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TIGECYCLINEBroad Spectrum Antibiotic
A Class Of Glycycline or Tetracycline Derivative
Content
• Introduction
• Indication
• Antimicrobial Spectrum Of Tigecycline
• Mode Of Action
• Clinical Studies On Complicated Skin Infections
• Clinical Studies On Complicated Intra Abdominal Infections
• Clinical Studies On Community Acquired Bacterial Pneumonia
• Pharmacokinetics / Pharmacodynamics
• Doses
• Target Market - Doctors / Institutional / Chemist Survey
Tigecycline
• Tigecycline: The Only FDA Approved Analog of Glycycline which is a
Derivative of Tetracycline.
• Tigecycline is Broad Spectrum Antibiotic
• It is Bacteriostatic in Antibiotic’s Classification
(i.e. It Inhibit and Stop the Growth Of Bacteria)
• FDA
Approved for the Treatment of Skin Infections : 2005
Approved for the Treatment of Intra-abdominal Infections : 2005
Approved for the Treatment of Community Acquired Pneumonia : 2009
Indications
Complicated Skin and Skin Structure
Infections (cSSSIs)
Complicated Intra-abdominal
Infections (cIAIs)
Community Acquired Bacterial
Pneumonia (CAP)
Animal or Human Bite, Ischemic
Ulcer, Post Surgical Infections, Soft
Tissue Infections.
Perforated Gastroduodenal Ulcers,
Small Bowel Perforation
Complicated Appendicitis
High Fever, Chills
Cough with Sputum, Shortness of Breath, Muscular Fatigue, Aches, Nausea, Vomiting, Low B.P,
Headache, Loss of Appetite. Mood Swings
Indications
Acute Myeloid Lukemia
Fever, Bone pain, Lethargy and fatigue, Shortness of breath, Pale skin, Frequent
infections, Easy bruising, Unusual bleeding, such as frequent
nosebleeds and bleeding from the gums.
Escherichia coli, Enterococcus faecalis (vancomycin-susceptible only),
Staphylococcus aureus (MRSA and methicillin-susceptible and resistant isolates),
Streptococcus pyogenes,
Streptococcus anginosus grp,
Streptococcus agalactiae,
or Bacteroides fragilis
E coli,
Enterococcus faecalis (vancomycin-susceptible only),
S aureus (methicillin-susceptible only),
Citrobacter freundii,
Enterobacter cloacae,
Klebsiella pneumoniae,
Streptococcus pneumonia (penicillin-susceptible isolates)
Haemophilus influenzae,
Legionella pneumophila
Antimicrobial Spectrum Of Tigecycline
Tigecyclines Mode Of Action
• Tigecycline, A Glycycline, Inhibits Protein Translation In
Bacteria By Binding To The 30S Ribosomal Subunit And
Blocking Entry Of Aminoacyl Trna Molecule In To The A Site Of
The Ribosome.
• The Substitution Pattern Is Not Present In Any Naturally
Occurring Or Semisynthetic Tetracycline And Imparts Certain
Microbiologic Properties To Tigecycline.
• Tigecycline Is Considered Bacteriostatic; However, Tygacil Has
Demonstrated Bactericidal Activity Against Isolates Of S.
Pneumoniae And L. Pneumophila.
• Tigecycline Is Not Affected By The Two Major Tetracycline-
resistance Mechanisms, Ribosomal Protection And Efflux.
Clinical Studies on Complicated Skin
Infections
Randomized, Double-blind, Active-controlled, Multinational,
Multicenter Studies
• These studies compared
TigecyclineL (100 mg i/v initial dose followed by 50 mg every 12 hours)
with Vancomycin (1 g i/v every 12 hours)/aztreonam (2 g intravenous
every 12 hours) for 5 to 14 days
• No. of Patients : 1116
• Patients Cured with Tigecycline were 566 and with combination are 550
• Duration : 14 days
• Nausea vomiting cause with Tigecycline / with combination elevated hepatic
aminotransferase
• Conclusion : Tigecycline is safe mono therapy then combination
https://scholar.google.com.pk/scholar?hl=en&as_sdt=0%2C5&as_vis=1&q=tigecycline+and+vancomycin+aztreonam&oq=tige
cycline+and+vancomycin+az#d=gs_qabs&u=%23p%3DCsMimYphEZkJ
Clinical Studies on Complicated Intra
Abdominal Infections
• These studies compared
Tigecycline (100 mg intravenous initial dose followed by 50 mg every 12 hours) with
imipenem/cilastatin (500 mg intravenous every 6 hours)
• Patients with complicated diagnoses including appendicitis, cholecystitis,
diverticulitis, gastric/duodenal perforation, intra-abdominal abscess, perforation
of intestine, and peritonitis were enrolled in the studies
• Complicated intra-abdominal infections (cIAI) remain challenging to treat because
of their polymicrobial etiology including multi-drug resistant bacteria. The
efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline
antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI.
• This study demonstrates that tigecycline is as efficacious as imipenem/cilastatin
in the treatment of patients with cIAI.
