This document summarizes information about the antibiotic Avalox (moxifloxacin) presented over multiple slides:
1) Avalox has a novel molecular structure that allows it to act on two bacterial targets, minimizing resistance. It demonstrates broad-spectrum in vitro activity against Gram-positive and Gram-negative respiratory pathogens.
2) Clinical studies showed Avalox to be effective in treating complicated skin and skin structure infections when administered sequentially via IV then oral routes, with clinical cure rates comparable to piperacillin-tazobactam/amoxicillin-clavulanate.
3) For diabetic foot infections specifically, clinical cure rates for Avalox were 68% compared to 61% for the
Moxifloxacin Hcl....A market analysis of the API in IndiaSunil Kumar
The presentation is on the market report of Moxifloxacin Hcl API in India.
The presentation includes :---
1. Introduction
2. Moxiflxoacin Hcl
3. Moxifloxacin Hcl market overview
4.Total Market Size by Value in INR
5. Total Market Size by Volume
6. Average Market Price INR/Kg
7. Domestic Market Size by Value in INR
8. Domestic Market Size by Volume
9. Domestic Market Average Price in INR/Kg
10. Export Market Size by Value in INR
11. Export Market Size by Volume
12. Export Market Price in INR/Kg
13. Import Market by Value in INR
14. Import Market Size by Volume
15. Import Average Price in INR/Kg
16. Market Share in 2014
17. Export Market Share by Value in 2014
18. Export Market Share by Volume in 2014
19. Export Market Average Price INR/Kg in 2014
20. Domestic Vs Export Market Ratio by Value
21. Domestic Vs Export Market Ratio by Volume
22. Projected Market by Value
23. Projected Market by Volume
24. Projected Average Market Price in INR/Kg
25. Projected Domestic Market by Value in INR
26. Projected Domestic Market by Volume
27. Projected Domestic Price/Kg in INR
28. Projected Export Market by Value in INR
29. Projected Export Market by Volume
30. Projected Average Export Market Price in INR/Kg
31. Projected Import by Value
32. Projected Import by Volume
33. Projected Average Import in INR/Kg
34. Other Important Conditional Projection
Feature, Advantage & Benefit of Cefixime and CefuroximeShuman Das
Cefixime is an oral third generation cephalosporin. On the other hand, Cefuroxime is a second generation cephalosporin antibiotic. There are lot of feature, Advangtage and Benefit of these antibiotic. Here this issue is discussed briefly.
Moxif (Moxifloxacin Hydrochloride Tablets) 400 mg film-coated tablets are used for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to Moxifloxacin.
Moxif is used to treat different types of bacterial infections of the skin, sinuses, lungs, or stomach. It is used to treat community acquired pneumonia, plague, bacterial sinusitis, and chronic bronchitis with bacterial infection.
Cephalosporins & other β lactam antibiotics & cell wall destructorsFarazaJaved
this ppt cover all 5 generations of cephalosporins and about beta lactam atibiotics and cell wall destructors data available till now. hope u ll find it useful.
Moxifloxacin Hcl....A market analysis of the API in IndiaSunil Kumar
The presentation is on the market report of Moxifloxacin Hcl API in India.
The presentation includes :---
1. Introduction
2. Moxiflxoacin Hcl
3. Moxifloxacin Hcl market overview
4.Total Market Size by Value in INR
5. Total Market Size by Volume
6. Average Market Price INR/Kg
7. Domestic Market Size by Value in INR
8. Domestic Market Size by Volume
9. Domestic Market Average Price in INR/Kg
10. Export Market Size by Value in INR
11. Export Market Size by Volume
12. Export Market Price in INR/Kg
13. Import Market by Value in INR
14. Import Market Size by Volume
15. Import Average Price in INR/Kg
16. Market Share in 2014
17. Export Market Share by Value in 2014
18. Export Market Share by Volume in 2014
19. Export Market Average Price INR/Kg in 2014
20. Domestic Vs Export Market Ratio by Value
21. Domestic Vs Export Market Ratio by Volume
22. Projected Market by Value
23. Projected Market by Volume
24. Projected Average Market Price in INR/Kg
25. Projected Domestic Market by Value in INR
26. Projected Domestic Market by Volume
27. Projected Domestic Price/Kg in INR
28. Projected Export Market by Value in INR
29. Projected Export Market by Volume
30. Projected Average Export Market Price in INR/Kg
31. Projected Import by Value
32. Projected Import by Volume
33. Projected Average Import in INR/Kg
34. Other Important Conditional Projection
Feature, Advantage & Benefit of Cefixime and CefuroximeShuman Das
Cefixime is an oral third generation cephalosporin. On the other hand, Cefuroxime is a second generation cephalosporin antibiotic. There are lot of feature, Advangtage and Benefit of these antibiotic. Here this issue is discussed briefly.
