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The following safety and warning information is crucial for anyone considering the use of Silodosin (Rapaflo). It is imperative to understand the potential risks, necessary precautions, and special instructions to ensure safe usage. Consult your healthcare provider for any concerns or questions.

• Low Blood Pressure Risk: Silodosin (Rapaflo) may cause a significant drop in blood pressure when transitioning from sitting to standing, potentially leading to dizziness or fainting. This effect is most pronounced when beginning treatment. Increased risk is associated with concurrent use of blood pressure medications or PDE5 inhibitors like sildenafil. Refrain from driving or operating heavy machinery until you understand how this medication affects you.

• Increased Side Effects in Kidney Impairment: Individuals with kidney dysfunction may experience heightened side effects as Silodosin (Rapaflo) can accumulate in the body. It is crucial to inform your healthcare provider of any kidney issues before starting the medication. A lower dose may be recommended to minimize side effects. Silodosin (Rapaflo) is contraindicated in severe kidney impairment.

• Drug Interactions: Silodosin (Rapaflo) can interact with various medications, including ketoconazole, clarithromycin, and ritonavir, which may increase its levels in the body. Additionally, combining it with PDE5 inhibitors can further lower blood pressure. Discuss all medications you are taking with your healthcare provider or pharmacist to ensure safe dosing and use.

• Prostate Cancer Screening: Symptoms of prostate cancer can mimic those of an enlarged prostate. Prior to initiating treatment with Silodosin (Rapaflo) for benign prostatic hyperplasia (BPH), your healthcare provider will assess and rule out prostate cancer.

• Floppy Iris Syndrome Risk: If you are undergoing cataract surgery, inform your eye care provider if you have taken or are currently taking Silodosin (Rapaflo). There is a rare risk of developing Floppy Iris Syndrome (FIS) during and after cataract surgery, which can occur even if you have stopped the medication.

Contraindications: Silodosin (Rapaflo) should not be used in individuals with severe kidney or liver problems, or by those taking certain medications such as ketoconazole, clarithromycin, itraconazole, or ritonavir. Consult your healthcare provider if any of these conditions apply to you before starting this medication.

Common side effects:

• Dizziness
• Diarrhea
• Sudden drop in blood pressure when standing up
• Retrograde ejaculation
• Headache
• Congestion
• Runny nose
• Stomach pain
• Trouble sleeping

Serious side effects:

• Fainting
• Prolonged and painful erection lasting four or more hours
• Severe allergic reaction with symptoms such as rash, itching, swelling (especially of the face, tongue, or throat), severe dizziness, or difficulty breathing

Interactions with high risk of serious adverse effects and should be avoided:

• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Nefazodone
• Nelfinavir
• Ritonavir
• Saquinavir
• Telithromycin

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Alfuzosin
• Bunazosin
• Cyclosporine
• Dapiprazole
• Doxazosin
• Moxisylyte
• Phenoxybenzamine
• Phentolamine
• Prazosin
• Simeprevir
• Tamsulosin
• Terazosin
• Tolazoline
• Trimazosin
• Urapidil

Interactions with low risk that usually do not require a change in therapy:

• Sildenafil
• Tadalafil
• Vardenafil