Doxazosin Mesylate description, usages, side effects, indications, overdosage, supplying and lots more!

Doxazosin Mesylate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION


DESCRIPTION




CLINICAL PHARMACOLOGY

Pharmacodynamics

Benign Prostatic Hyperplasia (BPH)





CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY





PLACEBODOXAZOSIN(N = 85)(N = 183)Sitting BP (mmHg) Baseline Change Baseline Change ** Standing BP (mmHg) Baseline Change Baseline Change ***

Hypertension




Pharmacokinetics




PRECAUTIONS


INDICATIONS & USAGE

INDICATIONS AND USAGE

Benign Prostatic Hyperplasia (BPH)


Hypertension


CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

WARNINGS

Syncope and "First-dose" Effect
DOSAGE AND ADMINISTRATION






Priapism
PRECAUTIONS: Information for Patients

PRECAUTIONS

General

Prostate Cancer


Cataract Surgery


Orthostatic Hypotension


Hypertension



Benign Prostatic Hyperplasia




INFORMATION FOR PATIENTS

Information for Patients
Patient Leaflet



DRUG & OR LABORATORY TEST INTERACTIONS

Drug/Laboratory Test Interactions


Impaired Liver Function
CLINICAL PHARMACOLOGY

Leukopenia/Neutropenia


DRUG INTERACTIONS

Drug Interactions



Cardiac Toxicity in Animals


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility




PREGNANCY

Teratogenic Effects

Pregnancy Category C



Nonteratogenic Effects


NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use


GERIATRIC USE

Geriatric Use



ADVERSE REACTIONS

Benign 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*





Hypertension



HYPERTENSIONDOXAZOSINPLACEBO(N=339)(N=336)CARDIOVASCULAR SYSTEMSKIN & APPENDAGESMUSCULOSKELETAL SYSTEMCENTRAL & PERIPHERAL N.S.AUTONOMICSPECIAL SENSESPSYCHIATRICGASTROINTESTINALRESPIRATORYURINARYGENERAL

PRECAUTIONS
PRECAUTIONS: General: Cataract Surgery

OVERDOSAGE

OVERDOSAGE



DOSAGE & ADMINISTRATION



Benign Prostatic Hyperplasia 1 to 8 mg Once Daily


Hypertension 1 to 16 mg Once Daily


HOW SUPPLIED



















STORAGE AND HANDLING











SPL PATIENT PACKAGE INSERT

PATIENT 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 INGREDIENT

INACTIVE INGREDIENT:
anhydrous lactose

colloidal silicon
magnesium stearate
microcrystalline cellulose
sodium lauryl sulfate
sodium starch glycolate
D&C Red No. 30 Aluminum Lake

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Doxazosin Mesylate

Doxazosin Mesylate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-268(NDC:0378-4022)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXAZOSIN MESYLATE DOXAZOSIN 2 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C RED NO. 30

Product Characteristics

Color Size Imprint Code Shape
pink 9 mm M;D10 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-268-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075509 2011-03-31


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