Moxif (Moxifloxacin Hydrochloride Tablets) 400 mg film-coated tablets are used for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to Moxifloxacin.
Moxif is used to treat different types of bacterial infections of the skin, sinuses, lungs, or stomach. It is used to treat community acquired pneumonia, plague, bacterial sinusitis, and chronic bronchitis with bacterial infection.
Cephalosporins & other β lactam antibiotics & cell wall destructorsFarazaJaved
this ppt cover all 5 generations of cephalosporins and about beta lactam atibiotics and cell wall destructors data available till now. hope u ll find it useful.
Levoflox (Levofloxacin Tablets) are used to treat bacterial infections of the skin, sinuses, kidneys, bladder, or prostate. Levofloxacin tablets are also used to treat bacterial infections that cause bronchitis or pneumonia, and to treat people who have been exposed to anthrax.
Esomeprazole Product Presentation for MPO's.
The primary uses of esomeprazole are gastroesophageal reflux disease, treatment and maintenance of erosive esophagitis, treatment of duodenal ulcers caused by H. pylori, prevention of gastric ulcers in those on chronic NSAID therapy, and treatment of gastrointestinal ulcers associated with Crohn's disease.
Therapeutic indications
Tavanic is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
• Acute bacterial sinusitis
• Acute exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Complicated skin and soft tissue infections
For the above-mentioned infections Tavanic should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections (see section 4.4)
• Chronic bacterial prostatitis
• Uncomplicated cystitis (see section 4.4)
• Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4)
Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The lectures in points :-
1- quinolones general information.
2-Fluoroquinolones action , side actions & interactions .
3-Fluroquinolones group members in detail .
4-Fluroquinolones in the clinical use .
5-Practical tips .
6-Rapid review .
7- Test yourself .
Buy Avelox Generic from GlobalDiscountDrugs.com, we are an online pharmacy offers Generic Medications at low price. We serve safe, effective medications and consider your health more than you. Order Now!
Veeprho Pharmaceuticals s.r.o. is a manufacturer and supplier of all impurities of Moxifloxacin as per pharmacopoeia RRT. We are also manufacturer and supplier of Moxifloxacin Impurity D, Moxifloxacin Impurity A, Moxifloxacin Impurity C, 8-Hydroxy Moxifloxacin and Methoxy Quinoline Ester Impurity.
Levoflox (Levofloxacin Tablets) are used to treat bacterial infections of the skin, sinuses, kidneys, bladder, or prostate. Levofloxacin tablets are also used to treat bacterial infections that cause bronchitis or pneumonia, and to treat people who have been exposed to anthrax.
Esomeprazole Product Presentation for MPO's.
The primary uses of esomeprazole are gastroesophageal reflux disease, treatment and maintenance of erosive esophagitis, treatment of duodenal ulcers caused by H. pylori, prevention of gastric ulcers in those on chronic NSAID therapy, and treatment of gastrointestinal ulcers associated with Crohn's disease.
Therapeutic indications
Tavanic is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
• Acute bacterial sinusitis
• Acute exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Complicated skin and soft tissue infections
For the above-mentioned infections Tavanic should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections (see section 4.4)
• Chronic bacterial prostatitis
• Uncomplicated cystitis (see section 4.4)
• Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4)
Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The lectures in points :-
1- quinolones general information.
2-Fluoroquinolones action , side actions & interactions .
3-Fluroquinolones group members in detail .
4-Fluroquinolones in the clinical use .
5-Practical tips .
6-Rapid review .
7- Test yourself .
Buy Avelox Generic from GlobalDiscountDrugs.com, we are an online pharmacy offers Generic Medications at low price. We serve safe, effective medications and consider your health more than you. Order Now!
