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| 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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