Indications
Trevox is indicated for the
treatment of mild, moderate and severe infections caused by susceptible strains
of the designated micro-organisms in the condition listed below:
Acute maxillary sinusitis due to
Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute bacterial exacerbation of
chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae,
Haemophilus influenzae, or Moraxella catarrhalis.
Community-acquired pneumonia due
to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae,
Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella
pneumophila, or Mycoplasma pneumoniae.
Uncomplicated & complicated
urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or
Staphylococcus saprophyticus.
Acute pyelonephritis caused by
Escherichia coli.
Uncomplicated & complicated
skin and soft tissue infections including abscesses, cellulitis, furuncles,
impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus
pyogenes, Proteus mirabilis or Enterococcus faecalis.
Enteric infections caused by
Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae,
Shigella sp., Salmonella sp.
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Description
Trevox is a synthetic,
broad-spectrum, third-generation fluoroquinolone derivative antibacterial agent
for oral administration. Chemically levofloxacin is a chiral fluorinated
carboxyquinolone.
Pharmacology
Levofloxacin is a synthetic,
broad-spectrum, third generation fluoroquinolone antibiotic. Chemically,
Levofloxacin is a chiral fluorinated carboxyquinolone. 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 gm-ve and gm+ve
microorganisms.
Dosage
The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or 2 hours after eating.
Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection 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. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.
Adults:
Acute sinusitis: 500 mg once
daily for 10-14 days, or 750 mg once daily for 5 days
Exacerbation of chronic
bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days
(Uncomplicated), 750 mg once daily for 5 days (Complicated)
Community-acquired pneumonia: 500
mg once daily for 7-14 days, or 750 mg once daily for 5 days
Uncomplicated urinary-tract
infections: 250 mg once daily for 3 days
Complicated urinary-tract
infections and acute pyelonephritis: 250 mg once daily for 7-10 days
Uncomplicated skin and
soft-tissue infections: 500 mg once daily for 7-10 days.
Complicated skin and soft-tissue
infections: 750 mg once daily for 7-14 days.
Enteric fever: 500 mg once daily
for 7-14 days.
Diarrhea, cholera, shigellosis
& enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever
case: 500 mg once daily for 3 days
Children:
Children 6 months to <5 years:
10 mg/kg every 12 hours.
Children >5 years: 10 mg/kg
every 24 hours
In each case, sequential therapy
(intravenous to oral) may be instituted at the discretion of the physician.
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Administration
Instructions for the Use of
Levofloxacin Infusion-
Check the container for minute
leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is
not intact, discard the solution.
Do not use if the solution is
cloudy or a precipitate is present.
Do not use flexible containers in
series connections.
Close flow control clamp of
administration set.
Remove cover from port at bottom
of container.
Insert piercing pin of administration
set into port with a twisting motion until the pin is firmly seated.
Suspend container from hanger.
Squeeze and release drip chamber
to establish proper fluid level in chamber during infusion of Levoxin
Injection.
Open flow control clamp to expel air
from set. Close clamp.
Regulate rate of administration
with flow control clamp.
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Interaction
No quinolone should be
co-administered with any solution containing multivalent cations, e.g.,
magnesium, through the same intravenous line. Antacids, Iron and Adsorbents
reduce absorption of Trevox. NSAID may increase the risk of CNS stimulation.
Warfarin may increase the risk of bleeding.
Contraindications
Levofloxacin is contraindicated
in patients with a history of hypersensitivity to levofloxacin, quinolone
antimicrobial agents, or any other components of this product.
Side Effects
Trevox is generally well
tolerated. However, a few side-effects can usually be seen. There is a risk of
retinal detachment. Other side-effects include: nausea, vomiting, diarrhea,
abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%).
Side-effects that may be seen very rarely include tremors, depression, anxiety,
confusion etc.
Pregnancy & Lactation
Levofloxacin is not recommended
for use during pregnancy or nursing, as the effects on the unborn child or
nursing infant are unknown.
Precautions & Warnings
The following measures should be
taken during administration of Trevox:
Trevox Injection should only be
administered by slow intravenous infusion over a period of 60 or 90 minutes
depending on the dosage.
While administrating Trevox,
adequate amount of water should be taken to avoid concentrated form of urine.
Dose adjustment should be
exercised during Trevox administration in presence of renal insufficiency.
Overdose Effects
Trevox exhibits a low potential
for acute toxicity. However, in the events of an acute overdosage, the stomach
should be emptied. The patients should be kept under observation and
appropriate hydration should be maintained.
Therapeutic Class
4-Quinolone preparations
Storage Conditions
Keep below 30°C temperature, away
from light & moisture. Keep out of the reach of children.
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