Cefblue AZ

CEFBLUE-AZ

Cefblue-AZCefixime 200mg + Azithromycin 250mg Tablet

Cefblue-AZ 500Cefixime 200mg + Azithromycin 500mg Tablet

Cefixime•  Oral third generation broad spectrum cephalosporin

antibiotic active against Gram negative, limited Gram positive and anaerobic bacteria..

• Used to treat infections of the: Ear (otitis media) Nose, Sinuses (sinusitis), Throat (tonsillitis, pharyngitis), Chest and lungs (bronchitis, pneumonia) and Urinary system and Uncomplicated gonorrhea.

•  Bactericidal action• Absorption: Only 40-50% is absorbed from the GI tract

(oral); rate may be decreased if taken with food. Greater absorption from oral suspensions than tablet.

• Adverse Drug Reactions include diarrhea, dyspepsia, nausea, vomiting. Hypersensitivity reactions like skin rashes, utricaria.

Mechanism of ActionCefixime

PBPs in Bacterial Cell Wall

Inhibits bacterial Cell Wall synthesis

Death of Bacteria

Affinity to bind

Cefixime Indications(1) Uncomplicated urinary tract infections caused by

Escherichia coli and Proteus mirabilis, (2) Otitis media caused by Haemophilus influenzae (beta-

lactamase positive and negative strains), Moraxella catarrhalis (most of which are beta-lactamase positive), and S. pyogenes,

(3) Pharyngitis and tonsillitis caused by S. pyogenes, (4) Acute bronchitis and acute exacerbations of chronic

bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains), and

(5) Uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains).

Azithromycin• It is an azalide, a subclass of macrolide antibiotics• Azithromycin retains the activity of erythromycin

against gram-positive organisms but offers increased gram-negative coverage over erythromycin and clarithromycin. 

• Azithromycin is used to treat or prevent certain bacterial infections, most often those causing middle ear infections, strep throat, pneumonia, typhoid, and sinusitis.

•  It is also effective against certain sexually transmitted infections

• Absorption is approximately 37% after a 500-mg oral dose

• Azithromycin exhibited a rapid bacteriostatic effect

Mechanism of ActionAzithromycin

50s Subunit of Bacterial Ribosomes

Inhibits translation of mRNA

Interfering with their protein synthesis

Affinity to bind

 Prevents bacteria from growing 

Azithromycin Indications(1) Acute Bacterial Sinusitis(2) Acute Otitis Media(3) Community-Acquired Pneumonia(4) Pharyngitis/Tonsillitis(5) Uncomplicated Skin & Skin Structure Infections(6) Chronic Obstructive Pulmonary Disease

Generic name Erythromycin Clarithromycin Azithromycin

FDA approval date April 09, 1959 October 31, 1991 November 1, 1991

Intravenous form Yes No Yes

Half-life 1-1.5 hours 3-7 hours 40-60 hours

Bioavailability 25% 55% 38%

Potential for interactions High High Low

FDA Pregnancy Category B C B

Macrolide Comparison

Cefixime + Azithromycin Combination

• Wide antibacterial spectrum against gram-positive and gram-negative bacterias with enhanced anti-staphylococcal activity and stability in the presence of several b-lactamases

• Excellent intracellular tissue penetration and a long elimination half life aids in the bacterial eradication.

• Synergy between two antibiotics against bacterial pathogens.

• Wide anti microbial spectrum covering respiratory and urinary tract pathogens.

• Minimum chances of resistance development• Alternative drug therapy for typhoid.

Ref.-1. Nihon Rinsho. 2009 Jan;67(1):129-35.2. Am Fam Physician. 2010 Apr 1;81(7):873-8.

Cefblue AZEach tablet of CEFBLUE AZ contains Cefixime Trihydrate IPEquivalent to anhydrous Cefixime……………………….200mgAzithromycin Dihydrate IP Equivalent to Azithromycin………………………………...250mg

Each tablet of CEFBLUE AZ 500 contains Cefixime Trihydrate IPEquivalent to anhydrous Cefixime……………………….200mgAzithromycin Dihydrate IP Equivalent to Azithromycin………………………………...500mgDosage: As directed by the physician.

Cefblue AZ

MRP- Rs. 192/- Only

MRP- Rs. 290/- Only

Market Analysis

Brand Name Company Pack MRP / Strip

Zifi-AZ (200+250) FDC 10’s 169.00

Clofee AZ (200+500) Nucleo Remedies 10’s 250.00

Cefdac AZ (200+250) Jaiwik Biotec 10’s 175.00

Zithrox-Plus (200+250) Macleods 10’s 178.00

AZIFINE-C (200+500) Glenmark 10’s 200.00

ZITHROX PLUS-KID tab (100+125)

Macleods 10’s 98.8

Marketing GuidelinesLaunching Month-• Do extensive RCPA and identify 20 doctors in each territory• Detail with Visual Aid (Cefixime). • Provide 5 strip samples to each doctor during the first visit.• Make a second and if possible 3rd visit and detail the product with

Literature.• Demand 10 prescriptions from each doctor for the month.

2nd Month onwards:• Identify most potential prescribers.• Sample 5 strips per Doctor for two visits• Make a third reminder visit.• Detail with Visual Aid for remaining doctors without any sampling.• Demand and monitor 10 prescriptions from each of the 5

identified most potential doctor for the month.