Dutasteride And Tamsulosin Hydrochloride
Pronunciation: JAY-lin (doo-TAS-ter-ide + tam-SOO-loh-sin).
- Generic name
- dutasteride and tamsulosin hydrochloride
- Brand names
- Combodart, Jalyn, Duodart, Urimax D, Veltam Plus, Dutas-T
- Drug class
- Alpha-1 adrenergic antagonist and 5-alpha-reductase inhibitor combination
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What dutasteride and tamsulosin hydrochloride is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how dutasteride and tamsulosin hydrochloride works
Dutasteride inhibits both type 1 and type 2 5-alpha-reductase enzymes, blocking the conversion of testosterone to dihydrotestosterone (DHT), which is responsible for prostate growth. Tamsulosin selectively blocks alpha-1A adrenergic receptors in the prostate and bladder neck, leading to smooth muscle relaxation and improved urinary flow. The combination provides both reduction in prostate size and symptomatic relief. (1) (2)
What dutasteride and tamsulosin hydrochloride is used for
Symptoms of benign prostatic hyperplasia (BPH / enlarged prostate) in adult men — difficulty urinating, frequent urination, and incomplete bladder emptying
Recovered from the clinician database description (a data-recovery fix — the automated extractor had left this field empty even though the description text names it). Jalyn does not cure BPH; it manages symptoms and may reduce the need for prostate surgery. Not approved for use in women or children. (2)
Before taking dutasteride and tamsulosin hydrochloride
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to dutasteride, tamsulosin, or capsule ingredients. (Contraindication) (2)
- women and children. (Contraindication) (2)
- severe hepatic impairment. (Contraindication) (2)
Tell your clinician about
(2)How to take dutasteride and tamsulosin hydrochloride
- General Instructions: Take Jalyn exactly as prescribed by your healthcare provider. Do not take more or less than directed.. Adult Dosing: The usual recommended dose is one capsule (containing 0.5 mg dutasteride and 0.4 mg tamsulosin) taken once daily, approximately 30 minutes after the same meal each day.. Pediatric Dosing: Jalyn is not approved for use in children or adolescents.. Administration: Swallow the capsule whole with water. Do not crush, chew, or open the capsule, as this may cause irritation of the mouth or throat.. When To Stop: Do not stop taking Jalyn without consulting your healthcare provider, even if you feel well. Stopping suddenly may cause symptoms to return.. Storage: Store at room temperature (20°C to 25°C/68°F to 77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention or contact a poison control center immediately. Symptoms may include severe dizziness, fainting, or low blood pressure. Supportive care is recommended as there is no specific antidote. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Ejaculation disorders
Incidence: 11% (coadministration arm, clinical trials)
Impotence / erectile dysfunction
Incidence: 5.4% in year 1 (coadministration arm, clinical trials)
Decreased libido
Incidence: 4.5% in year 1 (coadministration arm, clinical trials)
Breast disorders (e.g., gynecomastia)
Incidence: 1.1% (coadministration arm, clinical trials)
Dizziness
Incidence: 1.1% in year 1 (coadministration arm, clinical trials); can be related to orthostatic hypotension
Serious warnings
FDA BOXED WARNING (ELEVATED — an earlier draft of this record had this only as an ordinary warning line) — serious
Symptoms: FDA BOXED WARNING (ELEVATED — an earlier draft of this record had this only as an ordinary warning line): JALYN should not be used by women or children. Women who are or may become pregnant should not use or handle JALYN capsules — dutasteride can be absorbed through the skin and may cause fetal harm, specifically abnormal development of external genitalia in a male fetus. If a woman who is or may become pregnant comes into contact with a leaking capsule, the contact area should be washed immediately with soap and water.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Blood donation restriction (ADDED — quantified duration) — serious
Symptoms: Blood donation restriction (ADDED — quantified duration): men being treated with Jalyn should not donate blood until at least 6 months have passed since their last dose, to prevent a pregnant transfusion recipient from being inadvertently exposed to dutasteride. Detectable serum dutasteride levels can persist for 4-6 months after stopping.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
May increase the risk of high-grade prostate cancer — serious
Symptoms: May increase the risk of high-grade prostate cancer. Can cause orthostatic hypotension (sudden drop in blood pressure when standing). May cause sexual side effects, including decreased libido and ejaculation disorders. Can affect PSA test results for prostate cancer screening.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to dutasteride, tamsulosin, or capsule ingredients; women and children; severe hepatic impairment. Use with caution in patients with orthostatic hypotension, history of sulfa allergy (tamsulosin), or impaired liver function. Monitor for signs of prostate cancer, as PSA levels may be artificially lowered.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Jalyn may interact with other medications, including other alpha-blockers, PDE5 inhibitors (such as sildenafil), antifungal agents (like ketoconazole), certain antibiotics, and medications that affect liver enzymes (CYP3A4 inhibitors). Always inform your healthcare provider about all medicines and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
FDA Pregnancy Category X: JALYN is not for use in women. Dutasteride may cause fetal harm — specifically abnormal development of external genitalia in a male fetus — if a pregnant woman is exposed, whether by taking the medicine or by skin contact with a leaking capsule. Women who are or may become pregnant should not use or handle JALYN capsules; see the boxed warning. (2)
Breastfeeding
Not applicable — JALYN is not approved for use in women. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children; JALYN is not approved for use in children. (2)
Renal_impairment
Contraindicated in severe hepatic impairment per the clinician database. Requires a primary-source research pass before this section can be completed. (2)
Hepatic_impairment
Contraindicated in severe hepatic impairment per the clinician database. Requires a primary-source research pass before this section can be completed. (2)
Monitoring
(2)Storage
Store at 25°C (77°F); excursions permitted 15-30°C (59-86°F). Capsules may become deformed or discolored if kept at high temperatures. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: BPH symptom relief
Dose summary: One capsule (0.5 mg dutasteride and 0.4 mg tamsulosin) taken orally once daily, approximately 30 minutes after the same meal each day.
