HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

ScieGen Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

HYDROCHLOROTHIAZIDE

Composição:

HYDROCHLOROTHIAZIDE 25 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. 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 du

Resumo do produto:

Hydrochlorothiazide tablets, USP are available containing 25 mg and 50 mg hydrochlorothiazide, USP The 25 mg tablets are White to off white, round shaped bevel edge, scored tablets debossed with 111 on one side of the tablet and S to the left of the score and G to the right of the score on the other side. They are available as follows: NDC 50228-111-30                                        bottles of 30 tablets NDC 50228-111-10                                        bottles of 1000 tablets The 50 mg tablets are White to off white, round shaped bevel edge, scored tablets debossed with 112 on one side of the tablet and S to the left of the score and G to the right of the score on the other side. They are available as follows: NDC 50228-112-30                                            bottles of 30 tablets NDC 50228-112-10                                            bottles of 1000 tablets Store at 20° to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
SCIEGEN PHARMACEUTICALS, INC.
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HYDROCHLOROTHIAZIDE TABLETS, USP
25 MG AND 50 MG
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-_2H_-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 very 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 and
50 mg hydrochlorothiazide, USP.
In addition, each tablet contains the following inactive
ingredients:microcrystalline cellulose, NF,
lactose anhydrous NF, pregelatinized starch NF, sodium lauryl sulfate
NF, silicon dioxide NF and
magnesium stearate, NF.
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