dutasteride


Also found in: Dictionary, Wikipedia.

dutasteride

Avodart

Pharmacologic class: Synthetic 4-azasteroid compound

Therapeutic class: 5-alpha-reductase inhibitor, sex hormone

Pregnancy risk category X

Action

Inhibits 5-alpha-reductase, an intracellular enzyme present in liver, skin, and prostate that's required for conversion of testosterone to 5-alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulating prostatic growth.

Availability

Capsules: 0.5 mg

Indications and dosages

Symptomatic benign prostatic hypertrophy (alone or in combination with tamsulosin)

Adults: 0.5 mg P.O. daily

Contraindications

• Hypersensitivity to drug, its components, other 5-alpha-reductase inhibitors, xanthines (such as coffee, theobromine), or ethylenediamine
• Women
• Children

Precautions

Use cautiously in:
• hepatic impairment.

Administration

• Don't handle drug if you're pregnant or plan to become pregnant.
• Don't open or crush capsule.
• Give without regard to food.

Adverse reactions

GI: dyspepsia

GU: decreased libido, decreased ejaculatory volume, erectile dysfunction, gynecomastia

Interactions

Drug-drug.Cimetidine, ciprofloxacin, diltiazem, ketoconazole, other drugs metabolized by CYP450-3A4 pathway, ritonavir, verapamil: increased dutasteride blood level

Drug-diagnostic tests.Prostate-specific antigen (PSA): decreased level

Thyroid-stimulating hormone: increased level

Patient monitoring

• Monitor fluid intake and output. Assess for ease of starting urine stream and for urinary urgency or frequency.
• Check baseline PSA level; reevaluate at 3 to 6 months.

Patient teaching

• Tell patient to take drug with full glass of water without crushing or opening capsule.
• Instruct patient not to take capsule if it's cracked or leaking.
• Inform patient that drug decreases testosterone production in prostate.
• Tell patient to report dysuria and urinary urgency.

Advise patient not to donate blood for at least 6 months after final dose.
• Inform patient that drug may decrease ejaculatory volume.
• Explain that sexual side effects eventually will subside.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

dutasteride

(doo-tas-te-ride) ,

Avodart

(trade name)

Classification

Therapeutic: benign prostatic hyperplasia bph agents
Pharmacologic: androgen inhibitors
Pregnancy Category: X

Indications

Management of the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland (alone or with tamsulosin).

Action

Inhibits the enzyme 5-alpha-reductase, which is responsible for converting testosterone to its potent metabolite 5-alpha-dihydrotestosterone in the prostate gland and other tissues. 5-Alpha-dihydrotestosterone is partly responsible for prostatic hyperplasia.

Therapeutic effects

Reduced prostate size with associated decrease in urinary symptoms.

Pharmacokinetics

Absorption: Well absorbed (60%) following oral administration; also absorbed through skin.
Distribution: 11.5% of serum concentration partitions into semen.
Protein Binding: 99% bound to albumin; 96.6% bound to alpha-1 glycoprotein.
Metabolism and Excretion: Mostly metabolized by the liver via the CYP3A4 metabolic pathway; metabolites are excreted in feces.
Half-life: 5 wk.

Time/action profile (reduction in dihydrotestosterone levels†)

ROUTEONSETPEAKDURATION
POunknown1–2 wkunknown
†Symptoms may only improve over 3–12 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Cross-sensitivity with other 5-alpha-reductase inhibitors may occur;Women; Pediatric: Children.
Use Cautiously in: Hepatic impairment.

Adverse Reactions/Side Effects

Central nervous system

  • depressed mood

Genitourinary

  • prostate cancer (high-grade) (life-threatening)
  • ↓ libido
  • ejaculation disorders
  • erectile dysfunction
  • testicular pain
  • testicular swelling

Endocrinologic

  • gynecomastia

Dermatologic

  • rash
  • urticaria

Miscellaneous

  • allergic reactions (life-threatening)
  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Blood levels and effects may be ↑ by ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, ciprofloxacin, or other CYP3A4 enzyme inhibitors.

Route/Dosage

Oral (Adults) 0.5 mg once daily (with or without tamsulosin).

Availability (generic available)

Soft gelatin capsules: 0.5 mg
In combination with: tamsulosin (Jalyn); see combination drugs.

