ADVAQUIN

Medical perspectives.
Levofloxacin
Levofloxacin

Originally discovered:  1987, Daiichi Pharmaceutical, Japan 

Generic name :  Levofloxacin
Brand names:  Levaquin, Leva-Pak (US);
Tavanic (Europe);
Cravit (Asia).
Therapeutic class:  Antibiotic
Pharmacologic class:  Fluoroquinolone, 3rd generation
FDA Approved: December 1996
Chemical Formula:  C36H42F2N6O9
Levofloxacin

History
• The optical S-(-) isomer of ofloxacin) was developed by the Daiichi
Pharmaceutical Co. Ltd. (now Daiichi Sankyo Pharmaceutical Co. Ltd - one
of Japan's largest pharmaceutical companies) in Japan.
• Was developed to ensure excellent ofloxacin's antibacterial potency and
minimize toxicity.
• First launched in Japan in 1993 under the brand name Cravit.
• Currently marketed in the U.S. by Ortho McNeil Pharmaceutical under the
name Levaquin, under license from Daiichi.
• Sanofi-Aventis sells levofloxacin under the brand Tavanic in Europe/ ME.
Levofloxacin- Background

• Ofloxacin – A FQ composed of 2 isomers- levo & dextro

• Optically active levo isomer of ofloxacin.

• Pharmacokinetic properties of levofloxacin permit

1. OD dosing , as opposed to ofloxacin, which is BID.
2. Efficacy, which is superior to commonly used FQs
(ofloxacin or ciprofloxacin).
Racemic mixtures

• Drugs are 50:50 mixtures of 2 stereoisomers of the drug

molecule and are hence called as a racemic mixture or
racemate.
• The 2 stereoisomers (enantiomers) are identical in chemically,
but structurally are mirror images of each other
– ‘Left-handed’ (‘levo’ or ‘s-’) form
• Designated as levorotatory, L-,l-, or (-) because
molecules rotate plane polarized light to the left
– ‘right-handed (‘dextro’ or ‘r-’) form
• Designated as dextrorotatory, D-,d-, or (+) because
molecules rotate plane polarized light to the right
Chirality

• The study of these 2 mirror images of the substance as enantiomers

or stereoisomers is chirality
• This can have significance on drug action e.g. interaction with
receptors. Analogy is like placing a hand in a glove.
– the ‘left handed’ drug will only fit the ‘left-handed’ receptor and
vice versa.
– So, within a racemic mixture, only ½ of the molecules are
responsible for effect.
Chirality- Advantages

• Potential advantages of chiral separation:

1. Increased potency & selectivity and fewer unwanted effects
2. Improved onset & duration of effect
3. Decreased risk for drug interactions

• Replacement of an approved racemate mixture by a single isomer is also used

– to decrease side effects
• Levocetirizine instead of cetirizine
– to enhance efficacy
• Levofloxacin from ofloxacin
Chirality- Advantages Mechanism of Action

• Dual MOA:
1. Inhibition of bacterial DNA Gyrase (Topoisomerase II)
1. Formation of quinolone-DNA-Gyrase complex
2. Induced cleavage of DNA
2. Inhibition of bacterial Topoisomerase IV
1. Mechanism poorly understood

Mechanism of DNA Gyrase

Levofloxacin – MIC

Organism Representative Gram Positive MIC90 values (range)

(mcg/ml)
Staphylococci
S. aureus (methicillin susceptible) 0.25 (0.25–0.5)
S. aureus (methicillin resistant) 16 (8–W32)
Coagulase-negative (methicillinsusceptible) 1 (0.5–2)

Coagulase-negative (methicillin resistant) (0.4–16)

Streptococci and enterococci
S. pneumoniae 1 (1–2)
S. pyogenes 1 (0.5–2)
S. agalactiae 1
Streptococcus spp. 2 (1–2)
E. faecalis (2–50)
E. faecium (2–64)
Other
Listeria monocytogenes 1 (1–2)
Corynebacterium spp. (2–W16)
Bacillus spp. 0.25 (0.06–2)
Levofloxacin – MIC

Organism Representative Gram Negative MIC90 values (range)

