TM Owner Waylis Therapeutics LLC
Jalyn 0.5mg/0.4mg Capsule
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Indications & Clinical Uses
- Jalyn capsules contain two medicines: dutasteride 0.5 mg, a 5-alpha-reductase inhibitor that shrinks the prostate gradually over months, and tamsulosin hydrochloride 0.4 mg, an alpha-blocker that relaxes muscle in the prostate and bladder neck for faster relief of urinary symptoms.
- Jalyn is approved in the United States for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
- It is for adult men only and must never be taken or handled by women who are or may become pregnant, or by children.
- Jalyn is not approved to prevent prostate cancer.
- The current US label is held by Waylis Therapeutics LLC rather than the originator GSK, and dutasteride and tamsulosin capsules are also available as generics from several manufacturers.
Side Effects
- Jalyn has NO boxed warning.
- The most common side effects are sexual: ejaculation problems in about 7.8% of men during the first year, impotence in about 5.4%, reduced sex drive in about 4.5%, breast tenderness or enlargement in about 1.1% and dizziness in about 1.1%.
- Dizziness, light-headedness or fainting on standing is most likely with the first doses.
- In a large prevention study, high-grade prostate cancer was found in 1.0% of men taking dutasteride compared with 0.5% on placebo.
- Rarely, tamsulosin causes a painful erection lasting more than four hours (priapism), which needs emergency treatment to prevent permanent damage.
- Seek urgent help for breast lumps or nipple discharge, severe rash, swelling of the face or throat, or fainting.
Precautions & Warnings
- Swallow Jalyn capsules whole about 30 minutes after the same meal each day; never chew or open them, as the contents irritate the mouth and throat.
- Because dutasteride is absorbed through the skin, women who are or could become pregnant must not handle leaking capsules.
- Do not donate blood while taking Jalyn or for 6 months after your last dose, so that a pregnant transfusion recipient is never exposed.
- Tell your eye surgeon that you take or have taken Jalyn before cataract or glaucoma surgery, because tamsulosin can cause intraoperative floppy iris syndrome.
- Jalyn roughly halves PSA readings, so any doctor interpreting your PSA for prostate cancer screening must know you take it.
- Stand up slowly because of the risk of low blood pressure and fainting, and take care driving until you know how the capsules affect you.
- Use caution if you are allergic to sulfa medicines.
Avoid Interactions
- Increase the effect or toxicity: strong CYP3A4 inhibitors such as ketoconazole should not be combined with Jalyn; moderate CYP3A4 inhibitors like erythromycin, CYP2D6 inhibitors such as paroxetine, and cimetidine raise tamsulosin levels and the risk of dizziness and fainting.
- Other alpha-blockers such as doxazosin or alfuzosin must not be taken at the same time, and PDE-5 inhibitors for erectile dysfunction such as sildenafil or tadalafil add to the blood-pressure-lowering effect.
- Alcohol and blood pressure medicines can make dizziness worse, and warfarin needs monitoring when Jalyn is started or stopped.
- Avoid taking a separate dutasteride or tamsulosin product alongside Jalyn, which already contains both.
- Tell your healthcare provider about every medicine, herbal product and supplement before starting.
References
Frequently Asked Questions
Jalyn treats symptomatic benign prostatic hyperplasia (an enlarged prostate) in adult men. It combines dutasteride 0.5 mg, which shrinks the prostate over months, with tamsulosin 0.4 mg, which relaxes the bladder neck for quicker relief of urinary symptoms. It is not approved to prevent prostate cancer.
Take one Jalyn capsule once a day, about 30 minutes after the same meal each day. Swallow it whole: never chew or open the capsule, because the dutasteride and tamsulosin contents irritate the mouth and throat. Take the next dose as usual if you miss one.
The commonest side effects of Jalyn are sexual: ejaculation problems in about 7.8% of men, impotence in 5.4%, lower sex drive in 4.5%, plus breast tenderness and dizziness in about 1.1% each. An erection lasting over four hours is a medical emergency.
Avoid ketoconazole, other alpha-blockers such as doxazosin, and taking separate dutasteride or tamsulosin products with Jalyn. Women who are or could become pregnant must not handle leaking capsules. Do not donate blood during treatment or for 6 months after your last dose.
Yes. Jalyn roughly halves PSA levels because of dutasteride, so tell any doctor measuring your PSA that you take it; the result is usually doubled for interpretation. A rising PSA during treatment still needs investigation. Dutasteride has been linked with a small increase in high-grade prostate cancer.
Yes. Tamsulosin in Jalyn can cause intraoperative floppy iris syndrome, which makes cataract or glaucoma surgery harder and riskier. Tell the eye surgeon before surgery even if you stopped Jalyn some time ago, so the operation can be planned safely. Do not stop the capsules without advice.
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