Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh
Inc. nor any other party involved in the preparation of this program shall be
liable for any special, consequential, or exemplary damages resulting in whole
or part from any user's use of or reliance upon this material. PLEASE READ THE
DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING
THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE
DISCLAIMER. [ Read the disclaimer
| <<Back |
New drug index
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® (silodosin) capsule for oral use
Initial U.S. Approval: 2008
RAPAFLO is the brand name for silodosin, a selective antagonist of
alpha-1 adrenoreceptors. The chemical name of silodosin is
and the molecular formula is C25H32F3N3O4 with a molecular weight of
Mechanism of Action
Silodosin is a selective antagonist of post-synaptic alpha-1
adrenoreceptors, which are located in the human prostate, bladder base,
bladder neck, prostatic capsule, and prostatic urethra. Blockade of
these alpha-1 adrenoreceptors can cause smooth muscle in these tissues
to relax, resulting in an improvement in urine flow and a reduction in
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
RAPAFLO is not indicated for the treatment of hypertension.
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
--Examine patients thought to have BPH prior to starting therapy
with RAPAFLO to rule out the presence of carcinoma of the
--Inform patients planning cataract surgery to notify their
ophthalmologist that they are taking RAPAFLO because of the
possibility of Intraoperative Floppy Iris Syndrome (IFIS).
--Strong P-glycoprotein inhibitors (e.g., cyclosporine):
Co-administration may increase plasma silodosin concentration.
Concomitant use is not recommended.
--Alpha-blockers: Interactions involving concomitant use have
not been determined. However, interactions are expected and
concomitant use is not recommended.
--Concomitant use of PDE5 inhibitors with alpha-blockers
including Rapaflo can potentially cause symptomatic hypotension.
USE IN SPECIFIC POPULATIONS
--Renal impairment: Dose adjustment in moderate disease .
Contraindicated in severe renal disease.
--Hepatic impairment: Contraindicated in severe disease.