Randomized, Double-blind, Active-controlled, Multinational,
Multicenter Studies
https://www.ncbi.nlm.nih.gov/pubmed/16236177
Clinical Studies on Community Acquired
Bacterial Pneumonia
• These studies compared
Tigecycline (100 mg intravenous initial dose followed by 50 mg every
12 hours) with levofloxacin (500 mg intravenous every 12 or 24 Hours)
• No. of Patients : 428
• Patients who received at least one dose of study drug, 79% had CAP
of mild-moderate severity according to their Fine score.
• Clinical cure rates for the CE population were 88.9% for Tigecycline
and 85.3% for levofloxacin.
CAP
Tigecycline Levofloxacin
https://www.ncbi.nlm.nih.gov/pubmed/27754764
Randomized, Double-blind, Active-controlled, Multinational,
Multicenter Studies
Pharmacokinetics / Pharmacodynamics
Clinical Pharmacology
Single Dose Multiple Dosea
100 mg 50 mg every 12h
Cmax (mcg/mL) 1.45 (22%) 0.87 (27%)
Cmax (mcg/mL) 0.90 (30%) 0.63 (15%)
AUC (mcg·h/mL) 5.19 (36%) - -
AUC0-24h (mcg·h/mL) - - 4.70 (36%)
Cmin (mcg/mL) - - 0.13 (59%)
t½ (h) 27.1 (53%) 42.4 (83%)
CL (L/h) 21.8 (40%) 23.8 (33%)
CLr (mL/min) 38.0 (82%) 51.0 (58%)
Vss (L) 568 (43%) 639 (48%)
• Absorption ---
• Distribution --- protein binding 89%
• Metabolism --- Tigecycline is not
extensively metabolized
• Elimination --- 59% of the dose is
eliminated by biliary/fecal excretion,
and 33% is excreted in urine
Dosing and Uses
• Tigecycline is an initial dose (loading dose) is 100 mg, followed by
50 mg every 12 hours.
• Intravenous infusions of TYGACIL should be administered over
approximately 30 to 60 minutes every 12 hours.
Recommended Duration Of Treatment With
Tigecycline :-
• complicated skin and skin structure infections or for complicated
intra-abdominal infections - 5 to 14 days
• community-acquired bacterial pneumonia - 7 to 14 days.
The duration of therapy should be guided by the severity and site of the infection and
the patient’s clinical and bacteriological progress.
Dose May Adjust
for Vent Patient
Target Market
• Board Certified Physician – Who Provide Special Care For Critically ill
Patients. (Critical Care Physicians)
• Competitors
• Analyzer
• Doctor’s Survey
• Institutional Survey
• Chemist Survey
Did
Presented By:
Dr. Muhammad Jawwad Shamsi
(Pharm-D)
Email: phrshamsi@gmail.com
Cell : +92-344-1313271

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Tigecycline

  • 1. TIGECYCLINEBroad Spectrum Antibiotic A Class Of Glycycline or Tetracycline Derivative
  • 2. Content • Introduction • Indication • Antimicrobial Spectrum Of Tigecycline • Mode Of Action • Clinical Studies On Complicated Skin Infections • Clinical Studies On Complicated Intra Abdominal Infections • Clinical Studies On Community Acquired Bacterial Pneumonia • Pharmacokinetics / Pharmacodynamics • Doses • Target Market - Doctors / Institutional / Chemist Survey
  • 3. Tigecycline • Tigecycline: The Only FDA Approved Analog of Glycycline which is a Derivative of Tetracycline. • Tigecycline is Broad Spectrum Antibiotic • It is Bacteriostatic in Antibiotic’s Classification (i.e. It Inhibit and Stop the Growth Of Bacteria) • FDA Approved for the Treatment of Skin Infections : 2005 Approved for the Treatment of Intra-abdominal Infections : 2005 Approved for the Treatment of Community Acquired Pneumonia : 2009
  • 4. Indications Complicated Skin and Skin Structure Infections (cSSSIs) Complicated Intra-abdominal Infections (cIAIs) Community Acquired Bacterial Pneumonia (CAP) Animal or Human Bite, Ischemic Ulcer, Post Surgical Infections, Soft Tissue Infections. Perforated Gastroduodenal Ulcers, Small Bowel Perforation Complicated Appendicitis High Fever, Chills Cough with Sputum, Shortness of Breath, Muscular Fatigue, Aches, Nausea, Vomiting, Low B.P, Headache, Loss of Appetite. Mood Swings
  • 5. Indications Acute Myeloid Lukemia Fever, Bone pain, Lethargy and fatigue, Shortness of breath, Pale skin, Frequent infections, Easy bruising, Unusual bleeding, such as frequent nosebleeds and bleeding from the gums.
