FDA label d6121404-16a8-4270-919d-97bed516e72b

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.

WARNINGS

ADVERSE REACTIONS Adverse effects are listed in decreasing order of severity. Hypersens itivity: Anaphylaxis, rash, urticaria, subacute cutaneous lupus erythematosus-like reactions, photosensitivity. Cardiovas cular: Arrhythmia, postural hypotension. Metabolic: Diabetes mellitus, hyperkalemia, hypokalemia, hyponatremia, acidosis, hypercalcemia, hyperglycemia, glycosuria, hyperuricemia, hypochloremia. Gastrointes tinal: 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. Musculos keletal: Muscle cramps. Central Nervous Sys tem: Weakness, fatigue, dizziness, headache, dry mouth. Miscellaneous : Impotence, sialadenitis. Thiazides alone have been shown to cause the following additional adverse reactions: Central Nervous Sys tem: Paresthesias, vertigo. Ophthalmic: Xanthopsia, transient blurred vision. Res piratory: 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.