Lithostat

U.S. BRAND NAMES — Lithostat®

PHARMACOLOGIC CATEGORY
Urinary Tract Product

DOSING: ADULTS — Susceptible infections: Oral: 250 mg 3-4 times/day for a total daily dose of 10-15 mg/kg/day

DOSING: PEDIATRIC — Susceptible infections: Oral: Initial: 10 mg/kg/day

DOSING: ELDERLY — Refer to adult dosing.

DOSING: RENAL IMPAIRMENT — Not recommended for use in significant renal impairment (Srcr >2.5 mg/dL).

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet:
Lithostat®: 250 mg

DOSAGE FORMS: CONCISE
Tablet:
Lithostat®: 250 mg

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Should be administered on an empty stomach.

USE — Adjunctive therapy in chronic urea-splitting urinary infection

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Deep vein thrombosis (rare), embolism, palpitation, phlebitis

Central nervous system: Anorexia, anxiety, depression, headache, malaise, nervousness, tremor

Dermatologic: Flushing (with ethanol consumption), rash (nonpruritic, macular)

Gastrointestinal: Nausea, vomiting

Hematologic: Hemolytic anemia (15% with laboratory evidence; ~3% severe requiring discontinuation; may be accompanied by GI symptoms or systemic complaints of malaise and/or fatigue); hyperbilirubinemia

Respiratory: Pulmonary embolism (rare)

CONTRAINDICATIONS — Hypersensitivity to acetohydroxamic acid or any component of the formulation; 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. Hepatotoxicity: May cause hepatic injury; close monitoring of hepatic function is recommended.

Disease-related concerns: Psychiatric disorders: Use with caution in patients with pre-existing psychiatric disorders; may be associated with nervousness, anxiety, and/or depression.

DRUG INTERACTIONS — 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)

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 — (data from drugstore.com)
Tablets (Lithostat)
250 mg (100): $172.79

MONITORING PARAMETERS — In patients receiving therapy >2 weeks, monitor CBC with reticulocytes at 3-month intervals during the duration of treatment.

CANADIAN BRAND NAMES — Lithostat®

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 may increase the antibacterial activity of some antibiotic agents.