HYDROCHLOROTHIAZIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Actavis Pharma, Inc.

Designació comuna internacional (DCI):

HYDROCHLOROTHIAZIDE

Composición:

HYDROCHLOROTHIAZIDE 12.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydrochlorothiazide tablets are 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 tablets 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. Use in Pregnancy 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, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate. Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.

Resumen del producto:

Hydrochlorothiazide Tablets, USP are available as follows: 12.5 mg — Each peach, round, tablet imprinted with on one side and 20 on the other side contains 12.5 mg of hydrochlorothiazide, USP and is supplied in bottles of 100 (NDC 0228-2820-11) and 1,000 (NDC 0228-2820-96). Dispense in a well-closed container as defined in the USP. Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 3/2023

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
ACTAVIS PHARMA, INC.
----------
HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
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, but freely soluble in sodium hydroxide
solution. Each tablet for
oral administration contains 12.5 mg of hydrochlorothiazide, USP. In
addition, each
tablet contains the following inactive ingredients: calcium stearate,
corn starch, FD&C
Yellow #6 (Sunset Yellow), lactose monohydrate, pregelatinized starch,
sodium lauryl
sulfate, and stearic acid.
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
7
8
3
4 2
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 tablets are indicated as adjunctive therapy in
edema assoc