Fluoroquinolones

1962 Nalidixic acid was the first quinolone discovered. Modified to enhance or limit the extent of antimicrobial activity & improve various other product attributes, such as pharmacokinetic profile, tolerability, drug interaction & toxicity of each new agent.
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Levofloxacin

Evolution of Fluoroquinolones
Addition of fluorine atom of Nalidixic acid at position 6 increased the antimicrobial potency with both gram +ve & gram -ve organisms coverage The piperazine substituent is responsible for the gram -ve activity (also anti - pseudomonal activity) of the fluroquinolones
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Spectrum of Activity of 4 generations of Quinolones

1st Gen
Gram -ve

2nd Gen
Gram-ve Gram +ve (Except S. pneumoniae)

3rd Gen
Gram -ve Gram +ve Gram +ve (including S. pneumoniae) Intracellular bacteria Anaerobic bacteria

4th Gen
Same as 3rd generation with extended anaerobic coverage

Moxifloxacin Nalidixic acid Norfloxacin, Lomefloxacin, Ofloxacin, Ciprofloxacin Levofloxacin, Sparfloxacin, Gatifloxacin Trovafloxacin (withdrawn due to toxicity)
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Spectrum of Activity
Levofloxacin is more active against Gram +ve & Gram -ve organisms, intracellular pathogens than earlier quinolones such as Ciprofloxacin. Has excellent activity against most commonly encountered pathogens in RTIs such as Strep. pneumoniae as well as H. influenzae, M. catarrhalis & against intracellular organisms.
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Unique Chemical Structure (Levofloxacin)

A fluoroquinolone - optically active Levo - isomer of Ofloxacin with side effects.

It has 2-4 times > activity than Ofloxacin.

It is a L-isomer of the D, L - racemate Ofloxacin. Antibacterial activity is due to L - isomer (Levofloxacin) that has > affinity for the target molecule DNA gyrase & has 128 times affinity than the D-isomer. Potency differences between these isomers is because of differences in their ability to inhibit DNA gyrase.
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Structure Activity Relationship

4-methyl piperazinyl group

Oxazine ring

oral absorption activity against gram-ve activity against some gram-ve coverage bacilli half life half life
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Inhibits DNA gyrase to exert bactericidal effects

Broad spectrum antibacterial with bactericidal activity Binds & inhibits bacterial DNA-gyrase. This enzyme (a type II topoisomerase) produces negative super-coiling of cellular DNA, needed for bacterial DNA synthesis. Bacterial DNA is approx. 1800 nm long, to fit inside a cell (2 x1 nm) it is super coiled with the help of DNA gyrase. This prevents DNA replication & results in bacterial cell death Sales Training

Safety : Only inhibits bacterial DNA gyrase

At clinically achievable concentrations Fluoroquinolones does not inhibit human topoisomerase II & therefore there is no disturbance to the human cell structures.

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Unique Mode of Action

Unique Mode of Action

Inhibits both the nicking & closing activity of gyrase resulting in +ve supercoiling & unstable DNA
GLEVO (Quinolones)

DNA

Stabilize
Stabilize

Formation of -ve DNA supercoils by DNA gyrase

(+) (-)

Break Back segment

Reseal Break on front

(-)

(-) (-)
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Pharmacokinetics Profile
Steady state attained after 3 days Cmax (g/ml) 5.09 5.7 AUC (g/ml.h) 44.7 47.5 tmax (h) 1.3 1.1 t (h) 6.33 7.6 CLR (ml/min) 125.5 116.0 Vd (L/kg) 1.2 1.35 Serum protein binding around 25-40 %
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Variable

Single doses 500 mg OD

Pharmacokinetics Profile
Offers nearly 100% bioavailability after oral administration, making it possible to administer the drug at the same dosages either orally or intravenously. Hence ideal for sequential therapy in CAP/AECB.

