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These highlights do not include all the information needed to use DUTASTERIDE capsules safely and effectively. See full prescribing information for DUTASTERIDE capsules.  DUTASTERIDE capsules for oral useInitial U.S. Approval: 2001 | Dutasteride [Proficient Rx LP] | BioPortfolio

12:54 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

      5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume or trial-related factors impacted the results of these trials has not been established.

      Prior to initiating treatment with dutasteride capsules, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.

      Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.

      From clinical trials with dutasteride capsules as monotherapy or in combination with tamsulosin:

      Monotherapy: Over 4,300 male subjects with BPH were randomly assigned to receive placebo or 0.5-mg daily doses of dutasteride capsules in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment trials, each followed by a 2-year open-label extension. During the double-blind treatment period, 2,167 male subjects were exposed to dutasteride capsules, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. When including the open-label extensions, 1,009 male subjects were exposed to dutasteride capsules for 3 years and 812 were exposed for 4 years. The population was aged 47 to 94 years (mean age: 66 years) and greater than 90% were Caucasian. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving dutasteride capsules and at a higher incidence than subjects receiving placebo.

Long-Term Treatment (Up to 4 Years):

      High-Grade Prostate Cancer: The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Subjects were randomized to receive placebo (N = 4,126) or 0.5-mg daily doses of dutasteride capsules (N = 4,105) for up to 4 years. The mean age was 63 years and 91% were Caucasian. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. There was a higher incidence of Gleason score 8-10 prostate cancer in men receiving dutasteride capsules (1.0%) compared with men on placebo (0.5%) [see  Indications and Usage ( 1.3 ), Warnings and Precautions ( 5.2 )]. In a 7-year placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).

      No clinical benefit has been demonstrated in patients with prostate cancer treated with dutasteride capsules.

      Reproductive and Breast Disorders: In the 3 pivotal placebo-controlled BPH trials with dutasteride capsules, each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. Among these 3 trials, there was 1 case of breast cancer in the dutasteride group and 1 case in the placebo group. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial.

      The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.

      Combination With Alpha-Blocker Therapy (CombAT): Over 4,800 male subjects with BPH were randomly assigned to receive 0.5-mg dutasteride capsules, 0.4-mg tamsulosin, or combination therapy (0.5-mg dutasteride capsules plus 0.4-mg tamsulosin) administered once daily in a 4-year double-blind trial. Overall, 1,623 subjects received monotherapy with dutasteride capsules; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. The population was aged 49 to 88 years (mean age: 66 years) and 88% were Caucasian. Table 2 summarizes adverse reactions reported in at least 1% of subjects in the combination group and at a higher incidence than subjects receiving monotherapy with dutasteride capsules or tamsulosin.

      Cardiac Failure: In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the combination therapy group (12/1,610; 0.7%) was higher than in either monotherapy group: dutasteride capsules, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating dutasteride capsules in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking dutasteride capsules was 0.6% (26/4,105) compared with 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both trials had co-morbidities associated with an increased risk of cardiac failure. Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between dutasteride capsules, alone or in combination with tamsulosin, and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either trial.

Table 1. Adverse Reactions Reported in ≥1% of Subjects Over a 24-Month Period and More Frequently in the Group Receiving Dutasteride Capsules Than the Placebo Group (Randomized, Double-Blind, Placebo-Controlled Trials Pooled) by Time of Onset
 Adverse Reaction  Adverse Reaction Time of Onset
 
