FULL PRESCRIBING INFORMATION: CONTENTS*
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- INFORMATION FOR PATIENTS
- DRUG & OR LABORATORY TEST INTERACTIONS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- INFORMATION FOR PATIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
Benign Prostatic Hyperplasia (BPH)
INDICATIONS & USAGEBenign Prostatic Hyperplasia (BPH)
Doxazosin, like other alpha-adrenergic blocking agents, can cause marked hypotension, especially in the upright position, with syncope and other postural symptoms such as dizziness. Marked orthostatic effects are most common with the first dose but can also occur when there is a dosage increase, or if therapy is interrupted for more than a few days. To decrease the likelihood of excessive hypotension and syncope, it is essential that treatment be initiated with the 1 mg dose. The 2, 4, and 8 mg tablets are not for initial therapy. Dosage should then be adjusted slowly (see DOSAGE AND ADMINISTRATION), with evaluations and increases in dose every two weeks to the recommended dose. Additional antihypertensive agents should be added with caution.
Patients being titrated with doxazosin should be cautioned to avoid situations where injury could result should syncope occur, during both the day and night.
If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary.
Benign prostatic hyperplasia
INFORMATION FOR PATIENTS(See Patient Package Insert)
DRUG & OR LABORATORY TEST INTERACTIONS
Impaired Liver Function
Cardiac Toxicity in Animals
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Pregnancy category C
ADVERSE REACTIONSBenign Prostatic Hyperplasia (BPH)
DOSAGE & ADMINISTRATIONDOSAGE MUST BE INDIVIDUALIZED.
Benign Prostatic Hyperplasia 1 to 8 mg once daily
Hypertension 1 to 16 mg once daily
Increases in dose beyond 4 mg increase the likelihood of excessive postural effects, including syncope, postural dizziness/vertigo and postural hypotension. At a titrated dose of 16 mg once daily, the frequency of postural effects is about 12% compared to 3% for placebo.
STORAGE AND HANDLING
INFORMATION FOR PATIENTSABOUT DOXAZOSIN TABLETS USP FOR BENIGN PROSTATIC HYPERPLASIA (BPH)
●before you start taking doxazosin tablets USP
●each time you get a new prescription
What is BPH?
●a weak or start-and-stop stream when urinating
●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
●If you are not bothered by your symptoms, you and your doctor may decide on a program ofwatchful waiting.It is not an active treatment like taking medication or surgery but involves having regular checkups to see if your condition is getting worse or causing problems.
●Treatment with doxazosin tablets USP or other similar drugs. Doxazosin tablets USP are the medication your doctor has prescribed for you. SeeWhat Doxazosin Tablets USP Do,below.
●Treatment with the medication class of 5-alpha reductase inhibitors (e.g., ProscarIt 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.
●If doxazosin tablets USP are helping you, you should notice an effect within 1 to 2 weeks after you start your medication. Doxazosin tablets USP have 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 tablets USP and they may help you, doxazosin tablets USP may not prevent the need for surgery in the future.
●Doxazosin tablets USP do 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.
●You should see an improvement of your symptoms within 1 to 2 weeks. In addition to your other regular checkups you will need to continue seeing your doctor regularly to check your progress regarding your BPH and to monitor your blood pressure.
●Doxazosin tablets USP are not a treatment for prostate cancer. Your doctor has prescribed doxazosin tablets USP 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 tablets USP.
Doxazosin Tablets USP Can Cause a Sudden Drop in Blood Pressure After the VERY FIRST DOSE.
●You will start with a 1 mg dose of doxazosin tablets USP once daily. Then the once daily dose will be increased as your body gets used to the effects of the medication. Follow your doctor's instructions about how to take doxazosin tablets USP. You must take it every day at the dose prescribed. Talk with your doctor if you don
●Other side effects you could have while taking doxazosin tablets USP, 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 tablets USP 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.
●Tell your surgeon if you take or have taken doxazosin tablets USP if you plan to have surgery for cataracts (clouding of the eye). During cataract surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen if you take or have taken doxazosin tablets USP.
●If you use doxazosin tablets USP with an oral erectile dysfunction medicine (phosphodiesterase-5 (PDE-5) inhibitor), it can cause a sudden drop in your blood pressure and you can become dizzy or faint. Talk with your healthcare provider before using PDE-5 inhibitors.
●Keep doxazosin tablets USP and all medicines out of the reach of children.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Doxazosin Mesylate TABLET
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!