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Susceptible infections: Oral: 250 mg 3-4 times daily for a total daily dose of 10-15 mg/kg/day; maximum dose: 1500 mg daily Dosing: Pediatric Susceptible infections: Oral: Initial: 10 mg/kg/day in 2 or 3 divided doses Dosing: Geriatric Refer to adult dosing. Dosing: Renal Impairment Serum creatinine >1.8 mg/dL: 10-15 mg/kg/day every 12 hours; maximum dose: 1000 mg daily Serum creatinine >2.5 mg/dL (or Cl cr <20 mL/minute): Use contraindicated Dosing: Hepatic Impairment No dosage adjustment provided in manufacturer’s labeling. Dosage Forms: U.S. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Tablet, oral: Lithostat®: 250 mg Generic Equivalent Available: U.S. No Administration Should be administered 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. Use Adjunctive therapy in chronic urea-splitting urinary infection Medication Safety Issues Sound-alike/look-alike issues: Lithostat® may be confused with Lithobid® Adverse Reactions Significant >10%: Central nervous system: Headache (30%), malaise (20% to 25%), anxiety (20%), depression (20%), nervousness (20%), tremulousness (20%) Gastrointestinal: Anorexia (20 to 25%), nausea (20% to 25%), vomiting (20% to 25%) Hematologic: Hemolytic anemia (3% to 15%) ≤1% to 10%: Cardiovascular: Deep vein thrombosis (rare), flushing, palpitation Dermatologic: Alopecia, macular skin rash Hematologic: Reticulocytosis (5% to 6%) Local: Phlebitis Respiratory: Embolism Contraindications In patients with disease who can otherwise be treated with surgical or antimicrobial therapy; urinary infection that can be controlled by culture-specific antimicrobial agents or is caused by a non-urease-producing organism; in patients with serum creatinine >2.5 mg/dL or creatinine clearance <20 mL/minute; women of childbearing potential who are not using a reliable form of contraception; pregnancy Warnings/Precautions

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 and systemic symptoms; use with caution in patients with anemia. Monitor hematologic parameters during extended therapy. Anemia is usually reversible after treatment is discontinued. • Hepatotoxicity: May cause hepatic injury; close monitoring of hepatic function is recommended.

Disease-related concerns: • Renal impairment: Use with caution; close monitoring of renal function is recommended. Dosage adjustments recommended. Metabolism/Transport Effects None known. Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) There are no known significant interactions. Ethanol/Nutrition/Herb Interactions Ethanol: Avoid ethanol (may increase incidence of rash and/or flushing). Food: May decrease absorption of acetohydroxamic acid. Pregnancy Risk Factor X ( show table ) Pregnancy Implications Teratogenic effects were observed in animal reproduction studies. Use is contraindicated in pregnant women. Lactation Excretion in breast milk unknown/not recommended Dietary Considerations Should be taken on an empty stomach, 1 hour before or 2 hours after meals. Pricing: U.S. (Medi-Span®)

Tablets (Lithostat Oral) 250 mg (100): $172.50 Monitoring Parameters In patients receiving therapy >2 weeks, monitor CBC with reticulocytes at 3-month intervals during the duration of treatment; renal function, liver function International Brand Names Uronefrex (BE, ES, FR, LU) Mechanism of Action 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. Pharmacodynamics/Kinetics Absorption: Oral: Well absorbed Half-life elimination: 5-10 hours (increased in patients with reduced renal function) Time to peak: 0.25-1 hour Excretion: Urine (36% to 65% as unchanged drug) Use of UpToDate is subject to the Subscription and License Agreement . Topic 9210 Version 33.0 © 2013 UpToDate, Inc. All rights reserved. | Subscription and License Agreement | Release: 21.6- C21.56 Licensed to: AsanBook Dig. Med. Lib. | Support Tag: [1004-115.25.216.6-7AD06D259D-S244013.14]