Jalyn

Jalyn is a prescription medicine containing dutasteride and tamsulosin. It is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Dutasteride shrinks the prostate, while tamsulosin relaxes muscles in the prostate and bladder neck.

Combining these two medications improves BPH symptoms more effectively than using either one alone.

Side effects of Jalyn

Jalyn may cause:

• Decreased blood pressure: This can lead to fainting, dizziness, and lightheadedness, especially at the beginning of treatment. Other symptoms include swelling of the face, tongue, or throat, difficulty breathing, and serious skin reactions.
• Sexual side effects: These include ejaculation problems, trouble getting or maintaining an erection, and a decrease in sex drive. If you experience breast lumps or nipple discharge, contact your healthcare provider.
• Other common side effects: Dizziness, enlarged or painful breasts, and a runny nose. Some of these events may persist even after stopping Jalyn.
• Depressed mood: Dutasteride, an ingredient of Jalyn, has been reported to cause depressed mood in some patients.
• Effects on male fertility: Dutasteride has been shown to reduce sperm count, semen volume, and sperm movement. The impact of Jalyn on male fertility is not yet known.
• Prostate-Specific Antigen (PSA) Test: Before and during Jalyn treatment, your healthcare provider may conduct a PSA test to check for other prostate problems, including prostate cancer. Jalyn can reduce PSA levels, but your healthcare provider can still use it to assess your risk of prostate cancer. Any increases in PSA levels while on Jalyn should be evaluated by your healthcare provider.
• Other possible side effects: This is not an exhaustive list of all possible side effects. If you experience any, contact your doctor and report them to the FDA.

Dosage for Jalyn

• The recommended dosage 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.
• Swallow the capsules whole and do not chew or open them to avoid irritation of the oropharyngeal mucosa.

Drug interactions with Jalyn

There have been no specific drug interaction studies conducted with Jalyn. The following information is based on the individual components of Jalyn.

Cytochrome P450 Inhibition

Dutasteride

• Dutasteride is metabolized by the CYP3A4 and CYP3A5 enzymes in humans. The effect of strong CYP3A4 inhibitors on dutasteride has not been studied. Exercise caution if prescribing dutasteride-containing products to patients taking potent CYP3A4 enzyme inhibitors (e.g., ritonavir).

Tamsulosin

Strong and Moderate Inhibitors of CYP3A4 or CYP2D6

• Tamsulosin is metabolized by CYP3A4 or CYP2D6. Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole) or strong CYP2D6 inhibitors (e.g., paroxetine) can increase tamsulosin exposure. Similar changes in exposure are expected in poor metabolizers of CYP2D6. Avoid using tamsulosin 0.4 mg capsules with strong CYP3A4 inhibitors. The effects of coadministration of both CYP3A4 and CYP2D6 inhibitors have not been evaluated.
• Treatment with cimetidine may moderately increase tamsulosin hydrochloride exposure.

Warfarin

Dutasteride

• Concomitant administration of dutasteride with warfarin does not affect the pharmacokinetics of warfarin or its effect on prothrombin time.

Tamsulosin

• No definitive drug-drug interaction trial has been conducted between tamsulosin hydrochloride and warfarin. Results from limited studies are inconclusive. Use caution when taking warfarin and tamsulosin-containing products concurrently.

Nifedipine, Atenolol, Enalapril

Tamsulosin

• No dosage adjustments are necessary when taking tamsulosin with nifedipine, atenolol, or enalapril.

Digoxin and Theophylline

Dutasteride

• Dutasteride does not alter the pharmacokinetics of digoxin.

Tamsulosin

• No dosage adjustments are necessary when taking tamsulosin with digoxin or theophylline.

Furosemide

Tamsulosin

• Tamsulosin does not affect the pharmacodynamics of furosemide. Although furosemide slightly reduces tamsulosin exposure, it is not clinically significant and does not require dose adjustment of tamsulosin.

Calcium Channel Antagonists

Dutasteride

• Coadministration of verapamil or diltiazem with dutasteride may increase dutasteride exposure, but the change is not considered clinically significant. No dutasteride dosage adjustment is recommended.

Cholestyramine

Dutasteride

• Administration of cholestyramine does not affect the bioavailability of dutasteride.

Pregnancy and breastfeeding

• No adequate studies have been conducted in pregnant women with Jalyn or its individual components.
• Jalyn is contraindicated for use in women of childbearing potential, including nursing women.
• The excretion of dutasteride and tamsulosin in human milk is not known.

Summary

Jalyn is a prescription medicine used to treat the symptoms of BPH in men with an enlarged prostate. It combines dutasteride and tamsulosin to improve BPH symptoms more effectively than either medication alone. However, Jalyn may cause serious side effects such as decreased blood pressure, allergic reactions, a higher risk of prostate cancer, eye problems, and prolonged painful erections. Consult your doctor if you experience any side effects while taking Jalyn.