   Dutasteride capsules (n)
   Placebo (n)
 Months 0-6
(n = 2,167)
(n = 2,158)
 Months 7-12
(n = 1,901)
(n = 1,922)
 Months 13-18
(n = 1,725)
(n = 1,714)
 Months 19-24
(n = 1,605)
(n = 1,555)
 Impotencea        
    Dutasteride capsules 
   Placebo
 4.7%
1.7%
 1.4%
1.5%
 1.0%
0.5%
 0.8%
0.9%
 Decreased libidoa        
    Dutasteride capsules
   Placebo
 3.0%
1.4%
 0.7%
0.6%
 0.3%
0.2%
 0.3%
0.1%
 Ejaculation disordersa        
    Dutasteride capsules
   Placebo
 1.4%
0.5%
 0.5%
0.3%
 0.5%
0.1%
 0.1%
0.0%
 Breast disordersb         
    Dutasteride capsules
   Placebo
 0.5%
0.2%
 0.8%
0.3%
 1.1%
0.3%
 0.6%
0.1%
a These sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
b Includes breast tenderness and breast enlargement.
Table 2. Adverse Reactions Reported Over a 48-Month Period in ≥1% of Subjects and More Frequently in the Coadministration Therapy Group Than the Groups Receiving Monotherapy With Dustateride Capsules or Tamsulosin (CombAT) by Time of Onset
   Adverse Reaction Time of Onset
 Adverse Reaction  Year 1      
   Months 0-6  Months 7-12  Year 2  Year 3  Year 4
 Combinationa
 Dutasteride capsules
Tamsulosin
(n = 1,610)
(n = 1,623)
(n = 1,611)
(n = 1,527)
(n = 1,548)
(n = 1,545)
 (n = 1,428)
(n = 1,464)
(n = 1,468)
 (n = 1,283)
(n = 1,325)
(n = 1,281)
 (n = 1,200)
(n = 1,200)
(n = 1,112)
Ejaculation
disordersb,c
     Combination
     Dutasteride capsules
     Tamsulosin
 

7.8%
1.0%
2.2%
 

1.6%
0.5%
0.5%
 

1.0%
0.5%
0.5%
 

0.5%
0.2%
0.2%
 

<0.1%
0.3%
0.3%
Impotencec,d
     Combination
     Dutasteride capsules
     Tamsulosin
 
5.4%
4.0%
2.6%
 
1.1%
1.1%
0.8%
 
1.8%
1.6%
1.0%
 
0.9%
0.6%
0.6%
 
0.4%
0.3%
1.1%
Decreased libidoc,e
     Combination
     Dutasteride capsules
     Tamsulosin
 
4.5%
3.1%
2.0%
 
0.9%
0.7%
0.6%
 
0.8%
1.0%
0.7%
 
0.2%
0.2%
0.2%
 
0.0%
0.0%
<0.1%
Breast disordersf
     Combination
     Dutasteride capsules
     Tamsulosin
 
1.1%
0.9%
0.4%
 
1.1%
0.9%
0.4%
 
0.8%
1.2%
0.4%
 
0.9%
0.5%
0.2%
 
0.6%
0.7%
0.0%
Dizziness
     Combination
     Dutasteride capsules
     Tamsulosin
 
1.1%
0.5%
0.9%
 
0.4%
0.3%
0.5%
 
0.1%
0.1%
0.4%
 
<0.1%
<0.1%
<0.1%
 
0.2%
<0.1%
0.0%
a Combination = Dutasteride capsules 0.5 mg once daily plus tamsulosin 0.4 mg once daily.
b Includes anorgasmia, retrograde ejaculation, semen volume decreased, orgasmic sensation decreased, orgasm abnormal, ejaculation delayed, ejaculation disorder, ejaculation failure, and premature ejaculation.
c These sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
d Includes erectile dysfunction and disturbance in sexual arousal.
e Includes libido decreased, libido disorder, loss of libido, sexual dysfunction, and male sexual dysfunction.
f Includes breast enlargement, gynecomastia, breast swelling, breast pain, breast tenderness, nipple pain, and nipple swelling.

      Dutasteride capsules 0.5 mg/day (n = 2,167) or placebo (n = 2,158) was evaluated in male subjects with BPH in three 2-year multicenter, placebo-controlled, double-blind trials, each with 2-year open-label extensions (n = 2,340). More than 90% of the trial population was Caucasian. Subjects were at least 50 years of age with a serum PSA ≥1.5 ng/mL and <10 ng/mL and BPH diagnosed by medical history and physical examination, including enlarged prostate (≥30 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index (AUA-SI). Most of the 4,325 subjects randomly assigned to receive either dutasteride or placebo completed 2 years of double-blind treatment (70% and 67%, respectively). Most of the 2,340 subjects in the trial extensions completed 2 additional years of open-label treatment (71%).

