HYDROCHLOROTHIAZIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Northwind Pharmaceuticals, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Hydrochlorothiazide Tablets, USP 25 mg, are peach colored, round, debossed on one side with "H" above and "2" below the bisect and plain on the other side. Hydrochlorothiazide Tablets, USP 25 mg are supplied as follows: Bottles of 90 NDC 51655-272-26 Bottles of 30 NDC 51655-272-52 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Rx only Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000307US05 Revised: 09/2021

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 _H_
-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. Its molecular formula is C
H
CIN
O
S
and its structural
formula is:
It is a white, or practically white, crystalline powder with a
molecular weight of 297.74
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 and 50 mg of
hydrochlorothiazide
respectively. In addition, each tablet contains following inactive
ingredients: anhydrous
lactose, D&C Yellow No.10 aluminum lake, FD&C Red No. 40 aluminum
lake, magnesium
stearate, pregelatinized starch 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.
7
8
3
4
2
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 bu