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Pharmacokinetics Profile

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Pharmacokinetics of Quinolones
Parameter Ciprofloxacin (I.V./Oral)
70-80

Levofloxacin Norfloxacin (I.V./Oral)

99 30-40

Ofloxacin (I.V./Oral)
98

Sparfloxacin

Bioavailability (%) Maximum Serum Concentration mcg/ml (Dose)

92

1.2 (250 mg) 2.4 (500 mg) 4.3 (750 mg) 5.4 (1000mg)

2.8 (250 mg) 5.1 (500mg)

0.8 (200 mg) 1.5 (400mg)

1.5 (200 mg) 2.4 (300 mg) 2.9 (400 mg) 14.1 (200 mg) 21.2 (300 mg) 31.4 (400 mg)

1.1 (200 mg) 1.3 (400 mg)

Area under curve (AUC) mcgxhr/ml (Dose)

4.8 (250 mg) 11.6 (500 mg) 20.2 (750 mg) 30.8 (1000mg)

27.2 (250 mg) 47.9 (500 mg)

5.4 (400 mg)

18.7 (200 mg) 20.6 (400 mg)

Source : Drug Facts and Comparison 1994 pg 340 Sales Training

Pharmacokinetics of Quinolones
Parameter
Protein Binding (%) Major Elimination Route Half-life (hours) Effect of food on absorption

Ciprofloxacin Levofloxacin Norfloxacin (I.V. / oral) (I.V. / oral)

20-40 Renal / hepatic 4/5-6 Delayed 24-30 Renal 6-8 Delayed (reduced by 14% Clinically 10-15 Renal / hepatic 3 - 4.5 Delayed

Ofloxacin Sparfloxacin (I.V. / oral)

32 Renal 5-8 Delayed 45 Renal / hepatic 20 None

insignificant) Source : Drug Facts and Comparison 1994 pg 340

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MIC breakpoints
Breakpoints as per National Committee for Clinical Laboratory Standards (NCCLS)

Categories Susceptible Intermediate Resistant

MIC (g/ml) <2 4 >8

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In vitro activity against Gram+ve bacteria

Organisms Mean MIC90 value (g / mL)
1.91 1.26 0.52 0.42 1.89 3.13
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Strep. pneumoniae S. pyogenes Staph. aureus (methicillin-resistant) S. epidermidis Enterococcus faecalis E. faecium

In vitro activity against Gram-ve bacteria

Organisms Mean MIC90 value (g / mL) (Enterobacteriaceae)
Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Serratia marcescens Proteus mirabilis Citrobacter freundii Morganella morganii Shigella spp. 0.07 0.18 0.28 7.42 0.18 0.80 0.13 0.05

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In vitro activity against Gram-ve bacteria

Organisms (Enterobacteriaceae) Salmonella spp. Providencia rettgeri Providencia stuartii Haemophilus influenzae Moraxella catarrhalis Neisseria gonorrhoeae Pseudomonas aeruginosa Campylobacter jejuni Mean MIC90 value (g / mL)

0.09 2.26 0.22 0.02 0.09 0.03 3.70 0.58

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In vitro activity against Intracellular pathogens & Anaerobic bacteria

Organisms Mean MIC90 value (g / mL) (Intracellular pathogens)
Chlamydia pneumoniae Mycoplasma pneumoniae Legionella pneumophila (Anaerobic bacteria) Bacteroides fragilis Clostridium difficile Clostridium perfringens Peptostreptocooccus spp. 0.5 0.5 0.125 3.52 5.00 0.75 4.62
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Eradication rates of Common Respiratory Pathogens

Pathogens
Gram-positive cocci Staphylococci aureus Streptococcus pneumoniae Gram-negative cocci Moraxella catarrhalis Gram-negative bacilli Escherichia coli Haemophilus influenzae H. parainfluenzae Klebsiella pneumoniae Pseudomonas aeruginosa Atypical pathogens Chlamydia pneumoniae Mycoplasma pneumoniae Legionella pneumophila

Levofloxacin 250-1000 mg/day % eradicated (Drugs 1998)