Renal context: FDA label (JALYN, section 8.6): the effect of renal impairment on dutasteride/tamsulosin pharmacokinetics has not been directly studied using the combination product itself. No dosage adjustment is necessary for moderate-to-severe renal impairment (creatinine clearance 10 to <30 mL/min/1.73 m2), based on data from the individual components. Patients with end-stage renal disease (creatinine clearance <10 mL/min/1.73 m2) have not been studied, so JALYN should be used with added caution and clinician oversight in that group. (1) (2)
Hepatic guidance
FDA label (JALYN, section 8.7): the effect of hepatic impairment on dutasteride/tamsulosin pharmacokinetics has not been directly studied using the combination product. From the individual components: dutasteride is extensively metabolized and exposure could be higher in hepatically impaired patients, though a study giving 10 times the therapeutic dutasteride dose for 24 weeks found no additional adverse events versus the therapeutic dose; tamsulosin does not require a dosage adjustment in moderate hepatic impairment, and has not been studied in severe hepatic impairment. Clinician oversight is advised, especially in more than mild hepatic impairment.
Frequently asked questions
How long does it take for Jalyn to work?
It may take several weeks to months to notice improvement in urinary symptoms. Maximum benefit is usually seen after 3 to 6 months of consistent use.
Can Jalyn be used for prostate cancer prevention?
Jalyn is not approved for prostate cancer prevention. It may lower PSA levels and mask early detection of prostate cancer. Discuss prostate cancer screening with your doctor.
What should I do if I experience dizziness while taking Jalyn?
Stand up slowly from sitting or lying positions to reduce dizziness. If dizziness persists or is severe, contact your healthcare provider.
Can women or children take Jalyn?
No, Jalyn is not approved for use in women or children. Women who are pregnant or may become pregnant should not handle the capsules.
Does Jalyn affect sexual function?
Yes, Jalyn can cause decreased libido, difficulty with ejaculation, or erectile dysfunction in some men.
Is it safe to donate blood while taking Jalyn?
No, you should not donate blood while taking Jalyn and for at least 6 months after stopping, to prevent exposure to pregnant women.
Can Jalyn be taken with food?
Yes, Jalyn should be taken approximately 30 minutes after the same meal each day to ensure consistent absorption.
What happens if I take too much Jalyn (Dutasteride + Tamsulosin)?
Taking too much Jalyn can lead to symptoms such as severe dizziness, fainting, or prolonged priapism. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Do not attempt to self-treat. Contact your local emergency services or poison control center right away.
Can I drink alcohol while taking Jalyn (Dutasteride + Tamsulosin)?
Drinking alcohol while taking Jalyn is generally not recommended. Alcohol can exacerbate the blood pressure-lowering effects of tamsulosin, potentially leading to increased dizziness, lightheadedness, or fainting. It's best to consult your healthcare provider regarding alcohol consumption to understand the specific risks for your situation.
Is Jalyn (Dutasteride + Tamsulosin) safe during pregnancy?
Jalyn is not indicated for use in women and is contraindicated in pregnant women. Dutasteride, a component of Jalyn, can cause serious harm to a male fetus. Therefore, pregnant women or women who may become pregnant should not handle Jalyn capsules. Always consult your doctor for specific guidance regarding pregnancy and medication.
What is the mechanism of action of dutasteride and tamsulosin hydrochloride?
Dutasteride inhibits both type 1 and type 2 5-alpha-reductase enzymes, blocking the conversion of testosterone to dihydrotestosterone (DHT), which is responsible for prostate growth. Tamsulosin selectively blocks alpha-1A adrenergic receptors in the prostate and bladder neck, leading to smooth muscle relaxation and improved urinary flow. The combination provides both reduction in prostate size and symptomatic relief. (1) (2)
What is the generic name of Dutasteride And Tamsulosin Hydrochloride?
The generic name is dutasteride and tamsulosin hydrochloride. It is sold under brand names including Combodart, Jalyn, Duodart, Urimax D, Veltam Plus, Dutas-T.
What class of drug is dutasteride and tamsulosin hydrochloride?
Dutasteride And Tamsulosin Hydrochloride is classed as: Alpha-1 adrenergic antagonist and 5-alpha-reductase inhibitor combination.
References
- Clinician-authored medicine record for Jalyn (Dutasteride + Tamsulosin) (MedGuideGlobal medicines database) · · accessed 2026-08-07 · source 1
- JALYN (dutasteride and tamsulosin hydrochloride) capsules — FDA DailyMed label · · accessed 2026-08-07 · source 2
- JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [WAYLIS THERAPEUTICS] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Dutasteride — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- Dutasteride and Tamsulosin Hydrochloride — FDA approval record (Drugs@FDA ANDA213300)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- dutasteride and tamsulosin — RxNorm normalized drug concept (RXCUI 1001472)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient dutasteride and tamsulosin hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Jalyn