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. 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 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.
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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. 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 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.
ADVERSE REACTIONS Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first regardless of frequency. The serious adverse effects associated with Triamterene and Hydrochlorothiazide Capsules have commonly occurred in less than 0.1% of patients treated with this product. Hypersensitivity: anaphylaxis, rash, urticaria, photosensitivity. Cardiovascular: arrhythmia, postural hypotension. Metabolic: diabetes mellitus, hyperkalemia, hyperglycemia, glycosuria, hyperuricemia, hypokalemia, hyponatremia, acidosis, 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.