Veeprho Pharmaceuticals s.r.o. is a manufacturer and supplier of all impurities of Moxifloxacin as per pharmacopoeia RRT. We are also manufacturer and supplier of Moxifloxacin Impurity D, Moxifloxacin Impurity A, Moxifloxacin Impurity C, 8-Hydroxy Moxifloxacin and Methoxy Quinoline Ester Impurity.
People buy from people that they like. If you understand the basic personality of each person you speak with and adapt your presentation to them, you close more business. Learn S4 and close more.
Formulation and evaluation of omeprazole floating tabletsmedicinefda
formulation and evaluation of omeprazole floating tablets, literature review and plan of work ,methods results and discussion,conclusion sample ppt http://www.medicinefda.com/
New Treatments for Severe HypercholesteremiaAllina Health
By Thomas Knickelbine, MD. New medication options for people with familial hypercholesteremia and statin intolerance: how they work, effectiveness, case examples and ongoing research. "We're getting to the point where we can offer just about anyone tools or treatments that will help reduce their risk of a cardiovascular event."
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Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
2. The Goal of Antimicrobial Therapy
Hit Early! Hit Hard!
Hit Appropriately!
A jump ahead 2
3. Agenda
Mode of Action
Spectrum of Activity
Tissue Concentration/In Vitro Activity
Clinical Efficacy
Important Safety Considerations
A jump ahead 3
4. Avalox® … Novel Molecular Structure
O OH
Moxifloxacin
F
O
H
N N
NH O 8-methoxy subgroup minimizes
H3C ability of Gram-positive bacteria to
H acquire resistance.
8-methoxy subgroup
Avalox® acts at two target sites to exert its bactericidal action:
• Topoisomerase II (DNA gyrase): mainly in Gram-negative bacteria
• Topoisomerase IV: mainly in Gram-positive bacteria
A jump ahead 4
5. Avalox® … Dual Target Action
Super coiled DNA
Topoisomerase
Ava
Ava
Relaxed DNA
llox
ox
Topoisomerase
Topoisomerase II (i.e. gyrase) in Gram-negative bacteria
Topoisomerase IV in Gram-positive bacteria
A jump ahead 5
6. Avalox MIC90s Against Common
Respiratory Pathogens
Organism Moxifloxacin
S. pneumoniae (PenS) 0.06-0.25
S. pneumoniae (PenR) 0.12-0.25
H. influenzae BL (–) 0.03-0.06
H. influenzae BL (+) 0.03-0.06
M. catarrhalis BL (–) 0.012-0.06
M. catarrhalis BL (+) 0.012-0.06
BL = β-lactamase; MIC = minimum inhibitory concentration (mg/L).
Blondeau JM. J Antimicrob Chemother. 1999;43(suppl B):1-11.
A jump ahead 6
7. Moxifloxacin: in vitro activity against
common Respiratory pathogens
MIC90 (mg/mL)
Organism Avalox Amoxicillin/
Levofloxacin Amoxicillin clavulanic Clarithromycin Cefuroxime
acid
Moxifloxacin
S. pneumoniae
0.06–0.25 1–2 0.03–0.06 0.03 0.03–0.25 0.06–0.25
(PenS)
S. pneumoniae
0.12–0.25 1–2 8 4 32–>256 8–16
(PenR)
H. influenzae BL
0.03–0.06 0.03–0.32 1 1–2 8–24 2–8
(–)
H. influenzae BL
0.03–0.06 0.03–0.47 8–128 1–2 8–16 2–4
(+)
M. catarrhalis BL
0.012–0.06 0.06 0.25 0.38 0.06–4 2
(–)
M. catarrhalis BL
0.012–0.06 0.06–0.094 >16 0.38 <0.06–0.38 3
(+)
PenS, penicillin-susceptible; PenR, penicillin-resistant; BL, β-lactamase
A jump ahead Blondeau. J Antimicrob Chemother 1999; 43(Suppl B): 1–11
7
8. Avalox® … Broad Spectrum of Activity
In vitro activity of Avalox® against pathogens commonly implicated in
uncomplicated SSSIs and cSSSIs.