(mcg/ml)
Enteric bacteria
Escherichia coli 0.5 (0.05–32)
Klebsiella pneumonia 0.5 (0.5–1)
Klebsiella oxytoca 0.12 (0.06–0.13)
Enterobacter cloacae 0.5 (0.05–2)
Enterobacter aerogenes 0.5 (0.06–16)
Citrobacter freundii 0.5 (0.6–2)
Citrobacter diversus 0.13 (0.03–0.13)
Serratia marcescens 2 (0.25–8)
Proteus mirabilis 0.12 (0.05–4)
Proteus vulgaris 0.12 (0.06–0.25)
Morganella morganii 0.12 (0.06–1)
Providencia rettgeri 1 (0.1–4)
Providencia stuartii 4 (0.25–W16)
Levofloxacin – MIC

Organism Representative MIC90 values (range)

(mcg/ml)
Nonenteric bacteria
Pseudomonas aeruginosa 2–128
Burkholderia cepacia 4–256
Stenotrophomonas maltophilia 2–32
Acinetobacter spp. 0.05–32
Pasteurella multocida 0.016–0.03
Gastrointestinal pathogens
Salmonella spp.. 0.03–0.25
Shigella spp. 0.016–0.03
Campylobacter jejuni 0.12–32
Yersinia enterocolitica 0.03–0.06
Aeromonas spp. r 0.015–0.03
Vibrio cholera 0.008–0.25
Helicobacter pylori 0.25–0.5
Levofloxacin – MIC

Organism Representative MIC90 values (range)

(mcg/ml)
Respiratory pathogens
Haemophilus influenza 0.015–0.5
Moraxella catarrhalis r0.03–0.5
Neisseria meningitides r0.008–0.016
Genital pathogens
Neisseria gonorrhoeae r0.008–2
Levofloxacin – MIC

Anaerobic bacteria

Bacteroides fragilis. 2–W16

Bacteroides spp. 4–16
Fusobacterium spp. 0.39
Clostridium spp. (0.12–4)
Clostridium perfringens 0.39
Clostridium difficile 6.25–128
Anaerobic Gram-positive cocci 0.39–0.78
Levofloxacin – MIC

Organism Representative MIC90 values (range)

(mcg/ml)
Mycobacteria
M. tuberculosis 0.5–1
M. avium complex (1–8)
M. chelonae (1–4)
M. fortuitum 0.25
M. kansasii 0.25
Pharmacokinetics

ABSORPTION
• Levofloxacin is rapidly and completely absorbed after oral
administration.
• Cmax - 5.7 + 1.4 mcg/ml.

• tmax - 1 to 2 hours

• bioavailiability - 100%

• Food prolongs tmax & decreases Cmax but the therapeutic efficacy is
not affected
Pharmacokinetics

DISTRIBUTION

• Volume of distributions (Vd) -74 to 112 L

• Distribution - Wide

• Lung Concentration - 2 to 5 fold of plasma.

Pharmacokinetics

METABOLISM

• Limited metabolism in humans.

• Primarily excreted as unchanged drug in urine.

• <5% of the administered dose is metabolized to desmethyl and

N-Oxide metabolites.
Pharmacokinetics

EXCRETION

• Largely excreted as unchanged drug in urine.

• Elimination half life ranges from approximately 6 to 8 hrs
• Plasma levels are maintained well above the MIC levels making
it suitable for once daily dosing.
• Clearance of levofloxacin is substatntially reduced and plasma
elimination half-life is substantially prolonged in patients with
impaired renal functions ( creatinine clearance<50ml/min)
requiring dosage adjustment in such patients to avoid
accumulation.
Levofloxacin - Indications

US FDA approved indications

• Acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus
influenzae, or Moraxella catarrhalis.

• Acute bacterial exacerbation of chronic bronchitis due to methicillin-

susceptible Staphylococcus aureus, Streptococcus pneumoniae,Haemophilus
influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

• Nosocomial pneumonia due to methicillin-susceptible Staphylococcus

aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli,Klebsiella
pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive
therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is
a documented or presumptive pathogen, combination therapy with an anti-
pseudomonal b-lactam is recommended.
Levofloxacin - Indications

US FDA approved indications

• Community-acquired pneumonia due to methicillin-susceptibleStaphylococcus

aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus
parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia
pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.

• Complicated skin and skin structure infections due to methicillin-

susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes,
or Proteus mirabilis.

• Uncomplicated skin and skin structure infections (mild to moderate)including

abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to
methicillin-susceptible Staphylococcus aureus orStreptococcus pyogenes.
Levofloxacin - Indications

US FDA approved indications

• Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or

methicillin-susceptible Staphylococcus epidermidis.

