Cefim

Medico Marketing
Training
 Bacterial Classification

• Aerobic
• - Organisms requiring oxygen for growth

• Anaerobic

• - Organisms that can survive in the absence or

in presence of very little oxygen
 Bacterial Classification

Gram Positive Gram Negative

Definition The bacteria which get stained by The bacteria which do not get stained
retaining the crystal-violet iodine
complex
Appearance Purple Pink
Cell wall High peptidoglycan content Low peptidoglycan content

Types of bacteria
- Cocci
a) Aerobic Staphylococcus spp. (Staphylococus
aureus), Streptococus spp. Neiseria spp.(N.meningitidis),
(Streptococus pneumoniae) Moraxella spp.(M.Catarrhalis),
b) Anaerobic
Peptostreptococcus Medically not important
- Bacilli
Listeria spp.(L.monocytogenes) Enterobacteriaceae spp.
a) Aerobic
(E.coli), Haemophilus spp. (H.influenza),
Vibrio spp. (V.cholerae),

Bacteroids spp.
b) Anaerobic Clostridium spp. (C.perfringens), Fusobacterium spp.
 Bacterial-Infections

Gram Positive Cocci

-S.auerus: Skin and soft tissue infections

-S.pneumoniae: RTI, Pneumonia, Meningitis
-S.pyogenes: RTI, SSTI

Gram Negative Cocci

-N.meningitidis: RTI, Meningitis,

Septicaemia
-N.gonorrhoeae: Gonorrhoea
 Bacterial-Infections

Gram Negative Bacilli

-H.influenza: RTI, Meningitis
-E.coli: UTI, Gastroenteritis
-Klebsiella: UTI, Pneumonia, wound infections
-Proteus: UTI, wound infections
-Salmonella: Typhoid, Gastroenteritis
-Pseudomonas: UTI, wound
-Shigella: Bacterial dysentery
-Chlamydia: STD, Pelvic infections
-Bacteroids: Intra –abdominal, bone infections

Gram Positive Bacilli

-Clostridium: Gas gangrene, Tetanus
-Listeria: Rare, mainly GI problems
 Important Definitions

Antibiotic: Chemical substances which inhibit or kill growing organisms

(bacteria/antibacterial)

Beta Lactamse: Is an enzyme secreted by some bacterial strains which

inactivates the beta lactam antibiotics by breaking their beta lactam ring

MIC: Minimum Inhibitory Concentration is the minimum concentration

required to inhibit the growth of microbes

MBC: Minimum Bactericidal Concentration is the concentration required

to kill the microbes
 Cephalosporin Classification

• Classified by ‘Generations’

• First, Second, Third and Fourth Generations

• Differentiation based on antibacterial spectrum and pharmacokinetic profile

• Progression from first to fourth generation the gm-ve coverage increases with
lesser gm+ve coverage

• Also efficacy against beta-lactamase strains increases

•Act by inhibiting the final stages in synthesis of peptidoglycans in bacterial cell

wall
• Active ingredient:
– Cefixime, the first oral 3rd generation cephalosporin
– Antimicrobial spectrum: comparable to parenteral third generation
cepahlosporins like ceftriaxone, cefotaxime etc.
– Synthesized and developed by Fujisawa, Japan and in market since
1987
– In 1999, it was available for Rx in 80 countries across the world
Mode of action

Inhibits the third and final stage of bacterial cell wall synthesis by
preferentially binding to specific penicillin-binding proteins (PBPs) i.e.
transpeptidases that are located inside the bacterial cell wall.

- bactericidal, disrupt the synthesis of the peptidoglycan layer of

bacterial cell walls.
 Broad Spectrum

Gm positive Gm negative

E. coli, Klebsiella, P. mirabilis,

Staph, Strep, S. Pneumoniae,
H. influenzae,
Group A Strept.
N. gonorrhoeae, and
Moraxella (Branhamella)
catarrhalis
Pharmacokinetics
• Administered orally
• Slowly absorbed from the GI tract.
• Food in the stomach slows the rate but not the extent of cefixime absorption
• Bioavailability is 40—50%
• Peak serum levels occur in 2—6 hours
• 65—70% of the circulating drug is protein-bound
• Penetrates urine; bile; sputum; maxillary sinus mucosa; and middle ear, bronchi, prostatic,
and blister fluid. It also penetrates inflamed meninges and crosses the placenta.
• Excreted into the urine primarily via glomerular filtration and tubular secretion
• Elimination half-life of cefixime is 3—4 hours
 The pharmacodynamics
A n t ib io t ic c o n c e n t r a t io n

Above MIC:
near constant kill rate
irrespective of drug
concentration

Killing begins when

MIC is reached

Below MIC:
regrowth begins when
Time above MIC Time levels fall below MIC
Pharmacokinetics and OD advantage
UTI - Definitions
 MICs90 of Oral
Cephalosporins against
Common Pathogens
Cephalosporin H. influenzaea M.catarrhalisa E.coli S.pneumoniae S.aureusb Gp A streptococci

