LEVOCIN Levofloxacin 750mg Film-Coated Tablet 1's

Levofloxacin (Levocin) is indicated for treatment of adults (18 years of age) with mild, moderate and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows: Acute bacterial sinusitis, Acute bacterial exacerbation of chronic bronchitis, Community-acquired pneumonia and nosocomial pneumonia, Typhoid & paratyphoid fever.
FC tablet: Acute maxillary sinusitis, Complicated skin and skin structure infections.
IV infusion: Uncomplicated skin and soft tissue infections, Complicated skin and soft tissue infections, Chronic bacterial prostatitis, Complicated urinary tract infections, Uncomplicated urinary tract infections, Acute pyelonephritis, Inhalation anthrax (post-exposure).

FC tablet: Levofloxacin (Levocin) tablets are administered once or twice daily. The dosage depends on the types and severity of the infections and the sensitivity of the presumed, causative pathogen.
Levofloxacin (Levocin) should be swallowed without crushing and with sufficient amount of liquid. The tablets may be taken during meals or between meals.
Levofloxacin (Levocin) tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc.
The dosage guidelines as per the infection are given as follows. (See Tables 1 and 2.)

 

 

IV infusion: Levofloxacin (Levocin) I.V. Infusion is indicated when intravenous administration offers a route of administration advantageous to the patient. Rapid or bolus intravenous infusion must be avoided. The usual dose of Levofloxacin (Levocin) I.V. Infusion is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. The dosage depends on the types and severity of the infections and the sensitivity of the presumed causative pathogen. Levofloxacin (Levocin) I.V. Infusion should not be mixed with heparin or alkaline solutions (e.g., sodium hydrogen carbonate).
The dosage guidelines as per the infection are given as follows. (See Tables 3 and 4.)

 

 

May be taken with or without food: May be taken during or between meals. Swallow whole, do not crush. Take at least 2 hr before or 2 hr after antacids containing Mg/Al, sucralfate, metal cations (eg, Fe), & multivit prep w/ Zn.

Levofloxacin is contraindicated in patients with a history or known hypersensitivity to this drug and/or other fluoroquinolone antibacterials.
FC tablet: Levofloxacin is not indicated for pediatric patients (less than 18 years of age). An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) has been observed in these patients.
IV infusion: Patients with epilepsy; history of tendon disorders related to fluoroquinolone administration.

