Treatment>Pharmacy>DutasterideDutasteride is a new drug prescribed for benign prostatic hyperplasia. Dutasteride has also shown very positive effects as a hair loss treatment for sufferers of male pattern baldness.
This page is dedicated to providing you with the most relevent and up-to-date information about Dutasteride, a drug recently introduced to treat Benign Prostatic Hyperplasia (BPH) and also known to have beneficial effect on hairloss.
What is Dutasteride used for?
Dutasteride is a recently approved drug developed by GlaxoSmithKline. Dutasteride is a dual 5-alpha-reductase inhibitor that 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
- Reduce the risk of the need for BPH-related surgery
Dutasteride is currently in trial phase for the treatment of alopecia (hairloss).
How does Dutasteride Work?
Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Dutasteride lowers DHT production in the body, leading to shrinkage of the enlarged prostate in most men. Just as your prostate became large over a long period of time, reducing the size of your prostate and improving your symptoms will take time. While some men have fewer problems and symptoms after 3 months of treatment with Dutasteride, a treatment period of at least 6 months is usually necessary to see if Dutasteride will work for you. Studies have shown that treatment with Dutasteride for 2 years reduces the risk of complete blockage of urine flow (acute urinary retention) and/or the need for surgery for benign prostatic hyperplasia (BPH).
Dutasteride is an FDA-Approved Drug
- Avodart™ FDA New Drug Application Number 21-319/S-001: 10-9-2002 Avodart ™ (Dutasteride 0.5mg) soft-gelatin capsules.
- FDA New Drug Application Number 21-319: Approved 11-20-2001 for treatment of Benign Prostatic Hyperplasia (BPH).
- Approvals in other markets are pending.
Dutasteride and Hairloss
Dutasteride is being developed for the treatment of Male Pattern Baldness (MPB). Dutasteride, which is taken in capsule form, has shown dramatic success in restoring hair to bald men in trials. It interferes with 5-alpha-reductase enzymes that break down the male hormone testosterone and turn it into dehydrotestosterone (DHT) - which causes hair to thin dramatically in later life. Dutasteride is has better DHT supression results than finasteride both Propecia and Proscar).
Availability of Dutasteride
United Pharmacies stocks Avodart™ and several versions of Generic Dutasteride available for shipment worldwide. All of the following are soft-gelatin capsules containing 0.5mg of Dutasteride.
- Avodart™ Capsules (manufactured by GlaxoSmithKline)
- Dutas Capsules (manufactured by Dr Reddy's)
- Duprost Capsules (manufactured by Cipla)
- Dutagen Capsules (manufactured by Ranbaxy)
Other Names for Dutasteride
Prior to deciding on Avodart™ as the marketing name for Dutasteride, several other names were discussed such as Duagen and Avolve. In addition, there are numerous versions of generic dutasteride, the most popular of which are Dutas, Duprost and Dutagen.
Dutasteride Patient Information
Dutasteride Facts
Generic Name: Dutasteride Brand Names: Avodart™ (GlaxoSmithKline)
Dutas (Generic by Dr Reddy's)
Duprost (Generic by Cipla)
Dutagen (Generic by Ranbaxy)Dosage: 0.5mg Medicine Form: Soft Gelatin Capsules Availabilty: Non-Controlled, Prescription Medicine FDA Approved: November 20th, 2001 What is the most important information I should know about Dutasteride?
- Dutasteride is for use by men only.
- Women who are or who may become pregnant must not handle dutasteride capsules. The medication can be absorbed through the skin and may cause birth defects in the unborn baby.
- Do not donate blood until at least 6 months have passed since the last dose of dutasteride is taken to prevent pregnant women from receiving dutasteride through blood transfusion.
What is Dutasteride?
- Dutasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).
- Dutasteride is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
- Dutasteride may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking dutasteride?
- Before taking dutasteride, tell your doctor if you have liver disease. You may not be able to take dutasteride, or you may need a dosage adjustment or special monitoring during therapy.
- Dutasteride is for use by men only.
- Do not handle this medication if you are pregnant or could become pregnant. Dutasteride is in the FDA pregnancy category X. This means that it will cause birth defects in an unborn baby. Women who are or who may become pregnant must not take dutasteride and must not handle dutasteride capsules. The medication can be absorbed through the skin and may cause birth defects in the unborn baby.
- It is not known whether dutasteride passes into breast milk. Dutasteride is not intended for use by women. Do not take this medication if you are breast-feeding a baby.
How should I take dutasteride?
- Take dutasteride exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
- Dutasteride is for use by men only.
- Take each dose with a full glass of water.
