Doxazosin Mesylate

INDICATIONS & USAGE

DOXAZOSIN MESYLATE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

DRUG & OR LABORATORY TEST INTERACTIONS

DRUG INTERACTIONS

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

DOXAZOSIN MESYLATE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL PATIENT PACKAGE INSERT

• ●before you start taking doxazosin.

• ●each time you get a new prescription.

• ●You and your doctor should discuss this treatment and your (BPH) symptoms before you start taking doxazosin and at your regular checkups. This leaflet does NOT take the place of discussions with your doctor.

• ●a feeling that the bladder is not completely emptied after urination

• ●a delay or difficulty in the beginning of urination

• ●a need to urinate often during the day and especially at night

• ●a feeling that you must urinate immediately.

• ●TREATMENT OPTIONS FOR BPH: The four main treatment options for BPH are:

• ●Treatment with doxazosin or other similar drugs. Doxazosin is the medication your doctor has prescribed for you. See "What Doxazosin Does", below.

• ●Treatment with the medication class of 5-alpha reductase inhibitors (e.g., finasteride). It can cause the prostate to shrink. It may take 6 months or more for the full benefit of finasteride to be seen.

• ●Various surgical procedures. Your doctor can describe these procedures to you. The best procedure for you depends on your BPH symptoms and medical condition.

• ●WHAT DOXAZOSIN DOES: Doxazosin works on a specific type of muscle found in the prostate, causing it to relax. This in turn decreases the pressure within the prostate, thus improving the flow of urine and your symptoms.

• ●If doxazosin is helping you, you should notice an affect within 1 to 2 weeks after you start your medication. Doxazosin has been studied in over 900 patients for up to 2 years and the drug has been shown to continue to work during long-term treatment. Even though you take doxazosin and it may help you, doxazosin may not prevent the need for surgery in the future.

• ●Doxazosin does not affect PSA levels. PSA is the abbreviation for Prostate Specific Antigen. Your doctor may have done a blood test called PSA. You may want to ask your doctor more about this if you have had a PSA test done.

• ●OTHER IMPORTANT FACTS:

• ●Doxazosin Mesylate is not a treatment for prostate cancer. Your doctor has prescribed doxazosin for your BPH and not for prostate cancer; however, a man can have BPH and prostate cancer at the same time. Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). A higher incidence of prostate cancer has been noted in men of African-American descent. These checks should continue even if you are taking doxazosin.

• ●HOW TO TAKE DOXAZOSIN AND WHAT YOU SHOULD KNOW WHILE TAKING DOXAZOSIN FOR BPH: Doxazosin Can Cause a Sudden Drop in Blood Pressure After the VERY FIRST DOSE. You may feel dizzy, faint or "light-headed", especially after you stand up from a lying or sitting position. This is more likely to occur after you've taken the first few doses or if you increase your dose, but can occur at any time while you are taking the drug. It can also occur if you stop taking the drug and then restart treatment. If you feel very dizzy, faint or "light-headed" you should contact your doctor. Your doctor will discuss with you how often you need to visit and how often your blood pressure should be checked.

• ●Other side effects you could have while taking doxazosin, in addition to lowering of the blood pressure, include dizziness, fatigue (tiredness), swelling of the feet and shortness of breath. Most side effects are mild. However, you should discuss any unexpected effects you notice with your doctor.

• ●WARNING: Extremely rarely, doxazosin and similar medications have caused painful erection of the penis, sustained for hours and unrelieved by sexual intercourse or masturbation. This condition is serious, and if untreated it can be followed by permanent inability to have an erection. If you have a prolonged abnormal erection, call your doctor or go to an emergency room as soon as possible.

• ●Keep doxazosin and all medicines out of the reach of children.

• ●FOR MORE INFORMATION ABOUT DOXAZOSIN AND BPH TALK WITH YOUR DOCTOR, NURSE, PHARMACIST OR OTHER HEALTH CARE PROVIDER.

INACTIVE INGREDIENT

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