Dutasteride & Tamsulosin

Dutasteride/tamsulosin is a prescription medication used to treat enlarged prostate, known medically as benign prostatic hyperplasia (BPH). Dutasteride/tamsulosin comes as a single capsule containing 2 prescription drugs.  Dutasteride belongs to a group of drugs called 5-alpha reductase inhibitors, which block a natural substance responsible for enlarging the prostate.  Tamsulosin belongs to a group of drugs called alpha blockers, which help the prostate and bladder muscles to relax, making urination easier.

This medication comes in capsule form and is taken once a day, 30 minutes after the same meal each day. Swallow capsules whole.

Common side effects of dutasteride/tamsulosin include ejaculation problems, impotence, and decreased sex drive.

Dutasteride/tamsulosin is a prescription medicine used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dutasteride & Tamsulosin may be found in some form under the following brand names:

• Jalyn

Dutasteride/tamsulosin may cause serious side effects, including:

• Decreased blood pressure. Dutasteride/tamsulosin 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
  • 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 surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken dutasteride/tamsulosin in the past. If you need to have cataract surgery, tell your surgeon if you take or have taken dutasteride/tamsulosin.
• A painful erection that will not go away. Rarely, dutasteride/tamsulosin 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/tamsulosin 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

Depressed mood has been reported in patients receiving dutasteride, an ingredient of dutasteride/tamsulosin.

Dutasteride, an ingredient of dutasteride/tamsulosin, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of dutasteride/tamsulosin 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/tamsulosin. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. Dutasteride/tamsulosin 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/tamsulosin (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/tamsulosin. For more information, ask your healthcare provider or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other alpha blocker medications such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin (Hytrin) and others
• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• antifungals such as ketoconazole (Nizoral)
• beta blockers such as carvedilol (Coreg), metoprolol (Toprol), propranolol (Inderal) and others
• cimetidine (Tagamet)
• ciprofloxacin (Cipro)
• diltiazem (Cardizem, Dilacor, Tiazac)
• erectile dysfunction (ED) medicines such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• ritonavir (Norvir)
• troleandomycin (TAO);
• verapamil (Calan, Covera, Isoptin, Verelan)

This is not a complete list of dutasteride/tamsulosin drug interactions. Ask your doctor or pharmacist for more information.

Dutasteride/tamsulosin is for use by men only.

Do Not Take dutasteride/tamsulosin if you are:

• pregnant or could become pregnant. Dutasteride/tamsulosin may harm your unborn baby. Pregnant women should not touch dutasteride/tamsulosin Capsules. If a woman who is pregnant with a male baby gets enough dutasteride/tamsulosin in her body by swallowing or touching dutasteride/tamsulosin, 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/tamsulosin 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/tamsulosin.
• taking another medicine that contains an alpha-blocker.
• allergic to other 5 alpha-reductase inhibitors, for example, Proscar (finasteride) Tablets.

While receiving dutasteride/tamsulosin:

• Avoid driving, operating machinery, or other dangerous activities when starting treatment with dutasteride/tamsulosin until you know how dutasteride/tamsulosin affects you. Dutasteride/tamsulosin 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/tamsulosin or for 6 months after you have stopped dutasteride/tamsulosin. This is important to prevent pregnant women from receiving dutasteride/tamsulosin through blood transfusions.

Before you take dutasteride/tamsulosin, tell your healthcare provider if you:

• have a history of low blood pressure
• take medicines to treat high blood pressure
• plan to have cataract 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 non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. Dutasteride/tamsulosin is approved for use by men only. It should not be used by women who are pregnant. If you are pregnant you should avoid touching dutasteride/tamsulosin capsules as the medicine can be absorbed through skin. Dutasteride/tamsulosin may cause harm to the unborn baby.

Dutasteride/tamsulosin is not approved for use in women, including nursing women. It is not known if dutasteride/tamsulosin is excreted in human breast milk or if it will harm your nursing baby.

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

If you take too much dutasteride/tamsulosin call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dutasteride/tamsulosin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store dutasteride/tamsulosin at room temperature (59° to 86°F or 15° to 30°C).
• Dutasteride/tamsulosin may become deformed and/or discolored if kept at high temperatures.
• Do not use or touch dutasteride/tamsulosin if your capsules are deformed, discolored, or leaking.
• Safely throw away medicine that is no longer needed.
• Keep dutasteride/tamsulosin and all medicines out of the reach of children.