Tamsulosin

Tamsulosin

Approved uses

• Dutasteride and tamsulosin hydrochloride capsules are 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 dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer.

Forms and strengths

• Dutasteride and tamsulosin hydrochloride capsules, USP containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are size "00" hard shell-capsules with opaque orange cap imprinted with 'DTT'...

How it is taken

• The recommended dosage of dutasteride and tamsulosin hydrochloride capsules 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 dutasteride and tamsulosin hydrochloride capsule may result in irritation of the oropharyngeal mucosa.
• Take one capsule daily approximately 30 minutes after the same meal each day.

Must not be used when

• Dutasteride and tamsulosin hydrochloride capsules are 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, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant female.

Interactions

• There have been no drug interaction trials using dutasteride and tamsulosin hydrochloride.
• The following sections reflect information available for the individual components.

Warnings and precautions

• 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 dutasteride and tamsulosin hydrochloride with other alpha-adrenergic antagonists, as this may increase the risk of hypotension.
• Dutasteride and tamsulosin hydrochloride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride and tamsulosin hydrochloride 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 dutasteride and tamsulosin hydrochloride 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.
• Exercise caution with concomitant use of phosphodiesterase-5 (PDE-5) inhibitors, as this may increase the risk of hypotension.
• Drugs that contain dutasteride, including dutasteride and tamsulosin hydrochloride, may increase the risk of high-grade prostate cancer.
• Prior to initiating treatment with dutasteride and tamsulosin hydrochloride, consideration should be given to other urological conditions that may cause similar symptoms.
• Females who are pregnant or may be pregnant should not handle dutasteride and tamsulosin hydrochloride capsules due to potential risk to a male fetus.

Common side effects

• 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.
• most common adverse reactions reported in subjects receiving coadministered dutasteride and tamsulosin were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.
• most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).

Pregnancy

Dutasteride and tamsulosin hydrochloride is contraindicated for use in pregnancy because it may cause harm to the male fetus. Dutasteride and tamsulosin hydrochloride is not indicated for use in females. Dutasteride, a component of dutasteride and tamsulosin hydrochloride, is a 5-alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.

How it acts

Dutasteride and tamsulosin hydrochloride are 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.

Label holder:

Aurobindo Pharma Limited

Label version:

19 July 2024

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.