      Effect on Symptom Scores: Symptoms were quantified using the AUA-SI, a questionnaire that evaluates urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) by rating on a 0 to 5 scale for a total possible score of 35, with higher numerical total symptom scores representing greater severity of symptoms. The baseline AUA-SI score across the 3 trials was approximately 17 units in both treatment groups.

      Subjects receiving dutasteride achieved statistically significant improvement in symptoms versus placebo by Month 3 in 1 trial and by Month 12 in the other 2 pivotal trials. At Month 12, the mean decrease from baseline in AUA-SI total symptom scores across the 3 trials pooled was -3.3 units for dutasteride and -2.0 units for placebo with a mean difference between the 2 treatment groups of -1.3 (range: -1.1 to -1.5 units in each of the 3 trials, P<0.001) and was consistent across the 3 trials. At Month 24, the mean decrease from baseline was -3.8 units for dutasteride and -1.7 units for placebo with a mean difference of -2.1 (range: -1.9 to -2.2 units in each of the 3 trials, P<0.001). See Figure 1. The improvement in BPH symptoms seen during the first 2 years of double-blind treatment was maintained throughout an additional 2 years of open-label extension trials.

      These trials were prospectively designed to evaluate effects on symptoms based on prostate size at baseline. In men with prostate volumes ≥40 cc, the mean decrease was -3.8 units for dutasteride and -1.6 units for placebo, with a mean difference between the 2 treatment groups of -2.2 at Month 24. In men with prostate volumes <40 cc, the mean decrease was -3.7 units for dutasteride and -2.2 units for placebo, with a mean difference between the 2 treatment groups of -1.5 at Month 24.

Figure 1. AUA-SI ScoreChange From Baseline (Randomized, Double-Blind Placebo-Controlled Trials Pooled)

AUA-SI score ranges from 0 to 35.

      Effect on Acute Urinary Retention and the Need for BPH-Related Surgery: Efficacy was also assessed after 2 years of treatment by the incidence of AUR requiring catheterization and BPH-related urological surgical intervention. Compared with placebo, dutasteride capsules were associated with a statistically significantly lower incidence of AUR (1.8% for dutasteride capsules versus 4.2% for placebo, P<0.001; 57% reduction in risk, [95% CI: 38% to 71%]) and with a statistically significantly lower incidence of surgery (2.2% for dutasteride capsules versus 4.1% for placebo, P<0.001; 48% reduction in risk, [95% CI: 26% to 63%]). See Figures 2 and 3.

Figure 2. Percent of Subjects Developing Acute Urinary Retention Over a 24-Month Period (Randomized, Double-Blind, Placebo-Controlled Trials Pooled)

Figure 3. Percent of Subjects Having Surgery for Benign Prostatic Hyperplasia Over a 24-Month Period (Randomized, Double-Blind, Placebo-Controlled Trials Pooled)

      Effect on Prostate Volume: A prostate volume of at least 30 cc measured by transrectal ultrasound was required for trial entry. The mean prostate volume at trial entry was approximately 54 cc.

      Statistically significant differences (dutasteride capsules versus placebo) were noted at the earliest post-treatment prostate volume measurement in each trial (Month 1, Month 3, or Month 6) and continued through Month 24. At Month 12, the mean percent change in prostate volume across the 3 trials pooled was -24.7% for dutasteride and -3.4% for placebo; the mean difference (dutasteride minus placebo) was -21.3% (range: -21.0% to -21.6% in each of the 3 trials, P<0.001). At Month 24, the mean percent change in prostate volume across the 3 trials pooled was -26.7% for dutasteride and -2.2% for placebo with a mean difference of -24.5% (range: -24.0% to -25.1% in each of the 3 trials, P<0.001). See Figure 4. The reduction in prostate volume seen during the first 2 years of double-blind treatment was maintained throughout an additional 2 years of open-label extension trials.

