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

Terazosin Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION


DESCRIPTION



CLINICAL PHARMACOLOGY

Pharmacodynamics



























  • ●     p
  • ●FIGURE 3. Mean Change in Peak Flow Rate from Baseline Long-Term, Open-Label, Non-Placebo Controlled Study (N=494)


















Pharmacokinetics



INDICATIONS & USAGE




CONTRAINDICATIONS



WARNINGS











PRECAUTIONS

General







INFORMATION FOR PATIENTS







DRUG INTERACTIONS













Use With Other Drugs



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY








NURSING MOTHERS



PEDIATRIC USE



ADVERSE REACTIONS

Benign Prostatic Hyperplasia











Hypertension































Post-marketing Experience



OVERDOSAGE



DOSAGE & ADMINISTRATION



Benign Prostatic Hyperplasia







Hypertension








HOW SUPPLIED






STORAGE AND HANDLING




SPL PATIENT PACKAGE INSERT














































LABORATORY TESTS


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Terazosin Hydrochloride

Terazosin Hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-298(NDC:59746-385)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TERAZOSIN HYDROCHLORIDE TERAZOSIN 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
SHELLAC
ALCOHOL
titanium dioxide
FERROSOFERRIC OXIDE
propylene glycol
SILICON DIOXIDE
SODIUM LAURYL SULFATE
D&C RED NO. 28

Product Characteristics

Color Size Imprint Code Shape
orange 15 mm TL;385 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-298-02 30 in 1 BLISTER PACK
2 NDC:49349-298-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075317 2011-06-09


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