Avodart

Prescription Drug Information for Avodart

Generic Name: Dutasteride

Avodart contains the active ingredient, dutasteride, which is a synthetic 4-azasteroid compound. Dutasteride selectively inhibits type I and type II dual 5-alpha-reductase isoforms, an intracellular enzyme responsible for converting testosterone to dihydrotestosterone (DHT). Avodart is used for the treatment of benign prostatic hyperplasia (BPH) in the male population with an enlarged prostate gland. It also improves urinary flow and decreases the chance of future prostate surgery. Avodart, available by prescription only.

Avodart is a medication that is used by men with an enlarged prostate due to benign prostatic hyperplasia, which is commonly referred to as BPH. The goal of this treatment is to improve the flow of urine and lower a man's risk for undergoing prostate surgery.

Dihydrotestosterone, or DHT, is a chemical present in the body which can cause an enlarged prostate. This medication treats an enlarged prostate by prohibiting the transformation of testosterone to DHT. By lowering amounts of DHT in the body, Avodart can relieve symptoms of an enlarged prostate and can cause it to shrink over time.

Indication/Usage: Avodart is indicated as monotherapy for treatment of benign prostatic hyperplasia in male patients with an enlarged prostate gland. It helps these patients as follows:

• Symptomatic improvement,
• Acute urinary retention risk reduction, and
• Reducing the need of BPH-related surgery.

Dose, Administration and Dosage Forms: Avodart is available as an opaque, dull- yellow gelatin capsule in 0.5 mg strength. The recommended dose of Avodart as monotherapy is 0.5 mg once daily. When used in combination therapy with alpha adrenergic antagonist tamsulosin, the recommended dose is 0.5 mg daily of Avodart and 0.4 mg daily of tamsulosin. Avodart capsules should be swallowed whole and should not be chewed or opened. If opened, they may irritate the oropharyngeal mucosa during administration. Avodart can be administered with or without food and should be stored between 15 C - 30 C (59-86 F).

Mechanism of Action: Avodart contains dutasteride as an active ingredient, which is a selective and competitive antagonist of type I and type II dual 5-alpha-reductase isoforms, an intracellular enzyme which converts testosterone into dihydrotestosterone (DHT). The type I isoenzyme is responsible for testosterone conversion in the reproductive tissues, skin and liver, while the type II isoenzyme mainly works to convert testosterone in the reproductive tissues. DHT converted from testosterone is thought to be involved in the development of benign prostatic hyperplasia (BPH) in males. It is actually the androgen primarily responsible for the initial development and later enlargement of the prostate gland. When dutasteride inhibits the 5-alpha reductase enzyme, the DHT formation is blocked, resulting in reduced levels of DHT in the body. When DHT levels decrease in the body, enlargement of the prostate glands is suppressed, a beneficial effect for BHP patients.

Side-effects and Safety Profile: Avodart is most commonly reported to cause various sexual side-effects such as decreased libido (sexual drive), suppressed amount of semen ejaculated during sex, impotency, ejaculation disorders, erection problems, breast tenderness or enlargement in males (gynecomastia), etc. Since these side-effects are moderately severe, they should be discussed with a physician immediately.

Various other Avodart side-effects include: dizziness, allergic reactions like hives, dyspnea, swelling of face, lips, tongue, or throat, etc. Patients experiencing these serious side-effects should seek immediate medical attention.

Various side-effects reported during postmarketing studies of Avodart include: localized edema, angioedema, rash, pruritus, urticaria, skin reactions, and male breast cancer.

Warnings and Contraindications:

• Serum prostate-specific antigen (PSA) concentration may be a signal of the presence of prostate cancer. Since Avodart may decrease PSA by about 50%, these levels should be closely monitored.
• Avodart is reported to increase the risks of high-grade prostate cancer.
• Pregnant women: Avodart is contraindicated and must be avoided in pregnant women because of the potential risks to male fetuses.
• Nursing women: Avodart is contraindicated in nursing women as it is not known whether dutasteride is excreted via human milk.
• Patients must not donate blood until 6 months after last taking Avodart.
• Avodart is contraindicated in pediatric patients.
• Semen characteristics: Avodart is reported to cause a reduction in total sperm count, semen volume, and sperm motility; however, it does not affect sperm concentration and sperm morphology.

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