triamterene and hydrochlorothiazide 75 mg; 50 mg Tablet, 100-count — NDC 70771-1362-01 package photo

triamterene and hydrochlorothiazide 75 mg; 50 mg Tablet, 100-count

by Zydus Lifesciences Limited · 100 TABLET in 1 BOTTLE (70771-1362-1)
NDC 70771-1362-01
🏷️ FDA NDC (as labeled) 70771-1362-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1535/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 27, 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) 70771-1362-1
Product NDC 70771-1362
11-digit billing NDC 70771136201
RxCUI 310812, 310818
UNII 0J48LPH2TH, WS821Z52LQ
Application # ANDA208360
SPL Set ID 1af80800-e7a5-42e5-aa6c-3f61aff4a77b
Established class (EPC) Thiazide Diuretic; Potassium-sparing Diuretic
Physiologic effect Increased Diuresis; Decreased Renal K+ Excretion
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-04
Route ORAL
Dosage form TABLET
Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70771-1362-1 — a 5-4-1 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 package segment → 70771-1362-01. 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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA208360 (ANDA)
Labeler code70771
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio717 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

📗 Our plain-language guide HelloPharmacist
  • Great question. Hydrochlorothiazide on its own works well for blood pressure and fluid retention, but it tends to flush out potassium along with the water — and low potassium can c...
  • Why am I on this combination instead of just a regular water pill?
  • Most people notice things like mild nausea, dizziness, headache, or muscle cramps, especially early on. You might also feel more tired or notice your urine looks a different color...
  • What side effects should I actually watch out for day to day?
📖 Read our full Triamterene and Hydrochlorothiazide 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 Green / Yellow
ShapeRound
Imprint857
Size1 mm
ScoringScored — splits in 2
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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

6 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $0.1535 $15.35 / 100 tablets
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 and Hydrochlorothiazide 75 mg/1; 50 mg 00591-0348-01 Actavis 100 tablets $0.125 Availability likely
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 60505-2657-01 Apotex 100 tablets $0.125 AB Availability likely
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 68001-0328-00 BluePoint 100 tablets $0.125 AB Availability likely
triamterene and hydrochlorothiazide 75 mg/1; 50 mg 68382-0857-01 Zydus 100 tablets $0.125 AB Availability likely
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 68001-0388-00 BluePoint 100 tablets $0.126 AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 50090-1834-00 A-S 30 tablets AB FDA listed
triamterene and hydrochlorothiazide 75 mg/1; 50 mg 50090-6736-00 A-S 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 51655-0582-26 Northwind 90 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 55289-0488-01 PD-Rx 100 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 63629-2585-01 Bryant 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 68071-4687-03 NuCare 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 68788-8624-01 Preferred 100 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 70518-4351-00 REMEDYREPACK 90 tablets AB FDA listed
triamterene and hydrochlorothiazide 75 mg/1; 50 mgthis 70771-1362-01 Zydus 100 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 71335-0326-01 Bryant 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 71335-2338-01 Bryant 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 71610-0431-45 Aphena 45 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 72888-0095-00 Advagen 1000 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 75 mg/1; 50 mg 82868-0032-30 Northwind 30 tablets 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
Sep 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.

🔬 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 and Hydrochlorothiazide — the ingredient across all brands.

Top reported reactions

Nausea407
Fatigue399
Pain327
Dizziness318
Diarrhoea309
Headache290
Dyspnoea286

Age at onset

Neonate1
Infant1
Adult323
Elderly337

Reporter sex

6,113 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization1,569
Life-threatening160
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 187 0
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
70771-1362-00 1000 TABLET in 1 BOTTLE (70771-1362-0) 2018-09-04 Active
70771-1362-01 You're viewing this 100 TABLET in 1 BOTTLE (70771-1362-1) 2018-09-04 Active
70771-1362-04 10 BLISTER PACK in 1 CARTON (70771-1362-4) / 10 TABLET in 1 BLISTER PACK 2018-09-04 Active
70771-1362-05 500 TABLET in 1 BOTTLE (70771-1362-5) 2018-09-04 Active

