Chlorothiazide (oral suspension)

Chlorothiazide (oral suspension)
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)

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

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

• DIURIL 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 (oral suspension) in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorothiazide (oral suspension) 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 (oral suspension) in the drug label.

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 - Both cholestyramine and colestipol resins have the potential of binding thiazide diuretics and reducing diuretic absorption from the gastrointestinal tract.

• 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 DIURIL.

• Non-steroidal Anti-inflammatory Drugs Including Selective Cyclooxygenase-2 (COX-2) Inhibitors - In some patients, the administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when DIURIL and non-steroidal anti-inflammatory agents or selective COX-2 inhibitors are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

• In some patients with compromised renal function (e.g., elderly patients or patients who are volume-depleted, including those on diuretic therapy) who are being treated with non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors, the co-administration of angiotensin II receptor antagonists or ACE inhibitors may result in a further deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

• These interactions should be considered in patients taking NSAIDs including selective COX-2 inhibitors concomitantly with diuretics and angiotensin II antagonists or ACE inhibitors. Therefore, the combination should be administered with caution, especially in the elderly.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Chlorothiazide (oral suspension) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorothiazide (oral suspension) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Chronic Overdose of Chlorothiazide (oral suspension) in the drug label.

Pharmacology

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Chlorothiazide (oral suspension) 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 (oral suspension) in the drug label.

Precautions with Alcohol

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

Brand Names

• DIURIL®

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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