• Complicated urinary tract infections (mild to moderate) due toEnterococcus

faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, or Pseudomonas aeruginosa.

• Acute pyelonephritis (mild to moderate) caused by Escherichia coli.

• Uncomplicated urinary tract infections (mild to moderate) due to Escherichia

coli, Klebsiella pneumoniae or Staphylococcus saprophyticus.

• Inhalational anthrax (post-exposure) 

Levofloxacin – Contra Indications

• Hypersensitivity to FQs
• Epilepsy
• Tendon disorders
• Children or growing adolescents
• Pregnancy
• Lactation
Levofloxacin – Side Effects

• CNS: Headache, dizziness, insomnia, anxiety, seizures,

encephalopathy, paresthesia, pseudotumor cerebri
• CV: Chest pain, palpitations, vasodilation, QT
prolongation
• EENT: Dry mouth, visual impairment
• GI: Nausea, flatulence, vomiting, diarrhea, abdominal
pain, pseudomembranous colitis, hepatotoxicity
• GU: Vaginitis, crystalluria
• HEMA: Eosinophilia, hemolytic anemia, lymphopenia
• INTEG: Rash, pruritus, photosensitivity, epidermal necrolysis
• MISC: Hypoglycemia, hypersensitivity, tendinitis, tendon
rupture
• RESP: Pneumonitis
• SYST: Anaphylaxis, multisystem organ failure
Levofloxacin – Drug Interactions

Antacids
• Interferes with absorption of Levofloxacin lower levels are
achieved than desired.
• Antacid to be taken 2 hrs before or after Levofloxacin.

Warfarin
• Levofloxacin enhances effect of warfarin. Patient should be
closely monitored for evidence of bleeding.
Theophylline
• No drug interaction is exhibited with theophylline like older
quinolones.
Levofloxacin – Warning

• Convulsions and CNS toxicity

• Skin rash or any other sign of hypersensitivity.

• Tendon rupture
Levofloxacin – Precaution

• Dosage adjustment is required in patients with impaired renal

function due to decreased clearance of Levofloxacin.

• Excessive exposure to sunlight should be avoided during

levofloxacin therapy to prevent development of phototoxicity
inspite of the fact of levofloxacin being least phototoxic among
other quinolones.
Levofloxacin – Precaution- Pregnancy and Lactation

Pregnancy

• Only if the potential benefit justifies the potential risk to the

foetus.

Lactation

• The decision to continue the drug in nursing mother is to be

taken, considering the importance of the drug to the mother
and if the drug cannot be discontinued, breast feeding should
be held.
Levofloxacin – Pediatric Use

Pediatric Use

• Safety and effectiveness of levofloxacin in children and

adolescents below the age of 18 years have not been
established.
Levofloxacin –

Dosage: Patients with normal renal functions

Infection Unit Dose Frequency Days

AECB 500 mg OD 7
CAP 500 mg OD 7-14
AMS 500 mg OD 10-14
USSSI 500 mg OD 7-10
CSSSI 750 mg OD 7-14
UUTI 250 mg OD 3
CUTI 250 mg OD 10
Acute pyelonephritis 250 mg OD 7-14
Levofloxacin –
Dosage: Patients with impaired Renal function
Renal Status Initial Dose Subsequent Dosing

AECB/ CAP/ AMS/ uSSSI

CLCR from 50 to 80 ml / min No dosage
adjustment
CLCR from 20 to 49 ml / min q24h 500 mg 250 mg

CLCR from 10 to 19 ml / min q48h 500 mg 250 mg

HD q48h 500 mg 250 mg

CAPD q48h 500 mg 250 mg
Levofloxacin –
Dosage: Patients with impaired Renal function

Renal Status Initial Dose Subsequent Dosing

CSSSI
CLCR from 50 to 80 ml / min No dosage adjustment

CLCR from 20 to 49 ml / min q24h 750 mg 750 mg

CLCR from 10 to 19 ml / min q48h 750 mg 500 mg

HD q48h 750 mg 500 mg

CAPD q48h 750 mg 500 mg
Levofloxacin –
Patients with impaired Renal function

Renal Status Initial Dose Subsequent Dosing

UUTI
No dosage adjustment is necessary
CUTI/ Acute Pyelonephritis
CLCR more than 20 ml / min No dosage adjustment

