Levorex Infusion

levorex Infusion - TJ

COMPOSITION:
Each 100 ml contains:
Levofloxacin Hemihydrate Equivalent to Levofloxacin 500 mg

INDICATIONS:
Levorex is indicated for:
Nosocomial pneumonia, Community acquired pneumonia,Acute bacterial sinusitis, Acute bacterial exacerbation of chronic bronchitis, Complicated and uncomplicated skin and skin structure infections, Chronic bacterial prostatitis, Complicated and uncomplicated urinary tract infections, Acute pyelonephritis, Intra-abdominal infections, Acute otitis media, Inhalation anthrax (post exposure) and Plague.

DESCRIPTION:
Clear greenish-yellow solution free of technical impurities.

CONTRAINDICATIONS:
Hypersensitivity to Levofloxacin or other quinolones, as well as to inactive ingredients of thedrug, epilepsy, in patients with history of tendon disorders related to fluoroquinolone administration, pregnancy, lactation, children and adolescents (under 18 years).

SIDE EFFECTS:
Digestive system: Nausea, vomiting, diarrhea (including with blood), indigestion, decreased appetite, pain in the abdomen, pseudomembranous colitis, increased activity of “liver” transaminases, hyperbilirubinemia, hepatitis and dysbacteriosis.
Cardio-vascular system: Lowering blood pressure, cardiovascular collapse, tachycardia, prolongation of the QT interval and ventricular fibrillation.
Metabolism: Hypoglycemia (Increased appetite, increased sweating, tremor and nervousness), hyperglycemia (dry mouth, thirst, increased urination, fatigue, blurred vision, dry or itchy skin and arrhythmia).
Nervous system: Headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, hallucinations, confusion, depression, movement disorders and seizures.
From the senses: Visual, hearing, smell, taste and tactile sensitivity.
On the part of the musculoskeletal system: Arthralgia, muscle weakness, myalgia, tendon tear, tendonitis and rhabdomyolysis.
Urinary system: Hypercreatinemia, interstitial nephritis and acute renal failure.
On the part of hematopoiesis: Eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia and hemorrhage.
Allergic reactions: Itching, and redness of the skin, swelling of the skin and mucous membranes, urticaria, erythema malignant (Stevens-Johnson Syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, asthma, anaphylactic shock, hypersensitivity pneumonitis and vasculitis.
Other: Photosensitivity, fatigue, exacerbation of porphyria, persistent fever and the development of superinfection.

DOSAGE:
The dosage, dosing frequency and duration of therapy should be decided on the severity of infections. Since oral absorption of Levofloxacin is rapid and complete, the daily dose is same for oral and intravenous administration.
The recommended dose for adults with normal renal function (Creatinine clearance > 50 mL / min):

Type of infection Dose Every 24 hours Duration (in days)
Nosocomial pneumonia 750 mg 7-14
Community acquired pneumonia 750 mg
500 mg
5
7-14
Acute bacterial sinusitis 750 mg
500 mg
5
10-14
Acute bacterial exacerbation of chronic bronchitis 500mg 7
Complicated skin and skin structure infections 750mg 7-14
Uncomplicated skin and skin structure infections 500mg 7-10
Chronic bacterial prostatitis 500mg 28
Complicated urinary tract infection or Acute pyelonephritis 500mg 7-10
Uncomplicated skin and skin structure infections 500mg 7-10
Uncomplicated skin and skin structure infections 750mg
250mg
5
10
Uncomplicated urinary tract infection 250mg 3
Inhalation anthrax (post- exposure)
• Adults &Pediatric Patients >50 kg and ≥ 6 months of age
• Pediatric Patients < 50 kg and ≥ 6 months of age
500 mg
8 mg/kg bid (Not to exceed 250 mg/dose)
60
60
Plague
• Adults and Pediatric patients >50 kg
• Pediatric patients
500 mg
8 mg/kg body weight bid (not to exceed 250 mg per dose)
10-14
10-14

Dosage adjustment in adult patients with renal impairment (Creatinine clearance <50 mL/min)

Dosage in normal renal function every 24 hours Creatinine clearance 20 to 49 mL/min Creatinine clearance 10 to 19 mL/min Hemodialysis or chronic ambulatory peritoneal dialysis (CAPD)
750 mg 750 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours
500 mg 500 mg initial dose, then 250 mg every 24 hours 500 mg initial dose, then 250 mg every 48 hours 500 mg initial dose, then 250 mg every 48 hours
250 mg No dosage adjustment required 250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required No information on dosing adjustment is available

STORAGE:
Store in a cool, dark & dry place. Keep out of reach of children.

PRESENTATION:
100 ml blow fill seal plastic bottle packed in a carton with insert.