Pack size FAQ

What quantity is in NDC 70771-1362-01?
NDC 70771-1362-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 70771-1362-01 and NDC 70771-1362-04?
Both are triamterene and hydrochlorothiazide 75 mg; 50 mg Tablet — the drug itself is identical. NDC 70771-1362-01 is the 100-count package, while NDC 70771-1362-04 is the 100 tablets package.
What NDC number is used to bill for this package of triamterene and hydrochlorothiazide 75 mg; 50 mg Tablet?
Bill NDC 70771-1362-01 — the 11-digit billing format is 70771136201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70771-1362-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70771-1362-01, written without dashes as 70771136201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70771-1362-01, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1362) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 100 tablets (70771-1362-04), 500 tablets (70771-1362-05), 1000 tablets (70771-1362-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
🚨 Boxed Warning 86 words

WARNINGS Hyperkalemia Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment), or elderly or severely ill patients. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide, when dosages are changed or with any illness that may influence renal function.

🎯 Indications and Usage ~2 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 tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).

Triamterene and hydrochlorothiazide tablets, USP may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets, USP may enhance the actions of these drugs, 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. Thiazides 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 ~2 min read

DOSAGE AND ADMINISTRATION The usual dose of triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium ( see WARNINGS ). The usual dose of triamterene and hydrochlorothiazide tablets, 75 mg/50 mg is one tablet daily, with appropriate monitoring of serum potassium ( see WARNINGS ). There is no experience with the use of more than one 75 mg/50 mg (75 mg triamterene and 50 mg hydrochlorothiazide) tablet daily or more than two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily.

Clinical experience with the administration of two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction. Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets, 75 mg/50 mg directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg directly.

In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked therapy may be initiated with triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg. If an optimal blood pressure response is not obtained with triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg, the dose should be increased to two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily as a single dose, or one triamterene and hydrochlorothiazide tablets, 75 mg/50 mg daily. If blood pressure still is not controlled, another antihypertensive agent may be added ( see PRECAUTIONS: Drug Interactions ).

Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets, 75 mg/50 mg should be monitored clinically and for serum potassium after the transfer.

Contraindications 128 words

CONTRAINDICATIONS Hyperkalemia Triamterene and hydrochlorothiazide should not be used in the presence of elevated serum potassium levels (greater than or equal to 5.5 mEq/liter). If hyperkalemia develops, this drug should be discontinued and a thiazide alone should be substituted. Antikaliuretic Therapy or Potassium Supplementation Triamterene and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents such as spironolactone, amiloride hydrochloride or other formulations containing triamterene.

Concomitant potassium supplementation in the form of medication, potassium-containing salt substitute or potassium-enriched diets should also not be used. Impaired Renal Function Triamterene and hydrochlorothiazide is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment. Hypersensitivity Triamterene and hydrochlorothiazide should not be used in patients who are hypersensitive to triamterene or hydrochlorothiazide or other sulfonamide-derived drugs.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Side effects observed in association with the use of triamterene and hydrochlorothiazide tablets, other combination products containing triamterene/hydrochlorothiazide, and products containing triamterene or hydrochlorothiazide include the following: Gastrointestinal: jaundice (intrahepatic cholestatic jaundice), pancreatitis, nausea, appetite disturbance, taste alteration, vomiting, diarrhea, constipation, anorexia, gastric irritation, cramping. Central Nervous System: drowsiness and fatigue, insomnia, headache, dizziness, dry mouth, depression, anxiety, vertigo, restlessness, paresthesias.

Cardiovascular: tachycardia, shortness of breath and chest pain, orthostatic hypotension (may be aggravated by alcohol, barbiturates or narcotics). Renal: acute renal failure, acute interstitial nephritis, renal stones composed of triamterene in association with other calculus materials, urine discoloration. Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia and megaloblastosis.

Ophthalmic: xanthopsia, transient blurred vision. Hypersensitivity: anaphylaxis, photosensitivity, rash, urticaria, purpura, necrotizing angiitis (vasculitis, cutaneous vasculitis), fever, respiratory distress including pneumonitis. Other: muscle cramps and weakness, decreased sexual performance and sialadenitis.

