Dutasteride-tamsulosin

Do not donate blood while taking this medication and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

Dutasteride and tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Tell your doctor about all other medications you use, especially:

• cimetidine (Tagamet);
• conivaptan (Vaprisol);
• cyclosporine (Gengraf, Neoral, Sandimmune);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• methimazole (Tapazole);
• pioglitazone (Actos);
• ropinirole (Requip);
• ticlopidine (Ticlid);
• a blood thinner such as warfarin (Coumadin, Jantoven);
• an antibiotic such as clarithromycin (Biaxin), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), metronidazole (Flagyl, Protostat), telithromycin (Ketek), terbinafine (Lamisil), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
• an antidepressant such as clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem), nefazodone, paroxetine (Paxil), sertraline (Zoloft), tranylcypromine (Parnate), or trazodone (Desyrel, Oleptro);
• antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
• anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);
• erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), nicardipine (Cardene), or quinidine (Quin-G), and others;
• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or
• medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and there are many other drugs that can interact with dutasteride and tamsulosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Contraindications

Previously demonstrated, clinically significant hypersensitivity (eg, serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5 alpha-reductase inhibitors, or tamsulosin

Pregnancy and women of childbearing potential should not take or handle drug

Children

Cautions

Prior to initiating treatment, rule out other urological conditions

Orthostatic hypotension and/or syncope can occur

Reduces total serum prostate-specific antigen (PSA) concentration by ~50%, evaluate any confirmed increases in PSA levels from nadir, even if those values are within normal range, for the presence of prostate cancer

Caution patients about the possibility and seriousness of priapism

Advise patients to not donate blood until 6 months after their last dose

Intraoperative floppy iris syndrome has been observed during cataract surgery after alpha-adrenergic antagonist exposure

Metabolized by both CYP3A4 and CYP2D6; concomitant use with known inhibitors can cause a marked increase in plasma levels resulting in an increased incidence of adverse effects; do not use with strong 3A4 or 2D6 inhibitors (eg, ketoconazole, paroxetine); exercise caution when coadministered with less potent inhibitors (eg, terbinafine, erythromycin)

Coadministration with PDE-5 inhibitors (eg, sildenafil) can increase risk of hypotension

Coadministration with other alpha-antagonists (eg, doxazosin, terazosin) may cause additive hypotension

Limited studies showed inconclusive results regarding coadministration of tamsulosin with warfarin (monitor INR)

5-ARIs and prostate cancer risk

• June 9, 2011: Recent data from 2 large, randomized, controlled trials observed an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer) in trial participants taking 5-alpha reductase inhibitors (5-ARIs)
• The 2 trials are the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial
• The revised prescribing information recommends that prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH)

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 is part of the drug class:

• DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY

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.

• 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.