Nursing implications

Nursing assessment

  • Assess patient for symptoms of prostatic hyperplasia (urinary hesitancy, feeling of incomplete bladder emptying, interruption of urinary stream, impairment of size and force of urinary stream, terminal urinary dribbling, straining to start flow, dysuria, urgency) before and periodically during therapy.
  • Digital rectal examinations should be performed before and periodically during therapy for BPH.
  • Lab Test Considerations: Serum prostate-specific antigen (PSA) concentrations, used to screen for prostate cancer, decrease by about 20% within the 1st mo of therapy and stabilize at about 50% of the pretreatment level within 6 mo. New baseline PSA concentrations should be established at 3 and 6 mo of therapy and evaluated periodically during therapy. Any increase in PSA during dutaseride therapy may be a sign of prostate cancer and should be evaluated, even those within normal limits. Isolated PSA values from men taking dutaseride for 3 mo or more should be doubled for comparison in untreated men.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)

Implementation

  • Oral: Administer once daily with or without meals. Do not break, crush, or chew capsule.

Patient/Family Teaching

  • Instruct patient to take dutasteride at the same time each day as directed, even if symptoms improve or are unchanged. Take missed doses as soon as remembered later in the day or omit dose. Do not make up by taking double doses the next day.
  • Caution patient that sharing of dutasteride may be dangerous.
  • Inform patient that the volume of ejaculate may be decreased during therapy but that this will not interfere with normal sexual function.
  • Advise patient to avoid donating blood for at least 6 mo after last dose of dutasteride to prevent a pregnant female from receiving dutasteride through a blood transfusion.
  • Inform patient of potential increase risk in high-grade prostate cancer.
  • Caution patient that dutasteride poses a potential risk to a male fetus. Women who are pregnant or may become pregnant should avoid exposure to semen of a partner taking dutasteride and should not handle dutasteride because of the potential for absorption.
  • Emphasize the importance of periodic follow-up exams to determine whether a clinical response has occurred.

Evaluation/Desired Outcomes

  • Decrease in urinary symptoms of BPH.

dutasteride

a sex hormone 5 alpha-reductase inhibitor used to treat benign prostatic hyperplasia in men with an enlarged prostate gland.

dutasteride

A drug that reduces production of dihydrotestosterone by inhibiting both types of the enzyme 5-alpha-reductase and is used to control benign prostatic hyperplasia and reduce the risk of acute urinary retention. Dutasteride is said to be more effective in this role than FINASTERIDE (Proscar). Like all testosterone antagonists this drug can cause reduced sexual interest, impotence, ejaculation problems, breast tenderness and breast enlargement (gynecomastia). A brand name is Avodart.
References in periodicals archive ?
All GSK-sponsored Phase III randomized, double-blind, controlled trials ([greater than or equal to]2 years' duration) with dutasteride compared to an active comparator/placebo in the treatment of BPH or risk reduction of prostate cancer were eligible for inclusion.
ODAC voted against recommending dutasteride for the prostate cancer risk reduction indication because, in the view of the ODAC members, the risk for an increase in high-grade tumours outweighed the benefits of prostate cancer risk reduction, given the potential for widespread use of this agent in the United States.
While we are disappointed by the Committee's conclusions on dutasteride as a prostate-cancer risk-reduction therapy, it is important to note that dutasteride has an established efficacy and safety profile in the treatment of BPH, including trials involving 10,000 men and the cumulative of 5.
Simons, president and chief executive officer of the Santa Monica-based Prostate Cancer Foundation, said, "We are optimistic that ODAC will send a strong signal to the FDA that the published clinical research on the benefits of dutasteride as an agent for the prevention of prostate cancer in the right patients outweigh the known side effects of this agent.
While both finasteride and dutasteride uses were associated with similar reductions in the overall rate of prostate cancer, there was one observed difference between the trials.
Food and Drug Administration for a generic version of dutasteride capsules, 0.
Both finasteride and dutasteride decreased prostatic volume, increased peak urinary flow rate, and improved LUTS within 6 to 9 months.
Serum testosterone and dihydrotestosterone and prostate cancer risk in the placebo arm of the Reduction by Dutasteride of Prostate Cancer Events trial.
The dual 5 alpha reductase inhibitor dutasteride induces atrophic changes and decreases cancer volume in the human prostate.
20) The current approach for medical management of LUTS associated with BPH depends on the usage of alpha-1 receptor blockers, such as alfuzosin, doxazosin, silodosin, tamsulosin and terazosin or suppression of the hormonal growth of the prostate by the 5-alpha reductase inhibitors finasteride and dutasteride.
A drug called dutasteride has a useful role to play in preventing benign prostatic enlargement from getting any worse.
PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial.