HYDROCHLOROTHIAZIDE 25MG USP Tablets HYDROCHLOROTHIAZIDE 50MG USP Tablets Rx Only

DESCRIPTION

id: 10300bc0-b82a-4625-abca-77272eff336f
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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-2H-1,2,4-benzothiadiazine
-7-sulfonamide 1,1-dioxide and has the following structural formula: 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 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.

CLINICAL PHARMACOLOGY

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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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.

INDICATIONS AND USAGE

id: 372a9e8e-781c-4cf9-ad86-f45f7582b53d
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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
pregnancy when edema is due to pathologic causes, just as they are in the
absence of pregnancy (see PRECAUTIONS,
Pregnancy).
Dependent edema in pregnancy, resulting from restriction
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.

CONTRAINDICATIONS

id: 1a258621-56b4-47c0-ba71-6f915237bd1e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Anuria.
Hypersensitivity to this product or to other sulfonamide-derived
drugs.

WARNINGS

id: 0091bc10-ca6f-4f1a-892b-5d58b0521607
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Use with caution in severe renal disease. In patients with renal
disease, thiazides may precipitate azotemia. Cumulative effects of the drug may
develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic
function or progressive liver disease, since minor alterations of fluid and
electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive
drugs. Sensitivity reactions may occur in patients with or without a history of
allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus
has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS,
Drug lnteractions).

PRECAUTIONS

id: bf86c252-9fe7-47e7-8031-635e1b2454fa
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

General All patients receiving diuretic therapy should be observed for
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. Hypokalemia may develop, especially with brisk diuresis, when severe
cirrhosis is present or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to
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. Although any chloride deficit is generally mild and usually does not require
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
choice. Hyperuricemia may occur or acute gout may be precipitated in certain patients
receiving thiazides. In diabetic patients dosage adjustments of insulin or oral hypoglycemic
agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus
latent diabetes mellitus may become manifest during thiazide therapy. The antihypertensive effects of the drug may be enhanced in the
post-sympathectomy patient. If progressive renal impairment becomes evident, consider withholding or
discontinuing diuretic therapy. Thiazides have been shown to increase the urinary excretion of magnesium;
this may result in hypomagnesemia. Thiazides may decrease urinary calcium excretion. Thiazides may cause
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.

ADVERSE REACTIONS

id: 33b7efe9-1fe6-4a01-9f52-970e53f44aa0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The following adverse reactions have been reported and, within
each category, are listed in order of decreasing severity. Body as a Whole

Weakness Cardiovascular

Hypotension including orthostatic
hypotension (may be aggravated by alcohol, barbiturates, narcotics or
antihypertensive drugs) Digestive

Pancreatitis, jaundice (intrahepatic
cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation,
gastric irritation, nausea, anorexia Hematologic

Aplastic anemia, agranulocytosis,
leukopenia, hemolytic anemia, thrombocytopenia Hypersensitivity

Anaphylactic reactions,
necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress
including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria,
rash, purpura Metabolic

Electrolyte imbalance (see PRECAUTIONS),
hyperglycemia, glycosuria, hyperuricemia Musculoskeletal

Muscle spasm Nervous System/Psychiatric

Vertigo, paresthesias,
dizziness, headache, restlessness. Renal

Renal failure, renal dysfunction,
interstitial nephritis (see WARNINGS)
Skin

Erythema multiforme including
Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal
necrolysis, alopecia Special Senses

Transient blurred vision,
xanthopsia Urogenital

Impotence Whenever adverse reactions are moderate or severe, thiazide dosage should be
reduced or therapy withdrawn.

OVERDOSAGE

id: 396a8b0d-b845-42f4-b54e-9dbd25024fa5
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

The most common signs and symptoms observed are those caused by
electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration
resulting from excessive diuresis. If digitalis has also been administered,
hypokalemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be
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. The oral LD₅₀ of hydrochlorothiazide is greater than
10 g/kg in the mouse and rat.

DOSAGE AND ADMINISTRATION

id: ee51f0f8-37f3-4c40-b5c7-79a258a05250
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Therapy should be individualized according to patient response.
Use the smallest dosage necessary to achieve the required response. Adults

For Edema The usual adult dosage is 25 to 100 mg daily as a single or
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. For Control of Hypertension The usual initial dose in adults is 25 mg daily given as a single
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
potassium (see also PRECAUTIONS). Patients usually do not require doses in excess of 50 mg of
hydrochlorothiazide daily when used concomitantly with other antihypertensive
agents.

Infants and Children

For Diuresis and For Control of Hypertension The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2
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. (See PRECAUTIONS,
Pediatric Use)

HOW SUPPLIED

id: 62acefcd-3fc8-4fdf-b793-b9131210d50f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrochlorothiazide Tablets USP are available as round, light orange, flat-faced
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: NDC 12634-445-91 UD Blister Pack
NDC 12634-445-85 Bottle of 15
NDC 12634-445-79 Bottle of 25
NDC 12634-445-78 Bottle of 28
NDC 12634-445-71 Bottle of 30
NDC 12634-445-50 Bottle of 50
NDC 12634-445-60 Bottle of 60
NDC 12634-445-90 Bottle of 90 Hydrochlorothiazide Tablets USP are available as round, light orange, flat-faced
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:

Storage and Dispensing

id: da9fc227-723a-49fd-b98a-371c7223f7af
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure.Store at controlled room temperature 20°-25°C (68°-77°F) (see USP).

Manufactured by:

Lannett Company, Inc.
Philadelphia, PA 19136

Repackaged and Distributed by:

Apotheca, Inc.
Phoenix, AZ 85006

PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

id: 25a204f2-d0c4-4fe8-92a3-a9ec498ce993
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

30 Tablets NDC 12634-471-71
HYDROCHLOROTHIAZIDE
Tablets, USP
Rx Only 50 MG