AZINEU

(AZITROMYCIN)
TABLETS/SUSPENSION.
250MG, 500MG
200MG/5ML(15ML)
 What are cells?
Cells are the
structural units of
the body. All living
things are made of
cells. The Amoeba is
one of the simplest
of living organisms;
it exists in water and
consists of only one
cell. Cell requires
food and oxygen for
living
 What is a tissue?
Cells combine to
form a tissue. If the
cells are building
bricks of the body,
the tissues must be
the walls
 What is organ?
An organ is a
collection of
tissues joined
in a structural
unit to serve
a common
function
 What is system?

Organs work
together to form an
organ system, such
as the Respiratory
System, Urinary
System. All of the
organ systems make
a living organism
Respiratory System
 Urinary System

Nephron
When trying to understand antibiotic
effect we have to first understand
bacteria and its types; this will help
us to understand mode of action of
antibiotic.
 Bacteriology

Microbiology
The science which deals with the study of micro organisms is
known as microbiology.
Micro-organism
Tiny creatures invisible to naked eyes, micro-organism can only
be seen by the help of a microscope.
Types of micro-organisms
Bacteria.
Viruses.
Fungi, yeast.
 Bacteria
Bacteria are
prokaryotes (unicellular
micro-organisms With
no membrane enclosed
nucleus) with simple
structures That typically
range in size from
About 0.5 to 20
micrometers. They
have a rigid cell wall
made of peptidoglycan,
which Maintains their
characteristic shape &
multiply by binary
fission
 Gram + Ve And Gram Ve
Bacteria
Bacteria are differentiated
on the basis of their ability to
hold or lose violet iodine
combinations in the
presence of alcohol.
Streptococcus pyogenes
Those which hold violet dye
are called gram +ve
bacteria. Those, which are
decolorized by alcohol &
take the red counter strain
are called gram ve bacteria.
Hemophilus ; Pseudomonas ;
Salmonella . E. coli.
An-aerobic bacteria: Which only survive in
the absence of oxygen. Clostridium tetani.

Aerobic bacteria: Which only survive in the

presence of oxygen. Staphylococcus,
Streptcoccus.

Facultative bacteria: That can live in the

presence of oxygen as well as in the absence
of oxygen. E. coli.
 Antibiotics
A substance, produced by or derived from other micro-organisms,
that can destroy or inhibit the growth of other microorganisms.
Antibiotics are Widely used in the prevention and treatment of
infectious diseases.

CLASSIFICATION OF ANTIBIOTICS

Antibiotics may be classified into two groups on the basis of their mode
of
action.
Bacteriostatic agents: Which inhibit the growth of bacteria.e.g.
Macrolides (Both)
Bactericidal agents: Which kill bacteria. e.g. Cephalosporins.
Antibiotics may be classified into two groups on the basis of their
coverage
spectrum.
Narrow spectrum antibiotics: Those which covers only gram-
positive or only gram negative bacteria.
Broad spectrum antibiotics: Those which are effective against
both gram-positive and gram-negative bacteria.

Classification Of Antimicrobial Agents By
Mechanism Of Action
MECHANISM OF ACTION AGENTS
Penicillins, Cephalosporins,
Inhibition of synthesis or damage to Monobactams,
cell Carbapenems, Bacitracin, Vancomycin,
wall Cycloserine
Inhibition of synthesis or damage to Polymyxins,Polyene antifungals
Cytoplasmic membrane.
Quinolones, Rifampin, Nitrofurantoin,
Inhibition of synthesis or metabolism Nitroimidazoles.
of
Nucleic acid
Macrolides (Azithromycin)
Inhibition of protien synthesis Aminoglycosides, Tetracyclines,
Choloramphenicol, Erythromycin,
Clindamycin, Spectinomycin.

Modification to energy metabolism Sulfonamides, Trimethoprim, Isoniazid.

Mechanism Of Action Of Antibacterial
Agents
 What Is Infection?
This is a pathological condition due to the growth of
micro- organism in a host or Successful invasion of
microorganism into the host causing pathogenic
condition
Describe Upper Respiratory Tract Infection
( Nose & Throat)?

