Generic drug: silodosin
Brand name: Rapaflo
What is Rapaflo (silodosin), and how does it work?
What are the side effects of Rapaflo?
Side effects of Rapaflo include:
- sleep problems (insomnia),
- stomach pain,
- decreased amount of semen released during sex,
- abnormal ejaculation,
- runny or stuffy nose, or
- sore throat.
Tell your doctor if you have serious side effects of Rapaflo including:
- feeling like you might pass out, or
- an erection that is painful or lasts 4 hours or longer.
What is the dosage for Rapaflo?
- The recommended dose is 8 mg orally once daily with a meal.
- Patients who have difficulty swallowing pills and capsules may carefully open the Rapaflo capsule and sprinkle the powder inside on a tablespoonful of applesauce.
- The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder.
- The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing.
- Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use.
- Subdividing the contents of a Rapaflo capsule is not recommended.
Dosage Adjustment In Special Populations
- Rapaflo is contraindicated in patients with severe renal impairment (CCr < 30 mL/min).
- In patients with moderate renal impairment (CCr 30-50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal.
- No dosage adjustment is needed in patients with mild renal impairment (CCr 50-80 mL/min).
- Hepatic impairment: Rapaflo has not been studied in patients with severe hepatic impairment (Child-Pugh score = 10) and is therefore contraindicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment.
What drugs interact with Rapaflo?
Moderate And Strong CYP3A4 Inhibitors
- In a clinical metabolic inhibition study, a 3.8-fold increase in silodosin maximum plasma concentrations and 3.2-fold increase in silodosin exposure were observed with concurrent administration of a strong CYP3A4 inhibitor, 400 mg ketoconazole. Use of strong CYP3A4 inhibitors such as itraconazole or ritonavir may cause plasma concentrations of silodosin to increase. Concomitant administration of strong CYP3A4 inhibitors and Rapaflo is contraindicated.
- The effect of moderate CYP3A4 inhibitors on the pharmacokinetics of silodosin has not been evaluated. Concomitant administration with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase concentration of Rapaflo. Exercise caution and monitor patients for adverse events when co-administering Rapaflo with moderate CYP3A4 inhibitors.
Strong P-glycoprotein (P-gp) Inhibitors
- In vitro studies indicated that silodosin is a P-gp substrate. Ketoconazole, a CYP3A4 inhibitor that also inhibits P-gp, caused significant increase in exposure to silodosin. Inhibition of P-gp may lead to increased silodosin concentration.
- Rapaflo is therefore not recommended in patients taking strong Pgp inhibitors such as cyclosporine.
- The pharmacodynamic interactions between silodosin and other alpha-blockers have not been determined. However, interactions may be expected, and Rapaflo should not be used in combination with other alpha-blockers.
- The effect of co-administration of Rapaflo and digoxin 0.25 mg/day for 7 days was evaluated in a clinical trial in 16 healthy males, aged 18 to 45 years.
- Concomitant administration of Rapaflo and digoxin did not significantly alter the steady state pharmacokinetics of digoxin. No dose adjustment is required.
- Co-administration of Rapaflo with a single dose of 100 mg sildenafil or 20 mg tadalafil was evaluated in a placebo-controlled clinical study that included 24 healthy male subjects, 45 to 78 years of age. Orthostatic vital signs were monitored in the 12-hour period following concomitant dosing.
- During this period, the total number of positive orthostatic test results was greater in the group receiving Rapaflo plus a PDE5 inhibitor compared with Rapaflo alone. No events of symptomatic orthostasis or dizziness were reported in subjects receiving Rapaflo with a PDE5 inhibitor.
Other Concomitant Drug Therapy
- The pharmacodynamic interactions between silodosin and antihypertensives have not been rigorously investigated in a clinical study. However, approximately one-third of the patients in clinical studies used concomitant antihypertensive medications with Rapaflo.
- The incidence of dizziness and orthostatic hypotension in these patients was higher than in the general silodosin population (4.6% versus 3.8% and 3.4% versus 3.2%, respectively).
- Exercise caution during concomitant use with antihypertensives and monitor patients for possible adverse events.
- In vitro data indicate that silodosin does not have the potential to inhibit or induce cytochrome P450 enzyme systems.
- The effect of a moderate fat, moderate calorie meal on silodosin pharmacokinetics was variable and decreased silodosin maximum plasma concentration (Cmax) by approximately 18 to 43% and exposure (AUC) by 4 to 49% across three different studies.
- Safety and efficacy clinical trials for Rapaflo were always conducted in the presence of food intake.
- Patients should be instructed to take silodosin with a meal to reduce risk of adverse events.
Is Rapaflo safe to use while pregnant or breastfeeding?
Rapaflo is not indicated for use in females, and therefore has not been tested in pregnant or lactating women.
Latest Men's Health News
Daily Health News
Rapaflo (silodosin) is an alpha-adrenergic blocker used to improve urination in men with benign prostatic hyperplasia (enlarged prostate). Side effects of Rapaflo include dizziness, weakness, headache, sleep problems (insomnia), diarrhea, stomach pain, decreased amount of semen released during sex, abnormal ejaculation, runny or stuffy nose, or sore throat.
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The prostate is a gland that is part of the male reproductive system and is located between the bladder and penis. Signs and symptoms of prostate problems include painful ejaculation, burning or pain while urinating, blood in the urine or semen, dribbling urine, frequent urination, urinary incontinence, and pain in the lower back, hips, upper thighs, or the pelvic or rectal area. Common causes of prostate problems in men are prostatitis, enlargement of the prostate gland (benign prostatic hyperplasia (BPH), and prostate cancer. Causes of prostate problems can assist in diagnosing prostate cancer. Treatments for prostate problems include medications, surgery, and hormone or radiation therapy.
