Dutasteride/Tamsulosin

DEA Class;  Rx

Common Brand Names; Jalyn

Clinically significant hypersensitivity (eg, serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5 alpha-reductase inhibitors, or tamsulosin

Females who are pregnant

Year 1

• Ejaculation disorders (1.6-7.8%)
• Impotence (1.1-5.4%)
• Decreased libido (≤4.5%)
• Breast disorders (≤1.1%)
• Dizziness (≤1.1%)

Year 2-4

• Impotence (1.1-5.4%)
• Ejaculation disorders (≤1%)

<1%

Cardiac failure

Year 2-4

• Decreased libido
• Breast disorders
• Dizziness

Postmarketing Reports

Dutasteride

• Immune system disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema
• Neoplasms: Male breast cancer
• Psychiatric disorders: Depressed mood
• Reproductive system and breast disorders: Testicular pain and testicular swelling

Tamsulosin

• Immune system disorders: Hypersensitivity reactions, including rash, urticaria, pruritus, angioedema, and respiratory problems have been reported with positive rechallenge in some cases
• Cardiac disorders: Palpitations, dyspnea, atrial fibrillation, arrhythmia, and tachycardia
• Skin disorders: Skin desquamation, including Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative
• Gastrointestinal disorders: Constipation, vomiting, dry mouth
• Reproductive system and breast disorders: Priapism
• Vascular disorders: Hypotension

Orthostatic hypotension and/or syncope can occur

Reduces total serum prostate-specific antigen (PSA) concentration by ~50%, evaluate any confirmed increases in PSA levels from nadir, even if those values are within normal range, for the presence of prostate cancer

Caution patients about the possibility and seriousness of priapism

Advise patients to not donate blood until 6 months after their last dose

Intraoperative floppy iris syndrome has been observed during cataract surgery after alpha-adrenergic antagonist exposure

Not indicated for use in females; contraindicated for use in pregnancy because may cause harm to male fetus; dutasteride is a 5-alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia

Lactation:

Therapy not indicated for use in females

Dutasteride/Tamsulosin hydrochloride

capsule

• 0.5mg/0.4mg