Whenever adverse reactions are moderate to severe, therapy should be reduced or withdrawn. Altered Laboratory Findings Serum Electrolytes: hyperkalemia, hypokalemia, hyponatremia, hypomagnesemia, hypochloremia ( see WARNINGS and PRECAUTIONS ). Creatinine , Blood Urea Nitrogen: Reversible elevations in BUN and serum creatinine have been observed in hypertensive patients treated with triamterene and hydrochlorothiazide.

Glucose: hyperglycemia, glycosuria and diabetes mellitus ( see PRECAUTIONS ). Serum Uric Acid , PBI and Calcium: ( see PRECAUTIONS ). Other: Elevated liver enzymes have been reported in patients receiving triamterene and hydrochlorothiazide.

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.

🔄 Drug Interactions 145 words

Drug Interactions Thiazides may add to or potentiate the action of other antihypertensive drugs. The thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Thiazides have also been shown to increase the responsiveness to tubocurarine. Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Refer to the package insert on lithium before use of such concomitant therapy.

Acute renal failure has been reported in a few patients receiving indomethacin and formulations containing triamterene and hydrochlorothiazide. Caution is therefore advised when administering non-steroidal anti-inflammatory agents with triamterene and hydrochlorothiazide. Potassium-sparing agents should be used very cautiously, if at all, in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to a greatly increased risk of hyperkalemia.

Serum potassium should be monitored frequently.

🤰 Pregnancy ~1 min read

Pregnancy Teratogenic Effects Triamterene and Hydrochlorothiazide Animal reproduction studies to determine the potential for fetal harm by triamterene and hydrochlorothiazide have not been conducted. Nevertheless, a One Generation Study in the rat approximated triamterene and hydrochlorothiazide's composition by using a 1:1 ratio of triamterene to hydrochlorothiazide (30:30 mg/kg/day). There was no evidence of teratogenicity at those doses that were, on a body-weight basis, 15 and 30 times, respectively, the MRHD, and, on the basis of body-surface area, 3.1 and 6.2 times, respectively, the MRHD.

The safe use of triamterene and hydrochlorothiazide in pregnancy has not been established since there are no adequate and well controlled studies with triamterene and hydrochlorothiazide in pregnant women. Triamterene and hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Triamterene 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. Hydrochlorothiazide Hydrochlorothiazide was orally administered to pregnant mice and rats during respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively. At these doses, which are multiples of the MRHD equal to 3000 for mice and 1000 for rats, based on body-weight, and equal to 282 for mice and 206 for rats, based on body-surface area, there was no evidence of harm to the fetus.

There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 105 words

OVERDOSAGE No specific data are available regarding triamterene and hydrochlorothiazide overdosage in humans and no specific antidote is available. Fluid and electrolyte imbalances are the most important concern. Excessive doses of the triamterene component may elicit hyperkalemia, dehydration, nausea, vomiting and weakness and possibly hypotension.

Overdosing with hydrochlorothiazide has been associated with hypokalemia, hypochloremia, hyponatremia, dehydration, lethargy (may progress to coma) and gastrointestinal irritation. Treatment is symptomatic and supportive. Therapy with triamterene and hydrochlorothiazide should be discontinued.

Induce emesis or institute gastric lavage. Monitor serum electrolyte levels and fluid balance. Institute supportive measures as required to maintain hydration, electrolyte balance, respiratory, cardiovascular and renal function.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Triamterene and hydrochlorothiazide is a diuretic, antihypertensive drug product, principally due to its hydrochlorothiazide component; the triamterene component of triamterene and hydrochlorothiazide reduces the excessive potassium loss which may occur with hydrochlorothiazide use. Hydrochlorothiazide Hydrochlorothiazide is a diuretic and antihypertensive agent. It blocks the renal tubular absorption of sodium and chloride ions.

