Dutas: Advanced 5α-Reductase Inhibitor for Androgen Control
Dutas
| Product dosage: 0.5mg | |||
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Dutas (dutasteride) is a potent, dual 5α-reductase inhibitor specifically engineered for the medical management of androgen-dependent conditions. As a second-generation inhibitor, it demonstrates superior enzymatic coverage compared to its predecessors, effectively suppressing both type I and type II isoforms of 5α-reductase. This comprehensive action results in a significant and sustained reduction of serum and intraprostatic dihydrotestosterone (DHT) levels—the primary androgen mediator in benign prostatic hyperplasia (BPH) and androgenetic alopecia. Clinicians prescribe Dutas for its reliable pharmacokinetic profile and evidence-based efficacy in improving urinary symptoms and arresting hair loss progression in appropriate patient populations.
Features
- Contains 0.5 mg dutasteride as the active pharmaceutical ingredient
- Formulated in a soft gelatin capsule for optimized bioavailability
- Dual inhibition of both type I and type II 5α-reductase enzymes
- Exhibits a long elimination half-life of approximately 5 weeks at steady state
- Provides >90% suppression of serum dihydrotestosterone (DHT) levels
- Manufactured under cGMP standards with consistent dissolution properties
Benefits
- Significantly reduces prostate volume in BPH patients, alleviating lower urinary tract symptoms
- Prevents further miniaturization of hair follicles in androgenetic alopecia, promoting hair retention
- Demonstrates superior DHT suppression compared to selective type II inhibitors
- Requires only once-daily dosing due to extended half-life, enhancing adherence
- Shows progressive improvement in symptoms with continued treatment over months
- May reduce the risk of acute urinary retention and BPH-related surgery in appropriate candidates
Common use
Dutas is primarily indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve urinary flow and reduce the risk of acute urinary retention and future surgical intervention. It is also used off-label in the management of male pattern hair loss (androgenetic alopecia) in men, where it helps to slow hair loss progression and may promote hair regrowth in some patients. Treatment is typically long-term, as symptoms return upon discontinuation. Dutas is not indicated for use in women or pediatric populations.
Dosage and direction
The recommended dosage for BPH treatment is one 0.5 mg capsule taken orally once daily, with or without food. For androgenetic alopecia (off-label use), the same 0.5 mg daily dosage is typically employed. Capsules should be swallowed whole and not crushed or chewed. Consistent daily dosing is important to maintain stable dutasteride concentrations and continuous enzyme inhibition. Steady-state plasma concentrations are achieved after approximately 3-6 months of continuous dosing. Dosage adjustment is not typically required in elderly patients or those with renal impairment, but caution is advised in hepatic impairment.
Precautions
Dutasteride is contraindicated in women who are or may become pregnant due to risk of fetal harm. Capsules should not be handled by women who are pregnant or may become pregnant, as dutasteride can be absorbed through the skin. Patients should be informed that they may experience decreased libido, erectile dysfunction, or ejaculation disorders. Serum prostate-specific antigen (PSA) levels decrease by approximately 50% after 6 months of treatment; this should be considered when interpreting PSA values for prostate cancer screening. Regular follow-up is recommended to assess therapeutic response and monitor for adverse effects.
Contraindications
Dutas is contraindicated in patients with known hypersensitivity to dutasteride, other 5α-reductase inhibitors, or any component of the formulation. It is contraindicated in women who are pregnant or may become pregnant due to the risk of abnormalities in the external genitalia of a male fetus. Use is also contraindicated in pediatric patients and in patients with severe hepatic impairment. Dutas should not be used by women who are breastfeeding, as it is not known whether dutasteride is excreted in human milk.
Possible side effects
The most common adverse reactions (≥1%) include: erectile dysfunction, decreased libido, ejaculation disorders (including decreased ejaculate volume), and breast enlargement and/or tenderness. These side effects often diminish with continued treatment. Less common but serious side effects may include allergic reactions (rash, itching, swelling, especially of the face/tongue/throat), depression, and male breast cancer. Some patients may experience hair growth elsewhere on the body. Most sexual side effects are reversible upon discontinuation, though some cases of persistent sexual dysfunction have been reported post-marketing.
Drug interaction
Dutasteride is primarily metabolized by CYP3A4 enzymes. Concomitant administration with potent CYP3A4 inhibitors (such as ketoconazole, ritonavir, indinavir, clarithromycin, itraconazole) may increase dutasteride exposure. While no dosage adjustment is recommended, patients should be monitored for potential increased adverse effects. No clinically significant interactions have been observed with tamsulosin, terazosin, warfarin, digoxin, or cholestyramine. However, concomitant use with other 5α-reductase inhibitors is not recommended due to the potential for additive effects.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, 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. Consistent daily dosing is important for maintaining therapeutic effect, but occasional missed doses are unlikely to significantly impact overall efficacy due to dutasteride’s long half-life.
Overdose
In clinical trials, single doses of dutasteride up to 40 mg (80 times the recommended dose) have been administered without significant adverse effects. In case of suspected overdose, symptomatic and supportive treatment should be instituted. Since dutasteride is highly protein-bound, dialysis is unlikely to be of benefit. Symptoms of overdose may include dizziness, headache, and gastrointestinal disturbances. Medical attention should be sought immediately if a large overdose is suspected.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the container tightly closed and protect from light and moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly discard any unused or expired medication through a medicine take-back program or according to local guidelines.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Dutas is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Patients should consult their physician for proper diagnosis and treatment recommendations. Individual results may vary, and not all patients will experience the same benefits or side effects. The off-label use for hair loss should be carefully discussed with a healthcare provider, considering potential risks and benefits.
Reviews
Clinical studies demonstrate that approximately 70-80% of BPH patients experience significant improvement in urinary symptoms and flow rate after 6-12 months of treatment with dutasteride 0.5 mg daily. In hair loss studies, dutasteride has shown superior efficacy to finasteride in increasing hair count and thickness, with one study showing a 12.9% increase in hair count at 24 weeks compared to 7.4% with finasteride. Patient satisfaction surveys indicate high continuation rates, with many patients reporting improved quality of life due to reduced urinary symptoms or preserved hair coverage. However, some patients discontinue treatment due to sexual side effects, which occur in approximately 3-5% of users.