Rapaflo Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ]. RAPAFLO is not indicated for the treatment of hypertension.
What should I know before taking it?
Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score > 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1) ]
What important warnings are listed?
Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning RAPAFLO treatment. (5.1) 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 carcinoma of the prostate. (5.6) Inform patients planning cataract surgery to notify their ophthalmologist that they are taking RAPAFLO because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS). (5.7)
How is this medication usually taken?
The 8 mg capsules are white, opaque, hard #1 gelatin capsules imprinted with “WATSON 152” in green on the cap and “8 mg” in green on the body. The 4 mg capsules are white, opaque, hard #3 gelatin capsules imprinted with “WATSON 151” in gold on the cap and “4 mg” in gold on the body.
What side effects are listed?
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.
What interactions are listed?
In a drug interaction study, co-administration of a single 8 mg dose of RAPAFLO with 400 mg ketoconazole, a strong CYP3A4 inhibitor, caused a 3.8-fold increase in maximum plasma silodosin concentrations and 3.2-fold increase in silodosin exposure (i.e., AUC). Concomitant use of ketoconazole or other strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) is therefore contraindicated [see Drug Interactions (7.1) ].
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=96425d91-cfe1-477d-a130-b58c330ca8a3
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.