Sinusitis: Inflammation of Sinus

 Upper Respiratory Tract
Infection
Tonsillitis Otitis
 Upper Respiratory Tract
Infection
Pharangitis
Laryngitis
 Lower Respiratory Tract
Infection

Bronchitis Broncho pneumonia

 Lower Respiratory Tract
Infection
Tracheatis
Empye
ma
 What Is Bronco-spasm?

It is the sudden
constriction
of bronchial tubes due
to
contraction of
involuntary
muscle in their walls.
 Skin & Soft Tissue Infection
Boils
Acute inflammatory condition surrounding the hair follicle caused by
Staphylococcus aureus , it has one opening for drainage in
contrast to carbuncle which has many openings.
Carbuncles
An infection of skin & subcutaneous tissues composed of clusters of
boil. Generally main cause is Staphylococcus aureus.
Pyoderma
An acute, specific infectious disease, caused by streptococcal
inflammation of skin & subcutaneous tissues, accompanied by
fever & constitutional disturbances
Erysipelas
A serious, toxin-spreading infection of dermis caused by
streptococcus pyogenes. Lesions are tender, red & inflamed with
sharply defined hardened area. Lesions frequently occur on face &
extremities
 ACNE VULGARIS
Acne vulgaris (or acne) is a common human skin
disease, characterized by areas of skin with seborrhea
(scaly red skin), papules (pinheads), pustules (pimples),
nodules (large papules) and possibly scarring. (Caused
by Staphyloccocus Epidermidis)
PAPULO-PUSTULAR LESIONS
Describing a rash that contains both papules and
pustules.
Pustule. A pustule is a small inflamed elevation of the
skin which is filled with pus.
Papule. A papule is similar to a pustule except that it
is solid in nature and does not contain pus.
 Enteric Fever/Typhoid Fever

Worldwide, typhoid fever affects roughly 17 million people

annually, causing nearly 600,000 deaths. The causative agent,
Salmonella enterica typhi (Salmonella typhi), is an obligate
parasite
that inhabits the lympathic tissues of the small intestine, liver,
spleen, and bloodstream of infected humans.
Infection of S. typhi leads to the development of typhoid, or
enteric fever. This disease is characterized by the sudden onset of
a sustained and systemic fever, severe headache, nausea, and
loss
of appetite.
Untreated typhoid fever cases result in mortality rates ranging
from 12-30% while treated cases allow for 99% survival.
 Nosocomial infections
Infections which are acquired
during hospitalization. Such
Infections are difficult to treat

Community-acquired
infections
Infection, which are acquired
by through normal contact
with the general community.
 Community Acquired Pnuemonia

Community-acquired pneumonia (CAP) is a term used

to describe one of several diseases in which individuals
who have not recently been hospitalized develop an
infection of the lungs (pneumonia).
CAP is a common illness and can affect people of all
ages.
CAP often causes problems like difficulty in breathing,
fever, chest pains, and a cough.
CAP occurs because the areas of the lung which absorb
oxygen (alveoli) from the atmosphere become filled
with fluid and cannot work effectively.
Causes of CAP include bacteria, viruses, fungi, and
parasites
 AECB (Acute Exacerbation of Chronic
Bronchitis)
AECB are episodes of difficulty in breathing in a person
with chronic bronchitis.
Acute Bacterial Sinusitis
Sinusitis is inflammation of the nasal sinuses, which
may be due to infection, or allergy.
Acute bacterial sinusitis is an infection of the sinus
cavities caused by bacteria, with symptoms that can last
for up to 4 weeks.
 Bronchitis

Bronchitis is an inflammation of the bronchi This

inflammation often results in the narrowing of
the bronchi which means that less air is able to
flow in and out of the lungs.
This condition often results in a persistent,
heavy cough accompanied by mucus production.
Chronic bronchitis is a long-term condition that
is characterized by excessive cough and mucus
production.
 Coverage Spectrum
Coverage Spectrum
Azithromycin has been shown to be active against most strains
of the following microorganisms.
Aerobic Gram-Positive Microorganisms
Staphylococcus aureus (skin infections, meningitis,
pneumonia)
Streptococcus agalactiae (septicemia)
Streptococcus pneumoniae (pneumonia)
Streptococcus pyogenes (skin infections)
Aerobic Gram-Negative Microorganisms

