Home Drug Guide Dutasteride and Tamsulosin Hydrochloride

Drug Guide

Generic Name

Dutasteride and Tamsulosin Hydrochloride

Brand Names Jalyn

Classification

Therapeutic: BPH treatment

Pharmacological: Combo alpha-adrenergic blocker and 5-alpha-reductase inhibitor

FDA Approved Indications

  • Benign prostatic hyperplasia (BPH)

Mechanism of Action

Dutasteride inhibits 5-alpha-reductase enzymes, reducing conversion of testosterone to dihydrotestosterone (DHT), leading to prostate size reduction. Tamsulosin is an alpha-1 adrenergic receptor blocker that relaxes muscles in the prostate and bladder neck, improving urine flow.

Dosage and Administration

Adult: One capsule (0.5 mg dutasteride and 0.4 mg tamsulosin) once daily

Pediatric: Not approved for pediatric use

Geriatric: Use with caution, start at lower doses if necessary, monitor for side effects

Renal Impairment: Adjust dose based on clinical response and tolerability

Hepatic Impairment: Use caution; no specific dose adjustment established

Pharmacokinetics

Absorption: Well absorbed, food does not affect absorption

Distribution: Dutasteride >99% protein bound, Tamsulosin approximately 95% protein bound

Metabolism: Primarily hepatic via CYP3A4 and CYP2D6 for Tamsulosin, Dutasteride extensively metabolized in the liver

Excretion: Dutasteride: metabolites in feces, Tamsulosin: metabolites in urine

Half Life: Dutasteride: ~5 weeks, Tamsulosin: ~15 hours

Contraindications

  • Hypersensitivity to dutasteride, tamsulosin, or any component of the formulation

Precautions

  • May cause orthostatic hypotension, dizziness; use caution in patients with cardiovascular disease, renal impairment, or hepatic impairment
  • Pregnancy Category X: contraindicated in women who are or may become pregnant

Adverse Reactions - Common

  • Dizziness (Common)
  • Ejaculatory dysfunction (Common)
  • Decreased libido (Common)
  • Gynecomastia (Less common)

Adverse Reactions - Serious

  • Priapism (Rare)
  • Severe orthostatic hypotension leading to falls (Rare)
  • Angioedema (Rare)

Drug-Drug Interactions

  • Other antihypertensives, phosphodiesterase inhibitors (e.g., sildenafil), agents affecting CYP3A4

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor blood pressure, symptom relief, side effects, PSA levels

Diagnoses:

  • Risk for falls due to orthostatic hypotension
  • Impaired urinary elimination

Implementation: Take medication at same time daily, monitor for adverse effects, educate patient about possible dizziness and precautions

Evaluation: Assess improvement in urinary symptoms, monitor for adverse reactions

Patient/Family Teaching

  • Take medication as prescribed, without missing doses
  • Rise slowly from sitting or lying position to prevent dizziness
  • Inform healthcare provider of any side effects, especially priapism or severe dizziness
  • Pregnant women should not handle crushed or broken tablets

Special Considerations

Black Box Warnings:

  • Pregnant women should not handle tablets; risk of birth defects
  • Potential risk of high-grade prostate cancer

Genetic Factors: Genetic variation in CYP2D6 may affect tamsulosin metabolism

Lab Test Interference: No significant interference reported

Overdose Management

Signs/Symptoms: Hypotension, dizziness, weakness

Treatment: Supportive care, monitor vital signs, caution with hypotension; no specific antidote

Storage and Handling

Storage: Store at room temperature, away from moisture and light

Stability: Stable under recommended storage conditions for the shelf life specified in the label

This guide is for educational purposes only and is not intended for clinical use.