Classes
DEA Class; Rx
Common Brand Names; Rapaflo
- BPH, Alpha Blockers
Description
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
Indications
Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Contraindications
Hypersensitivity
Severe renal impairment (CrCl <30 mL/min)
Severe hepatic impairment (Child-Pugh Score >10)
Concomitant strong CYP3A4 inhibitors or P-glycoprotein inhibitors
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
Therapy is not indicated for use in females
Maximum Dosage
8 mg/day PO.
8 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Silodosin
capsule
- 4mg
- 8mg