  • 6. Escherichia coli, Enterococcus faecalis (vancomycin-susceptible only), Staphylococcus aureus (MRSA and methicillin-susceptible and resistant isolates), Streptococcus pyogenes, Streptococcus anginosus grp, Streptococcus agalactiae, or Bacteroides fragilis E coli, Enterococcus faecalis (vancomycin-susceptible only), S aureus (methicillin-susceptible only), Citrobacter freundii, Enterobacter cloacae, Klebsiella pneumoniae, Streptococcus pneumonia (penicillin-susceptible isolates) Haemophilus influenzae, Legionella pneumophila Antimicrobial Spectrum Of Tigecycline
  • 7. Tigecyclines Mode Of Action • Tigecycline, A Glycycline, Inhibits Protein Translation In Bacteria By Binding To The 30S Ribosomal Subunit And Blocking Entry Of Aminoacyl Trna Molecule In To The A Site Of The Ribosome. • The Substitution Pattern Is Not Present In Any Naturally Occurring Or Semisynthetic Tetracycline And Imparts Certain Microbiologic Properties To Tigecycline. • Tigecycline Is Considered Bacteriostatic; However, Tygacil Has Demonstrated Bactericidal Activity Against Isolates Of S. Pneumoniae And L. Pneumophila. • Tigecycline Is Not Affected By The Two Major Tetracycline- resistance Mechanisms, Ribosomal Protection And Efflux.
  • 8. Clinical Studies on Complicated Skin Infections Randomized, Double-blind, Active-controlled, Multinational, Multicenter Studies • These studies compared TigecyclineL (100 mg i/v initial dose followed by 50 mg every 12 hours) with Vancomycin (1 g i/v every 12 hours)/aztreonam (2 g intravenous every 12 hours) for 5 to 14 days • No. of Patients : 1116 • Patients Cured with Tigecycline were 566 and with combination are 550 • Duration : 14 days • Nausea vomiting cause with Tigecycline / with combination elevated hepatic aminotransferase • Conclusion : Tigecycline is safe mono therapy then combination https://scholar.google.com.pk/scholar?hl=en&as_sdt=0%2C5&as_vis=1&q=tigecycline+and+vancomycin+aztreonam&oq=tige cycline+and+vancomycin+az#d=gs_qabs&u=%23p%3DCsMimYphEZkJ
  • 9. Clinical Studies on Complicated Intra Abdominal Infections • These studies compared Tigecycline (100 mg intravenous initial dose followed by 50 mg every 12 hours) with imipenem/cilastatin (500 mg intravenous every 6 hours) • Patients with complicated diagnoses including appendicitis, cholecystitis, diverticulitis, gastric/duodenal perforation, intra-abdominal abscess, perforation of intestine, and peritonitis were enrolled in the studies • Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI. • This study demonstrates that tigecycline is as efficacious as imipenem/cilastatin in the treatment of patients with cIAI. Randomized, Double-blind, Active-controlled, Multinational, Multicenter Studies https://www.ncbi.nlm.nih.gov/pubmed/16236177
  • 10. Clinical Studies on Community Acquired Bacterial Pneumonia • These studies compared Tigecycline (100 mg intravenous initial dose followed by 50 mg every 12 hours) with levofloxacin (500 mg intravenous every 12 or 24 Hours) • No. of Patients : 428 • Patients who received at least one dose of study drug, 79% had CAP of mild-moderate severity according to their Fine score. • Clinical cure rates for the CE population were 88.9% for Tigecycline and 85.3% for levofloxacin. CAP Tigecycline Levofloxacin https://www.ncbi.nlm.nih.gov/pubmed/27754764 Randomized, Double-blind, Active-controlled, Multinational, Multicenter Studies
  • 11. Pharmacokinetics / Pharmacodynamics Clinical Pharmacology Single Dose Multiple Dosea 100 mg 50 mg every 12h Cmax (mcg/mL) 1.45 (22%) 0.87 (27%) Cmax (mcg/mL) 0.90 (30%) 0.63 (15%) AUC (mcg·h/mL) 5.19 (36%) - - AUC0-24h (mcg·h/mL) - - 4.70 (36%) Cmin (mcg/mL) - - 0.13 (59%) t½ (h) 27.1 (53%) 42.4 (83%) CL (L/h) 21.8 (40%) 23.8 (33%) CLr (mL/min) 38.0 (82%) 51.0 (58%) Vss (L) 568 (43%) 639 (48%) • Absorption --- • Distribution --- protein binding 89% • Metabolism --- Tigecycline is not extensively metabolized • Elimination --- 59% of the dose is eliminated by biliary/fecal excretion, and 33% is excreted in urine
  • 12. Dosing and Uses • Tigecycline is an initial dose (loading dose) is 100 mg, followed by 50 mg every 12 hours. • Intravenous infusions of TYGACIL should be administered over approximately 30 to 60 minutes every 12 hours. Recommended Duration Of Treatment With Tigecycline :- • complicated skin and skin structure infections or for complicated intra-abdominal infections - 5 to 14 days • community-acquired bacterial pneumonia - 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress. Dose May Adjust for Vent Patient
  • 13. Target Market • Board Certified Physician – Who Provide Special Care For Critically ill Patients. (Critical Care Physicians) • Competitors • Analyzer • Doctor’s Survey • Institutional Survey • Chemist Survey Did
  • 14. Presented By: Dr. Muhammad Jawwad Shamsi (Pharm-D) Email: phrshamsi@gmail.com Cell : +92-344-1313271