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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: 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 Calcium and/or magnesium products: Acetohydroxamic acid may chelate divalent metals, decreasing the absorption of both agents; avoid concurrent use.
Iron: Orally-administered iron may be chelated by acetohydroxamic acid, decreasing the absorption of both agents. To treat hypochromic anemia, parenteral iron should be used.
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): $143.36
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 — Lithostat (CA)
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.
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