Avodart

Brand Name and Generics

Avodart is the brand name for the generic drug dutasteride, which is classified as a 5-alpha-reductase inhibitor.

Indications for Use

Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery.

Pharmacological Mechanism

Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT), a key androgen in the development and growth of the prostate gland. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men.

Dosage Forms and Strengths

Avodart is available as 0.5 mg soft gelatin capsules. The capsules are opaque, yellow, and marked with the GX CE2 code.

Dosing Recommendations

The recommended dose of Avodart is one 0.5 mg capsule taken orally once daily, with or without food. The capsule should be swallowed whole and not chewed or opened.

Adjustments for Specific Populations

No dosage adjustment is necessary for the elderly or for patients with renal impairment. However, the drug has not been studied in patients with liver disease, and caution is advised in this population.

Drug Interactions

Avodart may interact with CYP3A4 inhibitors, potentially increasing the concentration of dutasteride. Care should be taken when co-administering with potent, chronic inhibitors of CYP3A4 such as clarithromycin, itraconazole, or ritonavir.

Concomitant Medications

When given with alpha-blocker therapy or phosphodiesterase-5 (PDE-5) inhibitors, which are also used in the management of BPH, no additional dosage adjustment is necessary.

Administration with Food

Avodart can be administered with or without food. Food does not significantly affect the bioavailability or absorption of the drug.

Potential for Capsule Softening

The soft gelatin capsules may become deformed and/or softened with prolonged exposure to heat above 30°C (86°F); store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

Time to Clinical Effect

Significant improvement in symptoms may be observed within 3 to 6 months of treatment with Avodart. Patients should be re-evaluated periodically to determine if the treatment is still effective.

Handling and Disposal

Pregnant women, or women who may become pregnant, should not handle Avodart capsules due to the potential for absorption and subsequent potential risk to a male fetus. If contact occurs, wash the affected area immediately with soap and water.

Potential for PSA Changes

Dutasteride can cause a decrease in the serum level of prostate-specific antigen (PSA). In interpreting PSA values in men undergoing treatment with dutasteride, a new PSA baseline should be established after 3-6 months of treatment, and PSA monitoring should be conducted thereafter.

Consideration in Cataract Surgery

Ophthalmologists should be informed of prior use of dutasteride before cataract or glaucoma surgery due to the potential for a condition known as Intraoperative Floppy Iris Syndrome (IFIS).

Monitoring Renal Function

There is no adjustment in dutasteride dosing for patients with renal impairment, but these patients may be at an increased risk of adverse reactions. Monitoring for adverse reactions should be considered.

Impact on Semen Characteristics

Dutasteride may cause a decrease in the volume of ejaculate; this does not necessarily impair sexual function.

Liver Enzyme Abnormalities

Rarely, Avodart can cause liver enzyme abnormalities. Monitoring liver function may be considered in cases of suspected drug-induced liver injury.

Use in Prostate Cancer

Dutasteride is not approved for the prevention of prostate cancer. It may increase the risk of developing high-grade prostate cancer. Any increase in PSA levels while on dutasteride should be evaluated for the possibility of prostate cancer.

Storage Instructions

Avodart should be stored in a dry place at room temperature, 25°C (77°F), away from direct sunlight, and kept in the original packaging until use to protect from moisture.

Proper Disposal Protocol

Because of the potential risk to a male fetus, Avodart capsules should not be disposed of via wastewater or household waste. Unused or expired Avodart should be returned to a pharmacy or disposed of in accordance with local requirements.