Levobac™
Levofloxacin 0.5% w/v
Intravenous Infusion BP
Presentation
Levobac™100 ml IV Infusion: Each 100 ml solution contains Levofloxacin Hemihydrate INN equivalent to 500 mg Levofloxacin.
Description
Levobac™ is a synthetic broad spectrum antibacterial fluoroquinolone containing levofloxacin which is the S (-) enantiomer (levorotatory form) of the racemic drug substance ofloxacin for intravenous administration. Levofloxacin acts on the DNA-DNA-gyrase complex by inhibiting DNA gyrase (bacterial topoisomerase II), an enzyme required for DNA replication, transcription, repair and recombination, and topoisomerase IV. Its antibacterial spectrum covers many Gram-positive and Gram-negative bacteria.
Indications
Levobac™ IV infusion is indicated for the 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 below:
Acute bacterial sinusitis due to Haemophilus influenzae, Streptococcus
pneumoniae, Staphylococcus aureus or Moraxella catarrhalis, Acute bacterial
exacerbation of chronic bronchitis due Staphylococcus aureus, Streptococcus
pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae or Moraxella
catarrhalis, Community-Acquired Pneumonia due to Staphylococcus aureus,
Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae,
Klebsiella pneumoniae, Moraxella catarrhalis, Mycoplasma pneumoniae,
Chlamydia pneumoniae or Legionella pneumophila, Complicated urinary tract
infections and acute pyelonephritis due to Escherichia coli, Klebsiella
pneumoniae, S. faecalis, P. mirabilis, Enterobacter cloacae, P. aeruginosa,
Uncomplicated skin and skin structure infections due to Staphylococcus
aureus, Streptococcus pyogenes, Acinetobacter calcoaceticus, Enterobacter
cloacae, P. mirabilis, P. aeruginosa, Escherichia coli, Klebsiella
pneumoniae or S. faecalis, Complicated skin and skin structure infections
due to Staphylococcus aureus, Streptococcus pyogenes, P. mirabilis,
Escherichia coli, Klebsiella pneumoniae, S. faecalis, Enterobacter cloacae
or K oxytoca. Intra-abdominal infections due to Escherichia coli and
anaerobic micro-organisms.
Dosage and Administration
1. Sinusitis: 100 ml (500 mg) once daily for 10 days,
2. Acute exacerbation of chronic bronchitis: 100 ml (500 mg) once daily for
5 - 10 days, 3. Community Acquired Pneumonia: 100 ml (500 mg) once or twice
daily for 10 - 14 days,
4. Complicated urinary tract infections and acute pyelonephritis: 50 ml (250
mg) once daily for 10 days,
5. Uncomplicated skin and skin structure infections: 50 to 100 ml (250 to
500 mg) once daily for 7 - 10 days,
6. Complicated skin and skin structure infections: 100 ml (500 mg) twice
daily for 10 - 14 days,
7. Intra-abdominal infections: 100 ml (500 mg) once daily in combination
with an antibiotic with anaerobic coverage for 10 - 14 days,
8. Above indications when bacteraemia or septicaemia is present: 100 ml (500
mg) twice daily for 10 - 14 days.
Side Effects
Levofloxacin is usually well tolerated but sometimes anorexia, diarrhoea,
vomiting, abdominal pain, dizziness, flatulence, rash, anxiety, insomnia,
constipation, increased sweating, tremor, urticaria have been reported.
Rarely phototoxicity (0.1%) has been noted.
Contraindications
Levofloxacin is contraindicated in individuals with a history of
hypersensitivity to Levofloxacin or Quinolone antimicrobial agents or any
other component of the product.
Precautions and Warnings
Patient should be advised to take plenty of fluid during the course of
treatment to avoid high concentration. Antacid containing aluminum or
magnesium, iron, multivitamin preparation with zinc, chewable/buffered
tablets should be taken at least hours before or two hours after
levofloxacin injection because they may hamper the absorption of drug. Dose
adjustment should be exercised during levofloxacin injection in presence of
renal insufficiency. Phototoxicity reactions have been observed in patients
exposed to direct sunlight therefore should be advised to avoid excessive
sunlight. Levofloxacin should be taken with caution in patients with known
and unknown CNS disorders that may predispose to seizures. Infusion of fluid
should be immediately discontinued if rigor arises for any reason during the
process. Do not use if the solution is cloudy, contains particles or after
expiry date.
Pharmaceutical Precautions
Levobac™should be stored at controlled room temperature. This Infusion is
not intended for multi-dose use.
Commercial Pack
Levobac™ 100 ml IV infusion: Available in 100 ml Polypropylene bag.
Administration Procedure
1. Check infusion set and infusion solution prior to use
2. Pull moderately to tear off the protective cover of the Eurohead
(Picture-1)
3. Hold lightly the Eurohead but not the bag (Picture-2)
4. Open the flow regulator fully and hold the giving set on the top white
area, but not the membrane venting region (Picture-2)
5. Insert the spike of the administration set to the Eurohead and fit the
connector of the administration set firmly to the needle
(Picture-2)
6. Gradually allow the fluid to flow down to the needle tip and close
7. Remove the protective cover of the needle
8. Locate the venipuncture site and clean the site with an antiseptic
solution, and then insert the needle (Picture-3)
9. Securely tape the puncture site
10. Securely tape the wings and tubing
11. Start infusion while adjusting drip speed
