| HIGHLIGHTS OF PRESCRIBING INFORMATION
RAPAFLO® (silodosin) capsules
Revised: November 2009
These highlights do not include all the information needed to use RAPAFLO® safely and effectively. See full prescribing information for RAPAFLO.
RAPAFLO® (silodosin) capsule for oral use
| CLINICAL PHARMACOLOGY
Mechanism of Action
An in vitro study examining binding affinity of silodosin to the three subtypes of the alpha-1 adrenoreceptors (alpha-1A, alpha-1B, and alpha-1D) was conducted. The results of the study demonstrated that silodosin binds with high affinity to the alpha-1A subtype.
| INDICATIONS AND USAGE
RAPAFLO, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
RAPAFLO is not indicated for the treatment of hypertension.
–Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)].
–Patients with severe hepatic impairment (Child-Pugh score >/= 10).
–Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir).
| WARNINGS AND PRECAUTIONS
–Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning RAPAFLO treatment.
–In patients with moderate renal impairment, RAPAFLO dose should be reduced to 4 mg once daily.
–RAPAFLO should not be used in combination with other alpha-blockers.
–Examine patients thought to have BPH prior to starting therapy with RAPAFLO to rule out the presence of carcinoma of the prostate.
–Inform patients planning cataract surgery to notify their ophthalmologist that they are taking RAPAFLO because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS).
USE IN SPECIFIC POPULATIONS
| ADVERSE REACTIONS
Most common adverse reactions (incidence >/= 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Watson Pharmaceuticals, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| DOSAGE AND ADMINISTRATION
8 mg capsules taken orally once daily with a meal.
4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30-50 mL/min].
| Package Insert data:
Watson Laboratories, Inc.
Corona, CA 92880 USA
Under license from:
Address medical inquiries to:
For additional information see:
Revised: November 2009
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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