Cephalexin 16 16 16 4 4 1
Cefadroxil 16 4 16 8 8 0.5
Cefaclor 4 2 4 2 16 0.25
Cefuroxime 2 2 4 0.12 2 0.25
axetil
Cefixime 0.25 0.25 0.5 1 > 16 0.25
Cefpodoxime 0.12 0.5 1 0.03 2 < 0.06
Ceftibuten 0.12 2 0.5 4 > 16 1

a
Includes -lactamase and non--lactamase strains
b
Methcillin-sensitive, penicillin-resistant strains
Infectious Diseases in Clinical practice, 1994, Vol.3, No.1
 Cefixime

MIC Values
• H.influenzae: 0.04mcg/ml

• M.catarrhalis: 0.12mcg/ml
• S.pneumoniae: 0.27mcg/ml
• Enterobacteriacae: 1mcg/ml
• N.gonorrhea: 0.5mcg/ml
 Indications

Urinary Tract Infection -

Inflammation and infection of urinary tract organs
Escherichia coli, Klebsiella spp. Proteus spp.

Cystitis: bladder

Pyelonephritis: Kidney,
renal pelvis

Prostatitis: the
prostate gland -
acute / chronic

Urethritis: Urethra
(STDs)
 Urinary Tract Infections

Uncomplicated: infection without underlying renal or neurologic disease

Complicated: with underlying structural, medical or neurologic disease

Symptoms :

- Dysuria
- Burning sensation
- Increased frequency
- Hematuria
- Fever
- Nausea/Vomiting (pyelonephritis)
- Flank pain (pyelonephritis)
- Cloudy urine

More common in female (short urethra)

than male
 Cefim in Urinary T Inf.
Susceptibility of most
common UTI pathogens

Clinical Efficacy
 Indications

Respiratory Tract Infection (RTIs)

H.influenzae, M. catarrhalis, S. pneumoniae

a. Upper Respiratory Tract Infections

• Otitis media (infection & inflammation of middle ear)
• Sinusitis (infection & inflammation of sinuses)
• Pharyngitis (infection & inflammation of pharynx)
• Tonsillitis (infection & inflammation of tonsil)

b. Lower Respiratory Tract Infections

• Acute bronchitis (infection & inflammation of bronchi)

• Acute exacerbations of chronic bronchitis

 Cefim in URTI
Otitis Media
 Cefim in URTI
In Otitis Media
Cefim in URTI

MICs against
Moraxella
catarrhalis,
one of the
most common
pathogen for
URTI
Cefim in URTI

MICs against
Haemophilus
Influenzae,
one of the
most common
pathogen for
URTI
 Cefim in URTI-Phayngitis/Tonsillitis

Most common pathogen…group A streptococci

Most of strains susceptible at 200mg BD or 400mg OD
Cure/Improvement rates = more than 90%

In another premarketing clinical trial…

• Favorable clinical result achieved in 99% cases
• Bacterial eradication: 93% similar to amoxicillin
 Cefim in LRTI

In Lower Resp. Tract infections Chronic Bronchitis

Dosage: 400mg once daily for 10days

 Indications

Gonorrhea ( Uncomplicated)
STD causing urethritis in males, PID in females Neisseria gonorrhea,
 Cefixime

Dosage

• Gonorrhoea, 400 mg single oral dose of

cefixime

• RTI/UTI, 400 mg as a single or divided

doses

• Pediatric, 8mg/kg/day (>6months)

Ideal for Switch therapy

• Similar coverage profile

• Efficacy and safety
• Improves patient compliance
• Reduced treatment cost
• Reduced hospital stay
 Marketing Communications

Contents-
-Positioning and Payline

-Why its needed?

-Why apple?

-Communication strategies
 Positioning and Payline

In RTI & UTI

Why RTI and UTI – Cefixime have proven high efficacy and success rate
in upper RTIs
Its has been most active against E.coli (UTI)

Focusing on Once-a-day dosage for Cefixime, that’s why Power of Once-a-

day
 Concept and Rationale

Need of Once A Day anti-infective:

Presently, in RTIs and UTIs,

most of the antibacterials used are of multiple doses –

-Amoxy Clav
-Cefaclor -poor compliance
thrice/ twice daily
-Cephalexin -incomplete therapy
-Cephadroxil - high relapse rate

-High compliance
Cefim Once-a-day
-Complete therapy
- No/ less relapse
 We just want to bang on this concept of once-a day dose

There is high opportunity to create noise level about once-a-day

dose, as no competitor has picked this point very aggressively.

Apple a Day,
Keeps Doctors away
 Mnemonic Apple: Why Apple?

Whenever we think of once-a-day, the first thing come in our mind is Apple.

Because since childhood, we have learnt about apple a day keeps doctors away.

So to correlate our concept of once-a-day, our mnemonic is apple.

We have designed our

Visual Aids in apple shape only
Our gifts, literatures will be reflecting apple.

Apple Apple Apple Apple Apple

 Communication Strategies

Focusing on The Power of Once A Day

Apple – will be reflected in most of the inputs for Cefim

 Once-a-day dose advantage over others

 Comparison with AmoxyClav, Cefaclor, Cephalexin etc

Focusing on UTIs, Upper RTIs, Gonorrhea

 Safety profile of Cefixime