HYDROCHLOROTHIAZIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Solco Healthcare U.S., LLC

INN (Mezinárodní Name):

HYDROCHLOROTHIAZIDE

Složení:

HYDROCHLOROTHIAZIDE 25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Hydrochlorothiazide Tablets, USP 25 mg, are peach-colored, round, scored tablets debossed "3571" and "V" on one side. They are supplied as follows: Hydrochlorothiazide Tablets, USP 50 mg, are peach-colored, round, scored tablets debossed "3572" and "V" on one side. They are supplied as follows: You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
SOLCO HEALTHCARE U.S., LLC
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HYDROCHLOROTHIAZIDE TABLETS, USP
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.
Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral
use. Each tablet contains the
following inactive ingredients: FD&C Yellow #6 Lake, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized starch.
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
barrier and is excreted in breast milk.
INDICATIONS AND USAGE
Hydrochlorothiazide table