Figure 4. Prostate Volume Percent Change From Baseline (Randomized, Double-Blind, Placebo-Controlled Trials Pooled)

      Effect on Maximum Urine Flow Rate: A mean peak urine flow rate (Q) of ≤15 mL/sec was required for trial entry. Q was approximately 10 mL/sec at baseline across the 3 pivotal trials.

      Differences between the 2 groups were statistically significant from baseline at Month 3 in all 3 trials and were maintained through Month 12. At Month 12, the mean increase in Q across the 3 trials pooled was 1.6 mL/sec for dutasteride capsules and 0.7 mL/sec for placebo; the mean difference (dutasteride minus placebo) was 0.8 mL/sec (range: 0.7 to 1.0 mL/sec in each of the 3 trials, P<0.001). At Month 24, the mean increase in Q was 1.8 mL/sec for dutasteride and 0.7 mL/sec for placebo, with a mean difference of 1.1 mL/sec (range: 1.0 to 1.2 mL/sec in each of the 3 trials, P<0.001). See Figure 5. The increase in maximum urine flow rate seen during the first 2 years of double-blind treatment was maintained throughout an additional 2 years of open-label extension trials.

Figure 5. Q Change From Baseline (Randomized, Double-Blind, Placebo-Controlled Trials Pooled)

      Summary of Clinical Trials: Data from 3 large, well-controlled efficacy trials demonstrate that treatment with dutasteride capsules (0.5 mg once daily) reduces the risk of both AUR and BPH-related surgical intervention relative to placebo, improves BPH-related symptoms, decreases prostate volume, and increases maximum urinary flow rates. These data suggest that dutasteride capsules arrests the disease process of BPH in men with an enlarged prostate.

      The efficacy of combination therapy (dutasteride capsules 0.5 mg/day plus tamsulosin 0.4 mg/day, n = 1,610) was compared with dutasteride capsules alone (n = 1,623) or tamsulosin alone (n = 1,611) in a 4-year multicenter, randomized, double-blind trial. Trial entry criteria were similar to the double-blind, placebo-controlled monotherapy efficacy trials described above in section 14.1. Eighty-eight percent (88%) of the enrolled trial population was Caucasian. Approximately 52% of subjects had previous exposure to 5 alpha-reductase inhibitor or alpha adrenergic antagonist treatment. Of the 4,844 subjects randomly assigned to receive treatment, 69% of subjects in the combination group, 67% in the group receiving dutasteride capsules, and 61% in the tamsulosin group completed 4 years of double-blind treatment.

      Effect on Symptom Score: Symptoms were quantified using the first 7 questions of the International Prostate Symptom Score (IPSS) (identical to the AUA-SI). The baseline score was approximately 16.4 units for each treatment group. Combination therapy was statistically superior to each of the monotherapy treatments in decreasing symptom score at Month 24, the primary time point for this endpoint. At Month 24 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.2 (±7.14) for combination, -4.9 (±6.81) for dutasteride capsules, and -4.3 (±7.01) for tamsulosin, with a mean difference between combination and dutasteride capsules of -1.3 units (P<0.001; [95% CI: -1.69, -0.86]), and between combination and tamsulosin of -1.8 units (P<0.001; [95% CI: -2.23, -1.40]). A significant difference was seen by Month 9 and continued through Month 48. At Month 48 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.3 (±7.40) for combination, -5.3 (±7.14) for dutasteride capsules, and -3.8 (±7.74) for tamsulosin, with a mean difference between combination and dutasteride capsules of -0.96 units (P<0.001; [95% CI: -1.40, -0.52]), and between combination and tamsulosin of -2.5 units (P<0.001; [95% CI: -2.96, -2.07]). See Figure 6.

