NEW ZEALAND DATA SHEET
AMOXICLAV MULTICHEM
1. PRODUCT NAME
Amoxiclav multichem, powder for injection 600 mg and 1.2 g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxiclav multichem 600 mg: each vial contains potassium clavulanate 119.15 mg equivalent
to clavulanate 100 mg and amoxicillin sodium 530 mg equivalent to amoxicillin 500 mg.
Amoxiclav multichem 1.2 g: each vial contains potassium clavulanate 238.3 mg equivalent to
clavulanate 200 mg and amoxicillin sodium 1.06 g equivalent to amoxicillin 1 g.
3. PHARMACEUTICAL FORM
Powder for injection. For reconstitution as an intravenous (IV) injection or infusion.
Glass vials containing sterile white to off-white powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Amoxiclav multichem should be used in accordance with local official antibiotic-prescribing
guidelines and local susceptibility data.
Amoxiclav multichem is indicated for the short term treatment of common bacterial infections
such as:
Upper respiratory tract infections (including ENT): e.g. tonsillitis, sinusitis, otitis media
Lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and
broncho-pneumonia
Genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections
Skin and soft tissue infections
Bone and joint infections: e.g. osteomyelitis
Other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia,
peritonitis, post-surgical infections
Amoxiclav multichem is indicated for prophylaxis against infection which may be associated
with major surgical procedures such as gastro-intestinal, pelvic, head and neck, cardiac, renal,
joint replacement and biliary tract surgery.
Susceptibility to Amoxiclav multichem will vary with geography and time. Local susceptibility
data should be consulted where available, and microbiological sampling and susceptibility
testing performed where necessary.
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Infections caused by amoxicillin susceptible organisms are amenable to Amoxiclav multichem
treatment due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible
organism in conjunction with Amoxiclav multichem-susceptible beta-lactamase-producing
organisms may therefore be treated by Amoxiclav multichem.
4.2 Dose and method of administration
Dose
Children 0-3 months: 30 mg/kg* amoxicillin-clavulanate every 12 hours in infants < 4 kg and 30
mg/kg* amoxicillin-clavulanate every 8 hours in infants >4 kg
Children 3 months - 12 years: Usually 30 mg/kg* amoxicillin-clavulanate 8 hourly. In more
serious infections, increase frequency to 6 hourly intervals.
Adults and children 40 kg and over: Usually 1.2 g 8 hourly. In more serious infections, increase
frequency to 6 hourly intervals.
*Each 30 mg amoxicillin-clavulanate provides 5 mg clavulanic acid with 25 mg amoxicillin.
Dosage for surgical prophylaxis
Surgical prophylaxis with amoxicillin-clavulanate should aim to protect the patient for the
period of risk of infection. Accordingly, procedures in adults lasting for less than 1 hour are
successfully covered by 1.2 g amoxicillin-clavulanate given at induction of anaesthesia. Longer
operations require subsequent doses of 1.2 g amoxicillin-clavulanate IV (up to 4 doses in 24
hours), and this regime can be continued for several days if the procedure has significantly
increased the risk of infection. Clear clinical signs of infection at operation will require a normal
course of IV or oral amoxicillin-clavulanate therapy post-operatively.
Special populations
Elderly
No adjustment needed, dose as for adults. If there is evidence of renal impairment, dose should
be adjusted as for renally impaired adults (see below).
Renal impairment
Adults
Dosing adjustments are based on the maximum recommended level of amoxicillin.
Method of Mild Impairment Moderate Severe Impairment
administration (creatinine clearance Impairment (creatinine clearance <10
>30 mL/min) (creatinine clearance mL/min)
10-30 mL/min)
Intravenous No change in dosage 1.2 g IV stat followed 1.2 g IV stat followed by
by 600 mg IV 12 600 mg IV 24 hourly.
hourly Dialysis decreases serum
concentrations of
amoxicillin-clavulanate.
