CEFBLUE-AZ

Cefblue-AZ
Cefixime 200mg + Azithromycin 250mg Tablet

Cefblue-AZ 500
Cefixime 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 Action
Cefixime
Affinity to bind

PBPs in Bacterial Cell Wall

Inhibits bacterial Cell Wall synthesis

Death of Bacteria

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 grampositive 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 Action
Azithromycin
Affinity to bind

50s Subunit of Bacterial Ribosomes

Inhibits translation of mRNA

Interfering with their protein synthesis

Prevents bacteria from growing

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

Macrolide Comparison
Generic name
FDA approval date Intravenous form Half-life Bioavailability Potential for interactions FDA Pregnancy Category

Erythromycin
April 09, 1959 Yes 1-1.5 hours 25% High B

Clarithromycin
October 31, 1991 No 3-7 hours 55% High C

Azithromycin
November 1, 1991 Yes 40-60 hours 38% Low B

 Wide antibacterial spectrum against gram-positive and gramnegative 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. 2. Nihon Rinsho. 2009 Jan;67(1):129-35. Am Fam Physician. 2010 Apr 1;81(7):873-8.

Cefixime + Azithromycin Combination

Cefblue AZ
Each tablet of CEFBLUE AZ contains Cefixime Trihydrate IP Equivalent to anhydrous Cefixime.200mg Azithromycin Dihydrate IP Equivalent to Azithromycin...250mg Each tablet of CEFBLUE AZ 500 contains Cefixime Trihydrate IP Equivalent to anhydrous Cefixime.200mg Azithromycin Dihydrate IP Equivalent to Azithromycin...500mg Dosage: As directed by the physician.

Cefblue AZ
MRP- Rs. 192/Only MRP- Rs. 290/Only

Market Analysis
Brand Name Zifi-AZ (200+250) Clofee AZ (200+500) Cefdac AZ (200+250) Zithrox-Plus (200+250) AZIFINE-C (200+500) ZITHROX PLUS-KID tab (100+125) Company FDC Nucleo Remedies Jaiwik Biotec Macleods Glenmark Macleods Pack 10s 10s 10s 10s 10s 10s MRP / Strip 169.00 250.00 175.00 178.00 200.00 98.8

Marketing Guidelines
Launching 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.