CLCR from 10 to 19 ml / min q48h 250 mg 250 mg

Levofloxacin –

Comparative Studies
Levofloxacin – UTI: vs Lomefloxacin

Once-daily levofloxacin is as effective as and has a superior tolerability profile

than lomefloxacin in the treatment of complicated UTIs 

Levofloxacin Lomefloxacin
Regimen 250 mg OD X 7-10 days 400 mg OD X 14 days
Bacterial eradication rate 95.5%(168/176) 91.7% (154/ 68)
Complete resolution of symptoms at the 5 to 84.8% 82.4%
9-day post-therapy
Decreased symptoms 8.2% 6.1%
Clinical success rate 93% 88.5%
Adverse events 10 patients (2.6%) 18 patients (5.2%)
Discontinuation because of adverse events 8 patients (3.4%) 14 patients (6.1%)
observed in 8 (3.4%) levofloxacin- and 14
(6.1%) lomefloxacin-treated patients.
Levofloxacin – UTI: vs Lomefloxacin

Levofloxacin is more effective than lomefloxacin in the treatment of acute

pyelonephritis

Levofloxacin Lomefloxacin

Regimen 250 mg OD 400 mg OD

Eradication of uropathogens rate at 5 to 9 95% 95%

days after the end of treatment
(predominant pathogen E. coli)

Clinical cure rate 92% 80%

Adverse events 2% 5%
Levofloxacin – AECB: vs Cefaclor

AECB
Levofloxacin v/s cefaclor
• Prospective multicentric, randomized study involving 373
adults.
• Levofloxacin was more effective than oral cefaclor.
• Bacteriological eradication - levofloxacin 94%
cefaclor 81%
Levofloxacin – AECB: : vs Cefuroxime

AECB

Levofloxacin v/s cefuroxime axetil

• Levofloxacin - (500mg/day)

• Cefuroxime axetil - (250mg twice daily)

• Levofloxacin was more effective than Cefuroxime axetil

• Bacteriological eradication rates were 97% with levofloxacin

and 95% with cefuroxime axetil.
Levofloxacin –vs Ceftriaxone/ Cefuroxime

CAP
Levofloxacin v/s ceftriaxone/cefuroxime axetil
• Randomized study involving 456 patients.
• Levofloxacin 500mg as 1-hour infusion or orally for 7 to 14
days parentral ceftriaxone or oral cefuroxime axetil 500mg
twice daily orally for 7 to 14 days.
• Levofloxacin has shown higher clinical success rates as
compared with these cephalosporins.
Levofloxacin –vs Ceftriaxone/ Cefuroxime
CAP…
CAP
• Levofloxacin treatment resulted in approximately a 97%
clinical success rates, while ceftriaxone or cefuroxime axetil
therapy achieved a 90% success rate.
• The microbiological eradicated rates for pneumonia patients
infected with Haemophilus influenzae, Streptococcus
pneumoniae, Staphylococcus aureus, Moroxella catarrhalis,
Haemophilis parainfluenzae and Klebsiella pneumoniae are
98%, 95%, 88%, 94% and 100% respectively.
Levofloxacin –SSSI: vs Ciprofloxacin

SSSI’s

Levofloxacin v/s ciprofloxacin

• Comparative, multicentric, randomized study involving 469

patients

• Levofloxacin 500mg once daily (n=231) for 7 to 10 days.

Ciprofloxacin 500mg twice daily (n=238) for 7 to 10 days.

• Clincal success rate - Levofloxacin 98%

Ciprofloxacin 94%
Levofloxacin –ABS: vs Cefuroxime

Bacterial sinusitis
Levofloxacin v/s cefuroxime axetil
• Clinical studies have demonstrated that oral levofloxacin is
about as effective as cefuroxime axetil for treating acute
bacterial sinusitis.
• For treatment of acute maxillary sinusitis, levofloxacin is
recommended for infections cause by Streptococcus
pneumoniae, Haemophilus influenza or Moraxella catarrhalis.
Levofloxacin –ABS: vs Co-amoxiclav

Bacterial sinusitis
Levofloxacin v/s amoxycillin/clavulanic acid

• In an open comparative trial in patients with acute maxillary

sinusutis oral levofloxacin 500mg/day was similar in clinical
efficacy and bacterial eradication rates to oral
amoxycillin/clavulanic acid 500mg/125mg three times daily.
Levofloxacin –ABS: vs Clarithromycin

