Adult Dosing

Benign prostatic hyperplasia (BPH)

• Dose: 8 mg PO qd given with food

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Benign prostatic hyperplasia (BPH)

• Hypersensitivity to any of the ingredients of the product
• Severe renal impairment (CrCl < 30 mL/min)
• Severe hepatic impairment (Child-Pugh score 10)
• Concomitant use of Cytochrome P450 3A4 (CYP3A4) inhibitors

• N/A

Renal Dose Adjustment (Based on CrCl)

• Mild renal impairment (CrCl 50-80 mL/min): No dose adjustments
• Moderate renal impairment (CrCl 30-50 mL/min): 4 mg PO qd
• Severe renal impairment (CrCl <30 mL/min): Contraindicated

Hepatic Dose Adjustment

• Mild or moderate hepatic impairment (Child-Pugh Score < 10): No dose adjustments
• Severe hepatic impairment (Child-Pugh score 10): Contraindicated

See Supplemental Patient Information

• It is not indicated for the treatment of hypertension
• Silodosin is not indicated for use in women
• Rule out prostate carcinoma before starting therapy as carcinoma of the prostate and BPH cause many of the same symptoms
• Postural hypotension with or without dizziness may develop when beginning therapy with silodosin
• It should not be used in combination with other alpha-blockers as there is potential for syncope
• Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy

Cautions: Use cautiously in

• Renal impairment (refer dose adjustment section)
• Hepatic impairment (refer dose adjustment section)
• Hypotension
• Co-administration of antihypertensives
• Patients undergoing cataract surgery (possibility of intraoperative floppy iris syndrome)
• Geriatric population (risk of orthostatic hypotension)
• Concomitant use with PDE5 inhibitors

Supplemental Patient Information

• Patients planning cataract surgery should inform their ophthalmologist that they are taking silodosin

Pregnancy Category:B

Breastfeeding: Safety unknown.

• CV: Orthostatic hypotension
• CNS: Dizziness, headache, asthenia, insomnia
• GI: Diarrhea, abdominal pain
• HEPA: Impaired hepatic function associated with increased transaminase values, jaundice
• EENT: Intraoperative floppy iris syndrome, nasal congestion, nasopharyngitis, rhinorrhea
• DERM: Purpura, toxic skin eruption
• GU: Retrograde ejaculation, increased prostate-specific antigen, priapism
• RESP: Sinusitis, URI symptoms

• Alpha-1 adrenergic receptor antagonist; selectively antagonizes lower urinary tract alpha-1a adrenergic receptors, relaxing smooth muscle and improving urine flow
• Absorption: 32% absorbed following oral administration
• Extensively metabolized by liver; CYP450: 3A4 substrate
• Renally excreted: 33.5%; feces: 54.9%
• Half-life: 13.3 hrs

US Trade Name(s)

• Rapaflo

US Availability

Rapaflo

• CAPS: 4, 8 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Urologic

Benign Prostatic Hyperplasia (BPH) Agents

Pricing data from www.DrugStore.com in U.S.A.

• Rapaflo 8 MG CAPS [Bottle] (WATSON LABS)
  30 mg = $137.93
  90 mg = $380.9

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Rapaflo 4 MG Oral Capsule

Ingredient(s): Silodosin

Imprint: WATSON;151;4;mg

Color(s): White

Shape: Capsule

Size (mm): 16.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Watson Pharma, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Rapaflo 8 MG Oral Capsule

Ingredient(s): Silodosin

Imprint: WATSON;152;8;mg

Color(s): White

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Watson Pharma, Inc.

DEA Schedule:
Non-Scheduled