HYDROCHLOROTHIAZIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
03-10-2011

Aktiv ingrediens:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Tilgjengelig fra:

Dispensing Solutions, Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Sammensetning:

HYDROCHLOROTHIAZIDE 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, ju

Produkt oppsummering:

Hydrochlorothiazide Tablets, USP 25 mg, are peach-colored, round, scored tablets debossed "3571" and "V" on one side. They are supplied as follows:     Bottles of 10, 30, 50, 100, 500, 1000 and 5000. Hydrochlorothiazide Tablets, USP 50 mg, are peach-colored, round, scored tablets debossed "3572" and "V" on one side. They are supplied as follows:     Bottles of 10, 30, 50, 100, 500 and 1000. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET
DISPENSING SOLUTIONS, INC.
----------
HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. Its chemical name is
6-chloro-3,4-dihydro-_2H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its empirical formula is C H CIN O S and its structural
formula is:
It is a white, or practically white, crystalline powder with a
molecular weight of 297.74, which is
slightly soluble in water, but freely soluble in sodium hydroxide
solution.
Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral
use. Each tablet contains the
following inactive ingredients: FD&C Yellow #6 Lake, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized starch.
CLINICAL PHARMACOLOGY
The mechanism of the antihypertensive effect of thiazides is unknown.
Hydrochlorothiazide does not
usually affect normal blood pressure.
Hydrochlorothiazide affects the distal renal tubular mechanism of
electrolyte reabsorption. At maximal
therapeutic dosage all thiazides are approximately equal in their
diuretic efficacy.
Hydrochlorothiazide increases excretion of sodium and chloride in
approximately equivalent amounts.
Natriuresis may be accompanied by some loss of potassium and
bicarbonate.
After oral use diuresis begins within 2 hours, peaks in about 4 hours
and lasts about 6 to 12 hours.
_Pharmacokinetics and Metabolism_
Hydrochlorothiazide is not metabolized but is eliminated rapidly by
the kidney. When plasma levels
have been followed for at least 24 hours, the plasma half-life has
been observed to vary between 5.6
and 14.8 hours. At least 61 percent of the oral dose is eliminated
unchanged within 24 hours.
Hydrochlorothiazide crosses the placental but not the blood-brain
barrier and is excreted in breast milk.
INDICATIONS AND USAGE
Hydrochlorothiazide is indicated as adjunctive therapy in edema
associated with congestive heart
failure, hepatic cirrhosis, and corticost
                                
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