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An additional 600 mg IV
dose may need to be
supplemented at the
end of dialysis
Each 1.2 g vial of Amoxiclav multichem contains 1.0 mmoL of potassium and 2.7 mmoL of
sodium.
Each 600 mg vial of Amoxiclav multichem contains 0.5 mmoL of potassium and 1.4 mmoL of
sodium.
Children:
Dosing adjustments are based on the maximum recommended level of amoxicillin.
Method of Mild Impairment Moderate Severe Impairment
administration (creatinine clearance Impairment (creatinine clearance <10
>30 mL/min) (creatinine clearance mL/min)
10-30 mL/min)
Intravenous No change in dosage 30 mg/kg 12 hourly 30 mg/kg every 24 hours
Dialysis decreases serum
concentrations of
amoxicillin-clavulanate.
An additional 15 mg/kg
may need to be
supplemented at the
end of dialysis, then 30
mg/kg/day
Hepatic impairment
Dose with caution; monitor hepatic function at regular intervals for both adults and children.
There are as yet insufficient data on which to base a dosage recommendation.
Method of administration
Amoxiclav multichem intravenous may be administered either by intravenous injection or by
intermittent infusion. It is not suitable for intramuscular administration.
IV injection: Amoxiclav multichem should be given by slow intravenous injection over a period
of 3-4 minutes and within 20 minutes of reconstitution. It may be injected directly into the vein
or via a drip tube.
IV infusion: Infuse Amoxiclav multichem over 30-40 minutes and complete within the times
stated.
For instructions on reconstitution of the medicine before administration, see section 6.6
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4.3 Contraindications
Amoxiclav multichem is contraindicated in patients with a previous history of amoxicillin-
clavulanate -associated jaundice/hepatic dysfunction.
Amoxiclav multichem is a penicillin and should not be given to patients with a history of
hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins).
Amoxiclav multichem is contraindicated in patients who have had previous experience of a
major allergy or anaphylaxis to a cephalosporin or penicillin.
Hypersensitivity to any of the excipients.
4.4 Special warnings and precautions for use
Before initiating therapy with Amoxiclav multichem, careful enquiry should be made
concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other
allergens.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe
cutaneous adverse reactions) have been reported in patients on penicillin therapy. These
reactions are more likely to occur in individuals with a history of penicillin hypersensitivity. If
an allergic reaction occurs, amoxicillin-clavulanate Amoxiclav multichem therapy should be
discontinued and appropriate alternative therapy instituted. Serious anaphylactoid reactions
require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and
airway management, including intubation may also be required.
Amoxicillin-clavulanate should be avoided if infectious mononucleosis is suspected since the
occurrence of a morbilliform rash has been associated with this condition following the use of
amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in
patients who develop diarrhoea during or after antibiotic use. If prolonged or significant
diarrhoea occurs or the patient experiences abdominal cramps, treatment should be
discontinued immediately and the patient investigated further.
In general amoxicillin-clavulanate is well tolerated and possesses the characteristic low toxicity
of the penicillin group of antibiotics. Periodic assessment of organ system functions, including
renal, hepatic and haematopoietic function is advisable during prolonged therapy.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in
patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be
undertaken when anticoagulation treatment is prescribed concomitantly. Adjustment in the
dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
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Amoxiclav multichem should be used with caution in patients with evidence of hepatic
dysfunction.
Amoxiclav multichem should be given with caution to patients who have experienced
symptoms of allergy associated with a cephalosporin or penicillin.
Massive doses of Amoxiclav multichem can cause hypokalaemia and sometimes
hypernatraemia. Use of a potassium-sparing diuretic may be helpful. In patients undergoing
high-dose treatment for more than 5 days, electrolyte balance, blood counts and renal
functions should be monitored.
Hepatic events have been reported predominantly in males and elderly patients and may be
associated with prolonged treatment. These events have been very rarely reported in children.
Signs and symptoms usually occur during or shortly after treatment but in some cases may not
become apparent until several weeks after treatment has ceased. These are usually reversible.