FC tablet: Although levofloxacin is more soluble than other quinolones, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine.
As with other quinolones, levofloxacin should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).
Moderate to severe phototoxicity reactions have been observed in patients exposed to direct sunlight while receiving drugs in this class. Excessive exposure to sunlight should be avoided. Therapy should be discontinued if phototoxicity (skin eruptions) occurs.
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity and supportive measures instituted.
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 tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.
As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during therapy.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents including levofloxacin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.
Levofloxacin should be discontinued 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.
Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and patients receiving class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
As with other quinolones, disturbances of blood glucose, including symptomatic hyper and hypoglycemia, have been reported with levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. Careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with levofloxacin, levofloxacin should be discontinued and appropriate therapy should be initiated immediately.
Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
An increased rate of aortic aneurysm and dissection has been reported within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve Levofloxacin for use only when there are no alternative antibacterial treatments available.
IV infusion: General: No fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous.
Infusion Time: The recommended infusion time of at least 30 minutes for 250 mg, 60 minutes for 500 mg or 90 minutes for 750 mg Levofloxacin solution for infusion should be observed. In rare cases, as a consequence of a profound drop in blood pressure, circulatory collapse may occur. Should a conspicuous drop in blood pressure occur during infusion of levofloxacin, the infusion must be halted immediately.
Tendinitis and tendon rupture: Tendinitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. The risk of tendinitis and tendon rupture is increased in the elderly and in patients using corticosteroids. Close monitoring of these patients is therefore necessary if they are prescribed levofloxacin. All patients should consult their physician if they experience symptoms of tendinitis.
Clostridium difficile-associated disease: Diarrhea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin solution for infusion, may be symptomatic of Clostridium difficile associated disease, the most severe form of which is pseudomembranous colitis. If pseudomembranous colitis is suspected, levofloxacin solution for infusion must be stopped immediately and patients should be treated with supportive measures with specific therapy without delay.
Patients predisposed to seizures: Quinolones, should be used with extreme caution in patients predisposed to seizures, such as patients with pre-existing central nervous system lesions, concomitant treatment with fenbufen and similar non-steroidal anti-inflammatory drugs or with drugs which lower the cerebral seizure threshold, such as theophylline.
Patients with G-6-phosphate dehydrogenase deficiency: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with quinolone antibacterial agents, and so levofloxacin should be used with caution.
Patients with renal impairment: Since Levofloxacin is excreted mainly by the kidneys, the dose of Levofloxacin should be adjusted in patients with renal impairment.
Hypoglycemia: As with all quinolones, hypoglycemia has been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin. In these diabetic patients, careful monitoring of blood glucose is recommended.
Prevention of photosensitisation: Although photosensitisation is very rare with levofloxacin, it is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g., sunray lamp, solarium), in order to prevent photosensitisation.
Patients treated with Vitamin K antagonists: Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g., warfarin), coagulation tests should be monitored when these drugs are given concomitantly.
Psychotic reactions: Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
QT interval prolongation: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: congenital long QT syndrome; concomitant use of drugs that are known to prolong the QT interval (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides); uncorrected electrolyte imbalance (e.g., hypokalemia,hypomagnesemia); elderly; cardiac disease (e.g., heart failure, myocardial infarction, bradycardia).
Peripheral neuropathy: Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including levofloxacin, which can be rapid in its onset. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.
Opiates: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.
Hepatobiliary disorders: Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Risk of Aortic Aneurysm and Dissection: An increased rate of aortic aneurysm and dissection has been reported within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve Levofloxacin for use only when there are no alternative antibacterial treatments available.
Renal insufficiency: FC tablet/ IV infusion: Levofloxacin should be administered with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced. In patients with impaired renal function (creatinine clearance<50 mL/min), adjustment of dose regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance.
Use in Pregnancy: Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
FC tablet: There are no adequate and well-controlled studies in pregnant women.
IV infusion: The safety and efficacy of levofloxacin in pregnant women has not been established.
Use in Lactation: FC tablet/IV infusion: Levofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from levofloxacin in nursing infants, nursing should not be undertaken by mothers who must use levofloxacin.

Levofloxacin is usually well tolerated. However, following are the adverse effects reported during its therapy.
Common: Moniliasis, insomnia, headache, dizziness, dyspnea, nausea, diarrhea, constipation, abdominal pain, vomiting, dyspepsia, rash, pruritus, vaginitis, edema, chest pain.
Less Common: Genital moniliasis, anemia, thrombocytopenia, granulocytopenia, allergic reaction, hyperglycemia, hypoglycemia, hyperkalemia, anxiety, agitation, confusion, depression, hallucination, nightmare, sleep disorder, anorexia, abnormal dreaming, tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncope, epistaxis, cardiac arrest, palpitation, ventricular tachycardia, ventricular arrhythmia, phlebitis, gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C. difficile colitis, abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase, urticaria, arthralgia, tendonitis, myalgia, skeletal pain, abnormal renal function, acute renal failure.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs): The concomitant administration of NSAIDs with a quinolone, including levofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
Antidiabetic Agents: Disturbances of blood glucose, including hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and an antidiabetic agent (e.g., glyburide/glibenclamide) or insulin. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.
FC tablet: Antacids, Sucralfate, Metal Cations, Multivitamins: Concurrent administration of levofloxacin with antacids containing magnesium or aluminum, as well as sucralfate metal cations such as iron and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin resulting in systemic levels considerably lower than desired. These agents should be taken at least 2 hours before or 2 hours after levofloxacin administration.
Theophylline, Cyclosporine, Digoxin, Probenecid and Cimetidine: No significant effect of levofloxacin on the plasma concentrations, AUC and other disposition parameters for theophylline, cyclosporine, digoxin, probenecid and cimetidine was detected in a clinical study.
Warfarin: There have been no reports during the post marketing experience in patients that levofloxacin enhances the effects of warfarin. Prothrombin time, International Normalized Ratio (INR) or other suitable anticoagulation tests should be closely monitored if levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
IV infusion: Multivalent cations: No quinolone should be co-administered with any solution containing multivalent cations, e.g. magnesium, through the same intravenous line.

Quinolones