HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Accord Healthcare Inc.

DCI (Denominação Comum Internacional):

HYDROCHLOROTHIAZIDE

Composição:

HYDROCHLOROTHIAZIDE 12.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets 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 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 pregnan

Resumo do produto:

Hydrochlorothiazide tablets, USP are available containing 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, USP. The 12.5 mg tablets are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side. They are available as follows: Bottle of 100 tablets                        NDC 16729-182-01 Bottle of 1000 tablets                      NDC 16729-182-17 The 25 mg tablets are light orange to peach colored, round, flat tablets with beveled edges and debossed with H & 2 on either side of break line and another side is plain. They are available as follows: Bottle of 100 tablets                        NDC 16729-183-01 Bottle of 1000 tablets                      NDC 16729-183-17 The 50 mg tablets are light orange to peach colored, round, flat tablets with beveled edges and debossed with H & 3 on either side of break line and another side is plain. They are available as follows: Bottle of 100 tablets                       NDC 16729-184-01 Bottle of 1000 tablets                      NDC 16729-184-17 Store at 20° - 25°C (68° - 77°F). [See USP for Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 009, India 10 4475 0 6001846 Issued April 2020

Status de autorização:

Abbreviated New Drug Application

Características técnicas

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
ACCORD HEALTHCARE INC.
----------
HYDROCHLOROTHIAZIDE TABLETS, USP
12.5 MG, 25 MG AND 50 MG
RX ONLY
DESCRIPTION:
Hydrochlorothiazide 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:
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 12.5 mg, 25 mg or 50 mg
hydrochlorothiazide, USP. In addition, each
tablet contains the following inactive ingredients: dibasic calcium
phosphate dihydrate, FD & C yellow,
lactose monohydrate, magnesium stearate, pregelatinized starch (starch
1500) and sodium starch
glycolate.
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% of the
oral dose is eliminated
unchanged within 24 hours. Hydrochlorothiazide crosses the placental
but not the blood-brain