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Product Info Mode of Action Indication Dose & Selling Points
Presentation On
Azithromycin
Azithromycin is a broad spectrum macrolide antibiotic. Azithromycin is an azalide, derived from
erythromycin, and a member of a subclass of macrolide antibiotics with bacteriocidal and
bacteriostatic activities.
Product Information Chemical Structure
Generic Name : Azithromycin
Specification : USP
Dosage Form : Tablet (3×4s) & Powder for Suspension
(15, 35 & 50 ml)
Composition : 500 mg per Tablet and
200 mg per 5 ml suspension.
Routes : Oral
Pregnancy Category : B
Suffix : -thromycin
Why Bacteria needs
protein?
For Bacteria survive it
requires protein for-
A. Reproduction
B. Growth
C. Repair and
D. Regulation of metabolism.
Which are coded by unique
genetic code present in DNA.
Bacterial Protein Synthesis-
There are two major steps in protein synthesis-
Transcription Translation
Bacterial
Protein
Synthesis
Firstly, the double stranded DNA molecule
must ‘unwind’ and ‘separate’ in the region
which will code the specific protein.
Transcription
Secondly, RNA polymerase selects only
one strand of the DNA.
Finally, mRNA is produced which is the
exact copy of the DNA segment.
Translation
Complete mRNA detaches from DNA
template and Ribosomes gets attached
to the mRNA.
Along the mRNA an alignment of tRNA
molecules occur in sequence. Each
tRNA carries an unique amino acid.
These amino acids joints together to
form a polypeptide chain which will
release finished protein molecule.
Mechanism of Action at a glance (Transcription & Translation)-
 mRNA is produced from Nucleus DNA
molecule through the interference of RNA
polymerase (Transcription).
 This mRNA act as a template and goes
out of the nucleus into the cytoplasm.
 Ribosomes present in cytoplasm binds
with mRNA molecule.
 A series of tRNA which individually carries
a certain amino acids binds with the
complex and creates a chain of amino
acids which is termed as “Protein”
(Translation).
How Azithromycin works
Azithromycin binds with the 50s
Ribosomal subunit during
Translation process.
Leading to inhibition of-
A.Transpeptidation
B. Translation
C. Chain elongation
And ultimately “Bacterial Protein
Synthesis”.
Mechanism of Action at a glance
Azithromycin
Binds with 50s ribosomal subunits of bacteria
Blocking the attachment of the transfer RNA-amino acid to the ribosome
Blocking of Bacterial Peptide elongation
Bacterial Protein synthesis is inhibited
Bacterial growth inhibited (Bacteriostatic Action)
Azithromycin Erythromycin
Topic
Cardiac & GI
side effects Less More
Drug-Drug
Interactions
Less More
Half Life 11-14 hr single dose, 68 hr
multiple dose
1.5-2 hr
Administration Orally better & can be taken with
or without food.
Orally less & should be taken
without food.
Activity in case of
Gram(-) Bacteria Higher Lower
Azithromycin VS Erythromycin
Clinical Study Efficacy Against Pathogens
A.Gram Positive Aerobes :
1. Step. Pneumoniae
2. MSSA (methicillin-
susceptible Staphylococcus
aureus)
3. Diphtheria (caused by
Corynebacterium)
*Except Enterococcus
B. Gram Negative Aerobes :
1. M.catarrhalis
2. H. influenzae
3. B. pertussis
4. N.Gonorrhea
5. Campylobacter
6. Salmonella typhi
7. H.pylori
*Not useful against
Enterobacteriacae
Indications
A. Enteric Fever : Typhoid Fever
Typhoid fever, also known as typhoid, is
a disease caused by Salmonella serotype
Typhi bacteria. Symptoms may vary from
mild to severe, and usually begin 6 to 30
days after exposure. Often there is a
gradual onset of a high fever over several
days.
This is commonly accompanied by-
 Weakness,
 Abdominal pain,
 Constipation,
 Headaches and
 Mild vomiting.
Fig : Salmonella typhi
B. RTI :
Respiratory tract infection (RTI) is defined as
any infectious disease of the upper or lower
respiratory tract.
1. Bronchitis : Bronchitis is an inflammation
of the lining of your bronchial tubes, which
carry air to and from your lungs.
2. Pneumonia : Pneumonia is an
inflammatory condition of the lung primarily
affecting the small air sacs known as alveoli.
3. Sinusitis :
Sinusitis is an inflammation or
swelling of the tissue lining the
sinuses. Sinuses become blocked and
filled with fluid.
4. Pharyngitis :
Pharyngitis is inflammation of the pharynx,
which is in the back of the throat. It’s most
often referred to simply as “sore throat.”
5. Tonsillitis :
Tonsillitis is inflammation of the tonsils, two
oval-shaped pads of tissue at the back of the
throat — one tonsil on each side.
C. Acute Otitis Media :
Acute otitis media is an inflammatory disease
which creates an infection of rapid onset that
usually presents with pain in the middle ear..