Hepatic events may be severe and in extremely rare circumstances, deaths have been
reported. These have almost always occurred in patients with serious underlying disease or
taking concomitant medications known to have the potential for hepatic effects.
In patients with renal impairment, dosage should be adjusted according to the degree of
impairment (see section 4.2).
Convulsions may occur in patients with impaired renal function or in those receiving high
doses.
The occurrence at treatment initiation of a feverish generalised erythema associated with
pustule may be a symptom of acute generalised exanthemous pustulosis (AEGP). This reaction
requires Amoxiclav multichem discontinuation and is a contraindication to subsequent
administration of amoxicillin.
The presence of clavulanic acid in Amoxiclav multichem may cause a non-specific binding of
IgG and albumin by red cell membranes leading to a false positive Coombs test.
If the parenteral administration of high doses is necessary, the sodium content must be taken
into account in patients on a sodium restricted diet.
In patients with reduced urine output crystalluria has been observed very rarely,
predominantly with parenteral therapy. During administration of high doses of amoxicillin it is
advisable to maintain adequate fluid intake and urinary output in order to reduce the
possibility of amoxicillin crystalluria (see section 4.9).
4.5 Interaction with other medicines and other forms of interaction
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular
secretion of amoxicillin. Concomitant use with amoxicillin-clavulanate may result in increased
and prolonged blood levels of amoxicillin, but not of clavulanic acid.
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Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of
allergic skin reactions. There are no data on the concomitant use of amoxicillin-clavulanate and
allopurinol.
In common with other antibiotics, amoxicillin-clavulanate may affect the gut flora, leading to
lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
In the literature there are rare cases of increased international normalised ratio in patients
maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-
administration is necessary, the prothrombin time or international normalised ratio should be
carefully monitored with the addition or withdrawal of amoxicillin.
The presence of clavulanic acid in Amoxiclav multichem may cause a non-specific binding of
IgG and albumin by red cell membranes leading to a false positive Coombs test.
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active
metabolite mycophenolic acid of approximately 50% has been reported following
commencement of oral amoxicillin plus clavulanic acid. The change in predose level may not
accurately represent changes in overall MPA exposure.
The efficacy of oral contraceptives may be impaired under concomitant administration of
Amoxiclav multichem, which may result in unwanted pregnancy. Women taking oral
contraceptives should be aware of this and should be informed about alternative methods of
contraception.
Penicillins reduce the excretion of methotrexate thereby increasing the risk of methotrexate
toxicity.
Penicillins may interfere with:
• urinary glucose test
• Coomb's tests
• tests for urinary or serum proteins
• tests which use bacteria e.g. Guthrie test
4.6 Fertility, pregnancy and lactation
Fertility
No fertility data available.
Pregnancy
Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with
orally and parentally administered amoxicillin-clavulanate have shown no teratogenic effects.
In a single study in women with preterm, premature rupture of the foetal membrane (pPROM),
it was reported that prophylactic treatment with amoxicillin-clavulanate may be associated
with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should
be avoided in pregnancy, unless considered essential by the physician.
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Lactation
Amoxiclav multichem may be administered during the period of lactation. With the exception
of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there
are no known detrimental effects for the breastfed infant.
Trace quantities of penicillin can be detected in breast milk with the potential for
hypersensitivity reactions (e.g. drug rashes) or gastrointestinal disorders (e.g. diarrhea or
candidosis) in the breast-fed infant. Consequently, breastfeeding might have to be
discontinued.
4.7 Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
During treatment with Amoxiclav multichem undesirable effects may occur (e.g. allergic
reactions, dizziness, convulsions) which may influence the ability to drive and use machines.
Patients should be cautious when driving or operating machinery.
