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Trovan
Overview
What is Trovan?
What does Trovan look like?
What are the available doses of Trovan?
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What should I talk to my health care provider before I take Trovan?
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How should I use Trovan?
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 .)
Nosocomial pneumonia
Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae
Staphylococcus aureus
Pseudomonas aeruginosa
Community acquired pneumonia
Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Mycoplasma pneumoniae, Moraxella catarrhalis, Legionella pneumophila,
Chlamydia pneumoniae
Complicated intra-abdominal infections, including post-surgical infections
Escherichia coli, Bacteroides fragilis,
Pseudomonas aeruginosa, Klebsiella pneumoniae, Peptostreptococcus
Prevotella
Gynecologic and pelvic infections including endomyometritis, parametritis, septic abortion and post-partum infections
Escherichia coli, Bacteroides fragilis,
Enterococcus faecalis, Streptococcus agalactiae, Peptostreptococcus
Prevotella
Gardnerella vaginalis.
Complicated skin and skin structure infections, including diabetic foot infections,
Staphylococcus aureus, Streptococcus agalactiae, Pseudomonas aeruginosa, Enterococcus faecalis, Escherichia coli,
Proteus mirabilis.
NOTE
What interacts with Trovan?
TROVAN is contraindicated in persons with a history of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobial agents or any other components of these products.
What are the warnings of Trovan?
Reserpine may cause mental depression. Recognition of depression may be difficult because this condition may often be disguised by somatic complaints (Masked Depression). The drug should be discontinued at first signs of depression such as despondency, early morning insomnia, loss of appetite, impotence, or self-deprecation. Drug-induced depression may persist for several months after drug withdrawal and may be severe enough to result in suicide.
(See boxed .)
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 .)
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 and .)
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 .)
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 and .)
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 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 colitis. (See .)
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.
What are the precautions of Trovan?
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 and .)
Information For Patients
Patients should be advised:
Drug Interactions
Antacids, Sucralfate, and Iron: The absorption of oral trovafloxacin is significantly reduced by the concomitant administration of some antacids containing magnesium or aluminum, citric acid/sodium citrate (Bicitra), as well as sucralfate and iron (ferrous ions). These agents as well as formulations containing divalent and trivalent cations such as Videx, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after oral trovafloxacin administration. (See .)
Morphine: Co-administration of intravenous morphine significantly reduces the absorption of oral trovafloxacin. Intravenous morphine should be administered at least 2 hours after oral TROVAN dosing in the fasted state and at least 4 hours after oral TROVAN is taken with food. Trovafloxacin administration had no effect on the pharmacokinetics of morphine or its metabolite, morphine-6-β-glucuronide. (See .)
Warfarin: There have been reports during the post-marketing experience that trovafloxacin/alatrofloxacin enhance the effects of warfarin, including cases of bleeding. The mechanism for this reaction is unknown. Prothrombin time, International Normalized Ratio (INR) or other suitable anticoagulation tests should be closely monitored if trovafloxacin/alatrofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
Minor pharmacokinetic interactions without clinical significance have been observed with co-administration of TROVAN Tablets with caffeine, omeprazole and calcium carbonate. (See .)
No significant pharmacokinetic interactions with theophylline, cimetidine, digoxin, warfarin, or cyclosporine have been observed with TROVAN Tablets. (See .)
Alatrofloxacin should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. (See .)
Laboratory Test Interactions
There are no reported laboratory test interactions.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long term studies in animals to determine the carcinogenic potential of trovafloxacin or alatrofloxacin have not been conducted.
TROVAN did not shorten the time to development of UV-induced skin tumors in hairless albino (Skh-1) mice; thus, it was not photo co-carcinogenic in this model. These mice received oral trovafloxacin and concurrent irradiation with simulated sunlight 5 days per week for 40 weeks followed by a 12-week treatment-free observation period. The daily dose of UV radiation used in this study was approximately 30% of the minimal dose of UV radiation that would induce erythema in Caucasian humans. The median time to the development of skin tumors in the hairless mice (42–43 weeks) was similar in the vehicle control group and those given 10 or 30 mg/kg of trovafloxacin daily. At a dose level of 30 mg/kg/day, the mice had skin trovafloxacin concentrations of approximately 7 µg/g. Following multiple 200 mg daily doses of trovafloxacin, the amount in human skin is estimated to be about 3 µg/g, based upon plasma concentrations measured at this dose level.
Trovafloxacin was not mutagenic in the Ames Salmonella reversion assay or CHO/HGPRT mammalian cell gene mutation assay and it was not clastogenic in mitogen-stimulated human lymphocytes or mouse bone marrow cells. A mouse micronucleus test conducted with alatrofloxacin was also negative. The positive response observed in the bacterial mutagenicity assay may be due to the inhibition of DNA gyrase by trovafloxacin.
Trovafloxacin and alatrofloxacin did not affect the fertility of male or female rats at oral and I.V. doses of 75 mg/kg/day and 50 mg/kg/day, respectively. These doses are 15 and 10 times the recommended maximum human dose based on mg/kg or approximately 2 times based on mg/m. However, oral doses of trovafloxacin at 200 mg/kg/day (40 times the recommended maximum human dose based on mg/kg or about 6 times based on mg/m) were associated with increased preimplantation loss in rats.
