Prescription Drug Information: Trovan (Page 4 of 8)


1
This interpretive standard is applicable only to broth microdilution susceptibility tests with Haemophilus spp. using Haemophilus Test Medium (HTM)1.
2
These interpretive standards are applicable only to broth microdilution susceptibility tests using cation adjusted Mueller-Hinton broth with 2–5% lysed horse blood.
3
This zone diameter standard is applicable only to tests with Haemophilus spp. using HTM2.
4
These zone diameter standards only apply to tests performed using Mueller-Hinton agar supplemented with 5% sheep blood incubated in 5% CO2 .

INDICATIONS AND USAGE

TROVAN is indicated for the treatment of patients initiating therapy in in-patient health care facilities (i.e., hospitals and long term nursing care facilities) with serious, life- or limb-threatening infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION.)

Nosocomial pneumonia caused by Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae , or Staphylococcus aureus. As with other antimicrobials, where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with either an aminoglycoside or aztreonam may be clinically indicated.

Community acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Mycoplasma pneumoniae, Moraxella catarrhalis, Legionella pneumophila, or Chlamydia pneumoniae.

Complicated intra-abdominal infections, including post-surgical infections caused by Escherichia coli, Bacteroides fragilis, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Peptostreptococcus species, or Prevotella species.

Gynecologic and pelvic infections including endomyometritis, parametritis, septic abortion and post-partum infections caused by Escherichia coli, Bacteroides fragilis, viridans group streptococci, Enterococcus faecalis, Streptococcus agalactiae, Peptostreptococcus species, Prevotella species, or Gardnerella vaginalis.

Complicated skin and skin structure infections, including diabetic foot infections, caused by Staphylococcus aureus, Streptococcus agalactiae, Pseudomonas aeruginosa, Enterococcus faecalis, Escherichia coli, or Proteus mirabilis. NOTE: TROVAN has not been studied in the treatment of osteomyelitis. (See WARNINGS.)

CONTRAINDICATIONS

TROVAN is contraindicated in persons with a history of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobial agents or any other components of these products.

WARNINGS

(See boxed WARNING.) TROVAN-ASSOCIATED LIVER ENZYME ABNORMALITIES, SYMPTOMATIC HEPATITIS, JAUNDICE, AND LIVER FAILURE (INCLUDING RARE REPORTS OF ACUTE HEPATIC NECROSIS WITH EOSINOPHILIC INFILTRATION, LIVER TRANSPLANTATION AND/OR DEATH) HAVE BEEN REPORTED WITH BOTH SHORT-TERM AND LONG-TERM DRUG EXPOSURE IN MEN AND WOMEN. TROVAN USE EXCEEDING 2 WEEKS IN DURATION IS ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF SERIOUS LIVER INJURY. LIVER INJURY HAS ALSO BEEN REPORTED FOLLOWING TROVAN RE-EXPOSURE. CLINICIANS SHOULD MONITOR LIVER FUNCTION TESTS (e.g., AST, ALT, BILIRUBIN) IN TROVAN RECIPIENTS WHO DEVELOP SIGNS OR SYMPTOMS CONSISTENT WITH HEPATITIS. CLINICIANS SHOULD CONSIDER DISCONTINUING TROVAN IN THOSE PATIENTS WHO DEVELOP LIVER FUNCTION TEST ABNORMALITIES.

THE SAFETY AND EFFECTIVENESS OF TROVAFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS LESS THAN 18 YEARS OF AGE, PREGNANT WOMEN, AND NURSING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS: Pediatric Use, Pregnancy, and Nursing Mothers subsections.)

As with other members of the quinolone class, trovafloxacin has caused arthropathy and/or chondrodysplasia in immature rats and dogs. The significance of these findings to humans is unknown. (See ANIMAL PHARMACOLOGY.)

Convulsions, increased intracranial pressure and psychosis have been reported in patients receiving quinolones. Quinolones may also cause central nervous system stimulation which may lead to tremors, restlessness, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares and insomnia. These reactions may occur following the first dose. If these reactions occur in patients receiving trovafloxacin or alatrofloxacin, the drug should be discontinued and appropriate measures instituted. (See PRECAUTIONS: General,Information for Patients, Drug Interactions and ADVERSE REACTIONS.)

