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Pronunciation |
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(fos
foe MYE
sin) |
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U.S. Brand
Names |
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Monurol™ |
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Generic
Available |
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No |
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Synonyms |
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Fosfomycin Tromethamine |
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Pharmacological Index |
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Antibiotic, Miscellaneous |
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Use |
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A single oral dose in the treatment of uncomplicated urinary tract infections
in women due to susceptible strains of E. coli and Enterococcus;
multiple doses have been investigated for complicated urinary tract infections
in men; may have an advantage over other agents since it maintains high
concentration in the urine for up to 48 hours |
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Pregnancy Risk
Factor |
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B |
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Pregnancy/Breast-Feeding
Implications |
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Breast-feeding/lactation: Milk concentration approximates 10% of
plasma |
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Adverse
Reactions |
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>1%:
Central nervous system: Headache
Dermatologic: Rash
Gastrointestinal: Diarrhea (2% to 8%), nausea, vomiting, epigastric
discomfort, anorexia
<1%: Dizziness, drowsiness, fatigue, pruritus |
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Overdosage/Toxicology |
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Symptomatic and supportive treatment is recommended in the event of an
overdose. |
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Drug
Interactions |
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Decreased effect: Antacids or calcium salts may cause precipitate formation
and decrease fosfomycin absorption
Metoclopramide: Increased gastrointestinal motility may lower fosfomycin
tromethamine serum concentrations and urinary excretion. This drug interaction
possibly could be extrapolated to other medications which increase
gastrointestinal motility. |
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Mechanism of
Action |
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As a phosphonic acid derivative, fosfomycin inhibits bacterial wall synthesis
(bactericidal) by inactivating the enzyme, pyruvyl transferase, which is
critical in the synthesis of cell walls by bacteria; the tromethamine salt is
preferable to the calcium salt due to its superior
absorption |
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Pharmacodynamics/Kinetics |
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Absorption: Well absorbed
Distribution: Vd: 2 L/kg; high concentrations in urine;
distributed well into other tissues, crosses maximally into CSF with inflamed
meninges
Protein binding: Minimal (<3%)
Metabolism: None
Bioavailability: 34% to 58%
Half-life: 4-8 hours; prolonged in renal failure (50 hours with
Clcr <10 mL/minute)
Time to peak serum concentration: 2 hours
Elimination: High urinary levels persist for >48 hours (100 mcg/mL);
excreted unchanged |
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Usual Dosage |
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Adults: Urinary tract infections: Oral:
Male: 3 g once daily for 2-3 days for complicated urinary tract infections
Dosing adjustment in renal impairment: Decrease dose; 80% removed by
dialysis, repeat dose after dialysis
Dosing adjustment in hepatic impairment: No dosage decrease needed
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Administration |
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Always mix with water before ingesting; do not give in its dry form; pour
contents of envelope into 90-120 mL of water (not hot), stir to dissolve. Drink
immediately after dissolving. |
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Monitoring
Parameters |
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Signs and symptoms of urinary tract infection |
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Mental Health: Effects
on Mental Status |
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May cause drowsiness |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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May be taken with or without food; avoid use of antacids or calcium salts
within 4 hours before or 2 hours after taking fosfomycin; contact your physician
if signs of allergy develop; if symptoms do not improve after 2-3 days, contact
your healthcare provider |
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Dosage Forms |
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Powder, as tromethamine: 3 g, to be mixed in 4 oz of
water |
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References |
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Patel SS, Balfour JA, and Bryson HM,
"Fosfomycin Tromethamine. A Review of Its Antibacterial Activity, Pharmacokinetic Properties, and Therapeutic Efficacy as a Single-Dose Oral Treatment for Acute Uncomplicated Lower Urinary Tract Infections,"
Drugs, 1997, 53(4):637-56. |
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