Source: FDA, National Drug Code (US) Revision Year: 2022
Acetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used in lieu of curative surgical treatment (for patients with stones) or antimicrobial treatment. Long-term treatment with AHA may be warranted to maintain urease inhibition as long as urea-splitting infection is present. Experience with AHA does not go beyond 7 years. A patient package insert should be distributed to each patient who receives AHA.
AHA should be administered orally, one tablet 3-4 times a day in a total daily dose of 10-15 mg/kg/day. The recommended starting dose is 12 mg/kg/day, administered at 6-8 hour intervals at a time when the stomach is empty. The maximum daily dose should be no more than 1.5 grams, regardless of body weight.
The dosage should be reduced in patients with reduced renal function. Patients whose serum creatinine is greater than 1.8 mg/dl should take no more than 1.0 gm/day; such patients should be dosed at q-12-h intervals. Further reductions in dosage to prevent the accumulation of toxic concentrations in the blood may also be desirable. Insufficient data exists to accurately characterize the optimum dose and/or dose interval in patients with moderate degrees of renal insufficiency.
Patients with advanced renal insufficiency (i.e., serum creatinine more than 2.5 mg/dl) should not be treated with AHA. The risk of accumulation of toxic blood levels of AHA seems to be greater than the chances for a beneficial effect in such patients.
In children an initial dose of 10 mg/kg/day is recommended. Close monitoring of the patient’s clinical condition and hematologic status is recommended. Titration of the dose to higher or lower levels may be required to obtain an optimum therapeutic effect and/or to reduce the risk of side effects.
Acute deliberate overdosage in man has not occurred, but would be expected to induce the following symptoms: anorexia, malaise, lethargy, diminished sense of well being, tremulousness, anxiety, nausea and vomiting. Laboratory findings are likely to include an elevated reticulocyte count and a severe hemolytic reaction requiring hospitalization, symptomatic treatment, and possibly blood transfusions. Concomitant reduction in platelets and/or white blood cells should be anticipated.
Milder overdosages resulting in hemolysis have occurred in an occasional patient with reduced renal function after several weeks or months of continuous treatment.
The acute LD50 of AHA in animals (rats) is 4.8 gm/kg.
Recommended treatment for an overdosage reaction consists of (1) cessation of treatment, (2) close monitoring of hematologic status, (3) symptomatic treatment, and (4) blood transfusions as required by the clinical circumstances. The drug is probably dialyzable, but this property has not been tested clinically.
LITHOSTAT should be stored in a dry place at room temperature, 15°-30°C (59°-86°F). Container should be closed tightly.
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