Pregnancy
Nursing Mothers
Trovafloxacin is excreted in human milk and was found in measurable concentrations in the breast milk of lactating subjects. (See .)
Because of the potential for unknown effects from trovafloxacin in nursing infants from mothers taking trovafloxacin, a decision should be made either to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of trovafloxacin in pediatric patients and adolescents less than 18 years of age have not been established. Quinolones, including trovafloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. (See .)
Geriatric Use
In multiple-dose clinical trials of trovafloxacin, 27% of patients were ≥65 years of age and 12% of patients were ≥75 years of age. The overall incidence of drug-related adverse reactions, including central nervous system and gastrointestinal side effects, was less in the ≥65 year group than the other age groups.
What are the side effects of Trovan?
Over 6000 patients have been treated with TROVAN in multidose clinical efficacy trials worldwide.
In TROVAN studies the majority of adverse reactions were described as mild in nature (over 90% were described as mild or moderate). TROVAN was discontinued for adverse events thought related to drug in 5% of patients (dizziness 2.4%, nausea 1.9%, headache 1.1%, and vomiting 1.0%).
Dizziness/lightheadedness on TROVAN is generally mild, lasts for a few hours following a dose, and in most cases, resolves with continued dosing. The incidence of dizziness and lightheadedness in TROVAN patients over 65 years is 3.1% and 0.6%, respectively. (See .)
TROVAN appears to have a low potential for phototoxicity. In clinical trials with TROVAN, only mild, treatment-related phototoxicity was observed in less than 0.03% (2/7096) of patients.
Additional reported drug-related events in clinical trials (remotely, possibly, probably or unknown) that occurred in <1% of TROVAN-treated patients are:
APPLICATION/INJECTION/INSERTION SITE:
AUTONOMIC NERVOUS:
CARDIOVASCULAR:
CENTRAL & PERIPHERAL NERVOUS SYSTEM:
GASTROINTESTINAL:
Clostridium difficile
ORAL CAVITY:
GENERAL/OTHER:
HEMATOPOIETIC:
LIVER/BILIARY:
METABOLIC/NUTRITIONAL:
MUSCULOSKELETAL:
PSYCHIATRIC:
REPRODUCTIVE:
RESPIRATORY:
SKIN/APPENDAGES:
SPECIAL SENSES:
URINARY SYSTEM:
LABORATORY CHANGES:
The incidence and magnitude of liver function abnormalities with TROVAN were the same as comparator agents except in the only study in which oral TROVAN was administered for 28 days. In this study (chronic bacterial prostatitis) nine percent (13/140) of TROVAN-treated patients experienced elevations of serum transaminases (AST and/or ALT) of ≥3 times the upper limit of normal. These liver function test abnormalities generally developed at the end of, or following completion of, the planned 28-day course of therapy, but were not associated with concurrent elevations of related laboratory measures of hepatic function (such as serum bilirubin, alkaline phosphatase, or lactate dehydrogenase). Patients were asymptomatic with these abnormalities, which generally returned to normal within 1–2 months after discontinuation of therapy. (See subsection.)
| 200 mg oralqd(N=3259) | 200 mg I.V.→200 mg oral qd(N=634) | 300 mg I.V.→200 mg oral qd(N=623) | ||
|---|---|---|---|---|
| Dizziness | 11% | 2% | 2% | |
| Lightheadedness | 4% | 2% | <1% | |
| Nausea | 8% | 5% | 4% | |
| Headache | 5% | 5% | 1% | |
| Vomiting | 3% | 1% | 3% | |
| Diarrhea | 2% | 2% | 2% | |
| Abdominal pain | 1% | 1% | 0% | |
| Application/ | ||||
| injection/insertion site | n/a | 5% | 2% | |
| reaction/ | ||||
| Vaginitis | 2% | 2% | <1% | |
| Pruritus | <1% | 2% | 2% | |
| Rash | <1% | 2% | 2% |
POST-MARKETING EXPERIENCE
Adverse reactions reported with TROVAN during the post-marketing period include:
GASTROINTESTINAL: symptomatic pancreatitis.
GENERAL/OTHER: anaphylaxis, Stevens-Johnson Syndrome.
HEMATOPOIETIC: agranulocytosis, aplastic anemia, pancytopenia.
LIVER/BILIARY: symptomatic hepatitis (some patients experienced an associated peripheral eosinophilia), liver failure (including acute hepatic necrosis with eosinophilic infiltration). TROVAN-associated liver enzyme abnormalities and/or symptomatic hepatitis have occurred during short-term or long-term therapy. (See .)
What should I look out for while using Trovan?
TROVAN is contraindicated in persons with a history of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobial agents or any other components of these products.
(See boxed .)
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.
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 .)
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 and .)
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 .)
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 and .)
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 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 colitis. (See .)
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.
What might happen if I take too much Trovan?
