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Triamterene 50 mg Capsule, 100-count — NDC 52817-0364-10 package photo

Triamterene 50 mg Capsule, 100-count

by TRUPHARMA LLC · 100 CAPSULE in 1 BOTTLE (52817-364-10)
NDC 52817-0364-10
🏷️ FDA NDC (as labeled) 52817-364-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 52817-364-10
Product NDC 52817-364
11-digit billing NDC 52817036410
NCPDP billing unit EA — each (per item)
RxCUI 198312, 198313
UNII WS821Z52LQ
UPC 0352817364104
Application # ANDA211581
SPL Set ID fea50328-b3d5-4300-8c67-82cda0a975b7
Established class (EPC) Potassium-sparing Diuretic
Physiologic effect Decreased Renal K+ Excretion; Increased Diuresis
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-12
Route ORAL
Dosage form CAPSULE
Substance TRIAMTERENE
GPI-14 37500030000105
GPI class Triamterene
GCN Seq No 008226
GCN 35041
HICL code 003666
Ingredient (HICL) Triamterene
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1H
Therapeutic class — specific (HIC3) Potassium Sparing Diuretics
AHFS code 40:28.16.00
AHFS class Potassium-Sparing Diuretics (40:28)
FDB label name TRIAMTERENE 50 MG CAPSULE
FDB brand name Triamterene
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 52817-364-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52817-0364-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Potassium-sparing Diuretic class.

Pharmacologic class Potassium-sparing Diuretic
Drug family (ATC) Other potassium-sparing agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTRUPHARMA LLC
Application holderAGNITIO INC
FDA applicationANDA211581 (ANDA)
Labeler code52817
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio39 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TRIAMTERENE 50 MG CAPSULE Ingredient Triamterene
📗 Our plain-language guide HelloPharmacist
  • Triamterene is a water pill — more specifically, a 'potassium-sparing' diuretic. It's used to reduce fluid buildup (edema) caused by conditions like congestive heart failure, liver...
  • Taking triamterene capsules after meals helps reduce the chance of stomach upset like nausea or vomiting. It's a simple step that makes the medication easier to tolerate day to day...
  • It's a real concern worth taking seriously. Triamterene keeps potassium in your body, which is helpful — but if potassium climbs too high, it can cause dangerous heart rhythm probl...
  • I've heard this medication can raise my potassium too high — should I be worried?
📖 Read our full Triamterene guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Red
ShapeCapsule
ImprintAT;100
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $6.069 $606.90 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $6.50 $649.83 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $7.93 $793.30 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Sep 2021 Feb 2026 May 2026 Aug 2026 $8.720 $6.069
▼ Down 30% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamterene 50 mgthis 52817-0364-10 TRUPHARMA 100 capsules $6.069 AB Availability likely
triamterene 50 mg 66993-0831-02 Prasco 100 capsules $6.069 AB Availability likely
Dyrenium 50 mg 59212-0002-01 Advanz 100 capsules AB FDA listed
Triamterene 50 mg 70377-0138-11 Biocon 30 capsules AB FDA listed
Triamterene 50 mg 72162-2265-01 Bryant 100 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 52817-0364-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1K
Units reimbursed last 4 qtrs
57.4K
Gross reimbursed last 4 qtrs
$372.9K
Avg / prescription
$358.23
Avg / unit
$6.4983
Latest quarter Q4 2025
185Rx
Medicaid pays / ea
$6.4983
gross reimbursed
vs
NADAC / ea
$6.0690
acquisition cost
=
Spread
+$0.4293
+7% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
55% FFS 45% MCO
Fee-for-service · 577 Rx Managed care · 464 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 570 units · 7.3 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 3,945 units · 66.8 per 100k residents WI Michigan: no data reported MI New York: 4,808 units · 24.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 9,265 units · 73.8 per 100k residents IL Indiana: no data reported IN Ohio: 3,750 units · 31.8 per 100k residents OH Pennsylvania: 660 units · 5.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 16,415 units · 42.1 per 100k residents CA Utah: no data reported UT Colorado: 3,690 units · 62.8 per 100k residents CO Nebraska: no data reported NE Missouri: 3,320 units · 53.6 per 100k residents MO Kentucky: 1,690 units · 37.3 per 100k residents KY West Virginia: 642 units · 36.3 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 3,370 units · 31.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,632 units · 79.4 per 100k residents LA Mississippi: no data reported MS Alabama: 420 units · 8.2 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,210 units · 4.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.079.4
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 79.4 /100k
2 Illinois 73.8 /100k
3 Wisconsin 66.8 /100k
4 Colorado 62.8 /100k
5 Missouri 53.6 /100k
6 California 42.1 /100k
7 Kentucky 37.3 /100k
8 West Virginia 36.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Triamterene — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Triamterene. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.11M
Claims incl. refills
3.1K
Beneficiaries
1.9K
Spend / beneficiary
$582.27
Spend / claim
$360.92
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Triamterene (this brand).

Top reported reactions

Chronic Kidney Disease469
Fatigue467
Pain428
Nausea415
Diarrhoea395
Dyspnoea344
Dizziness334

Age at onset

Child3
Adolescent2
Adult490
Elderly608

Reporter sex

7,119 reports
Male · 24%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization1,766
Death401
Disabling188
Life-threatening118
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 235 134
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
52817-0364-10 You're viewing this 100 CAPSULE in 1 BOTTLE (52817-364-10) 2018-12-12 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

INDICATIONS & USAGE Triamterene Capsules USP 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. Triamterene Capsules USP 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.

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 (however, see PRECAUTIONS below) 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.

