Triamterene

Triamterene
Black Box Warning
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: Gerald Chi

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Black Box Warning

WARNINGS See full prescribing information for complete Boxed Warning. * Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium, when dosages are changed or with any illness that may influence renal function.

Overview

Triamterene is a potassium-sparing diuretic that is FDA approved for the {{{indicationType}}} of edema associated with congestive heart failure, cirrhosis, nephrotic syndrome, steroid, and secondary hyperaldosteronism. There is a Black Box Warning for this drug as shown here. Common adverse reactions include electrolyte disturbances and hyperuricemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Edema

• Dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.

• Dyrenium may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.

• When Dyrenium (triamterene) is added to other diuretic therapy or when patients are switched to Dyrenium from other diuretics, all potassium supplementation should be discontinued.

• Dosing Information

• When used alone, the usual starting dose is 100 mg PO bid after meals.
• When combined with another diuretic or antihypertensive agent, the total daily dosage of each agent should usually be lowered initially and then adjusted to the patient’s needs. The total daily dosage should not exceed 300 mg.

Usage in Pregnancy

• The routine use of diuretics in an otherwise healthy woman 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 developed toxemia.
• Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics 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 expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Triamterene in adult patients.

Non–Guideline-Supported Use

Hypertension

• Dosing Information

• 200 mg PO qd
• 50 mg PO qd in combination with chlorthalidone 50 mg

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Triamterene in pediatric patients.

Non–Guideline-Supported Use

Hypertension

• Dosing Information

• 1–2 mg/kg in 2 divided doses

Contraindications

• Anuria
• Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis.
• Severe hepatic disease.
• Hypersensitivity to the drug or any of its components.
• Hyperkalemia

• Dyrenium (triamterene) should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. Patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with Dyrenium.
• Dyrenium should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing triamterene. Two deaths have been reported in patients receiving concomitant spironolactone and Dyrenium or Dyazide®. Although dosage recommendations were exceeded in one case and in the other serum electrolytes were not properly monitored, these two drugs should not be given concomitantly.

Warnings

WARNINGS See full prescribing information for complete Boxed Warning. * Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium, when dosages are changed or with any illness that may influence renal function.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Triamterene in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Triamterene in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

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 Triamterene in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Triamterene during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Triamterene with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Triamterene with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Triamterene with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Triamterene with respect to specific gender populations.

Race

There is no FDA guidance on the use of Triamterene with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Triamterene in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Triamterene in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Triamterene in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Triamterene in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Triamterene in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Triamterene in the drug label.

Pharmacology

There is limited information regarding Triamterene Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Triamterene in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Triamterene in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Triamterene in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Triamterene in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Triamterene 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 Triamterene in the drug label.

Precautions with Alcohol

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

Brand Names

• Dyrenium®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

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

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