Fixed-dose combination
Dutasteride and Tamsulosin is a fixed-dose combination of a 5-alpha reductase inhibitor and an alpha-adrenergic blocker indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. MedsAcross supplies Dutasteride and Tamsulosin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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 (BPH) in men with an enlarged prostate. Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
Source: US FDA prescribing information
JALYN is a combination of 2 drugs with different mechanisms of action to improve symptoms in patients with BPH: dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an antagonist of alpha 1A -adrenoreceptors. Dutasteride Dutasteride inhibits the conversion of testosterone to 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.
Source: US FDA prescribing information
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. Take one capsule daily approximately 30 minutes after the same meal each day. Swallow capsule whole.
Source: US FDA prescribing information
JALYN is contraindicated for use in: Pregnancy. Dutasteride use is contraindicated in females who are pregnant. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, JALYN may cause fetal harm when administered to a pregnant female. 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. Pregnancy.
Source: US FDA prescribing information
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, a combination of both CYP3A4 and CYP2D6 inhibitors, or known poor metabolizers of CYP2D6.
Source: US FDA prescribing information
The most common adverse reactions, reported in ≥1% of subjects treated with coadministered dutasteride and tamsulosin are ejaculation disorders, impotence, decreased libido, dizziness, and breast disorders.
Source: US FDA prescribing information
There have been no drug interaction trials using JALYN. The following sections reflect information available for the individual components. Cytochrome P450 Inhibition Dutasteride Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes. The effect of potent CYP3A4 inhibitors on dutasteride has not been studied. 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) Tamsulosin Strong and Moderate Inhibitors of CYP3A4 or CYP2D6: Tamsulosin is extensively metabolized, mainly by CYP3A4 or CYP2D6. Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in increases in the C max and area under the concentration-time curve (AUC) of tamsulosin by factors of 2.2 and 2.8, respectively.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Dutasteride and Tamsulosin, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Dutasteride and Tamsulosin 0.5 mg/0.4 mg capsuleOralGeneric name | Dutasteride and Tamsulosin | — | US FDA | Available on request |
| Jalyn 0.5 mg/0.4 mg capsuleOral | Dutasteride and Tamsulosin | Waylis Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 14 June 2010 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 2 presentations of Dutasteride and Tamsulosin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Dutasteride and Tamsulosin, including Jalyn.
Yes. The US FDA first approved Dutasteride and Tamsulosin on 14 June 2010, according to Drugs@FDA.
No listed presentation of Dutasteride and Tamsulosin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Dutasteride and Tamsulosin is classified under ATC code G04CA52 (Dutasteride and Tamsulosin).
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