Description
id: 25dc5c9b-b838-6150-e054-00144ff8d46c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Clinical Pharmacology
id: 25dc7842-ae96-634b-e054-00144ff8d46c
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Indications and Usage
id: 25dc942e-cadc-14cf-e054-00144ff88e88
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Contraindications
id: 25dc5c9b-b83a-6150-e054-00144ff8d46c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Warnings
id: 25dcc096-1616-69c2-e054-00144ff8d46c
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Precautions
id: 25dcd892-0f55-5e09-e054-00144ff8d46c
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
Adverse Reactions
id: 25dcd892-0f5a-5e09-e054-00144ff8d46c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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Whenever adverse reactions are moderate to severe, therapy should be reduced or withdrawn.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.
to report suspected adverse reactions call 1-800-332-1088
to report suspected adverse reactions call 1-800-332-1088
Overdosage
id: 25dbcc8b-c65d-634f-e054-00144ff88e88
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
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.
Dosage and Administration
id: 25dcf497-a5b8-06cf-e054-00144ff8d46c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Note: 37.5 mg/25 mg = 37.5 mg triamterene and 25 mg hydrochlorothiazide
75 mg/50 mg = 75 mg triamterene and 50 mg hydrochlorothiazide
The usual dose of Triamterene and Hydrochlorothiazide 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 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 tablet daily or more than two 37.5 mg/25 mg tablets daily. Clinical experience with the administration of two 37.5 mg/25 mg 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 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg triamterene/25 mg hydrochlorothiazide directly.
In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with 37.5 mg/25 mg of triamterene and hydrochlorothiazide. If an optimal blood pressure response is not obtained with 37.5 mg/25 mg of triamterene and hydrochlorothiazide, the dose should be increased to two 37.5 mg/25 mg tablets daily as a single dose, or one 75 mg/50 mg tablet 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 37.5 mg/25 mg of triamterene and hydrochlorothiazide daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide should be monitored clinically and for serum potassium after the transfer.
Package Label
id: 25dcd892-0f60-5e09-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
