HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Hydrochlorothiazide tablets, USP are available containing 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, USP. The 12.5 mg tablets are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side. Blistercards of 30 tablets                        NDC 0615-8149-39 The 25 mg tablets are light orange to peach colored, round, flat tablets with beveled edges and debossed with H & 2 on either side of break line and another side is plain. They are available as follows: Blistercards of 30 tablets                        NDC 0615-7974-39 Blistercards of 15 tablets                        NDC 0615-7974-05 Unit dose boxes of 30 tablets                 NDC 0615-7974-30             The 50 mg tablets are light orange to peach colored, round, flat tablets with beveled edges and debossed with H & 3 on either side of break line and another side is plain. Store at 20° - 25°C (68° - 77°F). [See USP for Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 009, India 10 9685 1 662364 Issued August 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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HYDROCHLOROTHIAZIDE TABLETS, USP
12.5 MG, 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. Each tablet for oral administration
contains 12.5 mg, 25 mg
or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains
the following
inactive ingredients: dibasic calcium phosphate dihydrate, FD & C
yellow, lactose
monohydrate, magnesium stearate, pregelatinized starch (starch 1500)
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.
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