TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25 mg/1
TRIAMTERENE AND HYDROCHLOROTHIAZIDE · CAPSULE · Chartwell RX, LLC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE is a capsule containing triamterene and hydrochlorothiazide at 25 mg/1, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Generic Name
- TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- NDC Code (Product)
62135-529- Manufacturer
- Chartwell RX, LLC
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA201407
- Drug Class
- Thiazide Diuretic [EPC]; Potassium-sparing Diuretic [EPC]
- Marketing Start
- 12/09/2011
Recall History
Mylan Pharmaceuticals Inc.
Subpotent Drug
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lannett Company Inc.
Failed Impurity/Degradation Specifications
Mylan Pharmaceuticals Inc.
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Sandoz Incorporated
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Lannett Company Inc.
Failed Impurity/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide is 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 may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide 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 pregnan…
Dosage & Administration
DOSAGE AND ADMINISTRATION: The usual dose of triamterene and hydrochlorothiazide tablets 37.5mg/25mg 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 75mg/ 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 triamterene and hydrochlorothiazide tablet 75mg/50mg daily or more than two triamterene and hydrochlorothiazide tablets 37.5mg/25mg daily. Clinical experience with the administration of two triamterene and hydrochlorothiazide tablets 37.5mg/25mg 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 75mg/50mg directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets 37.5mg/25mg directly. In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot b…
Warnings
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. 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 mild hyperkalemia may not be associated with ECG changes. If hyperkalemia is present, triamterene and hydrochlorothiazide should be discontinued immediately and a thiazide alone should be substituted. If the serum potassium exceeds 6.5 mEq/liter, more vigorous therapy is required. T…
Contraindications
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.
Drug Interactions
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.
Adverse Reactions
ADVERSE REACTIONS: Side effects observed in association with the use of triamterene and hydrochlorothiazide, 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, cutane…
Frequently Asked Questions
What is TRIAMTERENE AND HYDROCHLOROTHIAZIDE used for?
TRIAMTERENE AND HYDROCHLOROTHIAZIDE contains TRIAMTERENE AND HYDROCHLOROTHIAZIDE. It is a capsule taken oral. Consult your doctor for specific uses.
Is TRIAMTERENE AND HYDROCHLOROTHIAZIDE a controlled substance?
TRIAMTERENE AND HYDROCHLOROTHIAZIDE is not classified as a controlled substance by the DEA.
What is the generic name for TRIAMTERENE AND HYDROCHLOROTHIAZIDE?
The generic name for TRIAMTERENE AND HYDROCHLOROTHIAZIDE is TRIAMTERENE AND HYDROCHLOROTHIAZIDE. There are 11 other brand versions of TRIAMTERENE AND HYDROCHLOROTHIAZIDE.
What is the NDC code for TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25 mg/1?
The NDC (National Drug Code) for TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25 mg/1 is 62135-529, listed by Chartwell RX, LLC.
Other Triamterene Brands
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- Triamterene and Hydrochlorothiazide25 mg/163629-8732
- Triamterene and Hydrochlorothiazide25 mg/168001-387
- Triamterene and Hydrochlorothiazide50 mg/168788-8624
- Triamterene and Hydrochlorothiazide25 mg/170518-1662
- triamterene and hydrochlorothiazide50 mg/170771-1362
- Triamterene and Hydrochlorothiazide50 mg/160505-2657
- Triamterene and Hydrochlorothiazide25 mg/168084-750
- Triamterene and Hydrochlorothiazide50 mg/172888-095
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)