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Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Capsule, 90-count — NDC 62135-0529-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Capsule, 90-count — NDC 62135-529-90 (Billing 62135-0529-90)

by Chartwell RX, LLC · 90 CAPSULE in 1 BOTTLE

This is a package of 90 capsules of Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Capsule from Chartwell RX, LLC, marketed since Dec 2011 and currently FDA-listed; retail pharmacies pay about $0.1181 per capsule (NADAC). It is this product's only package size.

NDC 62135-0529-90
🏷️ FDA NDC (as labeled) 62135-529-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-529-90
Product NDC 62135-529
11-digit billing NDC 62135052990
NCPDP billing unit EA — each (per item)
RxCUI 198316
UNII WS821Z52LQ, 0J48LPH2TH
UPC 0362135529901
Application # ANDA201407
SPL Set ID 261dd83f-8048-488f-8b71-c4abd9692720
Established class (EPC) Potassium-sparing Diuretic; Thiazide Diuretic
Physiologic effect Decreased Renal K+ Excretion; Increased Diuresis
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-12-09
Route ORAL
Dosage form CAPSULE
Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 37990002300105
GCN Seq No 021718
GCN 88731
HICL code 003647
Ingredient (HICL) Triamterene/Hydrochlorothiazid
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1L
Therapeutic class — specific (HIC3) Potassium Sparing Diuretics In Combination
AHFS code 24:36.20.00
AHFS class Thiazide Diuretics (24:36)
FDB label name TRIAMTERENE-HCTZ 37.5-25 MG CP
FDB brand name Triamterene-Hydrochlorothiazid
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021718
  • GCN: 88731
  • GPI-14 (Medi-Span): 37990002300105
  • HICL (First Databank): 003647
  • AHFS class code: 24:36.20.00
  • RxCUI (RxNorm): 198316
Why two NDCs? The FDA registers this code as 62135-529-90 — 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 → 62135-0529-90. 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.

Clinical

Label name TRIAMTERENE-HCTZ 37.5-25 MG CP Ingredient Triamterene/Hydrochlorothiazid
📖 What it is MedlinePlus · NLM

The combination of triamterene and hydrochlorothiazide is used to treat high blood pressure and edema (fluid retention; excess fluid held in body tissues) in patients who have lower amounts of potassium in their bodies or for whom low potassium levels in the body could be dangerous. The combination of triamterene and hydrochlorothiazide is in a class of medications called diuretics ('water pills'). They work by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition, and when not treated it can cause damage to the brain,...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats high blood pressure or fluid swelling (edema). It is mainly for people who lose too much potassium on hydrochlorothiazide alone, or who need a water pill but can't risk l...
  • Take it by mouth, usually once a day, exactly as your prescriber directs. Don't split the daily dose unless told to. You'll need regular blood tests to check your potassium.
  • No, not unless your doctor tells you to. Most salt substitutes are full of potassium. With this medicine, they can push your potassium dangerously high.
  • Can I use salt substitutes or potassium supplements?
📖 Read our full Triamterene and Hydrochlorothiazide guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 $0.118 $10.63 / 90 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.129 $0.113
▼ Down 6% over the last 13 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0529-90 You're viewing this Main listing 90 CAPSULE in 1 BOTTLE 2023-04-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 00781-2074-01 Sandoz 100 capsules $0.118 AB Availability likely —
Triamterene And Hydrochlorothiazide 37.5 mg/1; 25 mgthis 62135-0529-90 Chartwell 90 capsules $0.118 AB Availability likely —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 72578-0090-01 Viona 100 capsules $0.118 AB Availability likely —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 33342-0467-11 Macleods 100 capsules — — FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-2028-00 A-S 30 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-6944-00 A-S 90 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-7437-00 A-S 30 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-7438-00 A-S 90 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 51655-0722-52 Northwind 30 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 60760-0783-90 St. 90 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 63187-0465-30 Proficient 30 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 63187-0905-30 Proficient 30 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 63629-8732-01 Bryant 100 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-2533-09 NuCare 90 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-3879-09 NuCare 90 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68382-0855-01 Zydus 100 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68788-8700-01 Preferred 100 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 70518-4270-00 REMEDYREPACK 90 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 70771-1474-00 Zydus 1000 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-0504-01 Bryant 100 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-2034-01 Bryant 100 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 72162-1084-06 Bryant 60 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 82868-0022-30 Northwind 30 capsules — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 82804-0308-30 Proficient 30 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

🏛️
2011
On the market since
Dec 2011
📍
2026
Currently FDA-listed
15 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.