Micro-organism MIC90
Gram-positive bacteria
S. aureus 0.03
S. Aureus (methicillin-sensitive)* 0.06
S. aureus (methicillin-resistant)
4
S. Pyogenes 0.25
S. Pyogenes 0.25
(constitutive resistance) S. 0.25
Pyogenes (inducible resistance) 0.25
S. pyogenes (M-
phenotype)
*Methicillin-sensitive = MIC ≤8.0 mg/l
Goldstein EJ, Antimicrob Agents Chemother 1997;41:1552–1557
Edlund C, Eur J Clin Microbiol Infect Dis 1998;17:193–195.
A jump ahead 8
9. Avalox® … Broad Spectrum of Activity
In vitro activity of Avalox® against pathogens commonly implicated in
uncomplicated SSSIs and cSSSIs.
Micro-organism MIC90
Enterobacteriaceae
Escherichia coli 0.015
Klebsiella pneumoniae 0.125
Proteus mirabilis 0.25
Enterobacter cloacae 0.06
Enterobacter spp. 0.062
Goldstein EJ, Antimicrob Agents Chemother 1997;41:1552–1557
Edlund C, Eur J Clin Microbiol Infect Dis 1998;17:193–195.
A jump ahead 9
10. Avalox® … Broad Spectrum of Activity
In vitro activity of Avalox® against pathogens commonly implicated in
uncomplicated SSSIs and cSSSIs.
Micro-organism MIC90
Anaerobes
Bacteroides fragilis 1.0
Clostridium perfringens 0.5
Peptostreptococcus spp. 1.0
Goldstein EJ, Antimicrob Agents Chemother 1997;41:1552–1557
Edlund C, Eur J Clin Microbiol Infect Dis 1998;17:193–195.
A jump ahead 10
11. Avalox® … Broad Spectrum of Activity
In vitro activity of Avalox® against aerobic and anaerobic isolates caused
by animal and human bites.
Micro-organism MIC90
Aerobes
Eikenella corrodens 0.06
Pasteurella canis –
P. multocida subsp. multocida 0.016
P. multocida subsp. septica 0.016
Pasteurella spp.* 0.03
Staphylococcus epidermidis 0.06
Staphylococcus spp.† –
EF-4b 0.25
Goldstein EJ, Antimicrob Agents Chemother 1997;41:1552–1557
A jump ahead 11
12. Avalox® … Broad Spectrum of Activity
In vitro activity of Avalox® against aerobic and anaerobic isolates caused
by animal and human bites.
Micro-organism MIC90
Anaerobes
F. nucleatum 4.0
Fusobacterium spp. 8.0
Prevotella heparinolytica
0.125
Prevotella spp.
0.5
Goldstein EJ, Antimicrob Agents Chemother 1997;41:1552–1557
A jump ahead 12
13. Rapid Penetration of Moxifloxacin Into
relevant Tissues
1000
100
Macrophages
Conc. (mg/l. mg/kg)
10
Epithelial lining fluid (ELF)
1 Bronchial Mucosa
Serum
0,1 MIC90 of S. pneumoniae and M. catarrhalis (0.12 mg/l)
MIC90 of H. influenzae (0.06 mg/l)
0,01
3 12 24 TIME (h)
Andrews J et al., 1998
A jump ahead 13
14. Avalox® … Rapid Tissue Penetration
10
Concentration of Moxifloxacin (mg/l)
8 7.6
6
4.6
4
3.1
2
1.7
1.0
*
0 **
Bone, Muscle Skin blister Subcutaneous Serum level
Spongiosa fluid tissue
* MIC90 ==0.25 mg/l, Enterococcus agalactiae, P. mirabilis, S.pyogenes
MIC90 0.5
mg/l, S. aureus, S.
faecalis
**
Gusinde A., et al., Klinik & Forschung 2004, 10 (suppl. 1):44-45
A jump ahead 14
15. Avalox® … Higher Conc. in Infected Tissue
Relative time (h) Concentration of
Moxifloxacin (mcg/l)
Relative time (h)
Concentrations measured in inflamed and normal tissue at the start of a 1-hour infusion of 400mg moxifloxacin I.v.
and at 30-minutes intervals thereafter in subjects with cSSSI (geometric means and SD, N=6)
Stass et al. Eur Congress Clin Microbiol Infect April 24 – 27, 2002, Milan,
Italy. Abstract O178
A jump ahead 15
16. Avalox® … Optimum Pharmacokinetics
Avalox® … Oral
Elimination half-life: ~12 hours
Bioavailability: ~ 91%
Protein binding
48 ± 2.5%
Tmax: 0.5 – 4 hours
Cmax (high): 3.1 - 4.5 mg/l
Following a 400 mg Oral single dose
A jump ahead 16
17. Avalox® … Optimum Pharmacokinetics
Avalox® … I.V.
