Dutasteride / Tamsulosin

What it is and how it works

Mechanism of Action 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. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2.

Mechanism class: 5-alpha Reductase Inhibitors

Indications

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. Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic 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.

Dosage and administration (summary)

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. Swallow capsule whole.

Contraindications

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 .

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%.

Pregnancy

Pregnancy Risk Summary 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.

Storage and supply

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’ in black ink and opaque brown body imprinted with ‘0.5/0.4’ in black ink containing one dutasteride soft gelatin capsule and white to off white tamsul…

Source: Dutasteride And Tamsulosin Hydrochloride (Dutasteride And Tamsulosin Hydrochloride) — US FDA prescribing information, 2024-07-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.