D. Other Complications may include :
 SSTI (Skin & Soft Tissue Infection),
 Dental Pain,
 STD : Syphilis, Gonorrhea etc.
• Adult : 500 mg orally once daily for 7 days or more
depending on the indication.
 : 1 gm orally as a single dose.
• Child : 10mg/kg body wt. orally in a single dose once
daily for 5 to 7 days.
 Azithromycin should be taken at least 1 hour before or 2 hours
after meal.
Side
Effects
Diarrhea
Nausea
&
Vomiting
Loss of
appetite
Headache &
Dizziness
Vision
Disturbance
& Rashes
Low Blood
cell count &
Hemoglobin
 Never skip azithromycin as it
may increase the risk of
further infection or resistance
to it.
Full
Course
 Do not take antacids within 2 hours
before or after taking azithromycin
because antacids reduces the
effectiveness of azithromycin.
Antacids
Precautions
oAllergy to
Azithrom-
ycin.
oViral
Infections
(Flue or
Common
Cold).
oHistory of
Jaundice or
Other Liver
Diseases.
When not to take Azithromycin
Caution
required
treating
patients with -
Abnormal
Heart
Rhythm
Kidney
Disorder
Myasthenia
Gravis
Babies less
than 6
month age
 Drug Interaction
 Antacids (E.g. Aluminium or Magnesium)
 Digoxin
 Warfarin
 Ciclosporin
 Tacrolimus
 Colchicine
 Ergot Alkaloids (E.g. Ergotamine or
Dihydroergotamine)
 Nelfinavir
 Cholesterol Lowering Agent (E.g. Simvastatin
or Atorvastatin)
 Rifabutin
 Amiodarone
 Sotalol
 Can be given with following drugs :
Ambroxol
Cefixime
Ceftriaxone
Fluconazole
Ornidazole
Secnidazole
Zinc
Lactobacillus
Pregnancy Category B
Azithromycin USP
500 mg Tab,
(15 ml,
35 ml, 50 ml)DS
Animal reproduction
studies have failed to
demonstrate a risk to
the fetus and there are
no adequate and well-
controlled studies
in pregnant women.
Target Doctors :
 For Tablet :
•Chest specialists
•Skin & VD specialist
•Medicine specialists
•ENT specialists
•Potential GPs
 Product positioning :
It’s a drug of choice in…
•RTIs
•Typhoid fever
 For dry suspension :
•Pediatricians
•Potential GPs
Lower
Treatment
Cost
Supply microb free
DM water with
mango flavor which
is highly palatable
Short Duration of
Therapy (5-7 d)
Highly
Effective
and Safe
Once Daily
Dose
Schedule
01 03 04 05
02
Selling Points
$
Prepared By,
Sabbir Ahmed
Stamford University
Bangladesh.

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Azithromycin

  • 1. Product Info Mode of Action Indication Dose & Selling Points Presentation On Azithromycin
  • 2. Azithromycin is a broad spectrum macrolide antibiotic. Azithromycin is an azalide, derived from erythromycin, and a member of a subclass of macrolide antibiotics with bacteriocidal and bacteriostatic activities. Product Information Chemical Structure Generic Name : Azithromycin Specification : USP Dosage Form : Tablet (3×4s) & Powder for Suspension (15, 35 & 50 ml) Composition : 500 mg per Tablet and 200 mg per 5 ml suspension. Routes : Oral Pregnancy Category : B Suffix : -thromycin
  • 3. Why Bacteria needs protein? For Bacteria survive it requires protein for- A. Reproduction B. Growth C. Repair and D. Regulation of metabolism. Which are coded by unique genetic code present in DNA. Bacterial Protein Synthesis- There are two major steps in protein synthesis- Transcription Translation Bacterial Protein Synthesis
  • 4. Firstly, the double stranded DNA molecule must ‘unwind’ and ‘separate’ in the region which will code the specific protein. Transcription Secondly, RNA polymerase selects only one strand of the DNA. Finally, mRNA is produced which is the exact copy of the DNA segment.
  • 5. Translation Complete mRNA detaches from DNA template and Ribosomes gets attached to the mRNA. Along the mRNA an alignment of tRNA molecules occur in sequence. Each tRNA carries an unique amino acid. These amino acids joints together to form a polypeptide chain which will release finished protein molecule.
  • 6. Mechanism of Action at a glance (Transcription & Translation)-  mRNA is produced from Nucleus DNA molecule through the interference of RNA polymerase (Transcription).  This mRNA act as a template and goes out of the nucleus into the cytoplasm.  Ribosomes present in cytoplasm binds with mRNA molecule.  A series of tRNA which individually carries a certain amino acids binds with the complex and creates a chain of amino acids which is termed as “Protein” (Translation).
  • 7. How Azithromycin works Azithromycin binds with the 50s Ribosomal subunit during Translation process. Leading to inhibition of- A.Transpeptidation B. Translation C. Chain elongation And ultimately “Bacterial Protein Synthesis”.