⏱️ Dosage and Administration 96 words

DOSAGE & ADMINISTRATION 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.

Contraindications 143 words

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. Triamterene Capsules USP 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 triamterene.

Triamterene 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 triamterene 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 ~1 min read

WARNINGS Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including triamterene. 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, when dosages are changed or with any illness that may influence renal function.

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 and any potassium supplementation, and substitute a thiazide alone. Sodium polystyrene sulfonate (Kayexalate®, Concordia Pharmaceuticals Inc.) 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 Kayexalate®. Infusion of glucose and insulin has also been used to treat hyperkalemia.

🤒 Adverse Reactions 105 words

ADVERSE REACTIONS 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 TruPharma, LLC at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read

DRUG INTERACTIONS Caution should be used when lithium and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. Patients receiving such combined therapy should have serum lithium levels monitored closely and the lithium dosage adjusted if necessary. A possible interaction resulting in acute renal failure has been reported in a few subjects when indomethacin, a nonsteroidal anti-inflammatory agent, was given with triamterene.

Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene. The effects of the following drugs may be potentiated when given together with triamterene: antihypertensive medication, other diuretics, preanesthetic and anesthetic agents, skeletal muscle relaxants (non-depolarizing). Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia.

The following agents, given together with triamterene, may promote serum potassium accumulation and possibly result in hyperkalemia because of the potassium-sparing nature of triamterene, especially in patients with renal insufficiency: blood from blood bank (may contain up to 30 mEq of potassium per liter of plasma or up to 65 mEq per liter of whole blood when stored for more than 10 days); low-salt milk (may contain up to 60 mEq of potassium per liter); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).

Triamterene may raise blood glucose levels; for adult-onset diabetes, dosage adjustments of hypoglycemic agents may be necessary during and/or after therapy; concurrent use with chlorpropamide may increase the risk of severe hyponatremia.

🔄 Drug / Laboratory Test Interactions 23 words

DRUG & OR LABORATORY TEST INTERACTIONS Triamterene and quinidine have similar fluorescence spectra; thus, triamterene will interfere with the fluorescent measurement of quinidine.

🤰 Pregnancy 120 words

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.

🧒 Pediatric Use 12 words

PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 158 words

OVERDOSAGE 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.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Triamterene has a unique mode of action; it inhibits the reabsorption of sodium ions in exchange for potassium and hydrogen ions at that segment of the distal tubule under the control of adrenal mineralocorticoids (especially aldosterone). This activity is not directly related to aldosterone secretion or antagonism; it is a result of a direct effect on the renal tubule. The fraction of filtered sodium reaching this distal tubular exchange site is relatively small, and the amount which is exchanged depends on the level of mineralocorticoid activity.

Thus, the degree of natriuresis and diuresis produced by inhibition of the exchange mechanism is necessarily limited. Increasing the amount of available sodium and the level of mineralocorticoid activity by the use of more proximally acting diuretics will increase the degree of diuresis and potassium conservation. Triamterene occasionally causes increases in serum potassium which can result in hyperkalemia.

It does not produce alkalosis, because it does not cause excessive excretion of titratable acid and ammonium. Triamterene has been shown to cross the placental barrier and appear in the cord blood of animals. Pharmacokinetics Onset of action is 2 to 4 hours after ingestion.

In normal volunteers the mean peak serum levels were 30 ng/mL at 3 hours. The average percent of drug recovered in the urine (0 to 48 hours) was 21%. Triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene.

Both the plasma and urine levels of this metabolite greatly exceed triamterene levels. Triamterene is rapidly absorbed, with somewhat less than 50% of the oral dose reaching the urine. Most patients will respond to triamterene during the first day of treatment.

Maximum therapeutic effect, however, may not be seen for several days. Duration of diuresis depends on several factors, especially renal function, but it generally tapers off 7 to 9 hours after administration.

📦 How Supplied / Storage and Handling 122 words

HOW SUPPLIED Each capsule for oral use, with opaque red cap and body, contains Triamterene USP, 50 mg or 100 mg, and is imprinted with AT 50 (for the 50-mg strength) and AT 100 (for the 100-mg strength) in white ink on both the cap and body and they are available as follows. 50 mg: NDC 52817-364-10 Bottles of 100 capsules 100 mg: NDC 52817-365-10 Bottles of 100 capsules STORAGE Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container.

Manufactured by: Agnitio Inc. N 800 County Road CB, Appleton, WI 54914 USA Distributed By: TruPharma, LLC Tampa, FL 33609 Revised: April 2019 Trademarks are the property of their respective owners.

📋 Description 111 words

DESCRIPTION Triamterene Capsules are potassium-sparing diuretics. Triamterene Triamterene is 2,4,7-triamino-6-phenyl-pteridine. Its molecular weight is 253.27.

At 50°C, triamterene is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide and dimethylformamide. It is sparingly soluble in methanol.

Each capsule for oral use, with opaque red cap and body, contains Triamterene USP, 50 mg or 100 mg, and is imprinted with AT 50 (for the 50-mg strength) and AT 100 (for the 100-mg strength) in white ink on both the cap and body. Inactive ingredients consist of Lactose monohydrate, Magnesium stearate, Gelatin, D&C Red No.33, FD&C yellow No.6, Titanium dioxide, Sodium lauryl sulfate, Shellac and Potassium hydroxide. triamterene-structure.jpg

💬 Information for Patients 67 words

INFORMATION FOR PATIENTS To help avoid stomach upset, it is recommended that the drug be taken after meals. If a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep. If a dose is missed, the patient should not take more than the prescribed dose at the next dosing interval.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.