HYDROCHLOROTHIAZIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

HYDROCHLOROTHIAZIDE

Composición:

HYDROCHLOROTHIAZIDE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are 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 i

Resumen del producto:

Hydrochlorothiazide Tablets USP, 25 mg are available as round, light orange, flat face, beveled edge tablets, bisected on one side, debossed "2083" and "TEVA" on the other side, containing 25 mg hydrochlorothiazide USP, packaged in Hydrochlorothiazide Tablets USP, 50 mg are available as round, light orange, flat face, beveled edge tablets, bisected on one side, debossed "2089" and "TEVA" on the other side, containing 50 mg hydrochlorothiazide USP, packaged in Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. G 9/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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HYDROCHLOROTHIAZIDE TABLETS USP
DESCRIPTION
Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2_
H_-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide and has the following structural formula:
C H ClN O S M.W. 297.74
Hydrochlorothiazide USP is a white, or practically white, crystalline
powder which is slightly soluble
in water, freely soluble in sodium hydroxide solution, in
n-butylamine, and in dimethylformamide;
sparingly soluble in methanol; insoluble in ether, in chloroform, and
in dilute mineral acids. Each tablet
for oral administration contains 25 mg or 50 mg hydrochlorothiazide
USP. In addition, each tablet
contains the following inactive ingredients: corn starch, dibasic
calcium phosphate, FD&C Yellow No.
6 Lake, lactose monohydrate and magnesium stearate.
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 efcacy.
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% 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
H