69.9 89.1 93.0 100 94.4 94.3 100 63.3 95.9 100 90

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Steady State Plasma Level

Achieves plasma levels that are above (MIC) values for 24 hours for most common pathogens after a single 500 mg Oral or I.V. dose. Clinical & microbiological outcomes can be predicted by site of infection & ratio of Cmax to MIC. 313 patients with respiratory, skin or UTI treated showed the median Cmax to MIC ratio of 12.1 Clinical cure or improvement was seen in 99% of patients with Cmax : ratio of > 12.2
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Distribution in relevant tissues & fluids

Body fluid or tissue Sputum Maxillary sinus Bronchial lavage fluid Alveolar Macrophage Lung Epithelial lining fluid Skin Blister fluid Prostate gland Testis Female genital tissues Urine Dose (mg) 100 100 200 500 500 500 200 500 100 200 200 200 Plasma Conc. (ug/ml) 1.10 0.45 2.52 4.1 2.93 4.1 1.73 5.0 0.90 2.85 0.73 1.01 Tissue fluid conc. (ug.ml) 1.27 0.67 0.12 27.7 11.28 10.9 1.85 4.7 1.15 4.73 0.94 286 Tissue/ fluid plasma conc. ratio 1.15 1.15 0.06 6.8 5.02 3.0 1.14 0.94 1.28 1.66 1.29 283 Sales Training

Minimal Metabolism & Excretion

Metabolized in liver to desmethyl-Levofloxacin & Levofloxacin-n-oxide. These metabolites make up < 5% of a dose excreted in urine within 24 hours. Since formation of metabolites is negligible, they have little relevant physiological activity. Renal excretion is primary responsible for elimination of Levofloxacin. Following oral administration, 80 to 86% of the dose was recovered in urine as unchanged drug within 24 hours & 2% recovered unchanged in faeces. i

Distinguishing Characteristics of Quinolones

Class & agent Half-life Route of Dosage administration adjustment required Oral Significant adverse effects Significant drug interactions

1st generation Nalidixic acid

60 to 90 mins

Renal Not used in poor impairment renal function Renal impairment Renal Phototoxicity, impairment headache 3 44 %, abdominal pain 11 % nausea 5.6%

Warfarin

2nd generation Norfloxacin 2.3 to 5.5 hours Lomefloxacin 7 to 8.5 hours

Oral Oral

Warfarin, Cyclosporine

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Distinguishing Characteristics of Quinolones

Class & agent Half-life Route of Dosage Significant administration adjustment adverse required effects Oral / IV Renal or Insomnia 13% hepatic impairment Significant drug interactions Warfarin

Ofloxacin

5 to 8 hrs

Ciprofloxacin

3 to 5.4 hours

Oral / IV

Renal Nausea, Warfarin, imparment vomiting, theophylline, abdominal pain caffeine, cyclosporine, glyburide
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Distinguishing Characteristics of Quinolones

Class & agent Half-life Route of Dosage Significant administration adjustment adverse required effects Oral, Renal Headache, intravenous impairment nausea 6.6 % , diarrhea, Phototoxicity 1% Oral Renal Phototoxicty impairment 8% QT interval prolongation , torsades des pointes Significant drug interactions Drug interactions are clinically insignificant Drugs that prolong QT interval, including class I antiarrhythmics, tricyclic antidepressants, phenothiazines, cisapride, pentamidine & Sales Training erythromycin 3rd Generation Levofloxacin 6 hrs

Sparfloxacin

21 hrs

Clinically significant antibiotic resistance has not emerged

No significant changes in resistance have been noted with Levofloxacin

Because compared with other fluoroquinolones, Levofloxacin has a low frequency of mutation as it inhibits both DNA-gyrase & Topoisomerase IV
Hence, bacteria will have to do double mutation to show resistance
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Lower phototoxicity compared to Sparfloxacin

Photosensitivity is infrequent (<1%), while is 8% with Sparfloxacin, as a result its use has been severely restricted in several countries. [A recent study found no difference in dermal reaction to UVA light or solar simulating radiation between healthy volunteers receiving Levofloxacin 500 mg once daily for days (n=24) or those receiving placebo (n=6)].
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Dosage
Indication
Acute sinusitis

