Dutasteride (dutasteride)
5 Alpha-Reductase Inhibitors Oral Capsule
Last reviewed · Source: First Databank (FDB) drug data
Overview
Dutasteride is a selective inhibitor of steroid 5alpha-reductase isoenzymes types 1 and 2, which are necessary for conversion of testosterone to 5alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulation of prostatic growth.
Dutasteride is a synthetic 4-azasteroid compound. The drug is a specific, competitive inhibitor of both the type 1 and type 2 isoenzymes of steroid 5alpha-reductase. The type 2 isoenzyme is active principally in the reproductive system; the type 1 isoenzyme also is present in high concentrations in the liver and skin.
The conversion of testosterone to 5alpha-dihydrotestosterone (DHT) depends on the presence of these enzymes, and DHT appears to be the principal androgen responsible for initial development and subsequent enlargement of the prostate gland.
Inhibition of steroid 5alpha-reductase type 1 and 2 isoenzymes by dutasteride reduces serum and prostatic DHT concentrations substantially in a dose-dependent fashion within 1-2 weeks of initiation of therapy. Dutasteride therapy also results in increases in serum testosterone (generally remaining within the normal range) and prostatic testosterone concentrations. In controlled clinical studies of patients with BPH, decreases in prostate volume averaged about 27% after 24 months of dutasteride therapy.
USES: This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night).
It may also reduce the need for surgery to treat BPH. Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer.
Talk to your doctor about the benefits and risks. This medication should not be used by women or children.
Generic name: dutasteride
Pronunciation: (due-TAST-er-ide)
Drug class: 5 Alpha-Reductase Inhibitors
Therapeutic class: Genitourinary Therapy
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Dutasteride
Indications
The following indications are listed for Dutasteride:
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptom
Also known as: Symptomatic Benign Prostatic Hyperplasia, Symptomatic Benign Prostatic Hypertrophy, Symptomatic Bph, Symptomatic Prostatic Hypertrophy.
Dosing
No dosing information is available for this tab.
Dutasteride is administered orally without regard to meals. Dutasteride capsules should be swallowed whole and not chewed or opened, since contact with the capsule contents may result in irritation of the oropharyngeal mucosa.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Dutasteride 0.5 Mg Capsule | Maintenance | Take 1 capsule (0.5 mg) by oral route once daily. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Dutasteride 0.5 Mg Capsule | Maintenance | Take 1 capsule (0.5 mg) by oral route once daily. |
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Pregnancy.
*Known hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride, other 5alpha-reductase inhibitors, or any ingredient in the formulation.
- Lactation
- Pregnancy
There are no severe contraindications for this drug.
- Disease of liver
- High-grade prostate cancer
Adverse reactions
Adverse effects reported in at least 1% of patients receiving dutasteride and more frequently than with placebo include impotence, decreased libido, ejaculation disorder, and breast disorders (including breast tenderness and enlargement). Ejaculation disorders have been reported more frequently with combined therapy with dutasteride and tamsulosin than with either drug alone.
Less Frequent
- High-grade prostate cancer
Rare or Very Rare
- Angioedema
- Gynecomastia
- Hypersensitivity drug reaction
- Localized edema
- Malignant tumor of male breast
- Skin rash
More Frequent
- Disorder of ejaculation
- Erectile dysfunction
- Libido changes
Less Frequent
- Asthenozoospermia
- Oligospermia
Rare or Very Rare
- Decrease ejaculate volume
- Depression
- Dizziness
- Mastalgia
- Pruritus of skin
- Testicular pain
- Testicular swelling
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy not established in children; the drug is not indicatedfor use in children.
Dutasteride is not indicated for use in women and is contraindicated in women who are pregnant. If used during pregnancy or if pregnancy occurs, apprise the pregnant woman of potential fetal hazard to a male fetus.
Because 5alpha-reductase inhibitors inhibit the conversion of testosterone to DHT, dutasteride may cause abnormalities of the external genitalia of male fetuses exposed to the drug during pregnancy. In animal reproduction studies, dutasteride inhibited normal development of externalgenitalia in male offspring when given to rats or rabbits during organogenesis at doses lessthan the maximum recommended human dose (MRHD) of 0.5 mg daily, in the absenceof maternal toxicity.
Because of the possibility of absorption through the skin and subsequent risk to a male fetus, women who are pregnant or who potentially may be pregnant should not handle dutasteride capsules; if contact with a leaking dutasteride capsuleoccurs during pregnancy, the affected area should be washed immediately with soap and water.
Not known whether dutasteride is distributed into milk in humans or if the drug has any effects on the breastfed infant or on milk production. Dutasteride is not indicated for use in women.
No substantial differences in safety and efficacy relative to younger men in clinical studies or experience to date, but increased sensitivity cannot be ruled out.
ICD codes
| Code | Type | Description |
|---|---|---|
| Benign prostatic hyperplasia with lower urinary tract symptom | ||
| N40.1 | ICD10CM | Benign prostatic hyperplasia with lower urinary tract symptoms |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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