is the Southern Africa, southernmost country in Africa. It is bounded to the south by of coastline that stretch along the Atlantic Ocean, South Atlantic and Indian Oceans; to the ...
, as well as in Latin America
Latin America or
* french: Amérique Latine, link=no
* ht, Amerik Latin, link=no
* pt, América Latina, link=no, name=a, sometimes referred to as LatAm is a large cultural region in the Americas where Romance languages — languages derived f ...
, Asia, and elsewhere. It is available as a generic medication in many countries, including the United States.
References
Further reading
*
External links
*
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Trifluoromethyl compounds
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