Administration: I.V. drip within
1 hour
AUC value (high): 39 mg.h/L
Cmax (high) : 4.1 - 5.9 mg/L
Following a 400 mg Oral single dose
A jump ahead 17
18. Avalox® … Optimum Pharmacokinetics
Oral dose Urinary
Cmax (mg/L) T1/2 (hours)
(mg) recovery (%)
Avalox® 1,2 400 4.5 12.7 19
Levofloxacin3 750 5.7 7.6 87
Ciprofloxacin4 500 3.6 4 40–50
†
Data shown are for the doses used in ABS
1) AVALOX® tablets US prescribing information, 2007
2) AVALOX® tablets UK prescribing information, 2006
3) LEVAQUIN® tablets US prescribing information, 2007
4) CIPRO® tablets US prescribing information, 2007
A jump ahead 18
19. Avalox® …Fast Bacterial Eradication
Survival (%) Over 99% killing after 150 minutes
99%
Time (min)
Bactericidal activity of maxifloxacin at 1.0 mg/l against a clinical
isolate of staphybcoocus aureus in nutrient broth, sensitive to
moxi.oxacin (mic 0.05 mg/l)
Lister et al. Clin Infect Dis 2001; 32 (suppl) : S33-8
A jump ahead 19
21. Sequential intravenous/oral moxifloxacin versus intravenous
piperacillin-tazobactam followed by oral amoxicillin-
clavulanate for the treatment of complicated skin and skin
structure infection
Giordano P, Song J, Pertel P, Herrington J, Kowalsky S
Int J Antimicrob Agents 2005; 26: 357–365
A jump ahead 21
Dec-05
22. Study protocol
Study design: Prospective, randomized, double-blind, double-dummy,
multicenter study
Treatments: Sequential IV/oral moxifloxacin, 400 mg once daily
IV piperacillin-tazobactam, 3.0/0.375 g 6-hourly, followed by
oral amoxicillin-clavulanate, 800 mg, b.i.d
Duration: The total treatment duration: 7–14 days
The IV treatments were given for at least 3 days
Switch to oral therapy made at the discretion of the investigator
A jump ahead 22
23. Patients:
Disposition: 617 patients randomized
367 satisfied the criteria for evaluation of efficacy
601 evaluable for safety
Diagnosis: • Hospitalized patients aged ≥ 18 years
• Complicated skin and skin structure infections
- Ischemic ulcers
- Diabetic foot,
- Decubitus ulcers
- Major abscesses, carbuncles
- SSSIs needing surgery
- Deep soft tissue infections (including
surgical wounds),
- Human or animal bite infections
Expected to require ≥ 1 week of antibiotic treatment
Over half had polymicrobial infections
A jump ahead 23
25. Subset with Diabetic Foot Infections
Moxifloxacin IV/PO
Piperacillin-Tazobactam IV Amoxicillin-Clavulanate
80 75 PO 76
68 68
70 63
61
60
52 50
Patients (%)
50
40
30
20
10
0
Per investigator n/N Per investigator with Any foot infection + Any foot infection with
25/37 25/41 ulcer n/N 21/28 13/25 history of diabetes n/N ulceration + history of
28/41 29/46 diabetes n/N 22/29
*P=0.054
13/26
Efficacy-valid population.
n=number of patients with response of clinical cure; N=total number of
patients.
A jump ahead 25
27. Summary
Overall clinical cure rates were similar in the moxifloxacin (79%) and
comparator (82%) groups
• Differences in the clinical cure/eradication rates within subgroups could not
be attributed directly to the treatments
Moxifloxacin was as effective as the comparator in eradicating the most
common pathogens
In the treatment of cSSSIs, IV/oral moxifloxacin once daily is at least as
effective and well tolerated as IV piperacillin-tazobactam four times daily
followed by oral amoxicillin-clavulanate twice daily
Results from this study support the role of moxifloxacin as monotherapy
for the treatment of patients with moderate to severe DFI
A jump ahead 27
28. Avalox® …Fast Cure Rate
Avalox®
Amoxicillin Clavulanate
45%
20%
0% 10% 20% 30% 40% 50%
Clinical cure rate on day 7 in patients with cSSSIs (%)
n=29 patients; all diabetic foot infections, n.s.