What Are the 5 Warning Signs of Prostate Cancer?
Prostate cancer rarely produces symptoms in the early stage; however, few signs can help in detecting prostate cancer.
Prostatitis (Inflammation of the Prostate Gland)
Prostatitis is an inflammation of the prostate gland. Signs and symptoms of prostatitis include painful or difficulty urinating; fever; chills; body aches; blood in the urine; pain in the rectum, groin, abdomen, or low back; and painful ejaculation or sexual dysfunction. Causes of prostatitis include STDs, bacteria from urinary tract infections, or E. coli. Treatment for prostatitis depends on if it is a bacterial infection or chronic inflammation of the prostate gland.
Prostate Cancer Staging and Prognosis
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
Does an Enlarged Prostate Affect a Man Sexually?
An enlarged prostate can cause sexual problems in men. Sexual problems, such as erectile dysfunction or ejaculation problems, may occur in men with noncancerous enlargement of the prostate (benign prostatic hyperplasia or BPH).
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Benign prostatic hyperplasia (BPH or enlarged prostate) is very common in men over 50 years of age. Half of all men over the age of 50 develop symptoms of BPH, but few need medical treatment. This noncancerous enlargement of the prostate can impede urine flow, slow the flow of urine, create the urge to urinate frequently and cause other symptoms like complete blockage of urine and urinary tract infections. More serious symptoms are urinary tract infections (UTIs) and complete blockage of the urethra, which may be a medical emergency. BPH is not cancer. Not all men with the condition need treatment, and usually is closely monitored if no symptoms are present. Treatment measures usually are reserved for men with significant symptoms, and can include medications, surgery, microwave therapy, and laser procedures. Men can prevent prostate problems by having regular medical checkups that include a prostate exam.
Prostatitis vs. BPH (Enlarged Prostate): What Is the Difference?
Prostatitis and BPH (benign prostatic hyperplasia, enlarged prostate gland) are both conditions of the prostate gland. There are four types of prostatitis that can be caused by infections (usually bacterial) or other health conditions or problems, acute bacterial prostatitis (type I), chronic bacterial prostatitis (type II), chronic prostatitis and chronic pelvic pain syndrome (type III), and asymptomatic inflammatory prostatitis (type IV). BPH is inflammation of the prostate gland, and most men have the condition by age 50. Doctor's don't know what causes this inflammation, but they theorize that it may be related to hormones. Both of these conditions can cause similar symptoms like low back pain, pain during urination, or difficulty or the inability to urinate. However, prostatitis has many more symptoms and signs than BPH, and they based on the type of prostatitis. Examples include low back pain and/or abdominal pain, painful urination, fever, chills, feeling tired, recurrent urinary tract infections (UTIs), painful urination intermittently, intermittent obstruction urinary tract symptoms (frequent, painful, or incomplete urination), pelvic pain and/or discomfort, pain with ejaculation, and erectile dysfunction (ED). If you think you have either of these conditions contact your doctor or other health care professional. Bacterial prostatitis can be cured with antibiotics; however, there is no cure for BPH.
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Prostate Cancer (Prostatic Cancer) Symptoms and Causes
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by digital rectal exam, prostate specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Can Prostate Cancer Be Completely Cured?
Prostate cancer is the second most common cancer in men. Due to routine screening of prostate-specific antigen (PSA) levels in the United States, nearly 90% of prostate cancers get detected in early stages. When found early, there are several treatment options available and prostate cancer has a high chance of getting cured.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
What Are the First Signs of Prostate Problems?
The first signs and symptoms of prostate disorder usually include problems with urination. Please consult your doctor if you experience any of the signs and symptoms to avoid the worsening of the prostate problems.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
Prostate Infection: Causes, Symptoms, and Remedies
If the prostate gland becomes swollen and tender, it is called prostatitis or prostate infection. The prostate gland is a walnut-shaped organ that lies just below a man's urinary bladder.
Prostate Cancer Treatment: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
What Are the Five Warning Signs of Prostate Cancer?
Prostate cancer primarily affects men over 50, but is easy to treat if found early. Learn the signs of prostate cancer, what causes prostate cancer, how doctors diagnose prostate cancer, and how they treat prostate cancer.
Prostate Cancer Treatment: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
What Is the Latest Treatment for Prostate Cancer?
Prostate cancer affects 1 in 5 men. Learn how it is diagnosed and treated by doctors.
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
The early signs of prostate cancer
Prostate cancer in its early stages usually causes no signs and symptoms. Screening can help detect the cancer early.
When Should You Screen for Prostate Cancer?
Screening for prostate cancer helps detecta tumor early, enabling timely treatment and prevention of any complications. According to the American Cancer Society (ACS), the decision to get screened should be made by men in consultation with their doctor. The doctor needs to counsel the men about the uncertainties involved in the screening process, the risks and potential benefits of getting screened for prostate cancer.
Where Is the Prostate?
The prostate gland, commonly known as the prostate, is one of the male reproductive organs located just below the bladder, above the penis, and in front of the rectum. It is connected to the penis by a tube (urethra) that empties urine from the bladder. The size and shape of the prostate are similar to a walnut.
How Is Prostate Cancer Screening Done?
There are no standard or routine screening tests for prostate cancer. Studies are being done to find ways to make prostate-specific antigen (PSA) testing more accurate for early cancer detection.
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