Haemophilus influenzae (influenza)

Moraxella catarrhalis (Ear,Respiratory infections)
"Other" Microorganisms
Chlamydia trachomatis (Urethritis, Prostatitis)
Beta-lactamase production should have no effect on
azithromycin activity.
 Azithromycin has been shown to be active in vitro and
in the prevention and treatment of disease caused by
the following microorganisms:
Mycobacteria
Mycobacterium avium (Tuberculosis)
Aerobic Gram-Positive Microorganisms
Streptococci
Aerobic Gram-Negative Microorganisms
Bordetella pertussis (Whooping cough)
Campylobacter jejuni (Gastroenteritis)
Legionella pneumophila (Legionella pneumonia)
Anaerobic Microorganisms
Clostridium perfringens (Tissue necrosis)
"Other" Microorganisms
Mycoplasma pneumoniae (CAP)
 Product Profile

Generic Name
Azithromycin

Drug Category
Macrolide
 Mechanism Of Action

Azithromycin prevents bacteria from growing by

interfering with their protein synthesis.
Azithromycin Inhibits RNA-dependent protein
synthesis by reversibly binding to the 50s ribosomal
subunits of susceptible microorganisms.
They induce dissociation of peptidyl transfer RNA
(tRNA) from the ribosome during the elongation
phase. Thus, RNA-dependent protein synthesis is
suppressed, and bacterial growth is inhibited.
Macrolides are mainly bacteriostatic but can be
bactericidal depending on bacterial sensitivity and
antibiotic concentration.
Mechanism Of Action
 Pharmacokinetics Properties

Bioavailability: 38%
Protein binding: 7%
Metabolism: Hepatic
Half-life: 68 hrs.
Time to peak: 2.1-3.2 hrs
Excretion: Renal
 Indications

Upper and lower respiratory tract infections.

Skin and soft tissue infections,
Otitis media,
Sexually transmitted diseases
Mild to moderate MDR typhoid fever
 Dosage And Administration
Adults: All infections; 500mg daily as single dose for three
days or alternatively, initially, 500mg as a single dose on day
one then followed by 250mg single daily dose for the next 4
days.
Children: 6 months and above, 10mg/kg as a single dose for 3
days.
Elderly: Same as adult. Sexually transmitted diseases; 1 gm as
a single dose.
(Azithromycin, a new macrolide antibiotic administered in a
dose of 1 gram once daily for 5 days is also useful for the
treatment of typhoid fever, The main advantage of
azithromycin is that they can be used in children and in
pregnant or nursing females.)
(Ref: Current Trends in management of Typhoid fever) MJAFI
(Medical Journal Armed Forces India)
Side Effects
Gastro-intestinal disturbances, allergic reaction & mild reduction in
neutrophil count.
Contraindications
Azinue is contraindicated in patients with known hypersensitivity to
azithromycin, erythromycin, or any macrolide. Azinue is also
contraindicated in Severe liver diseases
Precautions
Use with caution in renal failure/impairment:
Should be used with caution.
Use in hepatic impairment:
As the liver is the principle route of excretion of azithromycin, it
should not be used in patients with hepatic disease.
Pregnancy And Lactation
Azithromycin is considered a pregnancy Category B medicine by the
U.S. Food and Drug Administration (FDA), It should be used during
pregnancy and lactation unless absolutely needed.
 Drug Interactions
Azithromycin should be taken at least 1 hour before or 2 hours after the
antacid & food.
Azithromycin interferes with metabolism of cyclosporine (immunosuppresent)
so caution should be exercised before co-administration of these two drugs.
Presentation
Azinue 250mg Tablets are present in blister pack of 1x6s and
Azinue 500mg Tablets are present in blister pack of 1x6s and
Azinue Suspension (After reconstitution) is available in glass bottle of 15ml
(200mg/5ml)
Target Customers
Medical Specialists
ENT Specialists
GPs
Dermatologist (Skin Specialist)
Chest physicians
Pediatricians
 Product Differentiation

Duration of treatment with Azinue is shorter as

compared to conventional antibiotics(3 days)
Azinue suspension is well tolerated and safer in
children as compared to other antibiotics
Azinue has better safety profile than other
macrolides.
(Category B Drug)