HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Med-Health Pharma, LLC

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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 due to pathologic causes, jus

Product summary:

Hydrochlorothiazide Tablets, USP are available as follows: 12.5 mg — Each peach, round, tablet imprinted with on one side and 20 on the other side contains 12.5 mg of Hydrochlorothiazide, USP and is supplied in bottles of 30 (NDC 51138-038-30) with a child-resistant closure. Dispense in a well-closed container as defined in the USP. Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F). Store at 20-25°C (68-77°F)[See USP Controlled Room Temperature]. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9079 Revised — January 2008 Repackaged By: Med-Health Pharma, LLC North Las Vegas, NV 89032 SP-60013 Rev01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE TABLET
MED-HEALTH PHARMA, LLC
----------
HYDROCHLOROTHIAZIDE TABLETS, USP
40-9079
REVISED — JANUARY 2008
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:
C H CLN O S
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 of hydrochlorothiazide. In addition, each tablet contains the
following inactive ingredients: calcium
stearate, corn starch, FD&C yellow #6 (sunset yellow), lactose
monohydrate, pregelatinized starch,
sodium lauryl sulfate, and stearic acid.
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.
INDICATIONS AND USAGE
7
8
3
4
2
Hydrochlorothiazide is indicated as adjunctive therapy in edema
assoc