Spreading Infectious Liveliness - GSKpro · 3/11/2014 · Augmentin SR - Designed to combat emerging resistance2,6,7,8 A Unique bilayer tablet, providing sustained release delivery

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Spreading Infectious Liveliness

Amoxicillin/Clavulanic AcidProlonged‐Release Tablets

SR1000 mg/62,5 mg

MLT_GIB_AES_0004_14(2)_Augmentin SR_A4_MT-9172612_D5.indd 1MLT_GIB_AES_0004_14(2)_Augmentin SR_A4_MT-9172612_D5.indd 1 5/25/2018 3:46:42 PM5/25/2018 3:46:42 PM

Gradual emergence of resistance to several commonly used antimicrobials is a growing healthcare concern2

CDC: “Antibiotic Resistance has been called one of the world’s most pressing public health problems”2

Recent Survey of Antibiotic Resistance (SOAR) studies reveal decreasing antibiotic susceptibility in CA-RTI S. pneumoniae isolates in many of the

participating countries*3,4,5

*Susceptibility patterns may vary with time and geography

Increasing burden of lower respiratory tract infections1

S. pneumoniae is the most common pathogen in CAP in both outpatient (44%) and inpatient (50%) settings1

Incidence rate increases with age > 70 years, and more prevalent in males1

The role of atypical pathogens in CAP is controversial; it is unknown whether atypicals are copathogens or if they predispose patients to subsequent bacterial infection.2

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Augmentin SR - Designed to combat emerging resistance2,6,7,8

A Unique bilayer tablet, providing sustained release delivery of amoxicillin2

Bacteriological and clinical efficacy demonstrated in trials7,8

Effective against emerging and increasing prevalence of strains of S. pneumoniae with high‐level penicillin and/or macrolide resistance7

Immediate-release layer:

Clavulanate 62.5 mg

Sustained-release layer:Crystalline Sodium Amoxicillin 437.5 mg maintains extended plasma concentrationAdapted from Benninger MS2

Amoxicillin trihydrate 562.5 mg allows for peak plasma concentration

3

Amoxicillin/Clavulanic Acid

SR1000 mg/62,5 mg

is indicated for the treatment of community‐acquired pneumonia in adults and adolescents aged at least 16 years, caused or thought

likely to be caused by penicillin‐resistant S. pneumoniae6

Community Acquired Pneumonia6


Augmentin SR uses sustained‐release technology to provide superior efficacy against resistant pathogens9

Maximizing bacterial eradication is a key goal in the selection of appropriate antimicrobial therapy in respiratory tract infections9

For amoxicillin, a T > MIC of 30‐40% of the dosing interval is required for maximal bacteriological efficacy against the key respiratory pathogens9

Mean plasma concentration‐time profile for amoxicillin after oral administration of pharmacokinetically enhanced Augmentin SR (2000/125 mg) (n=55) compared with conventional release Augmentin 1g (875/125 mg) (n=14). Adapted from White AR9

0

2

2 4 6 8 10 12

4

6

8

10

12

14

16

18

20

Immediate-release of562,5 mg amoxicillin62,5 mg clavulanate

Sustained-release of 437,5 mg amoxicillin

Sustained release:T> MIC at 4 mg/L ≥ 40%

Time (h)

Augmentin 875/125 mgAugmentin SR 2000/125 mg

Mea

n am

oxic

illin

pla

sma

conc

entr

atio

n (m

g/L)

4

Bacteriological efficacy of antimicrobials is dependent on their pharmacokinetic/pharmacodynamic (PK/PD) properties9


Augmentin SR has been developed to maximise PK/PD against resistant strains9

Against pathogens with MICs of 4 mg/L, Augmentin SR 2000/125 mg twice daily achieves a mean T > MIC of 49% of the dosing interval9

Augmentin Formulations Ratio Dosing

Regimen

Mean T>MIC for amoxicillin (% of dosing interval) for MICs (mg/L) of:

1 2 4 8Augmentin 625 mg

(500/125 mg) 4:1 TDS 55 43 — —

Augmentin 1 g(875/125 mg) 7:1

BD 44 40 — —

TDS 69 57 34 —

Augmentin SR2000/125 mg

16:1 BD 70 60 49 35

Adapted from White AR9 —,T>MIC ≤ 30%

“For macrolides, limitations in pharmacokinetics and safety prevent dosages being increased or modified sufficiently to overcome macrolide resistant