4.8 Undesirable effects
Data from large clinical trials was used to determine the frequency of very common to rare
undesirable effects. The frequencies assigned to all other undesirable effects (i.e., those
occurring at <1/10,000) were mainly determined using post-marketing data and refer to a
reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency:
very common ≥1/10
common ≥1/100 and <1/10
uncommon >1/1000 and <1/100
rare ≥1/10,000 and <1/1000
very rare <1/10,000
Infections and infestations:
Common: Mucocutaneous candidiasis
Blood and lymphatic system disorders:
Rare: Reversible leucopenia (including neutropenia) and thrombocytopenia
Very rare: Reversible agranulocytosis and haemolytic anaemia. Prolongation of
bleeding time and prothrombin time
Immune system disorders:
Very rare: Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome,
hypersensitivity vasculitis
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Nervous system disorders:
Uncommon: Dizziness, headache
Very rare: Aseptic meningitis, reversible hyperactivity and convulsions.
Convulsions may occur in patients with impaired renal function or in
those receiving high doses.
Vascular disorders:
Rare: Thrombophlebitis at the site of injection
Gastrointestinal disorders following intravenous administration:
Common: Diarrhoea
Uncommon: Nausea, vomiting, indigestion
Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and
haemorrhagic colitis) (see section 4.4) are less likely to occur after
parenteral administration.
Hepatobiliary disorders:
Uncommon: A moderate rise in AST and/or ALT has been noted in patients treated
with beta-lactam class antibiotics, but the significance of these findings
is unknown.
Very rare: Hepatitis and cholestatic jaundice. These events have been noted with
other penicillins and cephalosporins (see section 4.4).
Skin and subcutaneous tissue disorders:
Uncommon: Skin rash, pruritus, urticaria
Rare: Erythema multiforme
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous
exfoliative-dermatitis, acute generalised exanthemous pustulosis
(AGEP), and drug reaction with eosinophilia and systematic symptoms
(DRESS).
If any hypersensitivity dermatitis reaction occurs, treatment should be
discontinued.
Renal and urinary disorders:
Very rare: Interstitial nephritis, crystalluria (see section 4.9).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It
allows continued monitoring of the benefit/risk balance of the medicine. Healthcare
professionals are asked to report any suspected adverse reactions
https://nzphvc.otago.ac.nz/reporting/
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4.9 Overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be
evident. They may be treated symptomatically, with attention to the water/electrolyte
balance.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section
4.4).
Amoxicillin has been reported to precipitate in bladder catheters after intravenous
administration of large doses. A regular check of patency should be maintained.
Amoxicillin-clavulanate can be removed from the circulation by haemodialysis.
A prospective study of 51 paediatric patients at a poison control centre suggested that
overdoses of less than 250 mg/kg of amoxicillin are not associated with significant clinical
symptoms and do not require gastric emptying.
Drug abuse and dependence
Drug dependency, addiction and recreational abuse have not been reported as a problem with
this compound.
For advice on the management of overdose please contact the National Poisons Centre on
0800 POISON (0800 764766).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Amoxicillin and enzyme inhibitor. ATC code: JO1CR02.
Mechanism of action
Amoxiclav multichem (beta-lactam antibacterial penicillin co-formulated with a beta-
lactamase inhibitor) is an antibiotic agent with a notably broad spectrum of activity against the
commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase
inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range
of organisms, including many resistant to other beta-lactam antibiotics.
Amoxicillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against
many gram-positive and gram-negative micro-organisms. Amoxicillin is, however susceptible
to degradation by beta-lactamases and therefore the spectrum of activity of amoxicillin alone
does not include organisms which produce these enzymes.
Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the
ability to inactivate a wide range of beta-lactamase enzymes commonly found in micro-
organisms resistant to penicillins and cephalosporins. In particular, it has good activity against
the clinically important plasmid mediated beta-lactamases frequently responsible for
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transferred drug resistance. It is generally less effective against chromosomally-mediated type
1 beta-lactamases.
The presence of clavulanic acid in Amoxiclav multichem formulations protects amoxicillin from
degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of
amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and
cephalosporins. Thus Amoxiclav multichem possesses the distinctive properties of a broad
spectrum antibiotic and a beta-lactamase inhibitor.