- Swallow the capsules whole. Do not chew, crush or break the capsules.
- Dutasteride can be taken with or without food.
- Do not stop taking dutasteride without first talking to your doctor. While some men have fewer problems and symptoms after 3 months of treatment with dutasteride, a treatment period of at least 6 months is usually necessary to see if treatment with dutasteride will be beneficial.
- Store dutasteride at room temperature away from moisture and heat. Dutasteride is supplied in soft gelatin capsules that may become soft and leak or may stick to other capsules if kept at high temperatures. If the capsules are cracked or leaking, do not use them and contact your pharmacist.
What happens if I miss a dose?
- Take the missed dose as soon as you remember during the same day. However, if you don't remember until the next day, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of the medication.
What happens if I overdose?
- Seek emergency medical attention.
- Symptoms of a dutasteride overdose are not known.
What should I avoid while taking Dutasteride?
- Do not donate blood until at least 6 months have passed since the last dose of dutasteride is taken to prevent pregnant women from receiving dutasteride through blood transfusion.
What are the possible side effects of dutasteride?
- Stop taking dutasteride and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
- Other, less serious side effects have been reported but usually resolve with continued treatment. Continue to take dutasteride and notify your doctor if you experience:
- decreased libido (sex drive)
- decreased amount of semen released during sex
- impotence (trouble getting or keeping an erection)
- breast tenderness or enlargement
- Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Dutasteride?
- Do not take dutasteride without first talking to your doctor if you are taking any of the following medicines:
- a protease inhibitor such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), or saquinavir (Invirase, Fortovase)
- itraconazole (Sporanox) or ketoconazole (Nizoral)
- verapamil (Calan, Calan SR, Covera-HS, Isoptin, Isoptin SR, Verelan, Verelan PM)
- diltiazem (Cardizem, Cardizem CD, Cardizem SR, Cartia XT, Dilacor XR, Tiazac, others)
- cimetidine (Tagamet, Tagamet HB, others)
- erythromycin (E-Mycin, Ery-Tab, Eryc, E.E.S., others)
- You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
- Drugs other than those listed here may also interact with dutasteride. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
Where can I get more information about Dutasteride?
- Your pharmacist has additional information about dutasteride written for health professionals that you may read.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- The information in this leaflet is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
Dutasteride Side Effects
Dutasteride side effects are usually mild and transient. Drug related adverse effects of dutasteride certainly appear to be less than those associated with finasteride. The most common side effects of dutasteride are sexual effects including:
- impotence
- decreased libido
- ejaculation disorders
- gynecomastia (breast tenderness)
Dutasteride side effects discovered in a clinical study are summarized in the table below. Approxiamtely 6% of each group (dutasteride and placebo) withdrew from the study due to adverse events, with the investigator attributing less than half of these withdrawals to drug related adverse effects.
Summary of Dutasteride Side Effects
Side Effect Dutasteride (n=2158) Placebo (n=2166) Impotence 117(5%) 59 (3%) Decreased Libido 74 (3%) 40 (2%) Gynecomastia 29(1%) 10 (<1%) Ejaculation Disorder 40 (2%) 14 (<1%) Side Effects of Long-Term Treatment with Dutasteride
The incidence of sexual adverse events considered to be drug-related decreased with duration of treatment. After the 6 months of treatment impotence, decreased libido, ejaculation disorders and gynecomastia were all <1% for both the dutasteride and placebo groups.
The incidence of drug-related events was lower during the second year of treatment compared with the first year of treatment. The only exception was gynecomastia which increased from 1% in the first year to 2% in the second year.
The table below shows the results of a study performed by Roehrborn et al (Efficacy and Safety of a Dual Inhibitor of 5-Alpha-Reductase Types 1 and 2 (Dutasteride) In Men With Benign Prostatic Hyperplasia", Roehrborn et al, Urology 60:434-441, 2002). The results show a significant decrease in side effect profiles as the treatment duration increases.
Dutasteride & Shedding
Dutasteride may cause an initial period of shedding approximately six to eight weeks into treatment. This is a normal response to treatment with dutasteride. For more information, see our page about dutasteride shedding.
What is Dutasteride used for?
Dutasteride is a recently approved drug developed by GlaxoSmithKline. Dutasteride is a dual 5-alpha-reductase inhibitor that 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
- Reduce the risk of the need for BPH-related surgery
Dutasteride is currently in trial phase for the treatment of alopecia (hairloss).