Figure 6. International Prostate Symptom Score Change From Baseline Over a 48-Month Period (Randomized, Double-Blind, Parallel Group Trial [CombAT Trial])

      Effect on Acute Urinary Retention or the Need for BPH-Related Surgery: After 4 years of treatment, combination therapy with dutasteride capsules and tamsulosin did not provide benefit over monotherapy with dutasteride capsules in reducing the incidence of AUR or BPH-related surgery.

      Effect on Maximum Urine Flow Rate: The baseline Q was approximately 10.7 mL/sec for each treatment group. Combination therapy was statistically superior to each of the monotherapy treatments in increasing Q at Month 24, the primary time point for this endpoint. At Month 24, the mean increases from baseline (±SD) in Q were 2.4 (±5.26) mL/sec for combination, 1.9 (±5.10) mL/sec for dutasteride capsules, and 0.9 (±4.57) mL/sec for tamsulosin, with a mean difference between combination and dutasteride capsules of 0.5 mL/sec (P = 0.003; [95% CI: 0.17, 0.84]), and between combination and tamsulosin of 1.5 mL/sec (P<0.001; [95% CI: 1.19, 1.86]). This difference was seen by Month 6 and continued through Month 24. See Figure 7.

      The additional improvement in Q of combination therapy over monotherapy with dutasteride capsules was no longer statistically significant at Month 48.

Figure 7. Q Change From Baseline Over a 24-Month Period (Randomized, Double-Blind, Parallel Group Trial [CombAT Trial])

Effect on Prostate Volume: The mean prostate volume at trial entry was approximately 55 cc. At Month 24, the primary time point for this endpoint, the mean percent changes from baseline (±SD) in prostate volume were -26.9% (±22.57) for combination therapy, -28.0% (±24.88) for dutasteride capsules, and 0% (±31.14) for tamsulosin, with a mean difference between combination and dutasteride capsules of 1.1% (P = NS; [95% CI: -0.6, 2.8]), and between combination and tamsulosin of -26.9% (P<0.001; [95% CI: -28.9, -24.9]). Similar changes were seen at Month 48: -27.3% (±24.91) for combination therapy, -28.0% (±25.74) for dutasteride capsules, and +4.6% (±35.45) for tamsulosin.

Dutasteride capsules 0.5 mg are yellow opaque gelatin capsules imprinted with 2292 in black ink packaged in bottles of 30 (NDC 63187-657-30) 60 (NDC 63187-657-60) and 90 (NDC 63187-657-90) with child-resistant closures.  

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dutasteride is absorbed through the skin. Dutasteride capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions ( 5.4 )].

See FDA-approved patient labeling (Patient Information).

Physicians should inform patients that dutasteride capsules reduce serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with dutasteride capsules may signal the presence of prostate cancer and should be evaluated by a healthcare provider [see Warnings and Precautions ( 5.1 )].

Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including dutasteride capsules, compared with those treated with placebo in trials looking at the use of these drugs to reduce the risk of prostate cancer [see Indications and Usage ( 1.3 ), Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 )].

Physicians should inform patients that dutasteride capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking dutasteride capsules, the contact area should be washed immediately with soap and water [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )].

Physicians should inform men treated with dutasteride capsules that they should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion [see Warnings and Precautions ( 5.5 )]. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends [see Clinical Pharmacology ( 12.3 )].

PHARMACIST—DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION Dutasteride (doo-TAS-ter-ide) Capsules

Dutasteride capsules are for use by men only. Read this patient information before you start taking dutasteride capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What are dutasteride capsules? Dutasteride capsules are prescription medicine that contain dutasteride. Dutasteride capsules are used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

Who should NOT take dutasteride capsules?

Do Not Take dutasteride capsules if you are:

What should I tell my healthcare provider before taking dutasteride capsules?

Before you take dutasteride capsules, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Dutasteride capsules and other medicines may affect each other, causing side effects. Dutasteride capsules may affect the way other medicines work, and other medicines may affect how dutasteride capsules work.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take dutasteride capsules?

What should I avoid while taking dutasteride capsules?

What are the possible side effects of dutasteride capsules?

