Chlorothiazide (tablet)

Chlorothiazide (tablet)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Chlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

• Chlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

• Chlorothiazide 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.

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. 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorothiazide (tablet) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorothiazide (tablet) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Chlorothiazide (tablet) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorothiazide (tablet) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorothiazide (tablet) in pediatric patients.

Contraindications

• Anuria.

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

Warnings

• 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

Adverse Reactions

Clinical Trials Experience

• 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, hyperglycemia, glycosuria, hyperuricemia.

• Musculoskeletal: Muscle spasm.

• Nervous System / Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness.

• Renal: Renal failure, renal dysfunction, interstitial nephritis.

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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Chlorothiazide (tablet) in the drug label.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorothiazide (tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chlorothiazide (tablet) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Chlorothiazide (tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Chlorothiazide (tablet) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Chlorothiazide (tablet) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Chlorothiazide (tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chlorothiazide (tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chlorothiazide (tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chlorothiazide (tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chlorothiazide (tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chlorothiazide (tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Chlorothiazide (tablet) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Chlorothiazide (tablet) in the drug label.

Overdosage

• 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 chlorothiazide sodium is removed by hemodialysis has not been established.

• The oral LD50 of chlorothiazide is 8.5 g/kg, greater than 10 g/kg, and greater than 1 g/kg, in the mouse, rat and dog respectively.

Pharmacology

There is limited information regarding Chlorothiazide (tablet) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Chlorothiazide (tablet) Mechanism of Action in the drug label.

Structure

There is limited information regarding Chlorothiazide (tablet) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Chlorothiazide (tablet) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Chlorothiazide (tablet) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Chlorothiazide (tablet) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Chlorothiazide (tablet) in the drug label.

How Supplied

Storage

There is limited information regarding Chlorothiazide (tablet) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Chlorothiazide (tablet) in the drug label.

Precautions with Alcohol

• Alcohol-Chlorothiazide (tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• CHLOROTHIAZIDE ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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