HYDROCHLOROTHIAZIDE- hydrochlorothiazide tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

H.J. Harkins Company, Inc.

Designació comuna internacional (DCI):

HYDROCHLOROTHIAZIDE

Composición:

HYDROCHLOROTHIAZIDE 25 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 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

Resumen del producto:

Hydrochlorothiazide tablets, USP 12.5 mg and 25 mg are available as light orange colored, round, flat face, beveled edge, uncoated tablets.  Hydrochlorothiazide tablets, USP 50 mg are available as white to off-white colored round, flat face, beveled edge uncoated tablets. Each tablet contains 12.5 mg hydrochlorothiazide, USP and is debossed with "I" and "27" on one side and plain on the other side. NDC 23155-137-16                                            Bottles of 10 NDC 23155-137-01                                            Bottles of 100 NDC 23155-137-10                                            Bottles of 1000 Each tablet contains 25 mg hydrochlorothiazide, USP and is debossed with ‘HP’ above the bisect and ‘47’ below the bisect on one side and plain on the other side. NDC 23155-047-16                                            Bottles of 10 NDC 23155-047-01                                            Bottles of 100 NDC 23155-047-10                                            Bottles of 1000 Each tablet contains 50 mg hydrochlorothiazide, USP and is debossed with ‘HP’ above the bisect and ‘46’ below the bisect on one side and plain on the other side. NDC 23155-046-16                                            Bottles of 10 NDC 23155-046-01                                            Bottles of 100 NDC 23155-046-10                                            Bottles of 1000 PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20 – 25°C (68 – 77°F).  [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET
H.J. HARKINS COMPANY, INC.
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HYDROCHLOROTHIAZIDE TABLETS, USP
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-_2H_-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 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, 25 mg and 50 mg hydrochlorothiazide, USP. In addition, each tablet
contains the following inactive
ingredients: corn starch, dibasic calcium phosphate, lactose
monohydrate, magnesium stearate,
pregelatinized starch, and sodium starch glycolate.Tablets of 12.5 mg
and 25 mg strengths also contain
FD&C yellow #6.
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.
7
8
3
4
2
INDICATIONS AND USAGE
Hydrochlorothiaz