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Basic Drug Info
Drug Name:Trovan
Manufacturer:Roerig
Other Info:Rx only70-5328-00-6April 2000



Clinical Trials:


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.)
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Mycoplasma pneumonia -- Interstitial pneumonia caused by extensive infection of the lungs (LUNG) and BRONCHI, particularly the lower lobes of the lungs, by MYCOPLASMA PNEUMONIAE in humans. In SHEEP, it is caused by MYCOPLASMA OVIPNEUMONIAE. In CATTLE, it may be caused by MYCOPLASMA DISPAR.

Abdominal Infection --

Pelvic Infection -- Infection involving the tissues or organs in the PELVIS.

Endomyometritis -- Inflammation of both the ENDOMETRIUM and the MYOMETRIUM, usually caused by infections after a CESAREAN SECTION.

Parametritis -- Inflammation of the parametrium, the connective tissue of the pelvic floor, extending from the subserous coat of the uterus laterally between the layers of the BROAD LIGAMENT.

Abortion, Septic -- Any type of abortion, induced or spontaneous, that is associated with infection of the UTERUS and its appendages. It is characterized by FEVER, uterine tenderness, and foul discharge.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Osteomyelitis -- inflammation of the bone marrow and adjacent bone caused by a pyogenic organism; it may remain localized or may spread through the bone to involve the marrow, cortex, cancellous tissue, and periosteum.

Contraindications
TROVAN is contraindicated in persons with a history of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobial agents or any other components of these products.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.

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