  • 8. Mechanism of Action at a glance Azithromycin Binds with 50s ribosomal subunits of bacteria Blocking the attachment of the transfer RNA-amino acid to the ribosome Blocking of Bacterial Peptide elongation Bacterial Protein synthesis is inhibited Bacterial growth inhibited (Bacteriostatic Action)
  • 9. Azithromycin Erythromycin Topic Cardiac & GI side effects Less More Drug-Drug Interactions Less More Half Life 11-14 hr single dose, 68 hr multiple dose 1.5-2 hr Administration Orally better & can be taken with or without food. Orally less & should be taken without food. Activity in case of Gram(-) Bacteria Higher Lower Azithromycin VS Erythromycin
  • 10. Clinical Study Efficacy Against Pathogens A.Gram Positive Aerobes : 1. Step. Pneumoniae 2. MSSA (methicillin- susceptible Staphylococcus aureus) 3. Diphtheria (caused by Corynebacterium) *Except Enterococcus B. Gram Negative Aerobes : 1. M.catarrhalis 2. H. influenzae 3. B. pertussis 4. N.Gonorrhea 5. Campylobacter 6. Salmonella typhi 7. H.pylori *Not useful against Enterobacteriacae
  • 11. Indications A. Enteric Fever : Typhoid Fever Typhoid fever, also known as typhoid, is a disease caused by Salmonella serotype Typhi bacteria. Symptoms may vary from mild to severe, and usually begin 6 to 30 days after exposure. Often there is a gradual onset of a high fever over several days. This is commonly accompanied by-  Weakness,  Abdominal pain,  Constipation,  Headaches and  Mild vomiting. Fig : Salmonella typhi
  • 12. B. RTI : Respiratory tract infection (RTI) is defined as any infectious disease of the upper or lower respiratory tract. 1. Bronchitis : Bronchitis is an inflammation of the lining of your bronchial tubes, which carry air to and from your lungs. 2. Pneumonia : Pneumonia is an inflammatory condition of the lung primarily affecting the small air sacs known as alveoli.
  • 13. 3. Sinusitis : Sinusitis is an inflammation or swelling of the tissue lining the sinuses. Sinuses become blocked and filled with fluid. 4. Pharyngitis : Pharyngitis is inflammation of the pharynx, which is in the back of the throat. It’s most often referred to simply as “sore throat.”
  • 14. 5. Tonsillitis : Tonsillitis is inflammation of the tonsils, two oval-shaped pads of tissue at the back of the throat — one tonsil on each side. C. Acute Otitis Media : Acute otitis media is an inflammatory disease which creates an infection of rapid onset that usually presents with pain in the middle ear.. D. Other Complications may include :  SSTI (Skin & Soft Tissue Infection),  Dental Pain,  STD : Syphilis, Gonorrhea etc.
  • 15. • Adult : 500 mg orally once daily for 7 days or more depending on the indication.  : 1 gm orally as a single dose. • Child : 10mg/kg body wt. orally in a single dose once daily for 5 to 7 days.  Azithromycin should be taken at least 1 hour before or 2 hours after meal.
  • 17.  Never skip azithromycin as it may increase the risk of further infection or resistance to it. Full Course  Do not take antacids within 2 hours before or after taking azithromycin because antacids reduces the effectiveness of azithromycin. Antacids Precautions
  • 18. oAllergy to Azithrom- ycin. oViral Infections (Flue or Common Cold). oHistory of Jaundice or Other Liver Diseases. When not to take Azithromycin
  • 20.  Drug Interaction  Antacids (E.g. Aluminium or Magnesium)  Digoxin  Warfarin  Ciclosporin  Tacrolimus  Colchicine  Ergot Alkaloids (E.g. Ergotamine or Dihydroergotamine)  Nelfinavir  Cholesterol Lowering Agent (E.g. Simvastatin or Atorvastatin)  Rifabutin  Amiodarone  Sotalol  Can be given with following drugs : Ambroxol Cefixime Ceftriaxone Fluconazole Ornidazole Secnidazole Zinc Lactobacillus
  • 21. Pregnancy Category B Azithromycin USP 500 mg Tab, (15 ml, 35 ml, 50 ml)DS Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well- controlled studies in pregnant women.
  • 22. Target Doctors :  For Tablet : •Chest specialists •Skin & VD specialist •Medicine specialists •ENT specialists •Potential GPs  Product positioning : It’s a drug of choice in… •RTIs •Typhoid fever  For dry suspension : •Pediatricians •Potential GPs
  • 23. Lower Treatment Cost Supply microb free DM water with mango flavor which is highly palatable Short Duration of Therapy (5-7 d) Highly Effective and Safe Once Daily Dose Schedule 01 03 04 05 02 Selling Points $
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  • 25. Prepared By, Sabbir Ahmed Stamford University Bangladesh.