Pharmacodynamic effects
In the list below, organisms are categorised according to their in vitro susceptibility to
amoxicillin-clavulanate.
In vitro susceptibility of micro-organisms to amoxicillin-clavulanate
Where clinical efficacy of amoxicillin-clavulanate has been demonstrated in clinical trials this
is indicated with an asterisk (*).
Organisms that do not produce beta-lactamase are identified (with †). If an isolate is
susceptible to amoxicillin, it can be considered susceptible to amoxicillin-clavulanate.
Commonly susceptible species
Gram-positive aerobes:
Bacillius anthracis
Enterococcus faecalis
Gardnerella vaginalis
Listeria monocytogenes
Nocardia asteroids
Streptococcus pneumoniae*†
Streptococcus pyogenes*†
Streptococcus agalactiae*†
Viridans group streptococcus†
Streptococcus spp. (other β-hemolytic)*†
Staphylococcus aureus (methicillin susceptible)*
Staphylococcus saprophyticus (methicillin susceptible)
Coagulase negative staphylococcus (methicillin susceptible)
Gram-negative aerobes:
Bordetella pertussis
Haemophilus influenzae*
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Haemophilus parainfluenzae
Helicobacter pylori
Moraxella catarrhalis*
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholera
Other:
Borrelia burgdorferi
Leptospira ictterohaemorrhagiae
Treponema pallidum
Gram-positive anaerobes:
Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.
Gram-negative anaerobes:
Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.
Species for which acquired resistance may be a problem
Gram-negative aerobes:
Escherichia coli*
Klebsiella oxytoca
Klebsiella pneumoniae*
Klebsiella spp.
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Proteus mirabilis
Proteus vulgaris
Proteus spp.
Salmonella spp.
Shigella spp.
Gram-positive aerobes:
Corynebacterium spp.
Enterococcus faecium
Inherently resistant organisms
Gram-negative aerobes:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomas maltophilia,
Yersinia enterolitica
Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetti
Mycoplasma spp.
5.2 Pharmacokinetic properties
Absorption
The two components of Amoxiclav multichem, amoxicillin and clavulanic acid are fully
dissociated in aqueous solution at physiological pH. The pharmacokinetic results for studies in
which amoxicillin-clavulanate was administered to groups of healthy volunteers as either
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500/100 (600 mg) or 1000/200 mg (1.2 g) given as a bolus intravenous injection are presented
below.
Mean pharmacokinetic parameters
Amoxicillin Amoxicillin Mean peak T½ AUC Urinary recovery
component dose serum conc (hours) hours 0 to 6 hours (%)
(mcg/ml) (h.mg/L)
Amoxicillin- 500 mg 32.2 1.07 25.5 66.5
clavulanate 500/100
mg
Amoxicillin- 1g 105.4 0.9 76.3 77.4
clavulanate
1000/200 mg
Mean pharmacokinetic parameters
Clavulanic acid Clavulanic Mean peak T½ AUC hours Urinary recovery
component acid dose serum conc (hours) (h.mg/L) 0 to 6 hours (%)
(mcg/ml)
Amoxicillin-clavulanate 100 mg 10.5 1.12 9.2 46.0
500/100 mg
Amoxicillin-clavulanate 200 mg 28.5 0.9 27.9 63.8
1000/200 mg
Distribution
Following intravenous administration therapeutic concentrations of both amoxicillin and
clavulanic acid may be detected in the tissues and interstitial fluid. Therapeutic concentrations
of both medicines have been found in gall bladder, abdominal tissue, skin, fat, and muscle
tissues; fluids found to have therapeutic levels include synovial and peritoneal fluids, bile and
pus.
Neither amoxicillin nor clavulanic acid is highly protein bound, studies show that about 13-25%
of total plasma drug content of each compound is bound to protein. From animal studies there
is no evidence to suggest that either component accumulates in any organ.