Dosage in Normal Renal Function:

Daily dose regimen
500mg once daily 250 to 500mg once daily or 750 mg once daily 500 mg / 750 mg once daily

Duration of treatment
10-14 days 7-10 days 5 days 7-14 days/ 5 days

Acute Exacerbation of Chronic Bronchitis (AECB) CAP / Nosocomial Pneumonia

Complicated urinary tract infections including Pyelonephritis /

Bacterial Prostatitis Skin & Soft tissue infection Gonorrhoea

250 mg/500 mg once daily

500 mg once daily 500 mg once daily 750 mg

7-10 days
28 days 7 days Single dose

Impaired renal clearance (creatinine clearance < 3 L / h or <50 ml /min ) Dosage adjustment is needed

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Dosage (Contd.)
Dosage in Normal Renal Function:
Indication
Bone related Infections Meningitis Opportunistic Infections (Pseudomonas aeruginosa) Bacterial Diarrhoea

Daily dose regimen

750mg once daily 500mg IV/Oral once daily 750 mg once daily 500 mg once daily

Duration of treatment
4weeks or more Titrated to symptoms as per need 5 days

Enteric Fever (Typhoid fever) Clostridium difficle associated

diarrhoea/CDAD MDR-TB cases

500 mg once daily

750 mg once daily 500 -750 mg OD

14 days
5 days Till Negative SputumCulture

Impaired renal clearance (creatinine clearance < 3 L / h or <50 ml /min ) Dosage adjustment is Sales Training needed

Acute Maxillary Sinusitis

Dosage (mg) Comparative studies LVFX 500 od AMC 500/125 tid LVFX 500 od CLR 500 bid Non-Comparative studies LVFX 500 od Clinical success Bacteriological rate (%) eradication rate (%) 88.4 87.3 96.0 93.3 NA NA NA NA

88.3

92

AMC = Amoxicillin / Clavulanic acid ; LVFX = Levofloxacin; CLR = Drugs 1998, 56 (3) pg 487-515 Clarithromycin Sales Training

Community Acquired Pneumonia

Dosage (mg) Comparative studies LVFX 500 od CXM 500 bid LVFX 500 od CRO 4000 od IV Non-Comparative studies LVFX 500 od IV or PO Clinical success Bacteriological rate (%) eradication rate (%) 96 90 87 86 94.7 NA NA 87 87 95.1

LVFX = Levofloxacin; CXM = Cefuroxime; CRO = Ceftriaxone; PO = Drugs 1998, 56 (3) pg 487-515 Oral Sales Training

Acute exacerbation of Chronic Bronchitis

Dosage (mg) Clinical success Bacteriological rate (%) eradication rate (%)

Comparative studies LVFX 500 od CXM 250 bid LVFX 500 od CEC 250 tid

94.6 92.6 92 92

97 95 94 87

LVFX = Levofloxacin; CXM = Cefuroxime; CEC = Cefaclor

Drugs 1998, 56 (3) pg 487-515
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Urinary tract infection

Dosage (mg) Clinical success Bacteriological rate (%) eradication rate (%)
92 88 93.6 97.5

Comparative studies
LVFX 250 od CIP 250 bid

LVFX = Levofloxacin; CIP = Ciprofloxacin

Drugs 1998, 56 (3) pg 487-515
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Skin & Soft tissue infection

Dosage (mg) Clinical success Bacteriological rate (%) eradication rate (%) 97.8 94.3 96.1 93.5 97.5 88.8 93.2 91.7

Comparative studies
LVFX 500 od CIP 500 bid LVFX 500 od CIP 500 tid

LVFX = Levofloxacin; CIP = Ciprofloxacin

Drugs 1998, 56 (3) pg 487-515
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Comparative Clinical Trials

