Each film-coated tablet of  LEVO global® 500  contains: 

• Levofloxacin USP         500 mg 

LEVO Global® has been used in the treatment of the following bacterial infections including:

• Nosocomial pneumonia.
• Community acquired pneumonia.
• Skin infections, complicated and uncomplicated.
• Chronic prostate infection.
• Inhalational anthrax ( post-exposure ) in adults and pediatrics.
• Plague in adults and pediatrics.
• Urinary tract infections, complicated and uncomplicated.
• Acute kidney infection (pyelonephritis).
• Acute worsening of chronic bronchitis.
• Acute sinus infection.

LEVO Global® is contraindicated in patients who: 

• Have hypersensitive to Levofloxacin or other fluoroquinolone.
• Have a history of tendon problems.
• Have a history of myasthenia gravis.
• Have a history of a nerve problem called peripheral neuropathy.
• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed .
• are children and growing adolescents .

• Concurrent administration of LEVO Global® Tablets 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.
• Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs: a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, nonsteroidal anti-inflammatory drugs, or other agents which lower the seizure threshold.Levofloxacin concentrations were about 13 % higher in the presence of fenbufen than when administered alone.
• Probenecid and cimetidine: The renal clearance of levofloxacin was reduced by cimetidine (24 %) and probenecid (34 %).
• Vitamin K antagonists: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists
• Drugs known to prolong the QT interval : Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotic).
• Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent.
• The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including LEVO Global®, may increase the risk of CNS stimulation and convulsive seizures.
• Levofloxacin Cmax and ke were slightly lower while Tmax and t½ were slightly longer in the presence of cyclosporine than those observed in other studies without concomitant medication. The half-life of cyclosporine was increased by 33 % when co-administered with levofloxacin.
• Some fluoroquinolones, including LEVO Global®, may produce false-positive urine screening results for opiates using commercially available immunoassay kits .

¤ The most common side effects of LEVO Global® include:

• headache, rash, dizziness, pruritus, dyspnea, vaginitis, nausea, anemia thrombocytopenia, granulocytopenia, diarrhea, allergic reaction, constipation, hyperglycemia, hpoglycemia, abdominal pain, hyperkalemia, vomitting, anxiety, agitation, confusion, depression, hallucination, nightmare and dyspepsia.

Less Common side effects  :

• Sleep disorder, anorexia and 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.
• Arthralgiatendinitis, myalgia, and skeletal pain.
• Abnormal renal function and acute renal failure.

Overdose:

• The most important signs to be expected following acute overdosage of LEVO Global® are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval as well as gastrointestinal reactions such as nausea and mucosal erosions.
• Symptomatic treatment should be implemented and ECG monitoring should be undertaken.
• Gastric lavgae should be considered and haemodialysis is not effective in removing Levofloxacin from the body.
• Antacids may be used for protection of gastric mucosa . 

• LEVO Global® should be swallowed without crushing and with sufficient amount of liquid. The dose may be taken during meals or between meals.
• The dosage depends on the type and severity of the infection and sensitivity of the presumed causative pathogen ( See the leaflet )
• Dosage in patients with normal renal function(creatinine clearance > 50 ml/min)
• No dosage adjustment is required in patient with impaired liver function and elderly patients.
• Dosage in adult patients with impaired renal function (creatinine clearance ≤ 50 ml/min)
• No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

• Tendinopathy and Tendon Rupture: This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants.
• Exacerbation of Myasthenia Gravis: Avoid use in patients with a known history of myasthenia gravis .
• Hypersensitivity Reactions: The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.
• Hematologic (including agranulocytosis, thrombocytopenia).
• renal toxicities may occur after multiple doses.
• Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur.
• Central Nervous System effects: including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose. Use with caution in patients with known or suspected disorders that may predispose them to seizures 
• Clostridium difficile-Associated Diarrhea (CDAD): has been reported with use of nearly all antibacterial agents, including LEVO Global®, and may range in severity from mild diarrhea to fatal colitis.
• Peripheral neuropathy: LEVO Global® should be discontinued immediately 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 .
• Prolongation of the QT Interval: Elderly patients may be more susceptible to drug-associated effects on the QT interval.
• Blood Glucose Disturbances: including symptomatic hyper-and hypoglycemia, have been reported with LEVO Global®, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with LEVO Global®, should be discontinued and appropriate therapy should be initiated immediately
• Photosensitivity/Phototoxicity: e.g., burning, erythema, exudation, vesicles, blistering, edema can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs .
• Development of Drug Resistant Bacteria: Prescribing LEVO Global® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication increases the risk of the development of drug-resistant bacteria.

• LEVO Global® 500 Tablets ( Blister of 5 Tablets, Pack of one blister )

• Store in a dry place at a temperature not exceeding 25 ºC.