Brand Name
Jalyn
Generic Name
Dutasteride
View Brand Information FDA approval date: November 02, 2015
Classification: 5-alpha Reductase Inhibitor
Form: Capsule
What is Jalyn (Dutasteride)?
JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia
Summary: This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia
Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial
Summary: The goal of this clinical trial is to compare how well Terazosin, Tamsulosin and standard care (no alpha-blocker) reduce urinary symptoms after ureteral stent placement. This trial also learn about the safety of these two study medications. Main objective: • To compare how well Terazosin, Tamsulosin and standard of care reduce post-stenting urinary symptoms. Secondary objectives: * To assess diffe...
Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
Summary: This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while min...
Related Latest Advances
Brand Information
Jalyn (DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE)
1DOSAGE AND ADMINISTRATION
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.
2DOSAGE FORMS AND STRENGTHS
JALYN capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong, hard-shell capsules with a brown body and an orange cap imprinted with "GS 7CZ" in black ink.
3CONTRAINDICATIONS
JALYN is contraindicated for use in:
- Pregnancy. Dutasteride use is contraindicated in females who are pregnant.
- Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any other component of JALYN
4DRUG INTERACTIONS
There have been no drug interaction trials using JALYN. The following sections reflect information available for the individual components.
5OVERDOSAGE
No data are available with regard to overdosage with JALYN. The following text reflects information available for the individual components.
6DESCRIPTION
JALYN (dutasteride and tamsulosin hydrochloride) capsules contain dutasteride (a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT and tamsulosin (an antagonist of alpha
- One dutasteride oblong, opaque, dull-yellow soft gelatin capsule, containing 0.5 mg of dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-di-glycerides of caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide.
- Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin hydrochloride and the inactive ingredients: methacrylic acid copolymer dispersion, microcrystalline cellulose, talc, and triethyl citrate.
The above components are encapsulated in a hard-shell capsule made with the inactive ingredients of carrageenan, FD&C yellow 6, hypromellose, iron oxide red, potassium chloride, titanıum dioxide, and imprinted with "GS 7CZ" in black ink.
7CLINICAL STUDIES
The trial supporting the efficacy of JALYN was a 4-year multicenter, randomized, double-blind, parallel-group trial (CombAT trial) investigating the efficacy of the coadministration of dutasteride 0.5 mg/day and tamsulosin hydrochloride 0.4 mg/day (n = 1,610) compared with dutasteride alone (n = 1,623) or tamsulosin alone (n = 1,611). Subjects were aged at least 50 years with a serum PSA ≥1.5 ng/mL and <10 ng/mL and BPH diagnosed by medical history and physical examination, including enlarged prostate (≥30 cc) and BPH symptoms that were moderate to severe according to the International Prostate Symptom Score (IPSS). Eighty-eight percent (88%) of the enrolled trial population was white. Approximately 52% of subjects had previous exposure to 5-alpha-reductase inhibitor or alpha-adrenergic antagonist treatment. Of the 4,844 subjects randomly assigned to receive treatment, 69% of subjects in the coadministration group, 67% in the dutasteride group, and 61% in the tamsulosin group completed 4 years of double-blind treatment.
8HOW SUPPLIED/STORAGE AND HANDLING
JALYN capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong hard-shell capsules with a brown body and an orange cap imprinted with "GS 7CZ" in black ink. They are available in bottles with child-resistant closures as follows:
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
10PATIENT INFORMATION JALYN (JAY-lin) (dutasteride and tamsulosin hydrochloride) capsules
JALYN is for use by men only.
What is JALYN?
JALYN is a prescription medicine that contains 2 medicines: dutasteride and tamsulosin. 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.
Do not take JALYN if you are:
- pregnant or may be pregnant. JALYN may harm your unborn baby. Pregnant females should not touch JALYN capsules. If a female who is pregnant with a male baby gets enough JALYN in her body by swallowing or touching JALYN, the male baby may be born with sex organs that are not normal. If a pregnant female comes in contact with leaking JALYN capsules, the contact area should be washed immediately with soap and water.
- allergic to dutasteride, tamsulosin, or any of the ingredients in JALYN.
See the end of this leaflet for a complete list of ingredients in JALYN.
- taking another medicine that contains an alpha-blocker.
- allergic to other 5-alpha-reductase inhibitors, for example, PROSCAR (finasteride) tablets.
Before you take JALYN, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of low blood pressure
- take medicines to treat high blood pressure
- plan to have cataract or glaucoma surgery
- have liver problems
- are allergic to sulfa medications
- have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JALYN and other medicines may affect each other, causing side effects. JALYN may affect the way other medicines work, and other medicines may affect how JALYN works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take JALYN?
- Take JALYN exactly as your healthcare provider tells you to take it.
- Swallow JALYN capsules whole. Do not crush, chew, or open JALYN capsules because the contents of the capsule may irritate your lips, mouth, or throat.
- Take your JALYN 1 time each day, about 30 minutes after the same meal every day. For example, you may take JALYN 30 minutes after dinner every day.
- If you miss a dose, you can take it later that same day, 30 minutes after a meal. Do not take 2 JALYN capsules in the same day. If you stop or forget to take JALYN for several days, talk with your healthcare provider before starting again.
- If you take too much JALYN, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking JALYN?
- Avoid driving, operating machinery, or other dangerous activities when starting treatment with JALYN until you know how JALYN affects you. JALYN can cause a sudden drop in your blood pressure, especially at the start of treatment. A sudden drop in blood pressure may cause you to faint, feel dizzy or lightheaded.
- You should not donate blood while taking JALYN or for 6 months after you have stopped JALYN. This is important to prevent pregnant females from receiving JALYN through blood transfusions.
What are the possible 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:
- fainting
- dizziness
- feeling lightheaded
- Rare and serious allergic reactions, including:
- swelling of your face, tongue, or throat
- difficulty breathing
- serious skin reactions, such as skin peeling
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)
- dizziness
- enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
- runny nose
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.
How should I store JALYN?
- Store JALYN capsules at room temperature (59° to 86°F or 15° to 30°C).
- JALYN capsules may become deformed and/or discolored if kept at high temperatures.
- Do not use or touch JALYN if your capsules are deformed, discolored, or leaking.
- Safety throw away medicines that is no longer needed.
Keep JALYN and all medicines out of the reach of children.
General information about the safe and effective use of JALYN.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Jalyn for a condition for which it was not prescribed. Do not give Jalyn to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about Jalyn that is written for health professionals.
For more information call 1-844-200-7910.
What are the ingredients in JALYN?
Active ingredient: dutasteride and tamsulosin hydrochloride
Inactive ingredients: black ink, butylated hydroxytoluene, carrageenan, FD&C yellow 6, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, hypromellose, iron oxide red, methacrylic acid copolymer dispersion, microcrystalline cellulose, mono-di-glycerides of caprylic/capric acid, potassium chloride, talc, titanium dioxide, and triethyl citrate.
Manufactured for:
The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed by Waylis Therapeutics LLC.
The maker of this brand is not affiliated with and does not endorse Waylis Therapeutics LLC or its products.
11PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
NDC 80725-809-13
Jalyn
30 Capsules
WARNING: JALYN should not be used by
12PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
NDC 80725-809-59
Jalyn
90 Capsules
WARNING: JALYN should not be used by