Aim : To assess serum bactericidal activity (SBA) of Levofloxacin compared to Ofloxacin against Methicillin-resistant Staphylococcus aureus. Levofloxacin was significantly more bacericidal than Ofloxacin against all strains of S. aureus tested. With Ofloxacin SBA was recorded for only a short period and thereafter only bacteriostatic activity remained. This study, therefore, confirms the superior activity of Levofloxacin over that of Ofloxacin against MSSA & MRSA.
Journal of Antimicrobial Chemotherapy (1999) 43, Suppl. C, 67-70.
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Comparative Clinical Trials

Aim : To compare bactericidal efficacy of Levofloxacin and Ofloxacin against Streptococcus pneumoniae. Conclusion : The data, together with the two-fold higher activity of Levofloxacin in comparison with Ofloxacin, indicate good therapeutic perspectives for Levofloxacin over Ofloxacin in the treatment of S. pneumoniae infections.
Journal of Antimicrobial Chemotherapy (1999) 43, Suppl. C, 77-82.
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Comparative Clinical Trials

Aim : To compare effectiveness of Levofloxacin (500 mg OD) and Amoxicillin-clavulanate (500/125 mg tid) for the treatment of acute sinusitis in adults Success rate : Levofloxacin 88.4% Amoxicillin-clavulanate : 87.3% Adverse effect : Levofloxacin 7.4% Amoxicillin-clavulanate : 21.2% Conclusion : Once daily Levofloxacin is as effective & better tolerated than Amoxicillin-clavulanate tid.
Otolaryngol Head Neck Surg 1999,120:320-7
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Clinical Trials
Pharmacodynamics & Pharmacokinetics : Pharmacodynamic analysis of the activity of Levofloxacin against Streptococcus pneumoniae revealed that, 99% of the time, actual hospitalized patients achieve an AUC / MIC of > 30. This indicates that Levofloxacin will be very effective in treating S. pneumoniae infections in majority of patients. (AUC/MIC of greater than 30 required for effective eradication of bacterial & good clinical outcome).
Chemotherapy 2000; 4(suppl 1):6-14
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Comparative Clinical Trials

Aim : To evaluate, efficacy and safety of Levofloxacin, Ciprofloxacin,

Lomefloxacin.
Bacterial eradication : Levofloxacin Ciprofloxacin Lomefloxacin Clinical cure : Levofloxacin Ciprofloxacin Lomefloxacin Adverse effects : Levofloxacin Ciprofloxacin Lomefloxacin 95% 94% 95% 92% 88% 80% 2% 8% 5%

The once-daily oral administration, has proven efficacy & good tolerability making Levofloxacin an excellent choice for empiric treatment of acute pyelonephritis. UTOLOGY : 1998, 52, p. 51-55 Sales Training

Comparative Clinical Trials

Aim : To compare efficacy and safety of oral Levofloxacin (500 od) versus Ciprofloxacin (500 mg bid) in the treatment of skin and skin structure infections. Success rate : Levofloxacin 96.1% Ciprofloxacin 93.5% Bacterial eradication :Levofloxacin 93.2% Ciprofloxacin 91.7% Findings support the efficacy of oral Levofloxacin for uncomplicated skin & skin structure infections due to S. aureus & S. pyogenes. (Int J Clin Pract 1998; 52(2): 69-74)
IJCP, March 1998 Vol. 52 No. 2
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Comparative Clinical Trials

Aim : To compare bactericidal activity of Levofloxacin, Ofloxacin, D-Ofloxacin, Ciprofloxacin, Sparfloxacin & Cefotaxime against Streptococcus pneumoniae Observation : Levofloxacin was found to be the most bactericidal followed by Ofloxacin, Ciprofloxacin, Sparfloxacin and DOfloxacin. Against penicillin-resistant pneumococcus, Levofloxacin was more potent than Cefotaxime Levofloxacin has enhanced activity against pneumococci compared with clinically available quinolones. In addition, Levofloxacin may be the future quinolone of choice in the treatment of penicillin-resistant pneumococci
Journal of Antimicrobial Chemotherapy (1997) 39, 719-723.
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Comparative Clinical Trials : CAP