S. pneumoniae or to confer in vivo bacteriological efficacy against H. influenzae9”

“Fluoroquinolones have a relatively narrow safety window, limiting the doses that can be given, and most agents would not be able to maintain an acceptable safety/tolerability profile and overcome quinolone resistance in S. pneumoniae9”

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SR1000 mg/62,5 mg


Efficacy, safety and tolerability with Augmentin SR

Undesirable effects, Contraindications, Precautions6: The most common adverse effects are diarrhoea, nausea, vomiting and mucocutaneous

candidiasis

Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking Augmentin at the start of a meal

Augmentin SR is indicated for use in adults and adolescents aged ≥ 16 years

Careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens, before initiating therapy with Augmentin

Should be used with caution in patients with evidence of hepatic dysfunction

Treatment should not be extended beyond 14 days without review.

Comparable clinical and bacteriological efficacy vs. Augmentin 1g TDS10,11

Comparable safety and tolerability when compared to other conventional Augmentin formulations9,10,11

0Clinical Success

% o

f Pat

ient

s

Bacteriological Success Radiological Success

2010

30

50

70

90

40

60

80

94.785

94.788.8

77.387.9

100

Amoxcillin/Clavulanate 2000/125 mg [n=114] Amoxcillin/Clavulanate 875/125 mg [n=116]

A randomized, double-blind, double-dummy, multicentre study compared the efficacy and safety of Augmentin SR (2000/125 mg) BD versus Augmentin 1g (875/125 mg) TDS, for 7 or 10 days, in the treatment of community-acquired pneumonia (CAP). The per-protocol (PP) population at follow-up (Days 18-39) comprised 114 patients receiving Augmentin SR (2000/125 mg) and 116 receiving Augmentin 1g (875/125 mg). Adapted from Garau J11

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References1. Ortqvist A. Treatment of community-acquired lower respiratory tract infections in adults. Eur Respir J Suppl. 2002 Jul; 36: 40s-53s. 2. Benninger MS. Amoxicillin/clavulanate potassium extended release tablets: a new antimicrobial for the treatment of acute bacterial sinusitis and community-acquired pneumonia. Expert Opin

Pharmacother. 2003 Oct; 4(10): 1839-46. 3. Torumkuney D, et al. J Antimicrob Chemother 2016;71(Suppl 1):i85–i91. 11. 4. Hu F, et al. J Antimicrob Chemother 2016;71(Suppl 1):i33-i43.5. Zafar A, et al. J Antimicrob Chemother 2016;71(Suppl 1):i103-i109. 6. Augmentin SR SPC, November 2017. 7. Petitpretz P, et al. The effi cacy and safety of oral pharmacokinetically enhanced amoxycillin-clavulanate 2000/125 mg, twice daily, versus oral amoxycillin-clavulanate 1000/125 mg, three times

daily, for the treatment of bacterial community-acquired pneumonia in adults. Int J Antimicrob Agents. 2002 Aug; 20(2): 119-29. 8. File TM Jr. The development of pharmacokinetically enhanced amoxicillin/clavulanate for the management of respiratory tract infections in adults. Int J Antimicrob Agents. 2007 Dec;30

Suppl 2:S131-4 .9. A. R. White et al. 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. 10. Siquier B, et al. Effi cacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a

country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. J Antimicrob Chemother. 2006 Mar; 57(3): 536- 45. Epub 2006 Jan 30. 11. Garau J, et al. Oral pharmacokinetically enhanced co-amoxiclav 2000/125 mg, twice daily, compared with co-amoxiclav 875/125 mg, three times daily, in the treatment of community-acquired

pneumonia in European adults. J Antimicrob Chemother. 2003 Nov; 52(5): 826-36. 12. Gilbert DN, et al. Sanford guide to Antimicrobial Therapy v.3.11–last updated March 11, 2014. Sperryville; Antimicrobial Therapy, Inc. 2014 .13. Mandell LA, Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar

1;44 Suppl 2:S27-72.

