Avodart

Avodart prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Product dosage: 0.5mg
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Avodart (dutasteride) is a prescription medication specifically formulated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. As a potent 5-alpha-reductase inhibitor, it works by targeting the hormonal pathway responsible for prostate growth, leading to a significant reduction in prostate volume. This mechanism of action not only alleviates obstructive and irritative urinary symptoms but also demonstrably improves urinary flow and reduces the risk of acute urinary retention and the need for BPH-related surgery. Its use represents a cornerstone in the long-term medical management of BPH, offering a non-surgical approach to controlling disease progression.

Features

• Active Pharmaceutical Ingredient: Dutasteride 0.5 mg.
• Pharmacological Class: Dual 5-alpha-reductase inhibitor (Type 1 and Type 2).
• Formulation: Soft gelatin capsules for oral administration.
• Mechanism: Inhibits the conversion of testosterone to dihydrotestosterone (DHT), the primary androgen responsible for prostate growth.
• Proven significant reduction in prostate volume, as measured by MRI and transrectal ultrasound.
• Long half-life (~5 weeks) supports a consistent, once-daily dosing regimen.

Benefits

• Sustained Improvement in Urinary Symptoms: Leads to a significant and sustained decrease in the International Prostate Symptom Score (IPSS), alleviating bothersome symptoms like weak stream, hesitancy, nocturia, and urgency.
• Reduced Risk of Serious Complications: Clinically proven to lower the probability of acute urinary retention (AUR) events, a painful condition requiring catheterization, and reduces the long-term risk of needing invasive BPH-related surgery.
• Disease Modification: Unlike alpha-blockers that only provide symptomatic relief, Avodart addresses the underlying pathophysiology of BPH by reducing prostate size, potentially altering the natural history of the disease.
• Convenient Dosing: A single, 0.5 mg capsule taken once daily simplifies the treatment regimen and improves long-term adherence.
• Objective Flow Rate Improvement: Results in a measurable and statistically significant increase in maximum urinary flow rate (Qmax), providing an objective parameter of improved urinary function.

Common use

Avodart is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It is used to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Treatment leads to a noticeable improvement in urinary flow and symptoms typically within 3-6 months of initiation, with continued improvement observed over a 24-month period. It is intended for long-term management and is not indicated for use in women or children. Avodart is also approved for use in combination with the alpha-blocker tamsulosin for added symptomatic relief in appropriate patients.

Dosage and direction

The recommended dosage of Avodart is one 0.5 mg capsule taken orally once a day. The capsule should be swallowed whole and must not be crushed or chewed due to the potential for mucosal irritation from the contents. Avodart may be taken with or without food, as bioavailability is not significantly affected by meals. To ensure consistent therapeutic drug levels, it is advisable to take the capsule at approximately the same time each day. A treatment period of at least 6 months is usually necessary to adequately assess whether the patient will respond to therapy. Patients should be advised that they may need to continue taking Avodart long-term to maintain symptom control and achieve the full benefits regarding risk reduction.

Precautions

• Pregnancy Warning: Dutasteride is absorbed through the skin and can cause abnormal development of external genitalia in a male fetus. Women who are or may become pregnant must not handle leaking Avodart capsules due to the risk of teratogenicity.
• Prostate Cancer Evaluation: Prior to initiating therapy, patients should be evaluated to rule out other urological diseases, including carcinoma of the prostate. Avodart causes a decrease in serum prostate-specific antigen (PSA) levels; clinicians must adjust their interpretation of PSA values for patients undergoing treatment.
• PSA Monitoring: PSA levels are approximately halved after 6 months of therapy. To interpret serial PSAs in a patient taking Avodart, the PSA value should be doubled for comparison to normal ranges in untreated men. Any confirmed increase in PSA while on Avodart warrants further evaluation.
• Blood Donation: Patients should not donate blood until at least 6 months have passed after their final dose to prevent administration of dutasteride to a pregnant female transfusion recipient.
• Hepatic Impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Caution is advised when administering Avodart to patients with liver disease.

Contraindications

Avodart is contraindicated in the following patient populations:

• Patients with a known hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, or any component of the formulation.
• Women who are pregnant or who may become pregnant. Dutasteride can cause fetal harm if administered during pregnancy.
• Pediatric patients.

Possible side effect

As with all medications, Avodart can cause side effects, although not everybody gets them. The most common side effects are related to its hormonal mechanism of action and include:

• Sexual Dysfunction: Decreased libido (1.9-4.2%), erectile dysfunction (4.7-7.3%), and ejaculation disorders (1.4-2.2%), including decreased ejaculate volume. These events are often transient but may persist in some patients after discontinuation of treatment.
• Reproductive System: Gynecomastia (including breast enlargement and breast tenderness) has been reported in 0.6-1.9% of men.
• Other: Less common side effects include dizziness and rash.

Post-marketing experience has also included reports of allergic reactions, including skin rash, pruritus, urticaria, and localized and generalized edema. Patients should be advised to report any persistent or bothersome side effects to their healthcare provider.

Drug interaction

Formal drug interaction studies have been conducted with Avodart. The following are clinically relevant interactions:

• Potent CYP3A4 Inhibitors (e.g., ritonavir, ketoconazole, verapamil, diltiazem, erythromycin): Coadministration with drugs that significantly inhibit the CYP3A4 isoenzyme may increase the serum concentration of dutasteride. While no dosage adjustment is recommended, clinicians should be aware of the potential for increased side effects.
• Tamsulosin: No clinically significant pharmacokinetic interaction was observed when dutasteride was coadministered with tamsulosin. The combination is approved for use and is well-tolerated.
• Warfarin: No interaction was observed in a formal drug interaction study.
• Digoxin, Cholestyramine, ACE Inhibitors, Calcium Channel Blockers, NSAIDs: No clinically significant interactions have been identified.

Missed dose

If a dose of Avodart is missed, the patient should take it as soon as he remembers. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed one. Maintaining a consistent daily routine is important for optimal efficacy.

Overdose

There is no specific antidote for Avodart overdose. Single doses of dutasteride up to 40 mg (80 times the recommended dose) have been administered in studies without significant adverse effects. In the event of an overdose, symptomatic and supportive treatment should be instituted. Since dutasteride is highly protein-bound, dialysis is unlikely to be of benefit.

Storage

Avodart capsules should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). The capsules must be kept in their original blister pack or bottle to protect them from light and moisture. Keep this medication out of the sight and reach of children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided may not cover all possible uses, directions, precautions, drug interactions, or adverse effects.

Reviews

• Clinical Trial Data (4-year CombAT Study): “Long-term combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy alone for improving symptoms and Qmax and reducing the relative risk of AUR and BPH-related surgery in men with moderate-to-severe LUTS at risk of disease progression.” - European Urology
• Urologist, 15 years experience: “In my practice, Avodart is a foundational therapy for men with moderate to severe BPH and significant prostate enlargement. The reduction in prostate volume is real and measurable, which translates to durable symptom control and a meaningful decrease in the need for surgical intervention down the line. The side effect profile is manageable and must be discussed openly with patients during the informed consent process.”
• Patient, 68 years old, on therapy for 3 years: “It took about 5 months to really notice the full effect, but the difference is night and day. I’m no longer getting up 4 times a night, and the constant urgency is gone. My urologist explained the potential side effects upfront, and for me, the trade-off has been well worth it for the quality of life improvement.”
• Meta-Analysis Review: “Dutasteride demonstrates consistent efficacy in improving urinary symptoms and flow rates, reducing prostate volume, and decreasing the incidence of AUR and surgery compared to placebo. It represents an effective medical option for altering the disease progression of BPH.”