What it looks like

Color white
ShapeCapsule
ImprintLANNETT;1632
Size14 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 Y4S76JWI15
    Methyl alcohol, also called methanol, is a simple organic solvent. It helps dissolve and carry active ingredients in liquid medicines, and helps the product mix evenly.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

20 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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderLANNETT CO INC
FDA applicationANDA201407 (ANDA)
Labeler code62135
First marketedDec 2011
Product typeHuman Prescription Drug
Portfolio521 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

Triamterene and hydrochlorothiazide capsules may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules may enhance the action of these agents, dosage adjustments may be necessary. 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.

⏱️ Dosage and Administration 35 words ▾

DOSAGE AND ADMINISTRATION The usual dose of triamterene and hydrochlorothiazide capsules is 1 or 2 capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect (see WARNINGS , Hyperkalemia) .

⛔ Contraindications 136 words ▾

CONTRAINDICATIONS Antikaliuretic Therapy and Potassium Supplementation: Triamterene and hydrochlorothiazide capsules should not be given to patients receiving other potassium-sparing agents such as spironolactone, amiloride, or other formulations containing triamterene. Concomitant potassium-containing salt substitutes should also not be used. Potassium supplementation should not be used with triamterene and hydrochlorothiazide capsules except in severe cases of hypokalemia.

Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary. Impaired Renal Function: Triamterene and hydrochlorothiazide capsules are contraindicated in patients with anuria, acute and chronic renal insufficiency, or significant renal impairment.

Hypersensitivity: Hypersensitivity to either drug in the preparation or to other sulfonamide-derived drugs is a contraindication. Hyperkalemia: Triamterene and hydrochlorothiazide capsules should not be used in patients with pre-existing elevated serum potassium.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Adverse effects are listed in decreasing order of severity. Hypersensitivity: Anaphylaxis, rash, urticaria, subacute cutaneous lupus erythematosus-like reactions, photosensitivity. Cardiovascular: Arrhythmia, postural hypotension.

Metabolic: Diabetes mellitus, hyperkalemia, hypokalemia, hyponatremia, acidosis, hypercalcemia, hyperglycemia, glycosuria, hyperuricemia, hypochloremia. Gastrointestinal: Jaundice and/or liver enzyme abnormalities, pancreatitis, nausea and vomiting, diarrhea, constipation, abdominal pain. Renal: Acute renal failure (one case of irreversible renal failure has been reported), interstitial nephritis, renal stones composed primarily of triamterene, elevated BUN and serum creatinine, abnormal urinary sediment.

Hematologic: Leukopenia, thrombocytopenia and purpura, megaloblastic anemia. Musculoskeletal: Muscle cramps. Central Nervous System: Weakness, fatigue, dizziness, headache, dry mouth.

Miscellaneous: Impotence, sialadenitis. Thiazides alone have been shown to cause the following additional adverse reactions: Central Nervous System: Paresthesias, vertigo. Ophthalmic: Xanthopsia, transient blurred vision.

Respiratory: Allergic pneumonitis, pulmonary edema, respiratory distress. Other: Necrotizing vasculitis, exacerbation of lupus. Hematologic: Aplastic anemia, agranulocytosis, hemolytic anemia.

Neonate and infancy: Thrombocytopenia and pancreatitis–rarely, in newborns whose mothers have received thiazides during pregnancy. Skin: Erythema multiforme, including Stevens-Johnson syndrome; exfoliative dermatitis, including toxic epidermal necrolysis. Postmarketing Experience: Non-Melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.

