Dutasteride and tamsulosin hydrochloride

What is Dutasteride and tamsulosin hydrochloride?

Dutasteride and tamsulosin hydrochloride (JALYN) is a combination of dutasteride, a 5 alpha-reductase inhibitor, and tamsulosin, an alpha adrenergic antagonist used for the treatment of adult male symptomatic benign prostatic hyperplasia (BPH).

What are the uses of this medicine?

• Dutasteride and tamsulosin hydrochloride (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.

Limitations of Use:

• Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.

How does this medicine work?

• JALYN contains 2 medications, dutasteride and tamsulosin. These 2 medications 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.

Dutasteride:

• Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT).
• DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland.
• Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2.
• The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.
• Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex.

Tamsulosin:

• Tamsulosin, an alpha1-adrenoceptor blocking agent, exhibits selectivity for alpha1-receptors in the human prostate.
• Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1-adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck.
• Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who are:

• pregnant or could become pregnant.
• allergic to dutasteride, tamsulosin, or any of the ingredients in JALYN.
• taking another medicine that contains an alpha-blocker.
• allergic to other 5 alpha-reductase inhibitors, for example, PROSCAR (finasteride) Tablets.

What drug interactions can this medicine cause?

• There have been no drug interaction studies using JALYN. The following sections reflect information available for the individual components.
• 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).
• Do not use JALYN with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole). Use caution in combination with moderate CYP3A4 inhibitors (e.g., erythromycin) or strong (e.g., paroxetine) or moderate CYP2D6 inhibitors, or known poor metabolizers of CYP2D6. Concomitant use with known inhibitors can cause a marked increase in drug exposure.
• Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension.

Is this medicine FDA approved?

• Jalyn was approved by the U.S. Food and Drug Administration (FDA) on June 14, 2010.
• In June 2011, the FDA approved a label change warning of "Increased Risk of High-grade Prostate Cancer" from Jalyn.

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride Capsules

This medicine is available in fallowing brand namesː

• JALYN

What side effects can this medication cause?

The most common side effects of this medicine 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

Dutasteride, an ingredient of JALYN, has been shown to reduce sperm count, semen volume, and sperm movement.

JALYN may cause serious side effects, including:

• Decreased blood pressure
• Rare and serious allergic reactions
• Higher chance of a more serious form of prostate cancer
• Eye problems during cataract surgery
• A painful erection that will not go away

What special precautions should I follow?

• 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 women from receiving JALYN through blood transfusions.
• Orthostatic hypotension and/or syncope can occur. Advise patients of symptoms related to postural hypotension and to avoid situations where injury could result if syncope occurs.
• Do not use JALYN with other alpha adrenergic antagonists, as this may increase the risk of hypotension.
• JALYN reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on JALYN may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men.
• Do not use JALYN with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole). Use caution in combination with moderate CYP3A4 inhibitors (e.g., erythromycin) or strong (e.g., paroxetine) or moderate CYP2D6 inhibitors, or known poor metabolizers of CYP2D6. Concomitant use with known inhibitors can cause a marked increase in drug exposure.
• Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension.
• Priapism (persistent painful penile erection unrelated to sexual activity) has been associated (probably less than 1 in 50,000) with the use of alpha-adrenergic antagonists, including tamsulosin, which is a component of JALYN.
• Intraoperative Floppy Iris Syndrome has been observed during cataract surgery after alpha adrenergic antagonist exposure. Advise patients considering cataract surgery to tell their ophthalmologist that they take or have taken JALYN Capsules.
• Exercise caution with concomitant use of warfarin.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Dutasteride:

• No additional adverse effects to those seen at therapeutic doses of 0.5 mg.

Tamsulosin:

• Overdosage of tamsulosin lead to hypotension.

Treatment of overdosage: Dutasteride:

• There is no specific antidote for dutasteride.
• Therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.

Tamsulosin:

• Treatment for overdose may include restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position.
• If this measure is inadequate, then administration of intravenous fluids should be considered.
• If necessary, vasopressors should then be used and renal function should be monitored and supported as needed.
• Tamsulosin is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.

Can this medicine be used in pregnancy?

• JALYN may harm your unborn baby.
• Pregnant women should not touch JALYN Capsules.
• There are no adequate and well-controlled studies in pregnant women with JALYN or its individual components.

Can this medicine be used in children?

• JALYN is contraindicated for use in pediatric patients.
• Safety and effectiveness of JALYN in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: 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.

Who manufactures and distributes this medicine?

• Jointly Manufactured by

Catalent Pharma Solutions Beinheim, France Schorndorf, Germany and Rottendorf Pharma GmbH Ennigerloh, Germany

• Distributed by

GlaxoSmithKline Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• 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.
• Safely throw away medicine that is no longer needed.

• Dailymed label info on Dutasteride and tamsulosin hydrochloride
• FDA Dutasteride and tamsulosin hydrochloride

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