pharmacopeia
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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 triamterene capsules. 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 triamterene capsules, when dosages are changed or with any illness that may influence renal function.

2D structure
6-phenylpteridine-2,4,7-triamine
SMILES C1=CC=C(C=C1)C2=NC3=C(N=C(N=C3N=C2N)N)N
InChIKey FNYLWPVRPXGIIP-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium-Potassium Exchanging ATPase Interactions.

Indications

Sourced from openFDA
  • Triamterene capsules are 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. Triamterene capsules may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential.ICD-10: I50.9, R60.9

Contraindications

Sourced from openFDA
  • Anuria. Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis.contraindicated

Dosage & administration

Sourced from openFDA

Adult Dosage Dosage should be titrated to the needs of the individual patient. When used alone, the usual starting dose is 100 mg twice daily 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. Please refer to PRECAUTIONS−General. When triamterene capsules are added to other diuretic therapy or when patients are switched to triamterene capsules from other diuretics, all potassium supplementation should be discontinued.

Warnings & precautions

Sourced from openFDA

There have been isolated reports of hypersensitivity reactions; therefore, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage or other idiosyncratic reactions. Periodic BUN and serum potassium determinations should be made to check kidney function, especially in patients with suspected or confirmed renal insufficiency. It is particularly important to make serum potassium determinations in elderly or diabetic patients receiving the drug; these patients should be observed carefully for possible serum potassium increases. If hyperkalemia is present or suspected, an electrocardiogram should be obtained. If the ECG shows no widening of the QRS or arrhythmia in the presence of hyperkalemia, it is usually sufficient to discontinue triamterene capsules and any potassium supplementation, and substitute a thiazide alone. Sodium polystyrene sulfonate may be administered to enhance the excretion of excess potassium. The presence of a widened QRS complex or arrhythmia in association with hyperkalemia requires prompt additional therapy . For tachyarrhythmia, infuse 44 mEq of sodium bicarbonate or 10 mL of 10% calcium gluconate or calcium chloride over several minutes. For asystole, bradycardia or A-V block transvenous pacing is also recommended. The effect of calcium and sodium bicarbonate is transient and repeated administration may be required. When indicated by the clinical situation, excess K+ may be removed by dialysis or oral or rectal administration of Sodium polystyrene sulfonate.

Adverse reactions

Sourced from openFDA

Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first, regardless of frequency. All adverse effects occur rarely (that is, 1 in 1000, or less). Hypersensitivity: anaphylaxis, rash, photosensitivity. Metabolic: hyperkalemia, hypokalemia. Renal: azotemia, elevated BUN and creatinine, renal stones, acute interstitial nephritis (rare), acute renal failure (one case of irreversible renal failure has been reported). Gastrointestinal: jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea. Hematologic: thrombocytopenia, megaloblastic anemia. Central Nervous System: weakness, fatigue, dizziness, headache, dry mouth. To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Reproduction studies have been performed in rats at doses as high as 20 times the Maximum Recommended Human Dose (MRHD) on the basis of body weight, and 6 times the MRHD on the basis of body-surface area, without evidence of harm to the fetus due to triamterene. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects: Triamterene has been shown to cross the placental barrier and appear in cord blood. The use of triamterene in pregnant women requires that the anticipated benefits be weighed against possible hazards to the fetus. These possible hazards include adverse reactions which have occurred in the adult.

Overdosage

Sourced from openFDA

In the event of overdosage, it can be theorized that electrolyte imbalance would be the major concern, with particular attention to possible hyperkalemia. Other symptoms that might be seen would be nausea and vomiting, other G.I. disturbances and weakness. It is conceivable that some hypotension could occur. As with an overdose of any drug, immediate evacuation of the stomach should be induced through emesis and gastric lavage. Careful evaluation of the electrolyte pattern and fluid balance should be made. There is no specific antidote. Reversible acute renal failure following ingestion of 50 tablets of a product containing a combination of 50 mg triamterene and 25 mg hydrochlorothiazide has been reported. The oral LD50 in mice is 380 mg/kg. The amount of drug in a single dose ordinarily associated with symptoms of overdose or likely to be life-threatening is not known. Although triamterene is 67% protein bound, there may be some benefit to dialysis in cases of overdosage.

Approval history

Sourced from openFDA
  • Aug 10, 1964NDANDA013174Advanz Pharma
  • Dec 8, 1987ANDAANDA071251Apotex Inc
  • Nov 30, 1988ANDAANDA071851Watson Labs
  • Sep 23, 1993ANDAANDA073449Watson Labs
  • Jun 5, 1997ANDAANDA074821Sandoz
  • Dec 9, 2011ANDAANDA201407Lannett Co Inc
  • Jun 29, 2018ANDAANDA208360Zydus Pharms
  • Feb 11, 2019ANDAANDA208358Cadila

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
13,179 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue8586.5%
  2. 2Drug Ineffective8486.4%
  3. 3Nausea8176.2%
  4. 4Pain7485.7%
  5. 5Diarrhoea7005.3%
  6. 6Dizziness6484.9%
  7. 7Dyspnoea6254.7%
  8. 8Headache5944.5%
  9. 9Chronic Kidney Disease5614.3%
  10. 10Asthenia5033.8%
  11. 11Arthralgia4983.8%
  12. 12Fall4483.4%
  13. 13Pain In Extremity4373.3%
  14. 14Pruritus4263.2%
  15. 15Renal Failure4243.2%

Literature

View JSON

Recent PubMed references pinned to Triamterene as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Triamterene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Triamterene work?
Mechanism-of-action class: Sodium-Potassium Exchanging ATPase Interactions.
What is Triamterene used for?
According to FDA labeling, Triamterene carries indications including: Triamterene capsules are 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. Triamterene capsules may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Triamterene?
Triamterene is classified as Other potassium-sparing agents, Potassium-sparing Diuretic, Sodium-Potassium Exchanging ATPase Interactions, Decreased Blood Pressure, Decreased Collecting Duct K+ Excretion, Decreased Distal Tubule K+ Excretion, Decreased Renal Ca++ Excretion, Decreased Renal K+ Excretion, Increased Collecting Duct Na+ Excretion, Increased Distal Tubule Na+ Excretion, Increased Diuresis, Increased Renal Mg++ Excretion.
What are the brand names for Triamterene?
Triamterene is marketed under brand names including Dyazide, Dyrenium, Maxzide.
What are the contraindications for Triamterene?
Triamterene labeling lists contraindications including: Anuria. Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis.. Always consult the full prescribing information and a clinician.
Note. Data for triamterene is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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