Dutasteride capsules may cause serious side effects, including:

The most common side effects of dutasteride capsules include:

        *Some of these events may continue after you stop taking dutasteride capsules.

Depressed mood has been reported in patients receiving dutasteride capsules.

Dutasteride capsules have been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of dutasteride capsules on male fertility is not known.

Prostate-Specific Antigen (PSA) Test: Your healthcare provider may check you for other prostate problems, including prostate cancer before you start and while you take dutasteride capsules. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. Dutasteride capsules will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with dutasteride capsules (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects with dutasteride capsules. For more information, ask you healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store dutasteride capsules? 

Keep dutasteride capsules and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use dutasteride capsules for a condition for which it was not prescribed. Do not give dutasteride capsules to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about dutasteride capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about dutasteride capsules that is written for health professionals.

For more information, go to www.actavis.com or call 1-800-272-5525.

What are the ingredients in dutasteride capsules?

Active ingredient: dutasteride.

Inactive ingredients: butylated hydroxytoluene, gelatin (from certified BSE-free bovine sources), glycerin, yellow iron oxide, medium chain triglyceride, mono-di-glycerides of caprylic/capric acid, propylene glycol, soy lecithin, titanium dioxide, and edible black ink, which also contains black iron oxide and shellac glaze.

How do dutasteride capsules work?

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Dutasteride capsules lower DHT production in the body, leading to shrinkage of the enlarged prostate in most men. While some men have fewer problems and symptoms after 3 months of treatment with dutasteride capsules, a treatment period of at least 6 months is usually necessary to see if dutasteride capsules will work for you.

Brands listed are the trademarks of their respective owners.

Manufactured by:Pharmaceutics International, Inc.Hunt Valley, MD 21031 USA

Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Revised: July 2015                                                                                        

206456

Principal Display Panel NDC 63187-657-90 Dutasteride Capsules 0.5 mg  30 Capsules Rx Only

Manufacturer

Proficient Rx LP

Active Ingredients

Source

Drugs and Medications [73 Associated Drugs and Medications listed on BioPortfolio]

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Dutasteride [epic pharma, llc]

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Dutasteride [proficient rx lp]

These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral...

Clinical Trials [46 Associated Clinical Trials listed on BioPortfolio]

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.

Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone a...

A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe,...

Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyper...

Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)

This study is for individuals electing to have GreenLight Photoselective Vaporization of the Prostate (PVP) to treat symptoms from an enlarged prostate gland. The purpose of this research...

PubMed Articles [8 Associated PubMed Articles listed on BioPortfolio]

Neuropsychological Assessment in Elderly Men with Benign Prostatic Hyperplasia Treated with Dutasteride.

Benign prostatic hyperplasia (BPH) is a common disease found in elderly men and 5α-reductase (5α-R) inhibitors are a commonly used treatment option. 5α-reduced steroids are compounds that play a ro...

Evaluation of the impact of dutasteride/tamsulosin combination therapy on libido in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH): a post hoc analysis of a prospective randomized placebo-controlled study.

Five-α reductase inhibitor (5ARI) therapy has been associated with sexual dysfunction in some patients. This study assessed the impact of a fixed-dose combination of the 5ARI dutasteride 0.5 mg and ...

Editorial Comment to Superiority of dutasteride 0.5 mg and tamsulosin 0.2 mg for the treatment of moderate-to-severe benign prostatic hyperplasia in Asian men.

Evaluating the effects of switching from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms: A randomized, open-label, multicenter study.

Methods of treatment patients with androgenetic alopecia based on reference of Department of Dermatology in Cracow.

Androgenetic alopecia (AGA in men/female pattern hair loss FPHL in women) has been associated with the most frequent culprit of hair loss concerning both men and women. It may be viewed as chronic, pr...

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Relevant Topics

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Benign Prostatic Hyperplasia (BPH)
An enlarged prostate (benign prostatic enlargement (BPE) or benign prostatic hyperplasia (BPH)) is common in men after the age of about 50. Having an enlarged prostate does not mean you have cancer. In some cases, an enlarged prostate can cause the ...

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...


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