Regimens
Levofloxacin 500 mg qd IV/PO Ceftriaxone 1 - 2 g qd -bid

%Clinical %Bacterial Cure Cure

97 (219 / 226) 90 (207 / 230) 100 (60 / 60) 98 88

Comments
Levofloxacin eradication rates: 100% H. influenzae (n = 30) 100% S. pneumoniae (n = 30) 100% Staphylococcus aureus (n=10) 88% H. parainfluenzae (n = 8) 100% M. catarrhalis (n = 7) 100% Klebsiella pneumoniae (n = 3) Levofloxacin eradication rates: 100% S. pneumoniae (n = 22) 100% H. influenzae (n = 18) 100% S. aureus (n = 3)
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Levofloxacin 200 mg qd IV/PO

100

The Annals of Pharmacotherapy : 1998 March, Volume 32, pg 320 -336

Comparative Clinical trials

Infection CAP Regimens Levofloxacin200 mg bid po Ofloxacin AECB 200 mg tid po % Clinical Cure 94.4 (17/18) 90 (18/20) 95.2 (20/21) 95.8 91.8 (98/107) % Bacterial Cure 93.3 89.5 93.3 89.5 100
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Levofloxacin200 mg bid po

Ofloxacin 200 mg tid po Sinusitis Levofloxacin 500 mg qd po

Comparative Clinical trials

%
Infection Regimens Clinical Cure 88.4

%
Bacterial Cure NA Comments 2.1% relapse at late follow-up 3.8% relapse at late follow-up

Sinusitis Levofloxacin 500 mg qd po

(236/267) Amoxicillin/Clavulanate 87.3 500/125mg tid po (234/268)

Acute pyeloLevofloxacin Nephritis 250 mg qd po 93 (83/90)

NA

95

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Salient Features
Nearly 100% bioavailability making it equivalent to IV administration & for sequential use in CAP.
Effective as monotherapy in serious CAP when

compared with standard regimens

High tissue penetration Higher t making it OD dosage Fewer side effects compared to 1st & 2nd generation quinolones
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Salient Features
Broad spectrum of activity covering gram +ve,
gram-ve, intracellular pathogens & anaerobic bacteria. Extended activity against respiratory pathogens such as Strep. pneumoniae, H. influenzae, M.

catarrhalis & intracellular pathogens

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Salient Features
2-4 times greater antibacterial activity than
Ofloxacin with fewer side effects Increased sensitivity to DNA gyrase compared to other quinolone (Ciprofloxacin) hence better activity against gram +ve & gram-ve organisms.

MIC equals bactericidal concentrations (MBC).

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Salient Features
Penetrates into neutrophils but does not interfere with its chemotaxis in vitro at concentrations upto 100 g/ml No significant changes in resistant pattern so far

reported because it has low frequency for mutations

Negligibly metabolised by the liver & mainly excreted unchanged in urine. Bioavailability is not affected by food
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Salient Features
Widely distributed in various tissues & fluids including inflammatory exudates. First quinolone to be approved for the treatment of acute sinusitis.

Phototoxicity is infrequent & is <1% while it is 8%

with Sparfloxacin.
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Salient Features
Incidence of seizures, tendinitis, pseudomembranous colitis, hemolytic episodes &

arrhythmias is rare to none.

Interactions with theophylline, NSAIDs, antihyperglycaemic drugs, Digoxin, Calcium carbonate, Probenecid, Cyclosporin are clinically insignificant & does not need dose adjustment.
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Glevo v/s Other Levofloxacin Brands

Advantage of having a Complete Range in Oral & I.V. form First to introduce 750 mg in Oral & I.V. form First to provide an Economical price after Tavanic First to introduce Glevo Eye / Ear Drops
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Glevo v/s Gatifloxacin

Bioavailability is 99% v/s Gatifloxacin 96% Higher Cmax & AUC (GLEVO 500 mg 5.08mcg/ml & 48mcg/ml v/s Gatifloxacin 3.86mcg/ml & 33.8mcg/ml) Unlike GLEVO, Gatifloxacin is not approved for 5 day short course treatment for CAP,CAP due to PRSP and MDRSP and even in Nosocomial Pneumonia Gatifloxacin causes Cardiac toxicity through changes in electrical conduction, GLEVO is least likely to cause this problem
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Glevo v/s Gatifloxacin (Contd.)

