Medication Guide App

Label Changes for:

Rapaflo (silodosin) Capsules

July 2013

Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

July 2013

CONTRAINDICATIONS

  • Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO

ADVERSE REACTIONS

Postmarketing Experience
  • skin rash, pruritis and urticaria
  • Immune system disorders: allergic-type reactions, not limited to skin reactions including swollen tongue and pharyngeal edema resulting in serious outcomes

 

March 2010

 

WARNINGS AND PRECAUTIONS

Pharmacodynamic Drug-Drug Interactions
  • Caution is also advised when alpha-adrenergic blocking agents including RAPAFLO are coadministered 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

DRUG INTERACTIONS

PDE5 Inhibitors
  • Co-administration of Rapaflo with a single dose of 100 mg sildenafil or 20 mg tadalafil was evaluated in a placebo-controlled clinical study that included 24 healthy male subjects, 45 to 78 years of age. Orthostatic vital signs were monitored in the 12-hour period following
    concomitant dosing. During this period, the total number of positive orthostatic test results was greater in the group receiving Rapaflo plus a PDE5 inhibitor compared with Rapaflo alone. No events of symptomatic orthostasis or dizziness were reported in subjects receiving Rapaflo with a PDE5 inhibitor.

 

Hide
(web5)