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DUTASTERIDE capsule


  1. Dutasteride Is A Prescription Medicine That Contains Dutasteride. Dutasteride Capsules Are Used To Treat The Symptoms Of Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To:
  2. Who Should Not Take Dutasteride?
  3. Before You Take Dutasteride, Tell Your Healthcare Provider If You:
  4. How Should I Take Dutasteride?
  5. What Should I Avoid While Taking Dutasteride?
  6. Rare And Serious Allergic Reactions, Including:
  7. The Most Common Side Effects Of Dutasteride Include:
  8. Prostate Specific Antigen (psa) Test:
  9. Active Ingredient:
  10. How Does Dutasteride Work?
  11. Patient Information
  12. Dutasteride Capsules Are A Prescription Medicine That Contains Dutasteride. Dutasteride Capsules Are Used To Treat The Symptoms Of Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To:
  13. Do Not Take Dutasteride Capsules If You Are:
  14. Before You Take Dutasteride Capsules, Tell Your Healthcare Provider If You:
  15. How Should I Take Dutasteride Capsules?
  16. What Should I Avoid While Taking Dutasteride Capsules?
  17. The Most Common Side Effects Of Dutasteride Capsules Include:
  18. Prostate-specific Antigen (psa) Test:
  19. Inactive Ingredients:
  20. How Do Dutasteride Capsules Work?

Dutasteride Is A Prescription Medicine That Contains Dutasteride. Dutasteride Capsules Are Used To Treat The Symptoms Of Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To: 

improve symptoms
reduce the risk of acute urinary retention (a complete blockage of urine flow)
reduce the risk of the need for BPH-related surgery

Who Should Not Take Dutasteride? 

Do Not Take Dutasteride if you are:

pregnant or could become pregnant. Dutasteride may harm your unborn baby. Pregnant women should not touch Dutasteride Capsules. If a woman who is pregnant with a male baby gets enough dutasteride in her body by swallowing or touching dutasteride, the male baby may be born with sex organs that are not normal. 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.
a child or a teenager.
allergic to dutasteride or any of the ingredients in Dutasteride Capsules.

Before You Take Dutasteride, Tell Your Healthcare Provider If You: 

have liver problems

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

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? 

Take 1 dutasteride capsule once a day.
Swallow dutasteride capsules whole. Do not crush, chew, or open dutasteride capsules because the contents of the capsule may irritate your lips, mouth, or throat.
You can take dutasteride with or without food.
If you miss a dose, you may take it later that day. Do not make up the missed dose by taking 2 doses the next day.

What Should I Avoid While Taking Dutasteride? 

You should not donate blood while taking dutasteride or for 6 months after you have stopped dutasteride. This is important to prevent pregnant women from receiving dutasteride through blood transfusions.

Rare And Serious Allergic Reactions, Including: 

swelling of your face, tongue, or throat
serious skin reactions, such as skin peeling
Get medical help right away if you have these serious allergic reactions.
Higher chance of a more serious form of prostate cancer.

The Most Common Side Effects Of Dutasteride Include: 

trouble getting or keeping an erection (impotence)1
a decrease in sex drive (libido)1
ejaculation problems1
enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.

1Some of these events may continue after you stop taking dutasteride.

Depressed mood has been reported in patients receiving dutasteride.

Dutasteride has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of dutasteride 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. A blood test called PSA (prostate-specific antigen) is sometimes used to

Store Dutasteride Capsules at room temperature (59 F to 86 F or 15 C to 30 C).
Dutasteride Capsules may become deformed and/or discolored if kept at high temperatures.
Do not use Dutasteride Capsules if your capsules are deformed, discolored, or leaking.
Safely throw away medicine that is no longer needed.

Keep dutasteride 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 for a condition for which it was not prescribed. Do not give dutasteride 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. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about dutasteride that is written for health professionals.

Active Ingredient: 

dutasteride.

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. 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.

* PROSCAR is a registered trademark of Merck & Co., Inc.

Made in India.

Manufactured by:
Cipla Limited
Kurkumbh, Maharashtra, India

Manufactured for:
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724

21057823
Revised November 2016

Patient Information 

See FDA-approved patient labeling (Patient Information).

17.1 PSA Monitoring

Physicians should inform patients that dutasteride reduces 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 may signal the presence of prostate cancer and should be evaluated by a healthcare provider[see Warnings and Precautions (5.1)].

17.2 Increased Risk of High-Grade Prostate Cancer

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, 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)].

17.3 Exposure of Women - Risk to Male Fetus

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)].

17.4 Blood Donation

Physicians should inform men treated with dutasteride 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)].

Made in India.

Manufactured by:
Cipla Limited
Kurkumbh, Maharashtra, India

Manufactured for:
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724

21057823
Revised November 2016

Dutasteride Capsules Are A Prescription Medicine That Contains Dutasteride. Dutasteride Capsules Are Used To Treat The Symptoms Of Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To: 

  • improve symptoms,
  • reduce the risk of acute urinary retention (a complete blockage of urine flow),
  • reduce the risk of the need for BPH-related surgery.

Do Not Take Dutasteride Capsules If You Are: 

  • pregnant or could become pregnant. Dutasteride capsules may harm your unborn baby. Pregnant women should not touch dutasteride capsules. If a woman who is pregnant with a male baby gets enough dutasteride capsules in her body by swallowing or touching dutasteride capsules, the male baby may be born with sex organs that are not normal. 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.
  • a child or a teenager.
  • allergic to dutasteride or any of the ingredients in dutasteride capsules.

Before You Take Dutasteride Capsules, Tell Your Healthcare Provider If You: 

  • have liver problems

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? 

  • Take 1 dutasteride capsule once a day.
  • Swallow dutasteride capsules whole. Do not crush, chew, or open dutasteride capsules because the contents of the capsule may irritate your lips, mouth, or throat.
  • You can take dutasteride capsules with or without food.
  • If you miss a dose, you may take it later that day. Do not make up the missed dose by taking 2 doses the next day.

What Should I Avoid While Taking Dutasteride Capsules? 

  • You should not donate blood while taking dutasteride capsules, or for 6 months after you have stopped dutasteride capsules. This is important to prevent pregnant women from receiving dutasteride capsules through blood transfusions.

The Most Common Side Effects Of Dutasteride Capsules Include: 

  • trouble getting or keeping an erection (impotence)*
  • a decrease in sex drive (libido)*
  • ejaculation problems*
  • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.

*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

  • Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 (59 to 86 F) [

Inactive Ingredients: 

Butylated hydroxytoluene, mono and di-glycerides of caprylic/capric acid, gelatin, glycerin, titanium dioxide, ferric oxide yellow, purified water, soy lecithin, medium chain triglycerides and edible red ink containing shellac glaze, ferric oxide red, NF, simethicone, USP, propylene glycol, USP, n-butyl alcohol, NF, isopropyl alcohol, USP, and ammonium hydroxide, NF.

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.

The brands listed are trademarks of their respective owners and are not trademarks of Vensun Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Vensun Pharmaceuticals, Inc. or its products.

PROSCARis a trademark of Merck & Co., Inc.

Manufactured for:
Vensun Pharmaceuticals, Inc.
Yardley, PA 19067

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

Rev. 00, July 2017



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