Rapaflo

Rapaflo comes as a capsule to take by mouth. It's usually taken once a day with food.

Don't take this medicine on an empty stomach.

Try to take Rapaflo around the same time each day.

Follow your doctor's instructions carefully when using this medicine. Don't take more or less Rapaflo than is prescribed.

Rapaflo Overdose

Symptoms of a Rapaflo overdose may include fainting, blurred vision, or extreme dizziness.

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Rapaflo

If you miss a dose of Rapaflo, take it as soon as you remember.

However, skip the missed dose if it's almost time for your next scheduled dose.

Don't take extra medicine to make up for a missed dose.

Silodosin is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine
• Eliglustat
• Simeprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Sildenafil
• Tadalafil
• Vardenafil

Rapaflo is part of the drug class:

• Alpha adrenoreceptor antagonists

Before taking Rapaflo, tell your doctor about all of your medical conditions. Especially tell your doctor if you: 

• are allergic to Rapaflo or to any of it's ingredients
• have or have had cataracts
• have liver or kidney problems
• have low blood pressure

Rapaflo is not intended for women or children.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.

Absorption

Bioavailability

Absolute bioavailability of approximately 32% following oral administration under fed conditions.1 Peak plasma concentrations attained in about 2.6 hours.1

Food

When administered with a moderate-fat, moderate-calorie meal, AUC and peak plasma concentrations are decreased by 4–49% and 18–43%, respectively, compared with administration in the fasting state.1 Administration with a high-fat, high-calorie meal not evaluated.1

Distribution

Plasma Protein Binding

Approximately 97%.1

Elimination

Metabolism

Extensively metabolized in the liver via glucuronidation, alcohol and aldehyde dehydrogenases, and CYP3A4 isoenzymes.1 The primary active metabolite, KMD-3213G, is formed via UGT2B7-mediated glucuronidation.1 Another major metabolite, KMD-3293, is formed via alcohol and aldehyde dehydrogenases.1 KMD-3293 is not expected to contribute substantially to the overall pharmacologic activity of silodosin.1

Elimination Route

Excreted in urine (33.5%) and feces (54.9%).1

Half-life

Approximately 13.3 hours.1

Special Populations

In patients with moderate hepatic impairment, the pharmacokinetics of silodosin were not substantially altered following administration of a single dose.1 The pharmacokinetics of silodosin in patients with severe hepatic impairment have not been evaluated.1

In patients with moderate renal impairment, AUC, peak plasma concentrations, and elimination half-life were 3.2, 3.1, and 2 times higher, respectively, than in healthy individuals.1

In geriatric individuals, AUC and elimination half-life were increased by approximately 15% and 20%, respectively, compared with younger individuals.1

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take this medicine with a meal.

If you have trouble swallowing capsules, you may open the capsule and pour the medicine into a small amount of cool or room temperature applesauce. Stir this mixture well and swallow it immediately (within 5 minutes) without chewing, and followed with a glass of cool water to ensure complete swallowing of the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For benign prostatic hyperplasia (BPH):
    • Adults—4 to 8 milligrams (mg) taken as a single dose once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take Rapaflo. 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 Rapaflo while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Rapaflo or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rapaflo (silodosin). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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.

6.1  Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In U.S. clinical trials, 897 patients with BPH were exposed to 8 mg Rapaflo daily. This includes 486 patients exposed for 6 months and 168 patients exposed for 1 year. The population was 44 to 87 years of age, and predominantly Caucasian. Of these patients, 42.8% were 65 years of age or older and 10.7% were 75 years of age or older.

In double-blind, placebo controlled, 12-week clinical trials, 466 patients were administered Rapaflo and 457 patients were administered placebo. At least one treatment-emergent adverse reaction was reported by 55.2% of Rapaflo treated patients (36.8% for placebo treated). The majority (72.1%) of adverse reactions for the Rapaflo treated patients (59.8% for placebo treated) were qualified by the investigator as mild. A total of 6.4% of Rapaflo treated patients (2.2% for placebo treated) discontinued therapy due to an adverse reaction (treatment-emergent), the most common reaction being retrograde ejaculation (2.8%) for Rapaflo treated patients. Retrograde ejaculation is reversible upon discontinuation of treatment.

Adverse Reactions observed in at least 2% of patients:

The incidence of treatment-emergent adverse reactions listed in the following table were derived from two 12-week, multicenter, double-blind, placebo-controlled clinical studies of Rapaflo 8 mg daily in BPH patients. Adverse reactions that occurred in at least 2% of patients treated with Rapaflo and more frequently than with placebo are shown in Table 1.

In the two 12-week, placebo-controlled clinical trials, the following adverse events were reported by between 1% and 2% of patients receiving Rapaflo and occurred more frequently than with placebo: insomnia, PSA increased, sinusitis, abdominal pain, asthenia, and rhinorrhea. One case of syncope in a patient taking prazosin concomitantly and one case of priapism were reported in the Rapaflo treatment group.

In a 9-month open-label safety study of Rapaflo, one case of Intraoperative Floppy Iris Syndrome (IFIS) was reported.

6.2  Postmarketing Experience

The following adverse reactions have been identified during post approval use of silodosin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Skin and subcutaneous tissue disorders: toxic skin eruption, purpura, skin rash, pruritus, and urticaria

Hepatobiliary disorders: jaundice, impaired hepatic function associated with increased transaminase values

Immune system disorders: allergic-type reactions, not limited to skin reactions including swollen tongue and pharyngeal edema resulting in serious outcomes

White, opaque, hard gelatin 8 mg capsules. Cap is imprinted with “WATSON 152” in green. Body is imprinted with “8 mg” in green. 8 mg capsules are supplied in unit of use HDPE bottles of:

• 30 capsules (NDC 52544-152-30)
  
• 90 capsules (NDC 52544-152-19)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

White, opaque, hard gelatin 4 mg capsules. Cap is imprinted with “WATSON 151” in gold. Body is imprinted with “4 mg” in gold. 4 mg capsules are supplied in unit of use HDPE bottles of:

• 30 capsules (NDC 52544-151-30)
  
• 90 capsules (NDC 52544-151-19)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.

Keep out of reach of children.

Common side effects of Rapaflo include: retrograde ejaculation. See below for a comprehensive list of adverse effects.