RAPAFLO

RAPAFLO- silodosin capsule
Watson Pharma, Inc.

1 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 (14)]. RAPAFLO is not indicated for the treatment of hypertension.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

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

Patients who have difficulty swallowing pills and capsules may carefully open the RAPAFLO capsule and sprinkle the powder inside on a tablespoonful of applesauce. The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use. Subdividing the contents of a RAPAFLO capsule is not recommended [see Clinical Pharmacology (12.3)].

2.2 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 (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

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 (5.3), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

3 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.

4 CONTRAINDICATIONS

  • Severe renal impairment (CCr < 30 mL/min)

  • Severe hepatic impairment (Child-Pugh score > 10)

  • Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1) ]

  • Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO [see Adverse Reactions (6.2) and Description (11)]

5 WARNINGS AND PRECAUTIONS

5.1 Orthostatic Effects

Postural hypotension, with or without symptoms (e.g., dizziness) may develop when beginning RAPAFLO treatment. As with other alpha-blockers, there is potential for syncope. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy [see Adverse Reactions (6), Use in Specific Populations (8.5), Clinical Pharmacology (12.2), and Patient Counseling Information (17)].

5.2 Renal Impairment

In a clinical pharmacology study, plasma concentrations (AUC and Cmax ) of silodosin were approximately three times higher in subjects with moderate renal impairment compared with subjects with normal renal function, while half-lives of silodosin doubled in duration. The dose of RAPAFLO should be reduced to 4 mg in patients with moderate renal impairment. Exercise caution and monitor such patients for adverse events [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

RAPAFLO is contraindicated in patients with severe renal impairment [see Contraindications (4)].

5.3 Hepatic Impairment

RAPAFLO has not been tested in patients with severe hepatic impairment, and therefore, should not be prescribed to such patients [see Contraindications (4), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

5.4 Pharmacokinetic Drug-Drug Interactions

In a drug interaction study, co-administration of a single 8 mg dose of RAPAFLO with 400 mg ketoconazole, a strong CYP3A4 inhibitor, caused a 3.8-fold increase in maximum plasma silodosin concentrations and 3.2-fold increase in silodosin exposure (i.e., AUC). Concomitant use of ketoconazole or other strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) is therefore contraindicated [see Drug Interactions (7.1)].

5.5 Pharmacodynamic Drug-Drug Interactions

The pharmacodynamic interactions between silodosin and other alpha-blockers have not been determined. However, interactions may be expected, and RAPAFLO should not be used in combination with other alpha-blockers [see Drug Interactions (7.3)].

A specific pharmacodynamic interaction study between silodosin and antihypertensive agents has not been performed. However, patients in the Phase 3 clinical studies taking concomitant antihypertensive medications with RAPAFLO did not experience a significant increase in the incidence of syncope, dizziness, or orthostasis. Nevertheless, exercise caution during concomitant use with antihypertensives and monitor patients for possible adverse events [see Adverse Reactions (6.1) and Drug Interactions (7.6)].

Caution is also advised when alpha-adrenergic blocking agents including RAPAFLO are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Drug Interactions (7.5)].

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