This natriuresis and diuresis is accompanied by a secondary loss of potassium and bicarbonate. Onset of hydrochlorothiazide's diuretic effect occurs within 2 hours and the peak action takes place in 4 hours. Diuretic activity persists for approximately 6 to 12 hours.

The exact mechanism of hydrochlorothiazide's antihypertensive action is not known although it may relate to the excretion and redistribution of body sodium. Hydrochlorothiazide does not affect normal blood pressure. Following oral administration, peak hydrochlorothiazide plasma levels are attained in approximately 2 hours.

It is excreted rapidly and unchanged in the urine. Well controlled studies have demonstrated that doses of hydrochlorothiazide as low as 25 mg given once daily are effective in treating hypertension, but the dose-response has not been clearly established. Triamterene Triamterene is a potassium-conserving (antikaliuretic) diuretic with relatively weak natriuretic properties.

It exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen. With this action, triamterene increases sodium excretion and reduces the excessive loss of potassium and hydrogen associated with hydrochlorothiazide. Triamterene is not a competitive antagonist of the mineralocorticoids and its potassium-conserving effect is observed in patients with Addison's disease, i.e., without aldosterone.

Triamterene's onset and duration of activity is similar to hydrochlorothiazide. No predictable antihypertensive effect has been demonstrated with triamterene. Triamterene is rapidly absorbed following oral administration.

Peak plasma levels are achieved within one hour after dosing. Triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene. Both the plasma and urine levels of this metabolite greatly exceed triamterene levels.

The amount of triamterene added to 50 mg of hydrochlorothiazide in triamterene and hydrochlorothiazide tablets, 75 mg/50 mg was determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (50 mg given once daily). Single daily doses of 75 mg triamterene resulted in greater increases in serum potassium than lower doses (25 mg and 50 mg), while doses greater than 75 mg of triamterene resulted in no additional elevations in serum potassium levels.

The amount of triamterene added to the 25 mg of hydrochlorothiazide in triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg was also determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (25 mg given once daily). Single daily doses of 37.5 mg triamterene resulted in greater increases in serum potassium than a lower dose (25 mg), while doses greater than 37.5 mg of triamterene, i.e., 75 mg and 100 mg, resulted in no additional elevations in serum potassium levels.

The dose-response relationship of triamterene was also evaluated in patients rendered hypokalemic by hydrochlorothiazide given 25 mg twice daily. Triamterene given twice daily increased serum potassium levels in a dose related fashion. However, the combination of triamterene and hydrochlorothiazide given twice daily also appeared to produce an increased frequency of elevation in serum BUN and creatinine levels.

The large…

📦 How Supplied / Storage and Handling 206 words

HOW SUPPLIED Triamterene and Hydrochlorothiazide Tablets USP, 37.5 mg/25 mg are yellowish green to green colored, spotted, round shaped, flat, uncoated tablets debossed with '856' on one side and breakline on the other side and are supplied as follows: NDC 70771-1361-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1361-5 in bottles of 500 tablets NDC 70771-1361-0 in bottles of 1000 tablets NDC 70771-1361-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Triamterene and Hydrochlorothiazide Tablets USP, 75 mg/50 mg are light yellow to yellow colored, round shaped, flat, uncoated tablets debossed with '857' on one side and breakline on the other side and are supplied as follows: NDC 70771-1362-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1362-5 in bottles of 500 tablets NDC 70771-1362-0 in bottles of 1000 tablets NDC 70771-1362-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Store at 20º to 25º C (68º to 77º F) [See USP Controlled Room Temperature].

Protect from light. Dispense in a tight, light-resistant container as defined in the USP. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India Rev.: 08/23

📋 Description ~1 min read

DESCRIPTION Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains: Triamterene, USP ..............................................................................37.5 mg Hydrochlorothiazide, USP ................................................................25 mg Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains: Triamterene, USP .............................................................................75 mg Hydrochlorothiazide, USP ................................................................50 mg Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No.

1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid.

It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides.

Its molecular weight is 253.26. Its structural formula is: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water.

It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids.

Its molecular weight is 297.7. Its structural formula is: figure figure

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.