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DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- dutasteride and tamsulosin hydrochloride capsules capsule


  1. Patient Information
  2. What Are Dutasteride And Tamsulosin Hydrochloride Capsules?
  3. Do Not Take Dutasteride And Tamsulosin Hydrochloride Capsules If You Are:
  4. Before You Take Dutasteride And Tamsulosin Hydrochloride Capsules, Tell Your Healthcare Provider If You:
  5. How Should I Take Dutasteride And Tamsulosin Hydrochloride Capsules?
  6. What Should I Avoid While Taking Dutasteride And Tamsulosin Hydrochloride Capsules?
  7. What Are The Possible Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules?
  8. May Cause Serious Side Effects, Including:
  9. Rare And Serious Allergic Reactions, Including:
  10. The Most Common Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules Include:
  11. Prostate-specific Antigen (psa) Test:
  12. Active Ingredients:
  13. Inactive Ingredients:
  14. How Do Dutasteride And Tamsulosin Hydrochloride Capsules Work?
  15. Manufactured By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Orthostatic Hypotension

Inform patients about the possible occurrence of symptoms related to orthostatic hypotension, such as dizziness and vertigo, and the potential risk of syncope when taking dutasteride and tamsulosin hydrochloride capsules. Caution patients starting treatment with dutasteride and tamsulosin hydrochloride capsules to avoid situations where injury could result should syncope occur (e.g., driving, operating machinery, performing hazardous tasks). Advise patients to sit or lie down at the first signs of orthostatic hypotension[seeWarnings and Precautions (5.1)].

Drug Interactions

Advise patients that dutasteride and tamsulosin hydrochloride capsules should not be used in combination with strong inhibitors of CYP3A4 [seeWarnings and Precautions (5.2), Drug Interactions (7.1)].

PSA Monitoring

Inform patients that dutasteride and tamsulosin hydrochloride capsules 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 and tamsulosin hydrochloride capsules may signal the presence of prostate cancer and should be evaluated by a healthcare provider[seeWarnings and Precautions (5.3)].

Risk of High-grade Prostate Cancer

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, which is a component of dutasteride and tamsulosin hydrochloride capsules, compared with those treated with placebo in trials looking at the use of these drugs to reduce the risk of prostate cancer[seeIndications and Usage (1.2), Warnings and Precautions (5.4), Adverse Reactions (6.1)].

Exposure of Women Risk to Male Fetus

Inform patients that dutasteride and tamsulosin hydrochloride 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 and tamsulosin hydrochloride capsules, the contact area should be washed immediately with soap and water[seeWarnings and Precautions (5.6), Use in Specific Populations (8.1)].

Instructions for Use

Dutasteride and tamsulosin hydrochloride capsules should be swallowed whole and not chewed, crushed, or opened. Dutasteride and tamsulosin hydrochloride capsules may become deformed and/or discolored if kept at high temperatures. If this occurs, capsules should not be used.

Priapism

Inform patients about the possibility of priapism as a result of treatment with dutasteride and tamsulosin hydrochloride capsules or other alpha-adrenergic-antagonist-containing medications. Inform patients that this reaction is extremely rare, but can lead to permanent erectile dysfunction if not brought to immediate medical attention[seeWarnings and Precautions (5.7)].

Blood Donation

Inform men treated with dutasteride and tamsulosin hydrochloride 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[seeWarnings and Precautions (5.8)]. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends[seeClinical Pharmacology (12.3)].

Intraoperative Floppy Iris Syndrome (IFIS)

Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they take or have taken dutasteride and tamsulosin hydrochloride capsules, an alpha adrenergic antagonist-containing product[seeWarnings and Precautions (5.9)].

What Are Dutasteride And Tamsulosin Hydrochloride Capsules? 

Dutasteride and tamsulosin hydrochloride capsules are a prescription medicine that contains 2 medicines: dutasteride and tamsulosin. Dutasteride and tamsulosin hydrochloride capsules are used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Do Not Take Dutasteride And Tamsulosin Hydrochloride Capsules If You Are: 

  • pregnant or could become pregnant. Dutasteride and tamsulosin hydrochloride capsules may harm your unborn baby. Pregnant women should not touch dutasteride and tamsulosin hydrochloride capsules. If a woman who is pregnant with a male baby gets enough dutasteride and tamsulosin hydrochloride capsules in her body by swallowing or touching dutasteride and tamsulosin hydrochloride 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 and tamsulosin hydrochloride capsules, the contact area should be washed immediately with soap and water.
  • a child or teenager.
  • allergic to dutasteride, tamsulosin, or any of the ingredients in dutasteride and tamsulosin hydrochloride capsules.

