Version May 2024
Chronic urea-splitting urinary infection: Oral: Initial: 12 mg/kg/day in 3 to 4 divided doses. Maintenance: 250 mg 3 to 4 times daily for a total daily dose of 10 to 15 mg/kg/day. Maximum daily dose: 1,500 mg/day.
Serum creatinine >1.8 mg/dL: 10 to 15 mg/kg/day divided every 12 hours; maximum daily dose: 1,000 mg/day.
Serum creatinine >2.5 mg/dL (or CrCl <20 mL/minute): Use is contraindicated.
There are no dosage adjustments provided in the manufacturer’s labeling.
Reticulocyte count >6%: Consider a reduction in the dosage.
Refer to adult dosing.
(For additional information see "Acetohydroxamic acid: Pediatric drug information")
Chronic urea-splitting urinary infection; adjunct therapy to decrease urinary ammonia levels and alkalinity: Children and Adolescents: Oral: Initial: 10 mg/kg/day in 2 or 3 divided doses; adjust dose as needed (higher or lower) for optimum therapeutic effect and minimization of side effects; in adults, usual dose is 250 mg/dose (10 to 15 mg/kg/day) and the maximum daily dose: 1,500 mg/day.
Dosing adjustment for toxicity: Children and Adolescents: Reticulocyte count >6%: Consider a reduction in the dosage.
There are no pediatric specific recommendations; based on experience in adult patients, dosing adjustment suggested and for sCr >2.5 mg/dL (or CrCl <20 mL/minute), use is contraindicated.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not always defined.
>10%:
Central nervous system: Headache (30%), malaise (20% to 25%), anxiety (20%), depression (20%), nervousness (20%)
Gastrointestinal: Anorexia (20% to 25%), nausea (20% to 25%), vomiting (20% to 25%)
Hematologic & oncologic: Hemolytic anemia (3% to 15%)
Neuromuscular & skeletal: Tremor (20%)
1% to 10%:
Cardiovascular: Deep vein thrombosis (rare), embolism, flushing, palpitations, phlebitis
Dermatologic: Alopecia, macular eruption
Hematologic & oncologic: Reticulocytosis (5% to 6%)
Patients whose physical state and disease are amenable to definitive surgery and appropriate antimicrobial agents; patients whose urine is infected by non-urease-producing organisms; patients whose urinary infections can be controlled by culture-specific oral antimicrobial agents; patients whose renal function is poor (ie, serum creatinine >2.5 mg/dL and/or creatinine clearance <20 mL/minute); female patients who do not evidence a satisfactory method of contraception; pregnancy
Concerns related to adverse effects:
• Bone marrow suppression: May suppress bone marrow function; use with caution in patients with prior bone marrow depression. Close monitoring of hematologic function is recommended.
• Hemolytic anemia: Has been associated with hemolytic anemia (Coombs' negative), which may be associated with gastrointestinal distress (eg, nausea, vomiting, anorexia) and generalized malaise; use with caution in patients with anemia. In patients receiving therapy for >2 weeks, monitor hematologic parameters (eg, CBC with reticulocytes) at 3-month intervals for the duration of treatment. If the reticulocyte count exceeds 6%, consider a reduction in the dosage. Anemia is usually reversible after treatment is discontinued.
• Hepatotoxicity: May cause hepatic injury; close monitoring of hepatic function is recommended.
• Rash: A nonpruritic, macular skin rash has occurred in the upper extremities and on the face of patients on long-term therapy, usually with concomitant ethanol use. The rash most often occurs 30 to 45 minutes after ethanol consumption and resolves spontaneously in 30 to 60 minutes. Patients should limit or avoid alcohol during therapy.
Disease-related concerns:
• Renal impairment: Use with caution; close monitoring of renal function is recommended. Dosage adjustments recommended.
Other warnings/precautions:
• Struvite kidney stones: Struvite stones, which occur as a result of urinary tract infections with urea splitting organisms, are typically surgically removed. However, in patients who are not candidates for surgical removal or in patients at risk for recurrent urinary tract infection with urease-producing organisms, treatment with acetohydroxamic acid may be beneficial (AUA guidelines [Pearle 2014]). Acetohydroxamic acid 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 acetohydroxamic acid may be warranted to maintain urease inhibition as long as urea-splitting infection is present. Experience with acetohydroxamic acid does not go beyond 7 years.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Lithostat: 250 mg
No
Tablets (Lithostat Oral)
250 mg (per each): $7.80
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Oral: Administer on an empty stomach, 1 hour before or 2 hours after meals. Administer 1 hour before or 2 hours after taking iron or any product that contains iron.
Oral: Administer on an empty stomach, 1 hour before or 2 hours after meals. Administer 1 hour before or 2 hours after taking iron or any product that contains iron.
Chronic urea-splitting urinary infection: Adjunctive therapy in chronic urea-splitting urinary infection
Lithostat may be confused with Lithobid
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): May enhance the adverse/toxic effect of Acetohydroxamic Acid. Specifically, Alcohol (Ethyl) may increase the risk of Acetohydroxamic Acid associated rash. Risk C: Monitor therapy
Food may decrease absorption of acetohydroxamic acid. Management: Administer on an empty stomach, 1 hour before or 2 hours after meals.
Use is contraindicated in females of childbearing potential who are not using a reliable form of contraception.
Adverse effects were observed in animal reproduction studies. Use is contraindicated in pregnant women.
It is not known if acetohydroxamic acid is present in breast milk.
Due to the potential for serious adverse reactions in the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.
Should be taken on an empty stomach, 1 hour before or 2 hours after meals.
CBC with reticulocytes after 2 weeks of treatment and at 3-month intervals during the duration of treatment; renal function, liver function, monitor for signs and symptoms of phlebitis.
Acetohydroxamic acid inhibits bacterial urease enzymes, decreasing the formation of ammonia in the urine by urea-splitting organisms. A reduction in urinary ammonia and decreased pH may increase the activity of some antimicrobial agents.
Absorption: Oral: Well absorbed.
Half-life elimination: 5 to 10 hours (increased in patients with reduced renal function).
Time to peak: 0.25 to 1 hour.
Excretion: Urine (36% to 65% as unchanged drug).
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