Triamterene and Hydrochlorothiazide 25; 37.5 mg; mg Capsule, 1,000-count
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.118 | $118.10 / 1000 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 · Q2 2026 | $0.1705 | $170.50 / 1000 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 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 25; 37.5 mg/1; mgthis 00527-1632-10 | Lannett | 1000 capsules | $0.118 | AB | Discontinued | — |
| 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 | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00527-1632-01 | 100 CAPSULE in 1 BOTTLE (0527-1632-01) | $0.1181 / ea | $11.81 | 2011-12-09 | Inactivated by FDA |
| 00527-1632-10 You're viewing this | 1000 CAPSULE in 1 BOTTLE (0527-1632-10) | $0.1181 / ea | $118.05 | 2011-12-09 | Inactivated by FDA |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1181 NADAC).
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What quantity is in NDC 00527-1632-10?
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Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| 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) | ✓ Available |
| 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. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Hyperkalemia: Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including triamterene and hydrochlorothiazide capsules, USP. 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 first receiving triamterene and hydrochlorothiazide capsules, USP, when dosages are changed, or with any illness that may influence renal function.
🎯 Indications and Usage ▾
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, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP 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, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP 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 ▾
DOSAGE AND ADMINISTRATION The usual dose of triamterene and hydrochlorothiazide capsules, USP is 1 or 2 capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect (see WARNINGS, Hyperkalemia ).
⛔ Contraindications ▾
CONTRAINDICATIONS Antikaliuretic Therapy and Potassium Supplementation: Triamterene and hydrochlorothiazide capsules, USP 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, USP 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, USP 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, USP should not be used in patients with pre-existing elevated serum potassium.
⚠️ Warnings ▾
WARNINGS Hyperkalemia: Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including triamterene and hydrochlorothiazide capsules, USP. 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 first receiving triamterene and hydrochlorothiazide capsules, USP, when dosages are changed, or with any illness that may influence renal function.
If hyperkalemia is suspected (warning signs include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, and shock), an electrocardiogram (ECG) should be obtained. However, it is important to monitor serum potassium levels because hyperkalemia may not be associated with ECG changes. If hyperkalemia is present, triamterene and hydrochlorothiazide capsules, USP should be discontinued immediately and a thiazide alone should be substituted.
If the serum potassium exceeds 6.5 mEq/L, more vigorous therapy is required. The clinical situation dictates the procedures to be employed. These include the intravenous administration of calcium chloride solution, sodium bicarbonate solution, and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation.
Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis. The development of hyperkalemia associated with potassium-sparing diuretics is accentuated in the presence of renal impairment (see CONTRAINDICATIONS ).
Patients with mild renal functional impairment should not receive this drug without frequent and continuing monitoring of serum electrolytes. Cumulative drug effects may be observed in patients with impaired renal function. The renal clearances of hydrochlorothiazide and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following administration of triamterene and hydrochlorothiazide capsules, USP to elderly patients and patients with impaired renal function.
Hyperkalemia has been reported in diabetic patients with the use of potassium-sparing agents even in the absence of apparent renal impairment. Accordingly, serum electrolytes must be frequently monitored if triamterene and hydrochlorothiazide capsules, USP are used in diabetic patients. Metabolic or Respiratory Acidosis: Potassium-sparing therapy should also be avoided in severely ill patients in whom respiratory or metabolic acidosis may occur.
Acidosis may be associated with rapid elevations in serum potassium levels. If triamterene and hydrochlorothiazide capsules, USP are employed, frequent evaluations of acid/base balance and serum electrolytes are necessary. Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
🤒 Adverse Reactions ▾
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.
🔄 Drug Interactions ▾
Drug Interactions: Angiotensin-Converting Enzyme Inhibitors: Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia. Oral Hypoglycemic Drugs: Concurrent use with chlorpropamide may increase the risk of severe hyponatremia. Nonsteroidal Anti-inflammatory Drugs: A possible interaction resulting in acute renal failure has been reported in a few patients on triamterene and hydrochlorothiazide capsules, USP when treated with indomethacin, a nonsteroidal anti-inflammatory agent.
Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene and hydrochlorothiazide capsules, USP. Lithium: Lithium generally should not be given with diuretics because they reduce its renal clearance and increase the risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy with triamterene and hydrochlorothiazide capsules, USP.
Surgical Considerations: Thiazides have been shown to decrease arterial responsiveness to norepinephrine (an effect attributed to loss of sodium). This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the paralyzing effect of nondepolarizing muscle relaxants such as tubocurarine (an effect attributed to potassium loss); consequently, caution should be observed in patients undergoing surgery.
Other Considerations: Concurrent use of hydrochlorothiazide with amphotericin B or corticosteroids or corticotropin (ACTH) may intensify electrolyte imbalance, particularly hypokalemia, although the presence of triamterene minimizes the hypokalemic effect. Thiazides may add to or potentiate the action of other antihypertensive drugs. See INDICATIONS AND USAGE for concomitant use with other antihypertensive drugs.
The effect of oral anticoagulants may be decreased when used concurrently with hydrochlorothiazide; dosage adjustments may be necessary. Triamterene and hydrochlorothiazide capsules, USP may raise the level of blood uric acid; dosage adjustments of antigout medication may be necessary to control hyperuricemia and gout. 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 potassium up to 30 mEq/L of plasma or up to 65 mEq/L of whole blood when stored for more than 10 days); low-salt milk (may contain potassium up to 60 mEq/L); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).
Exchange resins, such as sodium polystyrene sulfonate, whether administered orally or rectally, reduce serum potassium levels by sodium replacement of the potassium; fluid retention may occur in some patients because of the increased sodium intake. Chronic or overuse of laxatives may reduce serum potassium levels by promoting excessive potassium loss from the intestinal tract; laxatives may interfere with the potassium-retaining effects of triamterene. The effectiveness of methenamine may be decreased when used concurrently with hydrochlorothiazide because of alkalinization of the urine.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects : Triamterene and hydrochlorothiazide capsules, USP: Animal reproduction studies to determine the potential for fetal harm by triamterene and hydrochlorothiazide capsules, USP have not been conducted. However, a One Generation Study in the rat approximated composition of triamterene and hydrochlorothiazide capsules, USP by using a 1:1 ratio of triamterene to hydrochlorothiazide (30:30 mg/kg/day); there was no evidence of teratogenicity at those doses which 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 capsules, USP in pregnancy has not been established since there are no adequate and well-controlled studies with triamterene and hydrochlorothiazide capsules, USP in pregnant women. Triamterene and hydrochlorothiazide capsules, USP 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 MRHD on the basis of body weight and 6 times the human dose 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 3,000 and 1,000 mg/kg/day, respectively. At these doses, which are multiples of the MRHD equal to 3,000 for mice and 1,000 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. Nonteratogenic Effects: Thiazides and triamterene have been shown to cross the placental barrier and appear in cord blood.
The use of thiazides and triamterene in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possible other adverse reactions which have occurred in the adult.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
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 ▾
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, USP 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, USP are similar. Onset of diuresis with triamterene and hydrochlorothiazide capsules, USP 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, USP 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, USP 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), hydroch…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Triamterene and Hydrochlorothiazide Capsules, USP contain 37.5 mg triamterene and 25 mg hydrochlorothiazide, 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 100, NDC 0527-1632-01 Bottles of 1000, NDC 0527-1632-10 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. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70286D Rev.
09/20
📋 Description ▾
DESCRIPTION Each triamterene and hydrochlorothiazide capsule for oral use contains triamterene 37.5 mg and hydrochlorothiazide 25 mg. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent. Hydrochlorothiazide is slightly soluble in water.
It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide 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 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 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. hctz-molec-struc triamterene-molec-struc