Floxel 500Mg I.V.100Ml
Description : Floxel 500 mg solution for infusion contains levofloxacin 500 mg, sodium chloride, sodium hydroxide, HCl and water for injection to make a volume of 100 mL.
Indications / Uses : Treatment of adults (=18 years) with mild, moderate and severe infections caused by susceptible strains of the designated microorganisms for the following conditions:
Tablet (250, 500 mg) and Solution for Infusion (500 mg): Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, chronic bacterial prostatitis, complicated urinary tract infections, acute pyelonephritis and uncomplicated urinary tract infections.
Tablet (750 mg): Acute bacterial sinusitis, complicated skin and skin structure infections, community-acquired pneumonia and nosocomial pneumonia.
Administration : May be taken with or without food: Ensure adequate fluid intake.
Contraindications : Hypersensitivity to levofloxacin or any other quinolone or any other component of Floxel.
Patients with a history of tendon disorders related to fluoroquinolone therapy.
Special Precautions :The safety and efficacy of levofloxacin in pediatric patients, adolescents (<18 years), pregnant women and nursing women have not been established. As with other quinolones, levofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower seizure threshold (eg, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or low seizure threshold (eg, certain drug therapy, renal dysfunction). If these reactions occur, levofloxacin should be discontinued and appropriate measures instituted.
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving quinolones, including levofloxacin. These reactions often occur following the 1st dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, larynx, throat or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath and respiratory distress), dyspnea, urticaria, itching and other serious skin reactions. Levofloxacin should be discontinued immediately at the 1st 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, IV 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 quinolones, including levofloxacin. These events may be severe and generally occur following multiple doses. Clinical manifestations may include =1 of the following: Fever, rash or severe dermatologic reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia and/or other hematologic abnormalities. Levofloxacin should be discontinued immediately at the 1st appearance of skin rash or any other sign of hypersensitivity and supportive measures instituted.
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting the small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including levofloxacin. Discontinue levofloxacin if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense and vibratory sensation in order to prevent the development of an irreversible condition.
Pseudomembranous colitis has been reported with nearly all antibacterial agents 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. 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 supplement and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Products inhibiting peristalsis are contraindicated in this condition.
Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Discontinue levofloxacin if the patient experience pain, inflammation or rupture of a tendon. Patients should rest and refrain from exercise until diagnosis of tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.
Administer levofloxacin with caution in the presence of renal insufficiency. Dosage adjustment and careful monitoring of renal function may be necessary.
Moderate to severe phototoxicity reactions have been observed in patients exposed to sunlight while receiving drugs in the class. Avoid excessive exposure to sunlight. Discontinue treatment if phototoxicity (eg, skin eruption) occurs.
As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemic, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (eg, glibenclamide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs. Levofloxacin should be discontinued and appropriate therapy should be initiated immediately.
As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic and hematopoietic, is advisable during treatment.
Prolongations of the QT interval on the electrocardiogram and infrequent cases of arrhythmia have been reported in some quinolones, including levofloxacin. Rare cases of torsades de pointes have been spontaneously reported during post-marketing surveillance in patients receiving quinolones, including levofloxacin. Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and patients receiving class 1A (quinidine, procainamide) or class 2 (amiodarone, sotalol) antiarrhythmic agents.
Gender Differences: There are no significant differences in levofloxacin pharmacokinetics between male and female subjects when subjects’ differences in creatinine clearance are taken into consideration. Drug absorption appears to be unaffected by gender, therefore, dose adjustment based on gender alone is not necessary.
Race: Race did not affect the apparent total body clearance and apparent volume of distribution of levofloxacin.
Hepatic Insufficiency: Pharmacokinetic studies in patients with liver impairment have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin is not expected to be affected by hepatic impairment.