Terazosin Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Terazosin Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TERAZOSIN HYDROCHLORIDE DESCRIPTION


Terazosin Hydrochloride




CLINICAL PHARMACOLOGY


PHARMACODYNAMICS

Benign Prostatic Hyperplasia (BPH)


Symptom Score (Range 027)Peak Flow Rate (mL/Sec)NMean BaselineMean Change (%)NMean BaselineMean Change (%)*Study 1 (10 mg)*Titration to fixed dose (12 wks)PlaceboTerazosinStudy 2 (2, 5, 10, 20 mg)Titration to response (24 wks)PlaceboTerazosinStudy 3 (1, 2, 5, 10 mg)Titration to response (24 wks)PlaceboTerazosin



Terazosin Hydrochloride


Terazosin Hydrochloride

Terazosin Hydrochloride




Normotensive Patients DBP90 mm HgHypertensive Patients DBP > 90 mm HgGroupNMean ChangeNMean Change*****
Hypertension










PHARMACOKINETICS




INDICATIONS & USAGE




TERAZOSIN HYDROCHLORIDE CONTRAINDICATIONS



WARNINGS

Syncope and "First-Dose" Effect



CLINICAL PHARMACOLOGY



Priapism
PRECAUTIONS: Information for Patients

PRECAUTIONS

General

Prostatic Cancer


Intraoperative Floppy Iris Syndrome (IFIS)


Orthostatic Hypotension
WARNINGS

INFORMATION FOR PATIENTS

Patient Package Insert




LABORATORY TESTS



DRUG INTERACTIONS



Use with Other Drugs
DOSAGE AND ADMINISTRATION

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY

Teratogenic Effects

Pregnancy Category C


Nonteratogenic Effects


NURSING MOTHERS



PEDIATRIC USE



TERAZOSIN HYDROCHLORIDE ADVERSE REACTIONS

Benign Prostatic Hyperplasia
PRECAUTIONS

BENIGN PROSTATIC HYPERPLASIABody SystemTerazosin (N=636)Placebo (N=360)*BODY AS A WHOLE*CARDIOVASCULAR SYSTEMDIGESTIVE SYSTEMMETABOLIC AND NUTRITIONAL DISORDERSNERVOUS SYSTEMRESPIRATORY SYSTEMSPECIAL SENSESUROGENITAL SYSTEM


BENIGN PROSTATIC HYPERPLASIABody SystemTerazosin (N=636)Placebo (N=360)BODY AS A WHOLECARDIOVASCULAR SYSTEMDIGESTIVE SYSTEMNERVOUS SYSTEMRESPIRATORY SYSTEMSPECIAL SENSESUROGENITAL SYSTEM
Hypertension


HYPERTENSIONBody SystemTerazosin (N=859)Placebo (N=506)*BODY AS A WHOLE*CARDIOVASCULAR SYSTEMDIGESTIVE SYSTEMMETABOLIC AND NUTRITIONAL DISORDERSMUSCULOSKELETAL SYSTEMNERVOUS SYSTEMRESPIRATORY SYSTEMSPECIAL SENSESUROGENITAL SYSTEM


HYPERTENSIONBody SystemTerazosin (N=859)Placebo (N=506)BODY AS A WHOLECARDIOVASCULAR SYSTEMDIGESTIVE SYSTEMMETABOLIC AND NUTRITIONAL DISORDERSNERVOUS SYSTEMRESPIRATORY SYSTEMSPECIAL SENSES
Post-Marketing Experience

PRECAUTIONS

OVERDOSAGE



DOSAGE & ADMINISTRATION



Benign Prostatic Hyperplasia

Initial Dose


Subsequent Doses


Use With Other Drugs
PRECAUTIONS

Hypertension


Initial Dose


Subsequent Doses


Use With Other Drugs


HOW SUPPLIED





STORAGE AND HANDLING






SPL PATIENT PACKAGE INSERT









  • ●     a weak or interrupted stream when urinating
  • ●     a feeling that you cannot empty your bladder completely
  • ●     a feeling of delay when you start to urinate
  • ●     a need to urinate often, especially at night, or
  • ●     a feeling that you must urinate right away.

  • ●     Program of monitoring or "Watchful Waiting". Some men have an enlarged prostate gland, but no symptoms, or symptoms that are not bothersome. If this applies, you and your doctor may decide on a program of monitoring including regular checkups, instead of medication or surgery.
  • ●     Medication. There are different kinds of medication used to treat BPH. Your doctor has prescribed terazosin hydrochloride for you. See "What Terazosin Hydrochloride Does to Treat BPH" below.
  • ●     Surgery. Some patients may need surgery. Your doctor can describe several different surgical procedures to treat BPH. Which procedure is best depends on your symptoms and medical condition.

  • ●     Terazosin hydrochloride helps relieve the symptoms of BPH. It does NOT change the size of the prostate, which may continue to grow. However, a larger prostate does not necessarily cause more or worse symptoms.
  • ●     If terazosin hydrochloride is helping you, you should notice an effect on your particular symptoms in 2 to 4 weeks of starting to take the medication.
  • ●     Even though you take terazosin hydrochloride and it may help you, terazosin hydrochloride may not prevent the need for surgery in the future.

  • ●     You should see an effect on your symptoms in 2 to 4 weeks. So, you will need to continue seeing your doctor to check your progress regarding your BPH and to monitor your blood pressure in addition to your other regular check-ups.
  • ●     Your doctor has prescribed terazosin hydrochloride 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). These checks should continue even if you are taking terazosin hydrochloride. Terazosin hydrochloride is not a treatment for prostate cancer.
  • ●     About Prostate Specific Antigen (PSA). Your doctor may have done a blood test called PSA. Your doctor is aware that terazosin hydrochloride does not affect PSA levels. You may want to ask your doctor more about this if you have had a PSA test done.


  • ●     You will start with a 1 mg dose of terazosin hydrochloride. Then the dose will be increased as your body gets used to the effect of the medication.
  • ●     Other side effects you could have while taking terazosin hydrochloride include drowsiness, blurred or hazy vision, nausea, or "puffiness" of the feet or hands. Discuss any unexpected effects you notice with your doctor.








PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Terazosin Hydrochloride

Terazosin Hydrochloride

Terazosin Hydrochloride

Terazosin Hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-348(NDC:59746-383)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TERAZOSIN HYDROCHLORIDE TERAZOSIN 1 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
SHELLAC
propylene glycol
FERROSOFERRIC OXIDE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
gray 14 mm TL;383 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-348-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075317 2011-07-01


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Be sure to consult your doctor before taking any medication!
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