Silodosin

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• dizziness
• fainting
• lightheadedness
• blurred vision

Tell your doctor about all the medicine you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil), itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine (Cardioquine, Quinact, Duraquin), ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)
• medications used to treat erectile dysfunction such as tadalafil (Cialis) and sildenafil (Viagra)
• digoxin
• Alpha 1- blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), and prazosin (Minipress)

This is not a complete list of silodosin drug interactions. Ask your doctor or pharmacist for more information.

Usual Adult Dose for Benign Prostatic Hyperplasia:

8 mg orally once a day with a meal

Comments: Patients who have difficulty swallowing may open the capsule and sprinkle the powder on a tablespoonful of applesauce. The applesauce should not be hot, and should be soft enough to be swallowed within 5 minutes without chewing and followed with 8 ounces of cool water.

• Risk of orthostatic hypotension (e.g., feeling faint or dizzy), particularly following initiation of therapy;1 importance of exercising caution when driving, operating machinery, or performing hazardous tasks.1

• Importance of taking silodosin once daily with a meal.1

• Risk of retrograde ejaculation.1 Importance of advising patients that this adverse effect occurs frequently and is reversible upon discontinuance of therapy.1

• Importance of advising male patients being considered for cataract surgery that they should inform their ophthalmologist of current or prior α1-blocker (e.g., silodosin) therapy.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chills
• cold sweats
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

• Abdominal or stomach pain
• clay-colored stools
• dark urine
• fever
• headache
• itching
• loss of appetite
• nausea
• pinpoint red or purple spots on the skin
• rash
• skin blisters
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change or problem with discharge of semen

• Diarrhea
• muscle aches
• sore throat
• stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take silodosin. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you are having cataract surgery or other eye procedure, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your blood pressure checked often. Talk with your doctor.
• Have a rectal exam (to check prostate gland) and blood work (PSA test). Talk with your doctor.
• Talk with your doctor before you drink alcohol.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Do not give to a child. Talk with your doctor.
• This medicine is not approved for use in women.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using silodosin while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Exposure and elimination half-life are approximately 15% and 20%, respectively, greater in subjects with a mean age of 69 years compared with subjects with a mean age of 24 years.

>10%: Genitourinary: Retrograde ejaculation (28%)

1% to 10%:

Cardiovascular: Orthostatic hypotension (3%; increased in elderly ≥65 years up to 5%)

Central nervous system: Dizziness (3%), headache (2%), insomnia (1% to 2%)

Gastrointestinal: Diarrhea (3%), abdominal pain (1% to 2%)

Genitourinary: Prostate specific antigen increased (1% to 2%)

Neuromuscular & skeletal: Weakness (1% to 2%)

Respiratory: Nasal congestion (2%), rhinorrhea (1% to 2%), sinusitis (1% to 2%)

<1% (Limited to important or life-threatening): Hepatic insufficiency, hypersensitivity reaction, increased serum transaminases, intraoperative floppy iris syndrome, jaundice, priapism, purpura, syncope, skin rash (including toxic)

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience sexual dysfunction. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), severe dizziness, passing out, angina, or priapism (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Mild renal dysfunction (CrCl 50 to 80 mL/min): No adjustment recommended
Moderate renal dysfunction (CrCl 30 to 50 mL/min): 4 mg orally once a day with a meal
Severe renal dysfunction (CrCl less than 30 mL/min): Contraindicated

Data not available

Patient advice:
-Inform patients regarding postural hypotension and related symptoms such as dizziness. Caution patients about driving, operating machinery, or performing hazardous tasks when initiating therapy.
-Inform patients that the most common adverse reaction, orgasm with reduced or no semen, does not pose a safety concern and is reversible upon discontinuation of this drug.
-Advise patients planning cataract surgery or other eye procedures to inform their ophthalmologist regarding use of this drug, even if they are no longer taking it.