va flox a
Alatrofloxacin Mesylate; CP-99,219-27|
Should be used only in life- or limb-threatening
History of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone
antimicrobial agents or any other components of these
For use only in serious life- or limb-threatening infections. Initiation of
therapy must occur in an inpatient healthcare facility. May alter GI flora
resulting in pseudomembranous colitis due to Clostridium difficile; use
with caution in patients with seizure disorders or severe cerebral
atherosclerosis; discontinue if skin rash or pain, inflammation, or rupture of a
tendon; photosensitivity; CNS stimulation may occur which may lead to tremor,
restlessness, confusion, hallucinations, paranoia, depression, nightmares,
insomnia, or lightheadedness. Hepatic reactions have resulted in death. Risk of
hepatotoxicity is increased if therapy exceeds 14 days.
Note: Fatalities have occurred in patients developing hepatic
Central nervous system: Dizziness, lightheadedness, headache
Dermatologic: Rash, pruritus
Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain
Hepatic: Increased LFTs
Local: Injection site reaction, pain, or inflammation
<1%: Anaphylaxis, hepatic necrosis, pancreatitis, Stevens-Johnson syndrome
Empty the stomach by vomiting or gastric lavage. Observe carefully and give
symptomatic and supportive treatment; maintain adequate
Decreased effect of oral trovafloxacin:
Morphine: Administer I.V. morphine at least 2 hours after oral trovafloxacin
in the fasting state and at least 4 hours after oral trovafloxacin when taken
Trovan™ I.V. should not be diluted with 0.9% sodium
chloride injection, USP (normal saline), alone or in combination with other
diluents. A precipitate may form under these conditions. In addition,
Trovan® I.V. should not be diluted with lactated Ringer's,
Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of
supercoiled DNA and promotes breakage of double-stranded
Distribution: Concentration in most tissues greater than plasma or serum
Protein binding: 76%
Metabolism: Hepatic conjugation
Half-life: 9-12 hours
Elimination: 50% excreted unchanged (43% feces, 6% urine)
Community-acquired pneumonia: Oral, I.V.: 200 mg/day for 7-14 days
Complicated intra-abdominal infections, including postsurgical
infections/gynecologic and pelvic infections: I.V.: 300 mg as a single dose
followed by 200 mg/day orally for a total duration of 7-14 days
Skin and skin structure infections, complicated, including diabetic foot
infections: Oral, I.V.: 200 mg/day for 10-14 days
Dosage adjustment in renal impairment: No adjustment is necessary
Dosage adjustment for hemodialysis: None required; trovafloxacin not
sufficiently removed by hemodialysis
Dosage adjustment in hepatic impairment:
Mild to moderate cirrhosis:
Initial dose for normal hepatic function: 300 mg I.V.; 200 mg I.V. or oral;
100 mg oral
Reduced dose: 200 mg I.V.; 100 mg I.V. or oral; 100 mg oral
Severe cirrhosis: No data available
Dairy products such as milk and yogurt reduce the absorption of oral
trovafloxacin - avoid concurrent use. The bioavailability may also be decreased
by enteral feedings.
Periodic assessment of liver function tests should be
|Mental Health: Effects
on Mental Status|
May cause dizziness; quinolones reported to cause restlessness,
hallucinations, euphoria, depression, panic, and paranoia
Effects on Psychiatric
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
No effects or complications reported
Take per recommended schedule; complete full course of therapy and do not
skip doses. Take on an empty stomach (1 hour before or 2 hours after meals,
dairy products, antacids, or other medication). Dizziness may be reduced if
taken at bedtime with food. Maintain adequate hydration (2-3 L/day of fluids
unless instructed to restrict fluid intake). You may experience dizziness or
lightheadedness (use caution when driving or engaging in tasks that require
alertness until response to drug is known); nausea or GI upset (small frequent
meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report
CNS disturbances (hallucinations, gait disturbances); chest pain or
palpitations; persistent GI disturbances; signs of opportunistic infection (sore
throat, chills, fever, burning, itching on urination, vaginal discharge, white
plaques in mouth); tendon pain, swelling, or redness; difficulty breathing, or
worsening of condition. Pregnancy/breast-feeding precautions: Inform
prescriber if you are or intend to be pregnant. Do not
Injection, as mesylate (alatrofloxacin): 5 mg/mL (40 mL, 60 mL)
Tablet, as mesylate (trovafloxacin): 100 mg, 200 mg
Cutler NR, Vincent J, Jhee SS, et al,
"Penetration of Trovafloxacin Into Cerebrospinal Fluid in Humans Following Intravenous Infusion of Alatrofloxacin,"
Antimicrob Agents Chemother, 1997, 41(6):1298-300.
Dalvie DK, Khosla N, and Vincent J,
"Excretion and Metabolism of Trovafloxacin in Humans," Drug Metab Dispos,
Ernst ME, Ernst EJ, and Klepser ME,
"Levofloxacin and Trovafloxacin: The Next Generation of Fluoroquinolones?" Am
J Health Syst Pharm, 1997, 54(22):2569-84.
Garey KW and Amsden GW, "Trovafloxacin: An Overview," Pharmacotherapy,
Haria M and Lamb HA, "Trovafloxacin," Drugs, 1997, 54(3):435-45.
Hecht DW and Osmolski JR,
"Comparison of Activities of Trovafloxacin (CP-99,219) and Five Other Agents Against 585 Anaerobes With Use of Three Media,"
Clin Infect Dis, 1996, 23(Suppl 1):S44-50.
" In vitro Activities of Ciprofloxacin, Levofloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Sparfloxacin, and Trovafloxacin Against Gram-Positive and Gram-Negative Pathogens From Respiratory Tract Infections,"
J Antimicrob Chemother, 1997, 40(3):427-31.
Teng R, Dogolo LC, Willavize SA, et al,
"Oral Bioavailability of Trovafloxacin With and Without Food in Healthy Volunteers,"
J Antimicrob Chemother, 1997, 39(Suppl B):87-92.
Thompson KS, Chartrand SA, Sanders CC, et al,
"Trovafloxacin, a New Fluoroquinolone With Potent Activity Against Streptococcus pneumoniae,"
Antimicrob Agents Chemother, 1997, 41(2):478-80.
"Trovafloxacin," Med Lett Drugs Ther, 1998, 40(1022):30-1.
Vincent J, Venitz J, Teng R, et al,
"Pharmacokinetics and Safety of Trovafloxacin in Healthy Male Volunteers Following Administration of Single Intravenous Doses of the Prodrug, Alatrofloxacin,"
J Antimicrob Chemother, 1997, 39(Suppl B):75-80.
Copyright © 1978-2000 Lexi-Comp Inc. All Rights Reserved