Dutasteride vs. Finasteride
Dutasteride & Finasteride Mechanisms of Action
Dutasteride and finasteride are both 5-alpha-reductase (5AR) inhibitors. Both treatments work by inhibiting 5AR, the enzyme responsible for converting testosterone to dihydrotestosterone (DHT). DHT is the primary androgen in the prostate. It is a primary factor in the development and progression of benign prostatic hyperplasia (BPH) and other prostate diseases and is also a major cause of hair loss.
Dutasteride is a competitive inhibitor of both type-1 and type-2 isoenzymes of DHT, with 45-fold greater potency than finasteride against type-1 and type-2 isoenzymes. Approximately 85% to 90% of DHT is suppressed by the inhibition of type-2 isozymes. The remaining DHT is hypothesized to be from type-1 5-alpha-reductase. Finasteride is a competitive inhibitor of 5-alpha-reductase that selectively inhibits the type-2 isoenzyme. The dual inhibition resulting from dutasteride treatment may be beneficial in prostatic diseases that depend on androgens, as both isoenzymes are up-regulated in BPH while only the type-1 isoenzyme is up-regulated in prostate cancer. It is not yet known if there are clinical differences between selective inhibitors and dual inhibitors of 5-alpha-reductase in the treatment of BPH.
Effect of Dutasteride and Finasteride on Serum DHT Concentrations
Serum DHT suppression when taking dutasteride is significantly greater than Serum DHT suppression when taking finasteride. treatment with dutasteride (0.5mg daily) in patients with BPH resulted in median reductions in serum DHT concentrations of 94% after one year of treatment and 93% after two years of treatment. Therapy with Finasteride (5 mg daily) for up to 4 years in patients with BPH suppressed serum DHT concentrations by only 70%.
Treatment with dutasteride resulted in fast decrease in serum DHT concentrations. After one week of treatment serum DHT concentrations were reduced by 85% and by 90% after two weeks of treatment.
Dutasteride resulted in a greater suppression of DHT than finasteride and the response to dutasteride was less variable than finasteride in longer term-studies. After four months of treatment 0.5mg dutasteride reduced serum DHT concentration by 94.7% (+/- 3.3%) while 5mg finasteride decreased serum DHT concentrations by 70.8% (+/- 18.3%).
After treatment had been stopped, serum DHT concentrations returned to within 20% of baseline values 4 weeks following the end of treatment in those subjects taking finasteride and 16 weeks in those taking dutasteride.
Effect of dutasteride and finasteride on Serum Testorsterone
Dutasteride and finasteride both increase median circulating testosterone concentration. Increase of 10-20% from baseline values have been noted, however concentrations remained within normal physiologic limits.
Effect of Dutasteride and inasteride on Bone Density and Lipid Metabolism
Neither dutasteride nor finasteride resulted in significant changes in bone density or lipid metabolism.
Intraprostatic DHT Reduction with Dutasteride
In patients taking 5mg of dutasteride mean DHT concentrations in prostatic tissue were significantly lower (784 pg/g compared with 5793 pg/g with placebo).
In another study dutasteride was administered at 10mg daily for the initial 7 days followed by 5mg daily thereafter. Intraprostatic DHT values were 2.9% of those in placebo group - a 97.1% reduction in intraprostatic DHT when taking dutasteride.
It should be noted that both studies used doasges above what is recommended to treat BPH. No data is yet available for dosages approved for treatment of BPH.
Intraprostatic DHT Reduction with Finasteride
Patients with BPH were treated with finasteride 1 to 100 mg daily (one-fifth to 200 times the normal daily dosage) for 7-10 days prior to prostate surgery. Intraprostatic DHT concentrations through the entire dosage range of were approximately 80% lower than those in patients receiving placebo.
In a longer-term study, 1mg finasteride or 5mg finasteride daily was administered for 6-8 weeks. Intraprostatic DHT concentrations were reduced by approximately 80% in patients taking 1mg and 90% in patients receiving 5mg compared with placebo.
Pharmacokinetic Parameters of Dutasteride and Finasteride
Dutasteride Finasteride Bioavailablity 59% 63% Protein Binding ~ 99.5% ~ 90% Half-Life 5 weeks 6hrs - 15hrs Metabolites 6-beta-hydroxydutasteride (active) Two metabolites with < 20% activity Elimination Fecal (~ 45%); Renal (~ 1%) Biliary (57%); Renal (39%) Dutasteride Dosage & Indications
Dutasteride Indications
Dutasteride is indicated for the treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland. Because if the increased DHT supression, dutasteride may also be an effective hair loss treatment for thos suffering from male pattern baldness.
Dosage and Administation of Dutasteride
The recommended dose of dutasteride is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole. Dutasteride can be administered with or without food.
Dutasteride Warning
Dutasteride is absorbed through the skin. Dutasteride should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus.