Bacterial sinusitis
Levofloxacin v/s clarithromycin
• In a open comparative study of oral levofloxacin 500mg
with clarithromycin 500mg bid clinical success rates were
found out to be 96% with levofloxacin and 93.3% with
clarithromycin.
Levofloxacin –UTI: vs Ciprofloxacin

Uncomplicated and complicated UTI

• Oral levofloxacin is indicated for the treatment of mild to
moderate uncomplicated UTI's due to Klebsiella pneumoniae,
Escherchia coli or Staphylococcus saprophyticus.
Levofloxacin v/s ciprofloxacin
• In an open comparative clinical trial comparing oral
levofloxacin 250mg once daily for 10 days versus ciprofloxacin
250mg twice daily for 10 days showed a clinical success rate of
92% and 88% respectively.
Levofloxacin –UTI: vs ciprofloxacin and lomefloxacin

Uncomplicated and complicated UTI

Levofloxacin v/s Ciprofloxacin and lomefloxacin

• In another study comparing oral levofloxacin 250mg once daily

for 10 days versus lomefloxacin 400mg once daily for 14 days,
the clinical success rate was 92.9% with patients receiving
levofloxacin whereas it was 88.5% with patients receiving
lomefloxacin and bacteriological eradications rates with
levofloxacin and lomefloxacin were 95.3 % and 92.1%
respectively.
Levofloxacin –UTI: vs ciprofloxacin and lomefloxacin

Uncomplicated and complicated UTI

Levofloxacin v/s Ciprofloxacin and lomefloxacin
• Oral levofloxacin 250mg once daily was as effective as oral
ciprofloxacin 500mg twice daily and oral lomefloxacin 400mg once
daily in treating patients with acute pyelonephritis in two
randomized multicentric trials.
• The combined clinical cure rates in both studies on days 5 to 9 after
therapy was 92% for levofloxacin treated patients, 88% for
ciprofloxacin treated patients and 80% for lomefloxacin treated
patients.
ADVAQUIN advantages over other antimicrobial agents

ADVAQUIN Vs Ciprofloxacin
a) More active against all types of Strep pneumoniae - 1st line in CAP.
b) Has better activity against B. fragilis, the commonest anaerobe.
c) Similar activity compared to Ciprofloxacin against atypicals & Legionella.
d) Does not interact with theophylline and hence safe in asthmatics on
theophylline while ciprofloxacin interacts altering plasma levels of
theophylline.
e) Less phototoxic than ciprofloxacin
f) Shows comparable efficacy in umcomplicated SSTI & complicated UTI.
g) Has convenient OD dosage (Vs bid of ciprofloxacin).
ADVAQUIN advantages over other antimicrobial agents

ADVAQUIN Vs Amoxycillin / Clavulanic acid (A/CA)

a) Has better activity against all types of S. pneumoniae (A/CA does not
cover - penicillin-intermediate & - resistant strains)

b) Has excellent activity against atypicals & Legionella (A/CA - not active).

c) Both drugs have shown comparable efficacy in CAP, AECB, Sinusitis.

d) Has convenient OD dosage (Vs tid of A/CA).

e) Minimal incidence of diarrhoea with levofloxacin which is a common

feature with amoxycillin/clavulanic acid.
ADVAQUIN advantages over other antimicrobial agents

ADVAQUIN Vs Gen. Cephalosporins

a) Levofloxacin has better activity against S. pneumoniae (Cephalosporins do

not cover - penicillin - intermediate & - resistant strains).

b) It has better activity against anaerobes, including B. fragilis.

c) Levofloxacin shows excellent activity against atypicals & Legionella

(Cephalosporins are not active).

d) Levofloxacin has comparable or better efficacy in CAP, AECB.

e) Levofloxacin has convenient OD dosage (Vs bid of cefuroxime).

