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
- SPL PATIENT PACKAGE INSERT
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
Benign Prostatic Hyperplasia (BPH)
PLACEBODOXAZOSIN(N = 85)(N = 183)Sitting BP (mmHg) Baseline Change Baseline Change ** Standing BP (mmHg) Baseline Change Baseline Change ***
INDICATIONS & USAGEINDICATIONS AND USAGE
Benign Prostatic Hyperplasia (BPH)
Syncope and "First-dose" Effect
DOSAGE AND ADMINISTRATION
PRECAUTIONS: Information for Patients
Benign Prostatic Hyperplasia
INFORMATION FOR PATIENTSInformation for Patients
DRUG & OR LABORATORY TEST INTERACTIONSDrug/Laboratory Test Interactions
Impaired Liver Function
DRUG INTERACTIONSDrug Interactions
Cardiac Toxicity in Animals
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITYCarcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy Category C
NURSING MOTHERSNursing Mothers
PEDIATRIC USEPediatric Use
GERIATRIC USEGeriatric Use
ADVERSE REACTIONSBenign Prostatic Hyperplasia
BENIGN PROSTATIC HYPERPLASIABody SystemDOXAZOSINPLACEBO(N=665)(N=300)BODY AS A WHOLE*CARDIOVASCULAR SYSTEM*DIGESTIVE SYSTEMMETABOLIC AND NUTRITIONAL DISORDERS*NERVOUS SYSTEM*RESPIRATORY SYSTEM*UROGENITAL SYSTEMSKIN & APPENDAGESPSYCHIATRIC DISORDERS*
HYPERTENSIONDOXAZOSINPLACEBO(N=339)(N=336)CARDIOVASCULAR SYSTEMSKIN & APPENDAGESMUSCULOSKELETAL SYSTEMCENTRAL & PERIPHERAL N.S.AUTONOMICSPECIAL SENSESPSYCHIATRICGASTROINTESTINALRESPIRATORYURINARYGENERAL
PRECAUTIONS: General: Cataract Surgery
DOSAGE & ADMINISTRATION
Benign Prostatic Hyperplasia 1 to 8 mg Once Daily
Hypertension 1 to 16 mg Once Daily
STORAGE AND HANDLING
SPL PATIENT PACKAGE INSERTPATIENT INFORMATION ABOUT DOXAZOSIN TABLETS, USP
FOR BENIGN PROSTATIC HYPERPLASIA (BPH)
●before you start taking doxazosin.
●each time you get a new prescription.
●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 of "watchful 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 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.
●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.
●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 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.
●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.
INACTIVE INGREDIENTINACTIVE INGREDIENT:
sodium lauryl sulfate
sodium starch glycolate
D&C Red No. 30 Aluminum Lake
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Doxazosin Mesylate TABLET
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!