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What is Jalyn, and how does it work?
Generic drug: dutasteride and tamsulosin hydrochloride
Brand name: Jalyn
Jalyn is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The 2 medications in Jalyn work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate and tamsulosin relaxes muscles in the prostate and neck of the bladder.
These 2 medications, when used together, can improve symptoms of BPH better than either medication when used alone.
What are the side effects of Jalyn?
Jalyn may cause serious side effects including:
- Decreased blood pressure. Jalyn may cause a sudden drop in your blood pressure upon standing from a sitting or lying position, especially at the start of treatment. Symptoms of low blood pressure may include:
- Rare and serious allergic reactions, including:
- swelling of your face, tongue, or throat
- difficulty breathing
- serious skin reactions, such as skin peeling
- Get medical help right away if you have these serious allergic reactions.
- Higher chance of a more serious form of prostate cancer.
- Eye problems during cataract or glaucoma surgery. During cataract or glaucoma surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen if you take or have taken Jalyn in the past. If you need to have cataract or glaucoma surgery, tell your surgeon if you take or have taken Jalyn.
- A painful erection that will not go away. Rarely, Jalyn can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, there could be lasting damage to your penis, including not being able to have an erection.
The most common side effects of Jalyn include:
- ejaculation problems*
- trouble getting or keeping an erection (impotence)*
- a decrease in sex drive (libido)*
- enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
- runny nose
*Some of these events may continue after you stop taking Jalyn.
Depressed mood has been reported in patients receiving dutasteride, an ingredient of Jalyn.
Dutasteride, an ingredient of Jalyn, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Jalyn on male fertility is not known.
Prostate-Specific Antigen (PSA) Test
- Your healthcare provider may check you for other prostate problems, including prostate cancer before you start and while you take Jalyn.
- A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer.
- Jalyn will reduce the amount of PSA measured in your blood.
- Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer.
- Increases in your PSA levels while on treatment with Jalyn (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.
- These are not all the possible side effects with Jalyn.
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Jalyn?
- The recommended dosage of Jalyn is 1 capsule (0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride) taken once daily approximately 30 minutes after the same meal each day.
- The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the Jalyn capsule may result in irritation of the oropharyngeal mucosa.
What drugs interact with Jalyn?
There have been no drug interaction trials using Jalyn. The following sections reflect information available for the individual components.
Cytochrome P450 Inhibition
- Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes.
- The effect of potent CYP3A4 inhibitors on dutasteride has not been studied.
- Because of the potential for drug-drug interactions, use caution when prescribing a dutasteride-containing product, including Jalyn, to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir).
Strong And Moderate Inhibitors Of CYP3A4 Or CYP2D6
- Tamsulosin is extensively metabolized, mainly by CYP3A4 or CYP2D6.
- Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in increases in the Cmax and area under the concentration-time curve (AUC) of tamsulosin by factors of 2.2 and 2.8, respectively.
- Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in increases in the Cmax and AUC of tamsulosin by factors of 1.3 and 1.6, respectively.
- A similar increase in exposure is expected in poor metabolizers (PM) of CYP2D6 as compared to extensive metabolizers (EM).
- Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in tamsulosin exposure exists when tamsulosin 0.4 mg is coadministered with strong CYP3A4 inhibitors in CYP2D6 PMs, tamsulosin 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole).
- The effects of coadministration of both a CYP3A4 and a CYP2D6 inhibitor with tamsulosin have not been evaluated.
- However, there is a potential for significant increase in tamsulosin exposure when tamsulosin 0.4 mg is coadministered with a combination of both CYP3A4 and CYP2D6 inhibitors.
- Treatment with cimetidine resulted in a moderate increase in tamsulosin hydrochloride AUC (44%).
- Concomitant administration of dutasteride 0.5 mg/day for 3 weeks with warfarin does not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time.
- A definitive drug-drug interaction trial between tamsulosin hydrochloride and warfarin was not conducted.
- Results from limited in vitro and in vivo studies are inconclusive.
- Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including Jalyn.
Nifedipine, Atenolol, Enalapril
- Dosage adjustments are not necessary when tamsulosin is administered concomitantly with nifedipine, atenolol, or enalapril.
Digoxin And Theophylline
- Dutasteride does not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.
- Dosage adjustments are not necessary when tamsulosin is administered concomitantly with digoxin or theophylline.
- Tamsulosin had no effect on the pharmacodynamics (excretion of electrolytes) of furosemide.
- While furosemide produced an 11% to 12% reduction in tamsulosin hydrochloride Cmax and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the dose of tamsulosin.
Calcium Channel Antagonists
- Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. The change in dutasteride exposure is not considered to be clinically significant. No dosage adjustment of dutasteride is recommended.
- Administration of a single 5-mg dose of dutasteride followed 1 hour later by a 12-g dose of cholestyramine does not affect the relative bioavailability of dutasteride.
Is Jalyn safe to use while pregnant or breastfeeding?
Latest Health News
Jalyn (dutasteride and tamsulosin hydrochloride) is a prescription medicine used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The 2 medications in Jalyn work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate and tamsulosin relaxes muscles in the prostate and neck of the bladder. These 2 medications, when used together, can improve symptoms of BPH better than either medication when used alone. Jalyn may cause serious side effects including decreased blood pressure, rare and serious allergic reactions, a higher chance of a more serious form of prostate cancer, eye problems, and a painful erection that will not go away.
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Related Disease Conditions
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.
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.
Early Prostate Cancer
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Prostate Cancer: Erectile Dysfunction
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Prostate Cancer Staging and Survival Rates
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.
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.
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).
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.
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.
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 a 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.
Prostate Cancer Early Signs and Symptoms
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.
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 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.
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.
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.
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.
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.
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.
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.
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: 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.
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.
Prostate Cancer: 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).
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.
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.
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.
Treatment & Diagnosis
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