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)






TABLE 1 SUMMARY OF EFFECTIVENESS DATA IN PLACEBO-CONTROLLED TRIALS
PHARMACODYNAMICS



PHARMACODYNAMICS







*****
Hypertension




PHARMACOKINETICS





PRECAUTIONS: Drug Interactions


INDICATIONS & USAGE

Benign Prostatic Hyperplasia (BPH)


Hypertension


CONTRAINDICATIONS



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

Patient Leaflet



DRUG & OR LABORATORY TEST INTERACTIONS



Impaired Liver Function
CLINICAL PHARMACOLOGY: Pharmacokinetics

Leukopenia/Neutropenia


DRUG INTERACTIONS



DOSAGE AND ADMINISTRATION

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

Cardiac Toxicity in Animals


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects. Pregnancy Category C



Nonteratogenic Effects


NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE


For Hypertension


ADVERSE REACTIONS

Benign Prostatic Hyperplasia (BPH)



******


Hypertension





PRECAUTIONS: Leukopenia/Neutropenia
PRECAUTIONS: General: Cataract Surgery

OVERDOSAGE




DOSAGE & ADMINISTRATION




Benign Prostatic Hyperplasia 1 mg to 8 mg Once Daily


Hypertension 1 mg to 16 mg Once Daily


HOW SUPPLIED



















STORAGE AND HANDLING





SPL PATIENT PACKAGE INSERT

PATIENT INFORMATION ABOUT DOXAZOSIN TABLETS, USP
(dox az'oh sin)
FOR BENIGN PROSTATIC HYPERPLASIA (BPH)

  • ●     before you start taking doxazosin tablets.
  • ●     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 tablets or other similar drugs. Doxazosin tablets is the medication your doctor has prescribed for you. See "What Doxazosin Tablets Do", 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 tablets are helping you, you should notice an affect within 1 to 2 weeks after you start your medication. Doxazosin tablets 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 and it may help you, doxazosin tablets may not prevent the need for surgery in the future.
  • ●     Doxazosin tablets 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 Mesylate is not a treatment for prostate cancer. Your doctor has prescribed doxazosin tablets 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.




  • ●     Other side effects you could have while taking doxazosin tablets, 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 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 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.
  • ●     If you use doxazosin tablets 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 and all medicines out of the reach of children.



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:49349-282(NDC:0378-4021)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXAZOSIN MESYLATE DOXAZOSIN 1 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
white 9 mm M;D9 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-282-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075509 2011-06-06


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Be sure to consult your doctor before taking any medication!
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