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Julmentin 2013
1.
2. 1.Lee YB, Kim DJ, Ahn CH, Scholtz EC. PHARMACEUTICAL FORMULATION OF CLAVULANIC ACID. United States Patent Application Publication. 12/258,062, 2008.
The preserved power to go on
Potassium clavulanate is:
• Extremely hygroscopic and susceptible to hydrolysis so that co-amoxicillin/clavulanate
formulations are prone to degradation on storage.
• Extremely heat sensitive.
Innovative packing ensuring maintained activity.
Polyvinyl alcohol blister
3. Post 6 months at 40 degrees C/75% relative humidity:
The preserved power to go on
Allinson JG, Dansereau RJ, Sakr A. The effects of packaging on the stability of a moisture sensitive compound. Int J Pharm 2001; 221 (1-2):49-
56.
The percentage of active moisture sensitive compounds
4. The preserved power to go on
Innovative packing ensuring maintained activity.
Dark amber glass to reduce the effect of light (heat).
Special & practical device for accurate dosing
Highly palatable taste.
Granting treatment completion and clinical success
6. The preserved power to work
Amoxicillin concentration in Julmentin®: Bio-equivalent to reference
antibiotic
Plasma Concentration-Time Profile of Amoxicillin 500 mg in Amoxiclav Tablets.
Najib NM, Idkaidek N, Ghanem EE, et al. Bioequivalence assessment of Julmentin® (Julphar, U.A.E.) as compared to Augmentin® (Smithkline Beecham, U.K.)-Two
brands of co-amoxiclav in healthy human volunteers. JAMA Middle East. 100-105.
Julmentin® (amoxicillin/clavulanate) tablets was found bioequivalent
to reference antibiotic tablets.1
7. The preserved power to work
Clavulanic acid concentration in Julmentin®: Bio-equivalent to
reference antibiotic
Plasma Concentration-Time Profile of Clavulanic acid 125 mg in Amoxiclav Tablets.
1.Najib NM, Idkaidek N, Ghanem EE, et al. Bioequivalence assessment of Julmentin® (Julphar, U.A.E.) as compared to Augmentin® (Smithkline Beecham, U.K.)-Two
brands of co-amoxiclav in healthy human volunteers. JAMA Middle East. 100-105.
Julmentin® (amoxicillin/clavulanate) tablets was found bioequivalent
to reference antibiotic tablets.1
8. The preserved power for assured eradication
Amoxicillin/clavulanate: Superior bacteriological activity against S.
pneumoniae
A contemporary (2002–2003) national collection of
2100 strains of Streptococcus pneumoniae obtained
from 30 sites in the nine United States (US) census
regions were tested to determine the comparative
antimicrobial properties of amoxicillin/clavulanate
and 3 other antimicrobials.
*Susceptible and resistant categories established by
using National Committee for Clinical Laboratory
Standards (NCCLS) criteria.
#Based upon PK/PD parameters, the susceptible
was defined as a MIC of ≤ 4 mg/L of amoxicillin
component of amoxicillin/clavulanate.
Pottumarthy S, Fritsche TR, Sader HS, Stilwell MG, Jones RN. Susceptibility patterns of Streptococcus pneumoniae isolates in North America (2002–2003):
contemporary in vitro activities of amoxicillin/clavulanate and 15 other antimicrobial agents. International Journal of Antimicrobial Agents 2005; 25 (4): 282–289.
9. The preserved power for assured eradication
Amoxicillin/clavulanate: High antibacterial activity against H.
influenzae
Peric M, Browne FA, Jacobs MR, Appelbaum PC. Activity of Nine Oral Agents Against Gram-Positive and Gram-Negative Bacteria Encountered in Community–
Acquired Infections: Use of Pharmacokinetic/Pharmacodynamic Breakpoints in the Comparative Assessment of Beta-Lactam and Macrolide Antimicrobial Agents.
Clin Ther 2003; 25 (1): 169–77.
A study was undertaken to provide data on current levels of
resistance among common community-acquired bacterial
species to 3 beta–lactam antimicrobial agents including the
combination product amoxicillin/clavulanate determined
through application of the PK/PD breakpoints. Adapted
from ref. 2
10. The preserved power for assured recovery in URTIs
Randomised clinical trial evaluating the
efficacy of amoxicillin/clavulanate (875
mg/125 mg BD) in adult patients with
recurrent tonsillitis.
Adapted from ref. 1
Amoxicillin/clavulanate provides a clinically and bacteriologically effective
treatment for patients with pharyngotonsillitis caused by GABHS*.2
# Upper respiratory tract infections.
* Group A beta hemolytic streptococci.