In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

🆘 Overdosage 111 words ▾

OVERDOSAGE Electrolyte imbalance is the major concern (see WARNINGS ). Symptoms reported include: polyuria, nausea, vomiting, weakness, lassitude, fever, flushed face, and hyperactive deep tendon reflexes. If hypotension occurs, it may be treated with pressor agents such as levarterenol to maintain blood pressure.

Carefully evaluate the electrolyte pattern and fluid balance. Induce immediate evacuation of the stomach through emesis or gastric lavage. 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. Although triamterene is largely protein-bound (approximately 67%), there may be some benefit to dialysis in cases of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY The triamterene and hydrochlorothiazide capsule is a diuretic/antihypertensive drug product that combines natriuretic and antikaliuretic effects. Each component complements the action of the other. The hydrochlorothiazide component blocks the reabsorption of sodium and chloride ions, and thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted.

A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen, and chloride ions. Hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide, and may reduce glomerular filtration rate.

The exact mechanism of the antihypertensive effect of hydrochlorothiazide is not known. The triamterene component of triamterene and hydrochlorothiazide capsules exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen ions. Its natriuretic activity is limited by the amount of sodium reaching its site of action.

Although it blocks the increase in this exchange that is stimulated by mineralocorticoids (chiefly aldosterone), it is not a competitive antagonist of aldosterone and its activity can be demonstrated in adrenalectomized rats and patients with Addison’s disease. As a result, the dose of triamterene required is not proportionally related to the level of mineralocorticoid activity but is dictated by the response of the individual patients and the kaliuretic effect of concomitantly administered drugs. By inhibiting the distal tubular exchange mechanism, triamterene maintains or increases the sodium excretion and reduces the excess loss of potassium, hydrogen, and chloride ions induced by hydrochlorothiazide.

As with hydrochlorothiazide, triamterene may reduce glomerular filtration and renal plasma flow. Via this mechanism, it may reduce uric acid excretion although it has no tubular effect on uric acid reabsorption or secretion. Triamterene does not affect calcium excretion.

No predictable antihypertensive effect has been demonstrated for triamterene. Duration of diuretic activity and effective dosage range of the hydrochlorothiazide and triamterene components of triamterene and hydrochlorothiazide capsules are similar. Onset of diuresis with triamterene and hydrochlorothiazide capsules takes place within 1 hour, peaks at 2 to 3 hours, and tapers off during the subsequent 7 to 9 hours.

Triamterene and hydrochlorothiazide capsules are well absorbed. Upon administration of a single oral dose to fasted normal male volunteers, mean pharmacokinetic parameters were determined (Table 1). Table 1.

Mean Pharmacokinetic Parameters after Single Oral Dose in Fasted Male Volunteers a AUC (0-48) ng*h/mL (± SD) C max ng/mL (± SD) Median T max h Ae Mg (± SD) Triamterene 148.7 (87.9) 46.4 (29.4) 1.1 2.7 (1.4) Hydroxytriamterene sulfate 1,865 (471) 720 (364) 1.3 19.7 (6.1) Hydrochlorothiazide 834 (177) 135.1 (35.7) 2.0 14.3 (3.8) a AUC (0-48) , C max , T max , and Ae represent area under the plasma concentration versus time plot, maximum plasma concentration, time to reach C max , and amount excreted in urine over 48 hours.

A capsule of triamterene and hydrochlorothiazide is bioequivalent to a single entity 25-mg hydrochlorothiazide tablet and 37.5-mg triamterene capsule used in the double-blind clinical trial below (see Clinical Trials ). In a limited study involving 12 subjects, coadministration of triamterene and hydrochlorothiazide capsules with a high-fat meal resulted in: (1) an increase in the mean bioavailability of triamterene by about 67% (90% confidence interval = 0.99, 1.90), p-hydroxytriamterene sulfate by about 50% (90% confidence interval = 1.06, 1.77), hydrochlorothiazide by about 17%… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 92 words ▾

