Prescription Drug Name:
HYDROCHLOROTHIAZIDE 25MG USP Tablets HYDROCHLOROTHIAZIDE 50MG USP Tablets Rx Only
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
derivative of chlorothiazide. It is chemically designated as
-7-sulfonamide 1,1-dioxide and has the following structural formula:
is slightly soluble in water, but freely soluble in sodium hydroxide solution.
Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide.
In addition, each tablet contains the following inactive ingredients: lactose
monohydrate, microcrystalline cellulose, FD and C yellow #6, D and C yellow #10,
colloidal silicon dioxide, sodium starch glycolate, and magnesium stearate; the
50 mg also contains stearic acid.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
unknown. Hydrochlorothiazide does not usually affect normal blood pressure.
reabsorption. At maximal therapeutic dosage all thiazides are approximately
equal in their diuretic efficacy.
approximately equivalent amounts. Natriuresis may be accompanied by some loss of
potassium and bicarbonate.
lasts about 6 to 12 hours.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
in edema associated with congestive heart failure, hepatic cirrhosis, and
corticosteroid and estrogen therapy.
various forms of renal dysfunction such as nephrotic syndrome, acute
glomerulonephritis, and chronic renal failure.
either as the sole therapeutic agent or to enhance the effectiveness of other
antihypertensive drugs in the more severe forms of hypertension.
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.
physiologic and mechanical consequences of pregnancy. Thiazides are indicated in
pregnancy when edema is due to pathologic causes, just as they are in the
absence of pregnancy
of venous return by the gravid uterus, is properly treated through elevation of
the lower extremities and use of support stockings. Use of diuretics to lower
intravascular volume in this instance is illogical and unnecessary. During
normal pregnancy there is hypervolemia which is not harmful to the fetus or the
mother in the absence of cardiovascular disease. However, it may be associated
with edema, rarely generalized edema. If such edema causes discomfort, increased
recumbency will often provide relief. Rarely this edema may cause extreme
discomfort which is not relieved by rest. In these instances, a short course of
diuretic therapy may provide relief and be appropriate.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Hypersensitivity to this product or to other sulfonamide-derived
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
disease, thiazides may precipitate azotemia. Cumulative effects of the drug may
develop in patients with impaired renal function.
function or progressive liver disease, since minor alterations of fluid and
electrolyte balance may precipitate hepatic coma.
drugs. Sensitivity reactions may occur in patients with or without a history of
allergy or bronchial asthma.
has been reported.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic
alkalosis, and hypokalemia. Serum and urine electrolyte determinations are
particularly important when the patient is vomiting excessively or receiving
parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance,
irrespective of cause, include dryness of mouth, thirst, weakness, lethargy,
drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular
fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances
such as nausea and vomiting.
cirrhosis is present or after prolonged therapy.
hypokalemia. Hypokalemia may cause cardiac arrhythmia and may also sensitize or
exaggerate the response of the heart to the toxic effects of digitalis (e.g.,
increased ventricular irritability). Hypokalemia may be avoided or treated by
use of potassium sparing diuretics or potassium supplements such as foods with a
high potassium content.
specific treatment except under extraordinary circumstances (as in liver disease
or renal disease), chloride replacement may be required in the treatment of
metabolic alkalosis. Dilutional hyponatremia may occur in edematous patients in
hot weather; appropriate therapy is water restriction, rather than
administration of salt, except in rare instances when the hyponatremia is life
threatening. In actual salt depletion, appropriate replacement is the therapy of
agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus
latent diabetes mellitus may become manifest during thiazide therapy.
discontinuing diuretic therapy.
this may result in hypomagnesemia.
intermittent and slight elevation of serum calcium in the absence of known
disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden
hyperparathyroidism. Thiazides should be discontinued before carrying out tests
for parathyroid function. Increases in cholesterol and triglyceride levels may
be associated with thiazide diuretic therapy.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
each category, are listed in order of decreasing severity.
Hypotension including orthostatic
hypotension (may be aggravated by alcohol, barbiturates, narcotics or
Pancreatitis, jaundice (intrahepatic
cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation,
gastric irritation, nausea, anorexia
Aplastic anemia, agranulocytosis,
leukopenia, hemolytic anemia, thrombocytopenia
necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress
including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria,
hyperglycemia, glycosuria, hyperuricemia
dizziness, headache, restlessness.
Renal failure, renal dysfunction,
Erythema multiforme including
Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal
Transient blurred vision,
reduced or therapy withdrawn.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration
resulting from excessive diuresis. If digitalis has also been administered,
hypokalemia may accentuate cardiac arrhythmias.
employed. Emesis should be induced or gastric lavage performed. Correct
dehydration, electrolyte imbalance, hepatic coma and hypotension by established
procedures. If required, give oxygen or artificial respiration for respiratory
impairment. The degree to which hydrochlorothiazide is removed by hemodialysis
has not been established.
10 g/kg in the mouse and rat.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Use the smallest dosage necessary to achieve the required response.
divided dose. Many patients with edema respond to intermittent therapy, i.e.,
administration on alternate days or on three to five days each week. With an
intermittent schedule, excessive response and the resulting undesirable
electrolyte imbalance are less likely to occur.
dose. The dose may be increased to 50 mg daily, given as a single or two divided
doses. Doses above 50 mg are often associated with marked reductions in serum
hydrochlorothiazide daily when used concomitantly with other antihypertensive
Infants and Children
mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in
infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age.
In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per
day in two divided doses may be required.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
beveled edge, bisected tablets, debossed with LCI on one side and 1413 on the
other side, containing 25 mg of hydrochlorothiazide USP, packaged as follows:
beveled edge, bisected tablets, debossed with LCI on one side and 1414 on the
other side, containing 50 mg of hydrochlorothiazide USP, packaged as follows:
- NDC 12634-471-91 UD Blister Pack
- NDC 12634-471-85 Bottle of 15
- NDC 12634-471-79 Bottle of 25
- NDC 12634-471-78 Bottle of 28
- NDC 12634-471-71 Bottle of 30
- NDC 12634-471-50 Bottle of 50
- NDC 12634-471-60 Bottle of 60
- NDC 12634-471-90 Bottle of 90
Storage and Dispensing
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7
Lannett Company, Inc.
Philadelphia, PA 19136
Phoenix, AZ 85006
PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx Only 50 MG