AUGMENTINS (Powder for Suspension)
AUGMENTINSF (Powder for Suspension Forte)
SCHEDULING STATUS:
S4
PROPRIETARY NAMES
(and dosage form):
AUGMENTINS (Powder for Suspension)
AUGMENTINSF (Powder for Suspension Forte)
COMPOSITION:
Augmentin S: powder for suspension, when reconstituted according to the instructions each 5mL contains amoxycillin trihydrate B.P. equivalent to 125mg amoxycillin and potassium clavulanate equivalent to 31,25mg clavulanic acid.
Augmentin SF: powder for suspension forte, when reconstituted according to instructions each 5mL contains amoxycillin trihydrate B. P. equivalent to 250mg amoxycillin and potassium clavulanate equivalent to 62,5mg clavulanic acid.
PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins
PHARMACOLOGICAL ACTION:
(a) Bacteriology
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(i) |
Spectrum |
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Augmentin is the group name for formulations containing 2, 4 and 5 parts of a broad spectrum penicillin, amoxycillin and 1part of potassium clavulanate. Potassium clavulanate has been shown in vitro to be an irreversible inhibitor of beta-lactamase produced by: Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Haemophilus influenzae, Neisseria gonorrhoea and Bacteroides fragilis. Potassium clavulanate does not inactivate the chromosomally mediated (Sykes Type1 Cephalosporinase) beta-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, Indole positive Proteus, Providencia species and Serratia marcescens. In vitro the formulation showed synergism against amoxycillin-resistant organisms, with no evidence of antagonism and the activity was not reduced in the presence of serum. (In vitro activity does not necessarily imply in vivo efficacy.) |
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(ii) |
Bactericidal action |
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The amoxycillin component of the formulations exert a bactericidal action against many strains of Gram-positive and Gram-negative organisms. The clavulanic acid component has very little bactericidal action. It does however, by inactivation of susceptible beta-lactamases, protect amoxycillin from degradation by a large number of beta-lactamase enzymes produced by penicillin resistant strains of organisms. |
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(b) |
Absorption |
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The pharmacokinetics of amoxycillin and clavulanic acid are closely allied and neither are adversely affected by the presence of food in the stomach. Doubling the dose virtually doubles the peak serum level. |
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(c) |
Excretion |
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Co-administration of probenecid has little effect on the excretion of the clavulanic acid component of the formulation. |
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(d) |
Stability: |
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The 4 parts amoxycillin and 1part clavulanic acid Augmentin S and SF powder for suspension and suspension forte are stable at room temperature (25°C) for two years. When reconstituted the suspensions are stable for 7days if kept in a refrigerator (5°C) and should be used within 7days. |
INDICATIONS:
Augmentin formulations are indicated for the treatment of infections caused by amoxycillin resistant organisms producing beta-lactamases sensitive to clavulanic acid:
upper respiratory tract (otitis media),
lower respiratory tract (bronchitis),
urinary tract,
skin and soft tissues.
Augmentin formulations will also be effective in the treatment of infections caused by amoxycillin sensitive organisms at the appropriate amoxycillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect.
Augmentin is also indicated in certain special situations listed below that require specified dosages:
Adults:
Bronchitis: caused by amoxycillin resistant beta-lactamase producing Escherichia coli, Haemophilus influenzae and Haemophilus para-influenzae.
Children:
Otitis media
CONTRA-INDICATIONS:
Allergy to penicillins. Safety in pregnancy has not been established. Safety in children under 6 months of age has not been established.
WARNINGS:
Transient hepatitis and cholestatic jaundice has been reported.
DOSAGE AND DIRECTIONS FOR USE:
Directions for use:
Suspensions should be taken immediately before a meal.
DOSAGES:
General Information:
For infections caused by amoxycillin sensitive organisms the dosage is that approved for amoxycillin as the clavulanic acid component does not contribute to the therapeutic effect.
Children: The dose of Augmentin in children is 25-50mg/kg/day of the 4 parts amoxycillin, 1 part clavulanic acid preparations (which corresponds to a daily dosage of the equivalent of 20-40mg/kg of amoxycillin and 5-10mg/kg of clavulanic acid) to be taken in divided doses every 8hours at the start of a meal.
DOSAGE GUIDE:
AMOXYCILLIN SENSITIVE ORGANISMS
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PRODUCT |
Upper Respiratory Tract Infections |
Lower Respiratory Tract Infections |
Urinary Tract Infections |
Skin and Soft Tissue Infections |
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Children: |
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AUGMENTINS
(9-18 kg) |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
AUGMENTINSF
(18-37 kg) |
5mL1)
8hourly |
5mL1)
8hourly |
5mL1)
8hourly |
5mL1)
8hourly |
AMOXYCILLIN RESISTANT ORGANISMS
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PRODUCT |
Upper Respiratory Tract Infections
(Otitis Media)
H. influenzae
H. parainfluenzae |
Lower Respiratory Tract Infections
(Bronchitis)
H. influenzae
H. parainfluenzae |
Urinary Tract Infections
E. coli
Klebsiellapneumoniae |
Skin and Soft Tissue Infections
Staphylococcus
aureus |
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Children: |
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AUGMENTINS
(9-18 kg) |
5-10mL2)
8hourly |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
AUGMENTINSF
(18-37 kg) |
5-10mL2)
8hourly |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
5-10mL1)
8hourly |
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1) |
To correspond to a dosage of 25-50mg/kg/day. |
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2) |
To correspond to a dosage of 50mg/kg/day. |
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Renal function should be monitored in patients with moderate to severe renal impairment and Augmentin dosage should be adjusted.
Transient hepatitis and cholestatic jaundice have been reported.
Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction, urticaria, angioedema, anaphylaxis or eosinophilia –Coombs’test may become positive. In this event, withdrawal of Augmentin and the administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, Augmentin should be discontinued and the patient treated with the usual agents: adrenalin, corticosteroids and antihistamines.
Pseudomembranous colitis has been reported.
Rarely erythema multiforme and Stevens-Johnson syndrome have been reported.
Treatment with Augmentin may give rise to a maculopapular rash during therapy or within a few days after completion. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy. Monilial overgrowth such as vaginitis and thrush have been reported.
Treatment with Augmentin can cause gastro-intestinal symptoms such as diarrhoea, nausea and vomiting which are dose related and can be minimised by administering the drug at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these gastro-intestinal symptoms occur and a higher concentration of amoxycillin is required, consideration should be given to administering the additional amoxycillin separately.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea, vomiting and diarrhoea may occur with overdosing. Treatment is symptomatic.
IDENTIFICATION:
Augmentin S: off-white powder for reconstitution to a white to off-white Augmentin suspension.
Augmentin SF: off-white powder for reconstitution to a white to off-white Augmentin suspension forte.
PRESENTATION:
Augmentin S: clear bottles containing off-white powder for reconstitution to Augmentin suspension.
Augmentin SF: clear bottles containing off-white powder for reconstitution to Augmentin suspension forte.
STORAGE INSTRUCTIONS:
Keep out of reach of children.
Augmentin preparations should be stored in a cool, dry place below 25°C.
Augmentin S and SF suspensions: once reconstituted should be kept in a refrigerator (5°C) and used within 7days.
REGISTRATION NUMBERS:
Augmentin S (suspension) –U/20.1.2/49
Augmentin SF (suspension forte) –U/20.1.2/50
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Limited
39 Hawkins Avenue, Epping Industria1
Cape Town, 7460
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11.01.1991
Augmentin and the SB logo are trade marks.
P2604
Updated on this site: April 2002
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