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Rapaflo (Silodosin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ see Clinical Studies ]. RAPAFLO is not indicated for the treatment of hypertension.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended dose is 8 mg orally once daily with a meal.

Dosage Adjustment in Special Populations

Renal impairment: RAPAFLO is contraindicated in patients with severe renal impairment (CCr < 30 mL/min). In patients with moderate renal impairment (CCr 30-50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal. No dosage adjustment is needed in patients with mild renal impairment (CCr 50-80 mL/min) [ see Contraindications (4) , Warnings and Precautions , Use in Specific Populations , and Clinical Pharmacology ].

Hepatic impairment: RAPAFLO has not been studied in patients with severe hepatic impairment (Child-Pugh score > 10) and is therefore contraindicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment [ see Contraindications (4) , Warnings and Precautions , Use in Specific Populations , and Clinical Pharmacology ].

DOSAGE FORMS AND STRENGTHS

The 8 mg capsules are white, opaque, hard #1 gelatin capsules imprinted with "WATSON 152" in green on the cap and "8 mg" in green on the body.

The 4 mg capsules are white, opaque, hard #3 gelatin capsules imprinted with "WATSON 151" in gold on the cap and "4 mg" in gold on the body.

HOW SUPPLIED/STORAGE AND HANDLING

White, opaque, hard gelatin 8 mg capsules . Cap is imprinted with "WATSON 152" in green. Body is imprinted with "8 mg" in green. 8 mg capsules are supplied in unit of use HDPE bottles of:

  • 30 capsules (NDC 52544-152-30)

  • 90 capsules (NDC 52544-152-19)

8 mg capsules are supplied in non-unit of use HDPE bottles of:

  • 1000 capsules (NDC 52544-152-10)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

White, opaque, hard gelatin 4 mg capsules . Cap is imprinted with "WATSON 151" in gold. Body is imprinted with "4 mg" in gold. 4 mg capsules are supplied in unit of use HDPE bottles of:

  • 30 capsules (NDC 52544-151-30)

  • 90 capsules (NDC 52544-151-19)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

Storage

Store at 25C (77F); excursions permitted to 15-30C (59-86F). [See USP controlled room temperature.] Protect from light and moisture.

Keep out of reach of children.

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