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

  • have a history of low blood pressure
  • take medicines to treat high blood pressure
  • plan to have cataract or glaucoma surgery
  • have liver problems
  • are allergic to sulfa medications
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Dutasteride and tamsulosin hydrochloride capsules and other medicines may affect each other, causing side effects. Dutasteride and tamsulosin hydrochloride capsules may affect the way other medicines work, and other medicines may affect how dutasteride and tamsulosin hydrochloride capsules 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 And Tamsulosin Hydrochloride Capsules? 

  • Take dutasteride and tamsulosin hydrochloride capsules exactly as your healthcare provider tells you to take it.
  • Swallow dutasteride and tamsulosin hydrochloride capsules whole. Do not crush, chew, or open dutasteride and tamsulosin hydrochloride capsules because the contents of the capsule may irritate your lips, mouth, or throat.
  • Take your dutasteride and tamsulosin hydrochloride capsules 1 time each day, about 30 minutes after the same meal every day. For example, you may take dutasteride and tamsulosin hydrochloride capsules 30 minutes after dinner every day.
  • If you miss a dose, you can take it later that same day, 30 minutes after a meal. Do not take 2 dutasteride and tamsulosin hydrochloride capsules in the same day. If you stop or forget to take dutasteride and tamsulosin hydrochloride capsules for several days, talk with your healthcare provider before starting again.
  • If you take too much dutasteride and tamsulosin hydrochloride capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

What Should I Avoid While Taking Dutasteride And Tamsulosin Hydrochloride Capsules? 

  • Avoid driving, operating machinery, or other dangerous activities when starting treatment with dutasteride and tamsulosin hydrochloride capsules until you know how dutasteride and tamsulosin hydrochloride capsules affects you. Dutasteride and tamsulosin hydrochloride capsules can cause a sudden drop in your blood pressure, especially at the start of treatment. A sudden drop in blood pressure may cause you to faint, feel dizzy or lightheaded.
  • You should not donate blood while taking dutasteride and tamsulosin hydrochloride capsules or for 6 months after you have stopped dutasteride and tamsulosin hydrochloride capsules. This is important to prevent pregnant women from receiving dutasteride and tamsulosin hydrochloride capsules through blood transfusions.

What Are The Possible Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules? 

Dutasteride and tamsulosin hydrochloride capsules

May Cause Serious Side Effects, Including: 

  • Decreased blood pressure.Dutasteride and tamsulosin hydrochloride capsules may cause a sudden drop in your blood pressure upon standing from a sitting or lying position, especially at the start of treatment. Symptoms of low blood pressure may include:
  • fainting
  • dizziness
  • feeling lightheaded

Rare And Serious Allergic Reactions, Including: 

  • swelling of your face, tongue, or throat
  • difficulty breathing
  • 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.
    • Eye problems during cataract or glaucoma surgery.During cataract or glaucoma surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen if you take or have taken dutasteride and tamsulosin hydrochloride capsules in the past. If you need to have cataract or glaucoma surgery, tell your surgeon if you take or have taken dutasteride and tamsulosin hydrochloride capsules.
    • A painful erection that will not go away.Rarely, dutasteride and tamsulosin hydrochloride capsules can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, there could be lasting damage to your penis, including not being able to have an erection.

    The Most Common Side Effects Of Dutasteride And Tamsulosin Hydrochloride Capsules Include: 

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

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

    Depressed mood has been reported in patients receiving dutasteride, an ingredient of dutasteride and tamsulosin hydrochloride capsules.

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

    • Store dutasteride and tamsulosin hydrochloride capsules at 20 to 25 C (68 to 77 F) [

    Active Ingredients: 

    dutasteride and tamsulosin hydrochloride

    Inactive Ingredients: 

    butylated hydroxytoluene, ethylcellulose, gelatin, glycerin, lecithin, medium chain triglycerides, methacrylic acid copolymer, mono- and di-glycerides of capryl/capric acid, polyethylene glycol, sugar spheres, talc, triethyl citrate, iron oxide yellow, hypromellose, titanium dioxide, D&C yellow #10, iron oxide black, FD&C blue #2, FD&C blue #1, propylene glycol, FD&C red #40, shellac, polyvinyl acetate phthalate, macrogol, ammonium hydroxide.

    How Do Dutasteride And Tamsulosin Hydrochloride Capsules Work? 

    Dutasteride and tamsulosin hydrochloride capsules contain 2 medications, dutasteride and tamsulosin. These 2 medications work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate and tamsulosin relaxes muscles in the prostate and neck of the bladder. These 2 medications, when used together, can improve symptoms of BPH better than either medication when used alone.

    Trademarks are the properties of their respective owners.

    Manufactured By: 

    Par Pharmaceutical

    Chestnut Ridge, NY 10977

    R05/18 OS280A-01-1-03



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