Bogner JR et al., Chemother Journal, 13 (26) 2004
A jump ahead 28
29. Avalox® …Shorter Therapy
Avalox®
Amoxicillin Clavulanate
4.3 days
I.V. therapy
7 days
15 days
Hospitalization
19 days
17 days
General therapy
32 days
0 5 10 15 20 25 30 35
Duration of therapy in patients with cSSSIs (days)
n=29 patients; all diabetic foot infections, n.s.
Bogner JR et al., Chemother Journal, 13 (26) 2004
A jump ahead 29
31. Treatment with sequential (I.V. /oral) moxifloxacin was associated with faster
clinical improvement than was standard therapy for hospitalized patients with
community-acquired pneumonia who received initial parenteral therapy
Welte T, Petermann W, Schuermann D, Bauer TT, Reimnitz P and the MOXIRAPID
Study Group
Clin Infect Dis 2005; 41: 1697–1705
32. Study protocol
Prospective, multicenter, randomized, open-label,
controlled trial in Europe.
Interventions:
• Moxifloxacin, 400 mg, once daily, given IV for at least 3 days;
switch to oral at discretion of clinician; overall treatment duration
7–14 days.
• IV ceftriaxone, 2 g, once daily ± IV erythromycin, 1 g, every 6–8
hours (if ‘atypical’ pathogen was proven or suspected).
Clinical responses assessed at days 3–5, 7–14
(end of treatment) and 5–20 (test of cure) after final
dose.
A jump ahead 32
33. Study Design
Randomization
Moxifloxacin 400 mg once daily IV or orally for 7-14 days
Patients with
community acquired 3-5 Days 7-10 Days 5-20 Days
Pneumonia
Ceftriaxone 2gm IV once daily + erythromycin 1 gm 3-4 times
daily IV if atypical pathogen suspected for 7-14 days
Time of End of Test of cure
Base Line therapy 5-20 days after
therapy
switch
7-10 days the final dose
3-5 Days
Clinical infectious disease 2005:41:1697-705
A jump ahead 33
34. Patients
Aged ≥ 18 years.
Admitted to hospital within the last 5 days, with a diagnosis
of community-acquired pneumonia.
Requiring initial IV treatment.
161 per protocol patients received moxifloxacin.
156 per protocol patients received ceftriaxone (59 also
received erythromycin).
A jump ahead 34
35. Results: clinical success at test of cure
100
87.6 88.5
80 Moxifloxacin
Ceftriaxone ±
60 erythromycin
Patients (%)
40
20 141/161 138/156
0
Clinical cure
A jump ahead 35
36. Results: clinical success amongst elderly and more severe
CAP patients
Ceftriaxone ±
Moxifloxacin erythromycin P value
Fine class IV+V 77.8% 70.4% 0.534
(21/27) (19/27)
Age >74 years 81.5% 70.6% 0.326
(22/27) (24/34)
A jump ahead 36
37. Results: speed of defervescence
100 98 100
Moxifloxacin (n=82)
Patients with fever (%)
81
80
Ceftriaxone ±
65
61 erythromycin (n=74)
60
42 40
40 38
22
20 18
0
1 2 3 4 5
Duration of treatment (days)
Defervescence was more rapid for moxifloxacin (median 3 days) than with
ceftriaxone ± erythromycin (median 4 days; P < 0.003)
Fever: body temperature > 38.5°C
A jump ahead 37
38. Results: patient-reported relief from symptoms
Compared to ceftriaxone + erythromycin,
moxifloxacin-treated patients reported a consistently
faster improvement in signs and symptoms specific to
CAP
• Chest pain (P = 0.021)
• Weakness (P = 0.015)
• Sputum color (P = 0.002)
Median time to feeling better:
• Moxifloxacin: 3 days
• Ceftriaxone + erythromycin: 4 days
A jump ahead 38
39. Results: duration of hospitalization
Shorter mean duration of hospitalization with moxifloxacin
(P < 0.001)
• Moxifloxacin: 9.8 days.
