HYDROCHLOROTHIAZIDE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Available from:
Direct_Rx
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 pregnancy
Product summary:
Hydrochlorothiazide Tablets, USP are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "128" debossed across the score line on one side and plain on other side containing 25 mg of hydrochlorothiazide, USP. Bottles of 100 : Bottles of 500 : Bottles of 1,000 : Bottles of 5,000 : Hydrochlorothiazide Tablets, USP are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "129" debossed across the score line on one side and plain on other side containing 50 mg of hydrochlorothiazide, USP. Bottles of 100 : Bottles of 500 : Bottles of 1,000 : Bottles of 5,000 : PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Please address medical inquiries to Unichem's toll free # 1-866-562-4616. Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: [Company Logo] Hasbrouck Heights, NJ 07604 05-R-09/2017 13009855
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-293-15

HYDROCHLOROTHIAZIDE- hydrochlorothiazide tablet

Direct_Rx

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HYDROCHLOROTHIAZIDE

Rx only

Hydrochlorothiazide, USP 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]

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 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet

contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate,

pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.

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.

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.

Anuria.

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

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 Interactions).

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient

myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or

ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure

glaucoma can lead to permanent vision loss. The primary treatment is to discontinue

hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be

considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-

closure glaucoma may include a history of sulfonamide or penicillin allergy.

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.

Laboratory Tests

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at

appropriate intervals.

Drug Interactions

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, barbiturates, or narcotics

Potentiation of orthostatic hypotension may occur.

Antidiabetic drugs - (oral agents and insulin)

Dosage adjustment of the antidiabetic drug may be required.

Other antihypertensive drugs

Additive effect or potentiation.

Cholestyramine and colestipol resins

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single

doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its

absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.

Corticosteroids, ACTH

Intensified electrolyte depletion, particularly hypokalemia.

Pressor amines (e.g., norepinephrine)

Possible decreased response to pressor amines but not sufficient to preclude their use.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)

Possible increased responsiveness to the muscle relaxant.

Lithium

Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and

add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of

such preparations with hydrochlorothiazide.

Non-steroidal Anti-inflammatory Drugs

In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic,

natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.Therefore,

when hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patient

should be observed closely to determine if the desired effect of the diuretic is obtained.

Drug/Laboratory Test Interactions

Thiazides should be discontinued before carrying out tests for parathyroid function (see

PRECAUTIONS, General).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology

Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female

mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to

approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for

hepatocarcinogenicity in male mice.

Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella

typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster

Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell

chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive

lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange

(clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of

hydrochlorothiazide from 43 to 1300 µg/ml, and in the Aspergillus nidulans non-disjunction assay at an

unspecified concentration.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies

wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively,

prior to conception and throughout gestation.

Pregnancy

Teratogenic Effects-Pregnancy Category B

Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their

respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg,

respectively, provided no evidence of harm to the fetus.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal

reproduction studies are not always predictive of human response, this drug should be used during

pregnancy only if clearly needed.

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal

jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers

Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing

infants, a decision should be made whether to discontinue nursing or to discontinue

hydrochlorothiazide, taking into account the importance of the drug to the mother.

Pediatric Use

There are no well-controlled clinical trials in pediatric patients. Information on dosing in this age group

is supported by evidence from empiric use in pediatric patients and published literature regarding the

treatment of hypertension in such patients. (See DOSAGE AND ADMINISTRATION, Infants and

Children).

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.

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.

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 3 to 5 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).

Hydrochlorothiazide Tablets, USP are available as light orange, circular, flat, beveled, uncoated

tablets, with score line having "U" and "128" debossed across the score line on one side and plain on

other side containing 25 mg of hydrochlorothiazide, USP.

Bottles of 100 :

Bottles of 500 :

Bottles of 1,000 :

Bottles of 5,000 :

Hydrochlorothiazide Tablets, USP are available as light orange, circular, flat, beveled, uncoated

tablets, with score line having "U" and "129" debossed across the score line on one side and plain on

other side containing 50 mg of hydrochlorothiazide, USP.

Bottles of 100 :

Bottles of 500 :

Bottles of 1,000 :

Bottles of 5,000 :

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure

(as required)

Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Please address medical inquiries to Unichem's toll free # 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

Manufactured for:

[Company Logo]

Hasbrouck Heights, NJ 07604

05-R-09/2017

13009855

HYDROCHLOROTHIAZIDE

hydrochlorothiazide tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -29 3(NDC:29 30 0 -128 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CHLO RO THIAZIDE (UNII: 0 J48 LPH2TH) (HYDROCHLOROTHIAZIDE -

UNII:0 J48 LPH2TH)

HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Dire ct_Rx

Color

o range ((Light Orange))

S core

2 pieces

S hap e

ROUND ((Ro und))

S iz e

Flavor

Imprint Code

U;128

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -29 3-15

15 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 9 0 7

0 8 /21/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -29 3)

Revised: 1/2020

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