No

Antibiotic, Quinolone

Should be used only in life- or limb-threatening infections

C

History of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobial agents or any other components of these products

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 necrosis

Central nervous system: Dizziness, lightheadedness, headache

Dermatologic: Rash, pruritus

Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain

Genitourinary: Vaginitis

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 hydration.

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 with food

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, USP.

Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA

Distribution: Concentration in most tissues greater than plasma or serum

Protein binding: 76%

Metabolism: Hepatic conjugation

Bioavailability: 88%

Half-life: 9-12 hours

Elimination: 50% excreted unchanged (43% feces, 6% urine)

Adults:

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 considered

May cause dizziness; quinolones reported to cause restlessness, hallucinations, euphoria, depression, panic, and paranoia

None reported

No information available to require special precautions

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 breast-feed.

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, 1997, 25(4):423-7.

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, 1999, 19(1):21-34.

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.

Hoogkamp-Korstanje JA, " 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.