• Ceftriaxone + erythromycin: 11.1 days.
A jump ahead 39
41. Conclusion
Sequential moxifloxacin is at least as effective in terms of clinical cure
as ceftriaxone ± erythromycin in the treatment of community-acquired
pneumonia requiring initial parenteral therapy.
Moxifloxacin is superior to ceftriaxone ± erythromycin in terms of:
• Speed of defervescence.
• Duration of hospital stay.
Moxifloxacin has advantages over ceftriaxone ± erythromycin in terms
of relief from symptoms like chest pain, weakness and sputum colour.
A jump ahead 41
42. Summary of clinical moxifloxacin experience in patients with
CAP:
Moxifloxacin;
Covers all the key pathogens including atypical and typical
species.
Accumulates in alveolar macrophages and epithelial lining
fluids.
Maintains bactericidal activity in macrophages.
Achieves clinical response 94.4%
bacteriological response 91%
with 400 mg once daily given for 10 days.
A jump ahead 42
43. Summary of clinical moxifloxacin experience in patients with
CAP (2)
Moxifloxacin
Has excellent clinical and bacteriological efficacy
independent from resistance to beta-lactams or
macrolides.
Has high clinical cure rates in polymicrobial community-
aquired pneumonia.
Offers clinical hints for a rapid onset of action.
A jump ahead 43
44. Avalox® … Metabolism & Elimination
Metabolites Elimination
Sulfo-compound (M-1) LIVER Hepatic ~ 60%
Acyl-glucuronide (M-2) inactive Renal ~ 40%
BILE
Parent + M-1, M-2
STOMACH
Enterohepatic cycling:
Parent + M-2
BLOOD KIDNEY
Fecal excretion:
M-1 (35% of dose)
Fecal excretion: unchanged Urine:
26% of dose M-1 (2.5% of dose)
M-2 (14% of dose)
Urinary excretion:
~ 20% of dose unchanged
A jump ahead 44
45. Avalox - Metabolism
®
• Avalox® is metabolised by conjugate formation
(Phase II metabolism), not by cytochrome P450
• The conjugates of Avalox® are pharmacologically
inactive (M1 and M2)
Hence, there is minimal risk of
drug–drug interactions during
A jump ahead
combination/concomitant therapy
45
46. Renal impairment
Pharmacokinetics of moxifloxacin p.o.
Mild-to-moderate renal dysfunction
• no clinically significant effect on PK*
Renally-impaired patients undergoing hemodialysis or peritoneal
dialysis
• PK after single-dose and at steady-state comparable to healthy subjects
and renally-impaired patients
No adjustments to dose or timing relative to hemodialysis or peritoneal
dialysis required
Stass et al 2002a,b,c
A jump ahead 46
47. Important Safety Considerations
Moxifloxacin is contraindicated in persons with a history of
hypersensitivity to moxifloxacin or any member of the
quinolone class of antimicrobial agents.
Anaphylactic reactions, some following the first dose, have
been reported in patients receiving quinolone therapy including
moxifloxacin.
The safety and effectiveness of moxifloxacin in pediatric
patients, adolescents (less than 18 years of age), pregnant
women, and lactating women have not been established.
A jump ahead 47
48. Moxifloxacin use in the elderly
Low risk of toxicity expected with MXF use in the elderly
• No CYP450 interactions, thus reduced risk of common drug-
drug interactions
• No need for dose adjustment in presence of mild-moderate
hepatic or severe renal dysfunction
MXF PK are unaffected by age and no dosage adjustments are
necessary
A jump ahead 48
49. Moxifloxacin
Interactions
No interaction with • calcium
• food / dairy products
• glyburide • p.o. contraceptives
• ranitidine • morphine
• theophylline
• itraconazole
• warfarin
• digoxin
Not metabolized by, nor affect, CYP 450 system
Decreased absorption with antacids (↓60% AUC) and iron
(↓40% AUC)*
*MXF should be taken at least 4 h before or 8 h after these agents
A jump ahead 49
50. Avalox® … Safety & Tolerability
Dose adjustment Dose adjustment
CYP450
for mild/moderate for severe renal
metabolism
hepatic impairment impairment
Avalox® 1 No No No
Levofloxacin2 Not stated No Yes
Caution and
Amoxicillin/ clavulanate 3 Not stated monitoring Yes
recommended
Cefuroxime axetil4 Not stated Not stated in SPC No
1) AVALOX® tablets UK prescribing information, 2006
2) TAVANIC® tablets UK prescribing information, 2006
3) AUGMENTIN® tablets US prescribing information, 2006
4) ZINNAT® tablets UK prescribing information, 2007
A jump ahead 50
51. Avalox® … Contraindications
Known hypersensitivity to moxifloxacin or other quinolones.
