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USP DI Vol. II - TAMSULOSIN (Systemic)

TAMSULOSIN (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Flomax

Category

  • Benign prostatic hypertrophy therapy agent

Description

Tamsulosin (tam-SOO-loh-sin) is used to treat thesigns and symptoms of benign enlargement of the prostate (benign prostatichyperplasia or BPH). Benign enlargement of the prostate is a problem thatcan occur in men as they get older. The prostate gland is located below thebladder. As the prostate gland enlarges, certain muscles in the gland maybecome tight and get in the way of the tube that drains urine from the bladder.This can cause problems in urinating, such as a need to urinate often, a weakstream when urinating, or a feeling of not being able to empty the bladdercompletely.

Tamsulosin helps relax the muscles in the prostate and the opening of thebladder. This may help increase the flow of urine and/or decrease the symptoms.However, tamsulosin will not shrink the prostate. The prostate may continueto get larger. This may cause the symptoms to become worse over time. Therefore,even though tamsulosin may lessen the problems caused by enlarged prostatenow, surgery still may be needed in the future.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

    Oral
  • Capsules (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For tamsulosin, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to tamsulosin. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Older adults?This medicine has been tested and has not been shown to causedifferent side effects or problems in older people than it doesin younger adults. However, older people may be more sensitive to the effectsof this medicine.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingtamsulosin, it is especially important that your health care professionalknow if you are taking any of the following:

  • Doxazosin (e.g., Cardura) or
  • Phentolamine or
  • Prazosin (e.g., Minipress) or
  • Terazosin (e.g., Hytrin)?Effects of these medicines or tamsulosinmay be increased
  • Warfarin (e.g., Coumadin)?These medicines should be used togetherwith caution

    Other medical problems?The presence of other medical problemsmay affect the use of tamsulosin. Make sure you tell your doctor if you haveany other medical problems, especially:

    • Cataract surgery?An eye problem called Intraoperative FloppyIris Syndrome (IFIS) has occurred in patients who are taking or who have recentlytaken this medicine when they are having cataract surgery. You should tellyour eye doctor before your surgery if you are taking or have taken tamsulosinin the past 9 months.
    • Sulfa drug (antibiotics such as sulfamethoxazole/trimethoprim [e.g.,Bactrim, Septra]) allergy?An allergic reaction to tamsulosin has beenrarely reported in patients with sulfa allergy. If you have ever had a seriousor life threatening sulfa allergy, you should tell your doctor before takingtamsulosin.

    Proper Use of This Medicine

    To help youremember to take your medicine, try to get into the habit of taking it atthe same time each day. Take it approximately 30 minutes after the same mealeach day.

    Swallow the capsules whole. Do not crush, chew, or open them, unless otherwisedirected by your doctor.

    Dosing?The dose of tamsulosin will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of tamsulosin. If your dose is different,do not change it unless your doctor tells you to do so.

    • For oral dosage form (capsules):
      • For benign enlargement of the prostate:
        • Adults?At first, 0.4 milligram (mg) once a day, about thirtyminutes after the same meal each day. Your doctor may increase the dose ifnecessary.

    Missed dose?If you miss a dose of this medicine, skip the misseddose and go back to your regular dosing schedule. Do not double doses.

    Storage?To store this medicine:

    • Keep out of the reach of children.
    • Store away from heat and direct light.
    • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
    • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

    Precautions While Using This Medicine

    It isimportant that your doctor check your progress at regular visits to make surethat this medicine is working properly.

    Dizziness, lightheadedness, or fainting may occur after you take this medicine,especially when you get up from a lying or sitting position. Getting up slowlymay help lessen this problem. If you feel dizzy, liedown so that you do not faint. Then sit for a few moments before standingto prevent the dizziness from returning.

    Because tamsulosin may cause some people to become dizzy, make sure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you are dizzy.

    You should seek medical attention right away, if youexperience a prolonged erection. This is an extremely rare side effect,but if it goes untreated, can result in permanent erectile dysfunction (impotence).


    Side Effects of This Medicine

    Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.

    The following side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

      More common

        Abnormal ejaculation; back pain; diarrhea; dizziness; headache; stuffy or runny nose; unusual weakness

      Less common

        Chest pain; decreased sexual drive orperformance; difficulty in sleeping; fainting or lightheadedness, especially when getting up froma lying or sitting position; drowsiness; nausea

      Incidence not known

        Painful or prolonged erection of the penis

    Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


    Developed: 03/02/1998
    Revised: 05/02/2006