Prescribing Information

Prescribing Information

18 Pages · 2017 · 351 KB · English

In patients with moderate renal impairment, RAPAFLO dose should be reduced to 4 mg once daily. (5.2). •. RAPAFLO should not be used in combination with other alpha- blockers. (5.5). •. Examine patients thought to have BPH prior to starting therapy with. RAPAFLO to rule out the presence of 

Prescribing Information free download

HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial US Approval: 2008 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 th e treatment of hypertension ( 1 ) DOSAGE AND ADMINISTRATION • 8 mg capsules taken orally once daily with a meal ( 21 ) • 4 mg capsules take n orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30 50 mL/min] ( 22 ) DOSAGE FORMS AND STRENGTHS Capsules: 8 mg and 4 mg ( 3 ) CONTRAINDICATIONS • Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)] ( 4 ) • Patients with severe hepatic impairment (Child Pugh score > 10) ( 4 ) • Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir) (4 ) • Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO ( 4 ) WARNINGS AND PRECAUTIONS • Postur al hypotension, with or without symptoms (eg, dizziness), may develop when beginning RAPAFLO treatment ( 51 ) • In patients with moderate renal impairment, RAPAFLO dose should be reduced to 4 mg once daily ( 52 ) • RAPAFLO should not be used in combination with other alpha blockers ( 55 ) • Examine patients thought to have BPH prior to starting therapy with RAPAFLO to rule out the presence of carci noma of the prostate (56 ) • Inform patients planning cataract surgery to notify their ophthalmologist that they are taking RAPAFLO because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS) (57 ) ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyng itis, and nasal congestion ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 800 678 1605 or FDA at 1 800 FDA 1088 or wwwfdagov/medwatch DRUG INTERACTIONS • Strong P glycoprotein inhibitors (eg, cyclosporine): Co administration may increase plasma silodosin concentration Concomitant use is not recommended ( 72 ) • Alpha blockers: Interactions involving concomitan t use have not been determined However, interactions are expected and concomitant use is not recommended ( 73 ) • Concomitant use of PDE5 inhibitors with alpha blockers including RAPAFLO can potentially cause sympto matic hypotension ( 55 ) ( 75 ) USE IN SPECIFIC POPULATIONS • Renal impairment: Dose adjustment in moderate disease ( 22 ) Contraindicated in severe renal disease ( 4) • Hepatic impairment: Contraindicated in severe disease ( 4 ) See 17 for Patient Counseling Information Revised: 06/2017 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAG E 2 DOSAGE AND ADMINISTRATION 21 Dosing Information 22 Dosage Adjustment in Special Populations 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 51 Orthostatic Effects 52 Renal Impairment 53

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