Silodosin

DEA Class;  Rx

Common Brand Names; Rapaflo

  • BPH, Alpha Blockers

Highly selective, oral alpha-1 blocker
Used for benign prostatic hyperplasia (BPH) in men; as effective as tamsulosin for improving BPH symptoms
Abnormal ejaculation is more common with silodosin than tamsulosin

Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Hypersensitivity

Severe renal impairment (CrCl <30 mL/min)

Severe hepatic impairment (Child-Pugh Score >10)

Concomitant strong CYP3A4 inhibitors or P-glycoprotein inhibitors

  • Retrograde ejaculation (28%)
  • Diarrhea (3%)
  • Headache (2%)
  • Insomnia ((1-2%)
  • Dizziness (3%)
  • Orthostatic hypotension (3%; increased in patients >65 years)
  • Nasopharyngitis (2%)
  • Nasal congestion (2%)
  • Sinusitis (1-2%)
  • Skin and subcutaneous tissue disorders: Toxic skin eruption, purpura, skin rash, pruritus, urticaria
  • Hepatobiliary disorders: Jaundice, impaired hepatic function associated with increased transaminase values
  • Immune system disorders: Allergic-type reactions, not limited to skin reactions including angioedema
  • Genitourinary system: Priapism

Use with caution in the elderly (risk of hypotension)

Not indicated for use in women or children

Not for use as hypertensive

Postural hypotension, with or without symptoms (eg, dizziness) may develop when initiating treatment; there is potential for syncope; patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy

Dose should be reduced to 4 mg in patients with moderate renal impairment; exercise caution and monitor such patients for adverse events

Not tested in patients with severe hepatic impairment, and therefore, should not be prescribed to such patients; use with caution in patients with mid-to-moderate hepatic impairment

Patients planning cataract surgery should be told to inform their ophthalmologist that they are receiving this therapy; intraoperative floppy iris syndrome observed during cataract surgery in some patients on alpha-1 blockers or previously treated with alpha-1 blockers; variant of small pupil syndrome is characterized by combination of a flaccid iris that billows in response to intraoperative irrigation currents; progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs; and potential prolapse of iris toward phacoemulsification incisions

Carcinoma of prostate and BPH cause many of same symptoms; these two diseases frequently co-exist; patients thought to have BPH should be examined prior to starting therapy to rule out the presence of carcinoma of the prostate

Therapy is not indicated for use in females

Adults

8 mg/day PO.

Geriatric

8 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Silodosin

capsule

  • 4mg
  • 8mg

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