Trovafloxacin has a low order of acute toxicity. The minimum lethal oral dose in mice and rats was 2000 mg/kg or greater. The minimum lethal I.V. dose for the prodrug, alatrofloxacin, was 50–125 mg/kg for mice and greater than 75 mg/kg for rats. Clinical signs observed included decreased activity and respiration, ataxia, ptosis, tremors and convulsions.
In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given symptomatic and supportive treatment. Adequate hydration should be maintained. Trovafloxacin is not efficiently removed from the body by hemodialysis.
How should I store and handle Trovan?
Trovan Tablets and Injection are being distributed only to hospitals and long term nursing care facilities for patients initiating therapy in these facilities
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Trovafloxacin is well-absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 88%. For comparable dosages, no dosage adjustment is necessary when switching from parenteral to oral administration (Figure 1). (See .)
Figure 1. Mean trovafloxacin serum concentrations determined following 1 hour intravenous infusions of alatrofloxacin at daily doses of 200 mg (trovafloxacin equivalents) to healthy male volunteers and following daily oral administration of 200 mg trovafloxacin for 7 days to six male and six female healthy young volunteers.
Non-Clinical Toxicology
TROVAN is contraindicated in persons with a history of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobial agents or any other components of these products.(See boxed .)
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.
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 .)
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 and .)
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 .)
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 and .)
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 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 colitis. (See .)
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.
Antacids, Sucralfate, and Iron: The absorption of oral trovafloxacin is significantly reduced by the concomitant administration of some antacids containing magnesium or aluminum, citric acid/sodium citrate (Bicitra), as well as sucralfate and iron (ferrous ions). These agents as well as formulations containing divalent and trivalent cations such as Videx, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after oral trovafloxacin administration. (See .)
Morphine: Co-administration of intravenous morphine significantly reduces the absorption of oral trovafloxacin. Intravenous morphine should be administered at least 2 hours after oral TROVAN dosing in the fasted state and at least 4 hours after oral TROVAN is taken with food. Trovafloxacin administration had no effect on the pharmacokinetics of morphine or its metabolite, morphine-6-β-glucuronide. (See .)
Warfarin: There have been reports during the post-marketing experience that trovafloxacin/alatrofloxacin enhance the effects of warfarin, including cases of bleeding. The mechanism for this reaction is unknown. Prothrombin time, International Normalized Ratio (INR) or other suitable anticoagulation tests should be closely monitored if trovafloxacin/alatrofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
Minor pharmacokinetic interactions without clinical significance have been observed with co-administration of TROVAN Tablets with caffeine, omeprazole and calcium carbonate. (See .)
No significant pharmacokinetic interactions with theophylline, cimetidine, digoxin, warfarin, or cyclosporine have been observed with TROVAN Tablets. (See .)
Alatrofloxacin should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. (See .)
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 and .)
Over 6000 patients have been treated with TROVAN in multidose clinical efficacy trials worldwide.
In TROVAN studies the majority of adverse reactions were described as mild in nature (over 90% were described as mild or moderate). TROVAN was discontinued for adverse events thought related to drug in 5% of patients (dizziness 2.4%, nausea 1.9%, headache 1.1%, and vomiting 1.0%).
Dizziness/lightheadedness on TROVAN is generally mild, lasts for a few hours following a dose, and in most cases, resolves with continued dosing. The incidence of dizziness and lightheadedness in TROVAN patients over 65 years is 3.1% and 0.6%, respectively. (See .)
TROVAN appears to have a low potential for phototoxicity. In clinical trials with TROVAN, only mild, treatment-related phototoxicity was observed in less than 0.03% (2/7096) of patients.
Additional reported drug-related events in clinical trials (remotely, possibly, probably or unknown) that occurred in <1% of TROVAN-treated patients are:
APPLICATION/INJECTION/INSERTION SITE:
AUTONOMIC NERVOUS:
CARDIOVASCULAR:
CENTRAL & PERIPHERAL NERVOUS SYSTEM:
GASTROINTESTINAL:
Clostridium difficile
ORAL CAVITY:
GENERAL/OTHER:
HEMATOPOIETIC:
LIVER/BILIARY:
METABOLIC/NUTRITIONAL:
MUSCULOSKELETAL:
PSYCHIATRIC:
REPRODUCTIVE:
RESPIRATORY:
SKIN/APPENDAGES:
SPECIAL SENSES:
URINARY SYSTEM:
LABORATORY CHANGES:
The incidence and magnitude of liver function abnormalities with TROVAN were the same as comparator agents except in the only study in which oral TROVAN was administered for 28 days. In this study (chronic bacterial prostatitis) nine percent (13/140) of TROVAN-treated patients experienced elevations of serum transaminases (AST and/or ALT) of ≥3 times the upper limit of normal. These liver function test abnormalities generally developed at the end of, or following completion of, the planned 28-day course of therapy, but were not associated with concurrent elevations of related laboratory measures of hepatic function (such as serum bilirubin, alkaline phosphatase, or lactate dehydrogenase). Patients were asymptomatic with these abnormalities, which generally returned to normal within 1–2 months after discontinuation of therapy. (See subsection.)
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).