This document provides information about the presentation of the drug Clacef® tablet. It begins with introducing the drug and contact information for the product executive. It then provides background on antibiotics in general, how they work, what they are used to treat. It discusses cephalosporins specifically, their classification and mechanism of action. It describes cefuroxime, clavulanic acid, and how their combination works to overcome antibiotic resistance from beta-lactamase producing bacteria. The document reviews indications for Clacef® and provides market analysis data on cefuroxime-containing brands. It concludes with actions to take to promote Clacef® to doctors and ensure proper stocking in pharmacies.
1. To the Presentation
on
Clacef®
Tablet
Sultan Mahmud
Sr. Product Executive, PMD
Cell: 01713-374701
Cefuroxime BP 125 mg + Clavulanic Acid USP 31.25 mg
Cefuroxime BP 250 mg + Clavulanic Acid USP 62.5 mg
Cefuroxime BP 500 mg + Clavulanic Acid USP 125 mg
2. What are antibiotics?
The US National Library of Medicine1
says that
antibiotics - powerful medicines that fight bacterial
infections - can save lives when used properly.
Antibiotics either stop bacteria from reproducing or
kill them. "Your body's natural defenses can usually
take it from there."
3. How do antibiotics work?
Although there are a number of different types of
antibiotic they all work in one of two ways:
A bactericidal antibiotic kills the bacteria. Penicillin
is a bactericidal. A bactericidal usually either
interferes with the formation of the bacterium's cell
wall or its cell contents.
A bacteriostatic stops bacteria from multiplying.
4. What are antibiotics used for?
An antibiotic is given for the treatment of an
infection caused by bacteria. Antibiotics target
microorganisms such as bacteria, fungi and
parasites. However, they are not effective against
viruses.
5. Cephalosporins
The cephalosporins are the largest and most diverse
family of beta-lactam antibiotics.
Cephalosporin compounds were first isolated from
cultures of bacteria Cephalosporium acremonium
found in a sewage outfall off the Sardinian coast in
1948 by Italian scientist Giuseppe Brotzu. The first
agent cephalothin (cefalotin) was launched by Eli Lilly
in 1964.
11. What is Beta-lactamases
Beta-lactamases are enzymes produced by some
bacteria that provide resistance to β-lactam antibiotics
like penicillins, cephamycins.
Beta-lactamase provides antibiotic resistance by
breaking the antibiotics' structure.
These antibiotics all have a common element in their
molecular structure: a four-atom ring known as a β-
lactam.
Through hydrolysis, the lactamase enzyme breaks the β-
lactam ring open, deactivating the molecule's
antibacterial properties.
12. What is cefuroxime?
Cefuroxime, a classical 2nd generation
cephalosporin can be the drug of choice due to-
Wide bacterial coverage
Gram Positive
Gram Negative
Anaerobes
Excellent safety profile
14. What is Clavulanic acid
Clavulanic acid is a β-lactam drug that functions as a
mechanism-based β-lactamase inhibitor.
It is not effective by itself as an antibiotic, when
combined with penicillin-group antibiotics.
it can overcome antibiotic resistance in bacteria that
secrete β-lactamase, which otherwise inactivates
most penicillins and Cephalosporins.
16. Antibiotic resistance
Antibiotic resistance occurs when bacteria
change in some way that reduces or eliminates the
effectiveness of drugs, chemicals, or other agents
designed to cure or prevent infections. The
bacteria survive and continue to multiply causing
more harm.
18. Due to…
The Overuse and Misuse of Cefuroxime
Increasing ß-lactamase enzyme producing
bacteria
Increasing Extended Spectrum ß-lactamase
(ESBL) producing organisms
19. Health Protection Agency, UK
Stated that…
Extended-Spectrum Beta- Lactamases (ESBLs)
are enzymes that can be produced by
bacteria making them resistant to the most
widely used antibiotic Cefuroxime in 2013.
20. Extended Spectrum ß-lactamase(ESBL)
The enzyme that capable of breaking down a wide
range of penicillin & Cephalosporin type antibiotics
of oral and a limited number of intravenous
treatment options.
Producing organisms:
Klebsiella species
Escherichia coli (E. coli), &
S. aureus
23. Clavulanic acid is added with Cefuroxime
Because Clavulanic Acid:
A suicidal inhibitor of ß-lactamase enzyme.
Irreversibly binds with ß-lactamase enzyme.
Increases the spectrum and
Restores antimicrobial activity of Cefuroxime
against ß-lactamase producing bacteria.
24. Major Indications
Respiratory Tract Infections
Urinary Tract Infections
Dental Infections
Surgical Site Infections
ENT infections
Skin and Soft Tissue Infections
27. Dear Sir/Madam,
In this visual you can see
that a man is fastening with
rope that’s why he can not
move normally as a result
his daily activity is
hampered,
Like that, Bacterial
resistance limits the activity
of Antibiotic
42. Actions to be taken
Ensures adequate shelving of Clacef®
125 mg,
250 mg, 500 mg Tablet.
Inform all the potential doctors about Clacef®
125 mg, 250 mg, 500 mg Tablet And
explain the superiority over other
43. Actions to be taken
Strictly monitor & identify the prescribers of direct
competitor- Cerox CV (ACI), Clavusef (Opsonin),
Cefaclav (Incepta) & indirect competitor-
Cefuroxime Prescriber like Cefotil (SQR), Furocef
(Renata), Kilbac (Incepta), Furex (DI), Sefur
(Opsonin); Amoxicillin-Clavulanate prescriber
like- Fimoxyclave (Aventis); Moxaclav (SQR),
Demoxil-Plus (DI) and pursue them to prescribe
Clacef®
by highlighting superiority.
We hope and believe that Clacef®
will help to
strengthen our position in antibiotic market.