 ADVAQUIN advantages over other
antimicrobial agents (Contd..)
ADVAQUIN Vs 3rd Gen. Cephalosporins ( Cefotaxime, Ceftriaxone)
a) Levofloxacin has better activity against all types of S. pneumoniae
(Cephalosporins partially cover penicillin-intermediate and do not
cover -resistant strains).
b) It has better activity against anaerobes, including B. fragilis.
c) Levofloxacin shows excellent activity against atypicals & Legionella
(Cephalosporins - not active)
d) Levofloxacin has shown comparable efficacy in CAP (Vs
Ceftriaxone).
e) Levofloxacin has convenient OD dosage (Vs Cefotaxime).
 Key Points
• Levofloxacin is a 3rd generation fluoroquinolone, and has
broad-spectrum anitibacterial activity against Gram-positive,
Gram-negative, anaerobic, atypical and intracellular
pathogens.

• Has excellent activity against all types of Strep pnemoniae,

including penicillin-resistant strains, making it a first-line drug
in the treatment of community-acquired pneumonia.

• Shows activity against atypical & intracellular pathogens,

ensuring utility in atypical pneumonia & intracellular
infections.
 Key Points
• Exhibits excellent distribution into tissues of respiratory tract,
skin & urine.

• Has excellent intracellular penetration making it suitable for

treatment of intracellular infections.

• Exhibits long elimination half life, ensuring convenient OD

dosage.

• Has similar bio-availability on oral & IV administration, allowing

switch-over from IV to oral therapy without dosage adjustment.
 Key Points
• Has demonstrated excellent clinical efficacy in the
treatment of community-acquired pneumonia, AECB,
maxillary sinusitis, skin & soft tissue infections and urinary
infections including acute pyelonephritis.
• Is comparable to co-amoxiclav, 2nd & 3rd generation
cephalosporins and 2nd & 3rd generation
fluoroquinolones in clinical efficacy.
• Has excellent tolerability profile.
• Scores over its competitors in offering the convenience of
one daily dosge.
 Guidelines and Recommendations
• AAO guidelines
– for acute bacterial sinusitis
• For initial treatment failures
• For adults with prior antibiotic exposure in the previous 4 to 6 weeks
• Stanford Guide
– for ABS and CAP in patients with
• Previous antibiotic therapy
• Severe ABS who have failed 3 days of initial therapy
• As primary therapy for CAP if comorbidity is present
– recommends levofloxacin 750 mg/once daily for 5 days
• ATS/IDSA guidelines
– for community acquired pneumonia
• First-line fluoroquinolone monotherapy in CAP for patients with previous antibiotic
therapy, as well as first-line for outpatients and hospitalized patients at increased
risk for infection with specific pathogens due to risk factors such as
cardiopulmonary disease
 Indicationwise – Target Doctors
Indication Speciality
ABS/ AMS ENT, Physician, GP

ABECB Chest Physician, Physician, GP

Nosocomial pneumonia  Chest Physician, Physician, GP

CAP Chest Physician, Physician, GP

Complicated SSSI  Dermatologist, GP, Physician

Uncomplicated skin and skin structure

infections (mild to moderate) Dermatologist, GP, Physician

Complicated UTI (mild to moderate)  GP, Physician, Urologist, Gynecologist

Acute pyelonephritis (mild to moderate)  GP, Physician, Urologist, Gynecologist

Uncomplicated UTI (mild to moderate)  GP, Physician, Urologist, Gynecologist

 Market
Value (SAR) Value (SAR)
Brand Company Units 2012 Gr 2012 Units 2013
2012 2013
Tavanic
Aventis 307,250 21,172,598 6.1
500 337,975 23,289,858
Levox 500 Spimaco 45,071 2,082,730 --- 54,085 2,499,276
Levonic
Jazeera 18,404 1,408,275 438.6
500 23,005 1,760,344
Levoflox
NPI 0 0 0
500 20,000 1,500,000
Total   370,725 24,663,603 26.56 435065 29,049,478
 Competition

Trade Name Manufacturer Name Price SAR

Levoflox 500mg National Pharmaceutical Industries Co 49.9
Jazeera Pharmaceutical Industries
Levonic 500mg 44.9
(JPI)
Levox 500mg SPIMACO 55.45
Levox 750mg SPIMACO 71.95
Tavanic 500mg Sanofi Winthrop Industrie 79.25
 Summary
Lower MICs

Excellent Guideline recommended

tolerability antibacterial

One a day antibacterial

Sequential therapy /
combination therapy Advaquin for a wide variety of
indications

Excellent success in
resistant typhoid 5 days therapy in URTI

Higher urine levels for

better UTI activity / ↓ in
PSA in ch. prostatitis
 When Success is Critical…

Rx the best…

ADVAQUIN