Gatifloxacin patients had 17 times greater risk of hyperglycemia compared to control (Macrolides & Cephalosporins) Gatifloxacin promotes insulin release & hypoglycemia by blocking the ATP-sensitive potassium channels of pancreatic islet cell to cause hypoglycemia Gatifloxacin triggers vacuolation (formation of small cavity in the cytoplasm or tissue) of pancreatic beta cells leading to reduced insulin levels & causes hyperglycemia Sales Training

Glevo v/s Gatifloxacin (Contd.)

Overall success rate in CAP - 98 % v/s 95% In MDR-TB Levofloxacin was used upto 1000mg in clinical trials with high safety whereas increasing the dosage of Gatifloxacin > 400 mg leads to severe adverse effects & treatment withdrawals Among fluoroquinolones, pseudomonal coverage is highest with GLEVO, hence ideal for Nosocomial Pneumonia
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Glevo v/s Gatifloxacin (Contd.)

Has lower incidence of adverse effects unlike Gatifloxacin Nausea = 1.2 % v/s 8 % Diarrhea = 1.2 % v/s 4 % Headache = 0.1 % v/s 4%

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Glevo v/s Roxithromycin

Has a wider spectrum than Roxithromycin (poor gram negative coverage & no action against atypical organisms) Offers higher potency than Roxithromycin against respiratory pathogens Effective against macrolide resistant strains (S. pneumoniae resistant to Erythromycin) Lesser cost of therapy Roxithromycin is only available in Oral OD dose convenience Sales Training

Glevo v/s Roxithromycin (Contd.)

Advantage of I.V./Oral ; Step down therapy possible Widely indicated for Sinusitis, other URTI cases, CAP, AECB & NP, UTI, Bacterial Prostatitis, SSTI, MDR-TB, Enteric Fever while Roxithromycin is used just for URTI & Uncomplicated SSTI

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Glevo v/s Cefadroxil

Offers wider spectrum of coverage against gram+ve & gram ve & atypical pathogens unlike Cefadroxil (mainly has action against gram +ve pathogens) Cefadroxil requires BID dosage, while GLEVO requires OD dosage Half the cost of therapy v/s Cefadroxil in URTIs Offers high success rates as compared to Cefadroxil in Sinusitis
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 Achieves double the AUC than twice daily dose of Ciprofloxacin Urinary excretion is 87 % as unchanged drug ,unlike with Ciprofloxacin it is only 25-35% Clinical success rates in complicated UTI : 92 % v/s 79 % Achieves 5 fold concentration in prostatic tissue than Ciprofloxacin, hence dosage is 500mg OD for 28 days v/s 500 mg BID for 28 days Convenience of OD dosage unlike Ciprofloxacin is BID Was associated with significantly greater pathogen susceptibility than Ciprofloxacin i.e. 94.7 % v/s 90.6 %
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Glevo v/s Ciprofloxacin

Glevo v/s Ciprofloxacin (Contd.)

Only fluoroquinolone for both gram+ve & gram-ve pathogens in Chronic Bacterial Prostatitis Has excellent activity against atypical pathogens, including Chlamydia trachomatis, Ureaplasma urealyticum & Mycoplasma hominis, unlike Ciprofloxacin Provides broad coverage of key pathogens in urogenital tract infection as compared to Ciprofloxacin Safety confirmed by > 10 years of Clinical experience & 300 million prescriptions
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Glevo v/s Norfloxacin

Excretion of drug as unchanged in urine with Norfloxacin is 26-32 %, while with GLEVO is 87 % Hence, ideal for UTI Convenience of OD dosage, unlike Norfloxacin requires a BID dosing

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