Pregnancy and lactation.
Children and adolescents.
Impaired liver function.
QTc-related contraindications.
A jump ahead 51
52. Avalox® … Dosage
Tablets 400 mg
I.V. 400 mg, 250 ml
A jump ahead 52
53. Avalox® … A jump ahead in the treatment of
SSSIs
Avalox® has many of the ideal features of an emperical treatment of CAP&SSSIs
Effective:
Broad spectrum of activity
Eradicates bacteria Fast
Highly active at sites of infection for 24 hrs.
High cure rates
Safe:
• Minimal interactions
• Low resistance potential
• Suitable for all adult patient types
• Well tolerated
Simple:
• Once-daily administration
• Short treatment duration
• Cost effectiveness
A jump ahead 53
Avalox ® possesses a novel 8-methoxy group at the 4-quinolone nucleus, giving it a distinctive molecular structure that confers significant improvements in antimicrobial activity, pharmacokinetics and pharmacodynamic features.
References: Blondeau JM, Felmingham D. In vitro and in vivo activity of moxifloxacin against community respiratory tract pathogens. Clin Drug Invest. 1999;18:57-78.
References: Blondeau JM, Felmingham D. In vitro and in vivo activity of moxifloxacin against community respiratory tract pathogens. Clin Drug Invest. 1999;18:57-78.
Suggest delete complicated erysipelas (however, should we add the figures to the ‘other’ row?)
Suggest delete some rows (probably Peptostreptococcus spp. and Prevotella spp.)
Gosh, these Germans like a snappy title eh? As I had to reduce the size of the title font to get it to fit on the slide, I also reduced the author/citation font to give the slide balance.
Need to adjust pink fill to correct colour.
I have ‘guessed’ the heights of the bars from the published figure (fig 2). Need to adjust pink fill to correct colour.
Need to adjust pink fill to correct colour.
Need to adjust pink fill to correct colour.
Description This slide summarizes the major aspects of moxifloxacin treatment in patients with CAP.
Description This slide summarizes the major aspects of moxifloxacin treatment in patients with CAP.
Data from a previously reported study have shown that there is no alteration in the pharmacokinetic profile of moxifloxacin in patients with renal dysfunction (Stass et al 2002). In addition, more recent studies have shown that there is no marked alteration in the pharmacokinetics of moxifloxacin in patients undergoing hemo- or peritoneal dialysis. Thus, there is no need for dosage adjustments in patients with complete renal failure. References Stass H et al. Poster no. A1383. ICAAC 2002a. Stass H et al. Poster no. A1384. ICAAC 2002b. Stass H et al. Br J Clin Pharmacology 2002c; S3: 232-237.
Dosage adjustments of moxifloxacin are not expected to be necessary in the elderly, since there is a lack of a need for dosage adjustment in renal insufficiency and a reduced risk of drug-drug interactions with drugs commonly prescribed in elderly patients.
Fluoroquinolones may increase the plasma concentrations of a number of compounds, including digoxin, anticoagulants, cyclosporine and theophylline. Pharmacokinetic studies have shown that moxifloxacin does not interact with any of these, or with food / dairy products and other commonly prescribed medications. Antacids and iron salts interfere with gastrointestinal absorption of fluoroquinolones, resulting in decreased serum levels. When moxifloxacin is administered concomitantly with antacids, absorption is decreased by 60% of the normal AUC, and in combination with iron, moxifloxacin absorption is decreased by 40% of the AUC. It is therefore recommended that moxifloxacin is administered either 4 h before or 8 h after these agents. Many fluoroquinolones are inhibitors of cytochrome P450 enzyme systems and may produce potentially important drug interactions when administered with other drugs (Robson 1992). M o xifloxacin is not metabolized by, and does not affect this system, reducing the potential for drug interactions. Reference Robson RA. Am J Med 1992; 92: 22S-25S.