As with other quinolones, TROVAN should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral atherosclerosis, epilepsy, and other factors that predispose to seizures. (See ADVERSE REACTIONS.)

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with TROVAN. These reactions may occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath and acute respiratory distress), dyspnea, urticaria, itching and other serious skin reactions, including generalized erythema.

Life-threatening hypotension has been reported with alatrofloxacin administration. This has occurred in patients receiving alatrofloxacin at either the recommended rate of infusion or if given more rapidly. Hypotension may be potentiated with the concomitant administration of anesthetic agents. Alatrofloxacin should only be administered by slow intravenous infusion over a period of 60 minutes. Blood pressure should be monitored closely during infusion.

TROVAN should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. (See PRECAUTIONS and ADVERSE REACTIONS.)

Serious and sometimes fatal events, some due to hypersensitivity and some due to uncertain etiology, have been reported in patients receiving therapy with all antibiotics. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: fever, rash or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis, arthralgia, myalgia, serum sickness; allergic pneumonitis, interstitial nephritis; acute renal insufficiency or failure; hepatitis, jaundice, acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including TROVAN, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent.

Treatment with antibacterial agents alters the flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is the primary cause of “antibiotic-associated colitis.”

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. (See ADVERSE REACTIONS.)

Although not seen in TROVAN clinical trials, ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. TROVAN should be discontinued if the patient experiences pain, inflammation or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones.

Trovafloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis.

PRECAUTIONS

General

Moderate to severe phototoxicity reactions have been observed in patients who are exposed to direct sunlight while receiving some drugs in this class. Therapy should be discontinued if phototoxicity (e.g., a skin eruption, etc.) occurs.

The safety and efficacy of TROVAN in patients with severe cirrhosis (Child-Pugh Class C) have not been studied.

Symptomatic pancreatitis has been reported on therapy. Clinicians should monitor pancreatic tests in patients who develop symptoms consistent with pancreatitis as clinically indicated.

Because a rapid or bolus intravenous injection may result in life-threatening hypotension, alatrofloxacin should only be administered by slow intravenous infusion over a period of 60 minutes. Profound hypotension has also been reported in patients receiving alatrofloxacin at the recommended rate of infusion. (See WARNINGS and DOSAGE AND ADMINISTRATION: Intravenous Administration.)

Information For Patients

Patients should be advised:

  • to discontinue therapy and to inform their physician immediately if they develop symptoms suggestive of hepatic dysfunction including fatigue, anorexia, vomiting, abdominal pain, jaundice, dark urine or pale stool. (See WARNINGS.)
  • to inform their physician if they develop symptoms suggestive of pancreatitis including abdominal pain and/or nausea and vomiting. (See PRECAUTIONS: General.)
  • that TROVAN Tablets may be taken without regard to meals;
  • that vitamins or minerals containing iron, aluminum- or magnesium-base antacids, antacids containing citric acid buffered with sodium citrate, or sucralfate or Videx® , (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after taking TROVAN tablets. (See PRECAUTIONS: Drug Interactions.);
  • that TROVAN may cause lightheadedness and/or dizziness. Dizziness and/or lightheadedness was the most common adverse reaction reported, and for females under 45 years, it was reported significantly more frequently than in other groups. The incidence of dizziness may be substantially reduced if TROVAN Tablets are taken at bedtime or with food. Patients should know how they react to trovafloxacin before they operate an automobile or machinery or engage in activities requiring mental alertness and coordination. (See WARNINGS and ADVERSE REACTIONS.);
  • to discontinue treatment and inform their physician if they experience pain, inflammation or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded;
  • that TROVAN may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. (See WARNINGS and ADVERSE REACTIONS.);
  • to avoid excessive sunlight or artificial ultraviolet light (e.g., tanning beds) while taking TROVAN and to discontinue therapy if phototoxicity (e.g., sunburn-like reaction or skin eruption) occurs.
  • that convulsions have been reported in patients taking quinolones, including trovafloxacin, and to notify their physician before taking this drug if there is a history of this condition

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