Triamterene and Hydrochlorothiazide description, usages, side effects, indications, overdosage, supplying and lots more!

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Triamterene and Hydrochlorothiazide

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TRIAMTERENE AND HYDROCHLOROTHIAZIDE DESCRIPTION




Triamterene and Hydrochlorothiazide


Triamterene and Hydrochlorothiazide

CLINICAL PHARMACOLOGY


Hydrochlorothiazide:


Triamterene:

WARNINGS


INDICATIONS & USAGE

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.



Usage in Pregnancy:


TRIAMTERENE AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS

Hyperkalemia:
Antikaliuretic Therapy or Potassium Supplementation:
Impaired Renal Function:
Hypersensitivity:

WARNINGS

Hyperkalemia
Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment) or elderly or severely ill patients. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide, when dosages are changed, or with any illness that may influence renal function.


CONTRAINDICATIONS

PRECAUTIONS, Drug Interactions
Metabolic or Respiratory Acidosis:

PRECAUTIONS

General
Electrolyte imbalance and BUN increases:





Hepatic Coma:
Renal Stones:
Folic Acid Deficiency:
Hyperuricemia:
Metabolic and Endocrine Effects:


Hypersensitivity:


DRUG INTERACTIONS







DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis:
Triamterene:

Hydrochlorothiazide:
Mutagenesis:
Triamterene:
Hydrochlorothiazide:
Impairment of Fertility:

PREGNANCY

Teratogenic Effects


Triamterene:

Hydrochlorothiazide:

Nonteratogenic Effects


NURSING MOTHERS



PEDIATRIC USE



TRIAMTERENE AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS


Gastrointestinal:
Central Nervous System:
Cardiovascular:
Renal:
Hematologic:
Ophthalmic:
Hypersensitivity:
Other:

Altered Laboratory Findings:
Serum Electrolytes:WARNINGSPRECAUTIONS
Creatinine, Blood Urea Nitrogen:
Glucose:PRECAUTIONS
Serum Uric Acids, PBI and Calcium:PRECAUTIONS
Other:

OVERDOSAGE




DOSAGE & ADMINISTRATION



WARNINGS

PRECAUTIONS, Drug Interactions


HOW SUPPLIED




STORAGE AND HANDLING





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Triamterene and Hydrochlorothiazide

Triamterene and Hydrochlorothiazide

Triamterene and Hydrochlorothiazide

Triamterene and Hydrochlorothiazide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-593(NDC:0591-0348)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TRIAMTERENE TRIAMTERENE 75 mg
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
cellulose, microcrystalline
POLACRILIN POTASSIUM
POLYETHYLENE GLYCOL 8000
povidone
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
yellow 10 mm WATSON;348 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-593-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071851 2011-10-24


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Be sure to consult your doctor before taking any medication!
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