Levonix 500

Chronic bronchitis, Acute bacterial sinusitis, Anthrax, Community-acquired pneumonia, Skin and skin structure infections, Nosocomial pneumonia, Urinary tract infections, Complicated skin and skin structure infections, Acute pyelonephritis, Chronic bacterial prostatitis

Oral soln: Should be taken on an empty stomach. Take on an empty stomach 1 hr before or 2 hr after meals. Ensure adequate fluid intake. Tab: May be taken with or without food. Ensure adequate fluid intake. IV Preparation Single-use vials: Dilute in 50-100 mL D5W or NS or D5/NS solution for injection to 5 mg/mL; alternative solutions include sodium lactate, Plasma-Lyte, D5/lactated Ringer, D5/NS and potassium chloride IV Administration Give by IV infusion only, not bolus; rapid or bolus administration has been associated with hypotension and must be avoided Infuse 250-500 mg over 60 minutes or 750 mg over 90 minutes

Community-Acquired Pneumonia 500 mg PO/IV once daily for 7-14 days or 750 mg PO/IV once daily for 5 days Nosocomial Pneumonia 750 mg PO/IV once daily for 7-14 days Acute Bacterial Sinusitis 500 mg PO/IV once daily for 10-14 days or 750 mg PO/IV once daily for 5 days Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg PO/IV once daily for 7 days Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis Inhalational Anthrax Postexposure therapy 500 mg PO once daily for 60 days, beginning as soon as possible after exposure Skin/Skin Structure Infections Uncomplicated: 500 mg PO/IV once daily for 7-10 days Complicated: 750 mg PO/IV once daily for 7-14 days Chronic Bacterial Prostatitis 500 mg PO/IV once daily for 28 days Complicated Urinary Tract Infections & Acute Pyelonephritis 250 mg PO/IV once daily for 10 days or 750 mg PO/IV once daily for 5 days Uncomplicated Urinary Tract Infections 250 mg PO/IV once daily for 3 days Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections Plague Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older 500 mg PO/IV once daily for 10-14 days

Children PO, IV 16 mg/kg/day div q12h up to 50 kg body weight, then 500 mg qd for postexposure anthrax prophylaxis q12h For respiratory infections: <5 y: 20 mg/kg/day q12h >5 y: 10 mg/kg/day q24h

Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hr. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hr. CrCl (ml/min) 20-49 Initially, 500 mg daily, then 250 mg every 24 hr. Alternatively: Initially, 750 mg daily, then 750 mg every 48 hr. 10-19 Initially, 500 mg daily, then 250 mg every 48 hr. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hr.

Hypersensitivity to levofloxacin or other quinolones. Child <18 yr.

Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gram-negative and gram-positive microorganisms.

Known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures. Avoid unnecessary exposure to sunlight or artificial UV light. History of prolonged QT interval, uncorrected electrolyte disturbances. DM (carefully monitor blood glucose levels). Periodically monitor renal, hepatic and haematopoietic functions during treatment. Pregnancy and lactation. Elderly. May impair ability to drive or operate machinery. Lactation: Drug excreted in breast milk; not recommended

1-10% Nausea (7%),Headache (6%),Diarrhea (5%),Insomnia (4%),Constipation (3%),Dizziness (3%),Dyspepsia (2%),Rash (2%),Vomiting (2%),Chest pain (1%),Dyspnea (1%),Edema (1%),Fatigue (1%),Injection-site reaction (1%),Moniliasis (1%),Pain (1%),Pruritus (1%),Vaginitis (1%) <1% Cardiac: Cardiac arrest, palpitation, ventricular tachycardia, arrhythmia Nervous system: Tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncope Metabolic: Hypoglycemia, hyperglycemia, hyperkalemia Blood/lymphatic system: Anemia, thrombocytopenia, granulocytopenia Musculoskeletal/connective tissue: Arthralgia, tendonitis, myalgia, skeletal pain Gastrointestinal (GI): Gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C difficile colitis Hepatobiliary: Abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase Psychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, anorexia, abnormal dreaming Other: Immune hypersensitivity reaction, acute renal failure, urticaria, phlebitis, epistaxis Potentially Fatal: Anaphylaxis.

Additive effects on QT interval prolongation w/ class IA (e.g. quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmics, fluoxetine or imipramine. Reduced absorption w/ sucralfate, didanosine, antacids containing Mg or Al, dietary supplements containing Zn, Ca, Mg or Fe. Altered glucose levels w/ antidiabetic agents (e.g. insulin, glibenclamide). Increased risk of severe tendon disorders w/ corticosteroids. Increased risk of CNS stimulation and seizures w/ NSAIDs. Increased prothrombin time w/ warfarin.