1.Bax R. Development of a twice daily dosing regimen of amoxicillin/clavulanate. International Journal of Antimicrobial Agents 2007; 30 (2): S118–S121.
2. Haczynski J, Bardadin J, Gryczynska D, et al. A comparative study of cefaclor vs. amoxicillin/clavulanate in tonsillopharyngitis. Med Sci Monit 2001; 7 (5): 1016–1022.
Amoxicillin/clavulanate: High clinical efficacy in tonsillitis
11. The preserved power for assured success in URTIs
Amoxicillin/clavulanate: High clinical efficacy in acute bacterial
Rhinosinusitis
Calculated clinical efficacy
of high dose
amoxicillin/clavulanate
in adult with mild acute
bacterial rhinosinusitis, no
recent antimicrobial use
(past 4–6 weeks).
Adapted from ref. 1, 2
# Upper respiratory tract infections.
*Macrolides include erythromycin, clarithromycin, and azithromycin.
1.Hadley JA, Pfaller MA. Oral β‐lactams in the treatment of acute bacterial rhinosinusitis. Diagnostic Microbiology and Infectious Disease 2007; 57: 47S‐54S.
2.Anon JB, Jacobs MR, Poole MD, et al. Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2004; 130 (1): 1-45.
12. Amoxicillin/clavulanate is recommended as first-line treatment for
acute bacterial sinusitis by…
3.White AR, Kaye C, Poupard J, Pypstra R, Woodnutt G, Wynne B. Augmentin® (amoxicillin/clavulanate) in the treatment of community-acquired respiratory tract infection: a
review of the continuing development of an innovative antimicrobial agent. Journal of Antimicrobial Chemotherapy 2004; 53 (Suppl. S1): i3–i20.
4.Klossek JM, Federspil P. Update on treatment guidelines for acute bacterial sinusitis. Int J Clin Pract 2005; 59 (2): 230-238.
1. Sinus & Allergy Health Partnership guidelines.3
2. Agence FranÇaise de Śecurité Sanitaire des
Produits de Sante (France).4
3. American Academy of Otolaryngology Head &
Neck Surgery (USA).4
The preserved power for assured success in URTIs
13. The preserved power for assured cure in LRTIs
Amoxicillin/clavulanate: High clinical efficacy in AECB*
An open randomized trial comparing the
clinical efficacy of amoxicillin/clavulanic acid
(amoxicillin 875 mg and clavulanic acid 125
mg) b.i.d. for 8 days with azithromycin (500
mg) single dose for three days in patients with
acute purulent exacerbation of chronic
bronchitis.
Adapted from ref. 1
Amoxicillin/clavulanate:
Is used as a first-choice drug in the treatment of exacerbation of
chronic bronchitis.2
#Lower respiratory tract infections.
*Acute exacerbation of chronic bronchitis.
1. Beghi G, Berni F, Carratù L, et al. Efficacy and tolerability of azithromycin versus amoxicillin/clavulanic acid in acute purulent exacerbation of chronic bronchitis. J Chemother 1995; 7 (2): 146-52.
2. Cazzola M, Vinciguerra A, Beghi GF, et al. Comparative evaluation of the clinical and microbiological efficacy of co‐amoxiclav vs cefixime or ciprofloxacin in bacterial exacerbation of chronic bronchitis. J
Chemother 1995; 7 (5): 432-41.
14. The preserved power for assured cure in LRTIs
Amoxicillin/clavulanate: Comparative efficacy with azithromycin in
management of CAP**
A randomized, open-label, non-inferiority
study designed to evaluate the efficacy of
oral amoxicillin/clavulanate (875/125 mg)
twice daily for 7 days (n = 131) versus
azithromycin (1 gm) once daily for 3 days in
the treatment of outpatients with
community-acquired pneumonia.
Adapted from ref. 3
**Community-acquired pneumonia.
3. Paris R, Confalonieri M, Dal Negro R, et al. Efficacy and safety of azithromycin 1 g once daily for 3 days in the treatment of community-acquired pneumonia: an open-label
randomised comparison with amoxicillin-clavulanate 875/125 mg twice daily for 7 days. Journal of Chemotherapy 2008; 20 (1): 77-86.
15. preserved Power … Recovery assured
• Innovative packing.
• High bacteriological efficacy
against main RTI pathogens.1,2
• Proven efficacy in treatment of:
o Tonsillopharyngitis.3
o Sinusitis.4
o AECB*.5
o CAP**.6
Why Julmentin?