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SR1000 mg/62,5 mg

AUGMENTIN SR Abridged Prescribing Information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing. TRADE NAME: Augmentin SR. ACTIVE INGREDIENTS: Amoxicillin (as trihydrate), potassium clavulanate. PHARMACEUTICAL FORM: 1000 mg/62.5 mg prolonged-release tablets. INDICATIONS: Treatment of community acquired pneumonia in adults and adolescents aged at least 16 years, caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae. POSOLOGY: Adults and adolescents ≥16 years: Oral use. 2 tablets, twice daily for seven to ten days. Administer with a meal. CONTRAINDICATIONS: Hypersensitivity to active substances/penicillins/excipients. History of: severe immediate hypersensitivity reaction to another beta-lactam agent, jaundice/hepatic impairment due to amoxicillin/clavulanic acid. PRECAUTIONS: Enquiry of previous hypersensitivity reactions to beta-lactams. Switch to an amoxicillin-only preparation (to be considered for infections proven due to amoxicillin susceptible organism). Convulsions may occur in patients receiving high doses or impaired renal function. Concomitant use of allopurinol increase likelihood of allergic skin reactions. Overgrowth of non-susceptible organisms with prolonged use. Occurrence of a feverish generalised erythema associated with pustula at treatment initiation may be symptom of AGEP (reaction requires discontinuation and contra-indicates subsequent administration of amoxicillin). Caution in patients with hepatic impairment. Hepatic events may be associated with prolonged treatment. Antibiotic-associated colitis. Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Appropriate monitoring when anticoagulants are prescribed concomitantly. Creatinine clearance less than 30 ml/min (not recommended). Possibility of amoxicillin crystalluria. Potential of incorrect diagnostic test results during treatment (refer to full SPC for details). Contains 29.3 mg (1.3 mmol) of sodium per tablet. Refer to the SPC for full details of precautions. pregnancy/FertilitY/lACTATION: Pregnancy: Use should be avoided unless considered essential by the physician. Lactation: benefit/risk assessment to be considered. UNDESIRABLE EFFECTS: Very common (³1/10): diarrhoea. Common (≥1/100 to <1/10): mucocutaneous candidosis, nausea, abdominal pain. Refer to full SPC for the full list of adverse reactions. LOCAL PRESENTATION: 28 tablets/pack. MARKETING AUTHORISATION NUMBER: AA1051/00102. MARKETING AUTHORISATION HOLDER: GlaxoSmithKline Bulgaria EOOD. LEGAL CATEGORY: POM. DATE OF PREPARATION: November 2017.

In order to ensure that this product information reflects the most up-to-date clinical and post-marketing surveillance data, please always refer to the latest Summary of Product Characteristics (SPC) which is available from GlaxoSmithKline (Malta) Ltd (Tel: +356 21238131)

REPORTING ADVERSE EVENTS (AEs):If you become aware of any AEs, medication errors and/or use during pregnancy in association with GSK products, please report the event promptly to: GSK (Malta) Ltd, 1, De la Cruz Avenue, Qormi QRM 2458, Malta (Tel: +356 21238131).

Alternatively, any suspected AEs and medication errors can be reported via the Medicines Authority Adverse Drug Reactions reporting website: www.medicinesauthority.gov.mt/adrportal


Co-amoxiclav Sustained Release - Recommended by Leading Guidelines in the treatment of CAP12,13

Two tablets BD for 7-10 days

RxRx:

Augmentin SRSR

2 - 0 - 22 - 0 - 2

X 7 - 10 days

Job No:MLT_GIB/AES/0004/14(2)Date of preparation: April 2018

Amoxicillin/Clavulanic AcidProlonged‐Release Tablets

SR1000 mg/62,5 mg

Sanford Guide to Antimicrobial Therapy 201412

Joint IDSA*/American Thoracic

Society Guidelines13

The Unique bilayer tablet provides sustained release delivery of amoxicillin2

Sustained‐release technology provides superior efficacy against resistant pathogens9

Effective against emerging and increasing prevalence of strains of S. pneumoniae with high‐level penicillin and/or macrolide resistance7


Documents

Spreading Infectious Liveliness - GSKpro · 3/11/2014 · Augmentin SR - Designed to combat emerging resistance2,6,7,8 A Unique bilayer tablet, providing sustained release delivery