HOW SUPPLIED Triamterene and Hydrochlorothiazide Capsules, USP contain 37.5 mg triamterene, USP and 25 mg hydrochlorothiazide, USP and are available in size # 4 white opaque/white opaque capsules imprinted with Logo “LANNETT” on the cap and “1632” on the body. They are supplied as follows: Bottles of 90, NDC 62135-529-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71344 Revised 03/2023

📋 Description ~1 min read ▾

DESCRIPTION Each triamterene and hydrochlorothiazide capsule, USP for oral use contains triamterene, USP 37.5 mg and hydrochlorothiazide, USP 25 mg. Hydrochlorothiazide, USP is a diuretic/antihypertensive agent and triamterene, USP is an antikaliuretic agent. Hydrochlorothiazide, USP is slightly soluble in water.

It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is: Molecular Formula: C 7 H 8 CIN 3 O 4 S 2 M.W.

297.74 At 50°C, triamterene, USP is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine and its structural formula is: Molecular Formula: C 12 H 11 N 7 M.W.

253.26 Inactive ingredients consist of lactose monohydrate, pregelatinized starch, sodium starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and magnesium stearate. The capsule shell consists of titanium dioxide and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.

Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules. image description image description

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Diabetes: Caution should be exercised when administering triamterene and hydrochlorothiazide capsules to patients with diabetes, since thiazides may cause hyperglycemia, glycosuria, and alter insulin requirements in diabetes. Also, diabetes mellitus may become manifest during thiazide administration. Impaired Hepatic Function: Thiazides should be used with caution in patients with impaired hepatic function.

They can precipitate hepatic coma in patients with severe liver disease. Potassium depletion induced by the thiazide may be important in this connection. Administer triamterene and hydrochlorothiazide capsules cautiously and be alert for early signs of impending coma such as confusion, drowsiness, and tremor; if mental confusion increases, discontinue triamterene and hydrochlorothiazide capsules for a few days.

Attention must be given to other factors that may precipitate hepatic coma, such as blood in the gastrointestinal tract or pre-existing potassium depletion. Hypokalemia: Hypokalemia is uncommon with triamterene and hydrochlorothiazide capsules; but, should it develop, corrective measures should be taken such as potassium supplementation or increased intake of potassium-rich foods. Institute such measures cautiously with frequent determinations of serum potassium levels, especially in patients receiving digitalis or with a history of cardiac arrhythmias.

If serious hypokalemia (serum potassium less than 3.0 mEq/L) is demonstrated by repeat serum potassium determinations, triamterene and hydrochlorothiazide capsules should be discontinued and potassium chloride supplementation initiated. Less serious hypokalemia should be evaluated with regard to other coexisting conditions and treated accordingly. Electrolyte Imbalance: Electrolyte imbalance, often encountered in conditions such as heart failure, renal disease, or cirrhosis of the liver, may also be aggravated by diuretics and should be considered during therapy with triamterene and hydrochlorothiazide capsules when using high doses for prolonged periods or in patients on a salt-restricted diet.

Serum determinations of electrolytes should be performed and are particularly important if the patient is vomiting excessively or receiving fluids parenterally. Possible fluid and electrolyte imbalance may be indicated by warning signs such as: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal symptoms. Hypochloremia: Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.

Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice. Renal Stones: Triamterene has been found in renal stones in association with the other usual calculus components.

Triamterene and hydrochlorothiazide capsules should be used with caution in patients with a history of renal stones. Laboratory Tests: Serum Potassium: The normal adult range of serum potassium is 3.5 to 5.0 mEq/L with 4.5 mEq often being used for a reference point. If hypokalemia should develop, corrective measures should be taken such as potassium supplementation or increased dietary intake of potassium-rich foods.

Institute such measures cautiously with frequent determinations of serum potassium levels. Potassium levels persistently above 6 mEq/L require careful observation and treatment. Serum potassium levels do not necessarily indicate true body potassium concentration.

A rise in plasma pH may cause a decrease in plasma potassium concentration and an increase in the intracellular pota… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 21 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Triamterene and Hydrochlorothiazide Capsules, USP 37.5 mg/25 mg - NDC 62135-529-90 - 90's Bottle Label image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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