Demadex tablet

Demadex tablet®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Routes and Preparations
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient information
Precautions with Alcohol
Look-Alike Drug Names
Drug Shortage Status
Price

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]{{{authorTag}}}

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Overview

Demadex tablet is a Loop diuretic drug that is FDA approved for the treatment of edema of congestive heart failure renal disease, hepatic disease and hypertension.. Adverse reactions include Polyuria, Rhinitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Routes and Preparations

Routes

Preparations

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Images

Drug Images

Package and Label Display Panel

Contraindications

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===Contraindications===

known hypersensitivity to DEMADEX or to sulfonylureas;anuric

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Warnings

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===Warnings===

Hepatic Disease With Cirrhosis and Ascites

DEMADEX should be used with caution in patients with hepatic disease with cirrhosis and ascites, since sudden alterations of fluid and electrolyte balance may precipitate hepatic coma. In these patients, diuresis with DEMADEX (or any other diuretic) is best initiated in the hospital. To prevent hypokalemia and metabolic alkalosis, an aldosterone antagonist or potassium-sparing drug should be used concomitantly with DEMADEX.

Ototoxicity

Tinnitus and hearing loss (usually reversible) have been observed after rapid intravenous injection of other loop diuretics and have also been observed after oral DEMADEX. It is not certain that these events were attributable to DEMADEX. Ototoxicity has also been seen in animal studies when very high plasma levels of torsemide were induced. Administered intravenously, DEMADEX should be injected slowly over 2 minutes, and single doses should not exceed 200 mg.

Volume and Electrolyte Depletion

Patients receiving diuretics should be observed for clinical evidence of electrolyte imbalance, hypovolemia, or prerenal azotemia. Symptoms of these disturbances may include one or more of the following: dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, and vomiting. Excessive diuresis may cause dehydration, blood-volume reduction, and possibly thrombosis and embolism, especially in elderly patients. In patients who develop fluid and electrolyte imbalances, hypovolemia, or prerenal azotemia, the observed laboratory changes may include hyper- or hyponatremia, hyper- or hypochloremia, hyper- or hypokalemia, acid-base abnormalities, and increased blood urea nitrogen (BUN). If any of these occur, DEMADEX should be discontinued until the situation is corrected; DEMADEX may be restarted at a lower dose. In controlled studies in the United States, DEMADEX was administered to hypertensive patients at doses of 5 mg or 10 mg daily. After 6 weeks at these doses, the mean decrease in serum potassium was approximately 0.1 mEq/L. The percentage of patients who had a serum potassium level below 3.5 mEq/L at any time during the studies was essentially the same in patients who received DEMADEX (1.5%) as in those who received placebo (3%). In patients followed for 1 year, there was no further change in mean serum potassium levels. In patients with congestive heart failure, hepatic cirrhosis, or renal disease treated with DEMADEX at doses higher than those studied in United States antihypertensive trials, hypokalemia was observed with greater frequency, in a dose-related manner. In patients with cardiovascular disease, especially those receiving digitalis glycosides, diuretic-induced hypokalemia may be a risk factor for the development of arrhythmias. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, in patients experiencing a brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes, and in patients receiving concomitant therapy with corticosteroids or ACTH. Periodic monitoring of serum potassium and other electrolytes is advised in patients treated with DEMADEX.

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Use in Specific Populations

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===Pregnancy===

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There is no FDA guidance on usage of {{BASEPAGENAME}} in women who are pregnant.

:'''[[Pregnancy category#Australia|Pregnancy Category (AUS)]]'''

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===Labor and Delivery===

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===Nursing Mothers===

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===Pediatric Use===

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===Geriatic Use===

There is no FDA guidance on the use of {{BASEPAGENAME}} in geriatric settings.

===Gender===

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===Race===

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===Renal Impairment===

There is no FDA guidance on the use of {{BASEPAGENAME}} in patients with renal impairment.

===Hepatic Impairment===

There is no FDA guidance on the use of {{BASEPAGENAME}} in patients with hepatic impairment.

===Females of Reproductive Potential and Males===

There is no FDA guidance on the use of {{BASEPAGENAME}} in women of reproductive potentials and males.

===Immunocompromised Patients===

There is no FDA guidance one the use of {{BASEPAGENAME}} in patients who are immunocompromised.

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Overdose

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Pharmacology

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===Mechanism of Action===

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===Pharmacodynamics===

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===Nonclinical Toxicology===

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