Cravit
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Levofloxacin merupakan suatu turunan asam pyridon karboksilat dimana rumus bangunnya mirip asam nalidixat dan termasuk antibakteri golongan kuinolon yang mengandung gugus fluor, jadi termasuk golongan fluorokuinolon.Mekanisme kerja levofloxacin sama seperti fluorokuinolon lainnya yakni menghambat enzim DNA girase, sejenis topoisomerase II.
Levofloxacin merupakan suatu fluorokuinolon sintetik berspektrum luas dan mengandung murni isomer S-(-) saja, dimana kekuatan isomer S-(-) 8-128 kali lebih aktif dari isomer R-(+). Secara in vitro levofloxacin 2 kali lebih aktif dari ofloxacin dan ciprofloxacin. Spektrum antibakterinya meliputi bakteri gram (+), gram (-), aerob, anaerob, dan atipik. Kadar hambat minimum Cravit terhadap kuman-kuman tersebut sangat rendah ditambah dengan efek pasca antibiotik, menjadikan Cravit efektif untuk eradikasi kuman-kuman tersebut. Profil farmakokinetik Cravit memungkinkan Cravit diberikan sekali sehari sehingga meningkatkan kepatuhan pasien.
Indication
Cravit is indicated in infections with susceptible microorganism, such as Acute maxillary sinusitis, Acute bacterial exacerbations of chronic bronchitis, Community acquired pneumoniae, Complicated skin and skin structure infections, Complicated urinary tract infection, including Acute pyelonephritis. Cravit® i.v. Only given to the patients who are unable to use the oral form.
Cravit is indicated in infections with susceptible microorganism, such as Acute maxillary sinusitis, Acute bacterial exacerbations of chronic bronchitis, Community acquired pneumoniae, Complicated skin and skin structure infections, Complicated urinary tract infection, including Acute pyelonephritis. Cravit® i.v. Only given to the patients who are unable to use the oral form.
Contra Indication
Cravit must not be used : · In patients hipersensitive to levofloxacin, quinolone antimicrobial agents or any other components of this product. · In patients with epilepsy. · In patients with history of tendon disorder related to fluoroquinolone administration.
Cravit must not be used : · In patients hipersensitive to levofloxacin, quinolone antimicrobial agents or any other components of this product. · In patients with epilepsy. · In patients with history of tendon disorder related to fluoroquinolone administration.
Warning
· The safety and efficacy of Cravit in children, adolescents (under the age of 18 years), pregnant women, and nursing women have not been established. · In immature rats and dogs, the oral and intravenous administration of levofloxacin increased the incidence and severity of osteochondrosis. Other fluoroquinolones also produce similar erosions in the weight bearing joints and other signs of arthropathy in immature animals of various species. · Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving levofloxacin, the drug should be discontinued and appropriate measured instituted. As with other quinolones, levofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction). · Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions often 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. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hipersensitivity. 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. · Serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones. 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-Johnsons 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. The drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity and supportive measures instituted. · Pseudomembranous colitis has been reported with nearly all antibacterial agents, including levofloxacin, 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 normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficille is one primary cause of "antibiotic - associated colitis". · After the diagnosis of pseudomembranous colitis has been established, therapeutic measure 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. diffile collitis. · Ruptures of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Levofloxacin 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, including levofloxacin.
· The safety and efficacy of Cravit in children, adolescents (under the age of 18 years), pregnant women, and nursing women have not been established. · In immature rats and dogs, the oral and intravenous administration of levofloxacin increased the incidence and severity of osteochondrosis. Other fluoroquinolones also produce similar erosions in the weight bearing joints and other signs of arthropathy in immature animals of various species. · Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving levofloxacin, the drug should be discontinued and appropriate measured instituted. As with other quinolones, levofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction). · Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions often 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. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hipersensitivity. 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. · Serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones. 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-Johnsons 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. The drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity and supportive measures instituted. · Pseudomembranous colitis has been reported with nearly all antibacterial agents, including levofloxacin, 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 normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficille is one primary cause of "antibiotic - associated colitis". · After the diagnosis of pseudomembranous colitis has been established, therapeutic measure 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. diffile collitis. · Ruptures of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Levofloxacin 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, including levofloxacin.
Dosage
Given the bioequivalence of the parenteral and oral forms, the same dosage can be used, ussually for 7-14 days depending on the severity of the disease. Usual dose in patients with normal renal function : 250 mg - 500 mg once daily depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen. Cravit i.v is adminstration by slow intravenous infusion. It is usually possible to switch from initial intravenous treatment to the oral route after a few days, according to the condition of the patient. · Cravit i.v is ready for use, and should only be administered by slow intravenous infusion. The infusion time for 500 mg (100 ml) should not be less than 60 minutes (1 hour). Protection from light is not necessary during infusion time. Once the vial has been opened (rubber stopper perforated) the solution should be used immediately (within 3 hours) in order to prevent any bacterial contamination. · Cravit i.v should not be mixed with heparin or alkaline solution (e.g. sodium hydrogen carbonate). · Cravit i.v should be administered alone unless compatibility with other infusion fluids has been demonstrated. Compatible infusion solutions include the following : · 0,9 % sodium chloride solution, USP, · 5 % dextrose injection, USP, · 2,5 % dextrose in Ringer solution, · Combination solution for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Given the bioequivalence of the parenteral and oral forms, the same dosage can be used, ussually for 7-14 days depending on the severity of the disease. Usual dose in patients with normal renal function : 250 mg - 500 mg once daily depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen. Cravit i.v is adminstration by slow intravenous infusion. It is usually possible to switch from initial intravenous treatment to the oral route after a few days, according to the condition of the patient. · Cravit i.v is ready for use, and should only be administered by slow intravenous infusion. The infusion time for 500 mg (100 ml) should not be less than 60 minutes (1 hour). Protection from light is not necessary during infusion time. Once the vial has been opened (rubber stopper perforated) the solution should be used immediately (within 3 hours) in order to prevent any bacterial contamination. · Cravit i.v should not be mixed with heparin or alkaline solution (e.g. sodium hydrogen carbonate). · Cravit i.v should be administered alone unless compatibility with other infusion fluids has been demonstrated. Compatible infusion solutions include the following : · 0,9 % sodium chloride solution, USP, · 5 % dextrose injection, USP, · 2,5 % dextrose in Ringer solution, · Combination solution for parenteral nutrition (amino acids, carbohydrates, electrolytes).
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