Amoxicillin, like most penicillins, can be detected in breast milk. Trace quantities of clavulanate
can also be detected in breast milk. With the exception of the risk of sensitisation associated
with this excretion, there are no known detrimental effects for the breastfed infant.
Reproduction studies in animals have shown that both amoxicillin and clavulanic acid penetrate
the placental barrier. However, no evidence of impaired fertility or harm to the foetus was
detected.
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Biotransformation
Amoxicillin is also partly excreted in the urine as the inactive penicilloic acid in quantities
equivalent to 10-25% of the initial dose. Clavulanic acid is extensively metabolised in man to
2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-
butan-2-one and eliminated in urine and faeces as carbon dioxide in expired air.
Elimination
As with other penicillins, the major route of elimination for amoxicillin is via the kidney,
whereas for clavulanate it is by both renal and non-renal mechanisms. Approximately 60-70%
of the amoxicillin and approximately 40-65% of the clavulanic acid are excreted unchanged in
urine during the first 6 hours after administration of a single 500/125 mg tablet or a single
500/100 mg or a single 1000/200 mg bolus intravenous injection.
Concomitant use of probenecid delays amoxicillin excretion but does not delay renal excretion
of clavulanic acid (see section 4.5).
5.3 Preclinical safety data
No further information of relevance is available.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Amoxiclav multichem powder for injection contains no excipients.
6.2 Incompatibilities
Amoxicillin-clavulanate should not be mixed with blood products, other proteinaceous fluids
such as protein hydrolysates or with intravenous lipid emulsions. If prescribed concomitantly
with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid
container or giving set because of loss of activity of the aminoglycoside under these conditions.
Amoxicillin-clavulanate solutions should not be mixed with infusions containing glucose,
dextran or bicarbonate.
6.3 Shelf life
3 years.
For the shelf-life of the reconstituted solution see section 6.6.
6.4 Special precautions for storage
Store below 30°C.
For storage conditions after reconstitution of the medicine, see section 6.3
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6.5 Nature and contents of container
Glass vial with synthetic bromobutyl rubber stopper and Al-polypropylene flip-off cap.
Pack size of 10 vials.
Not all strengths may be marketed.
6.6 Special precautions for disposal and other handling
Preparation of intravenous injections
Vial Water for Injection Diluent Displacement Volume Final Volume
(mL) (mL) (mL)
600 mg 10 0.33 10.33
(500/100 mg)
1.2 g 20 0.97 20.97
(1000/200 mg)
Water for Injections B.P. is the normal diluent. A transient pink colouration may or may not
develop during reconstitution. Reconstituted solutions are normally colourless or a pale yellow
colour.
Amoxiclav multichem should be administered within 20 minutes of reconstitution.
Preparation of intravenous infusions and stability
Add without delay 600 mg reconstituted solution to 50 mL infusion fluid or 1.2 g reconstituted
solution to 100 mL infusion fluid (e.g. using a mini-bag or in-line burette).
Intravenous infusions of amoxicillin-clavulanate may be given in a range of different
intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room
temperature (25°C) in the recommended volumes of the following infusion fluids. If
reconstituted and maintained at room temperature, infusions should be completed within the
time stated.
Intravenous Infusion Stability Period 25°C
Water for Injections B.P. 4 hr
Sodium Chloride Intravenous infusion B.P. (0.9% w/v) 4 hr
Sodium Lactate Intravenous infusion B.P. (M/6) 4 hr
Compound Sodium Chloride Injection B.P.C. 1959 (Ringer's) 3 hr
Compound Sodium Lactate Intravenous Infusion B.P. (Ringer- 3 hr
Lactate: Hartmann's)
Potassium Chloride and Sodium Chloride Intravenous Infusion B.P. 3 hr
The stability of amoxicillin-clavulanate intravenous solutions is concentration dependent. In
the event that the use of more concentrated solutions is required, the stability period should
be adjusted accordingly.
For storage at 5°C, the reconstituted solutions of 1000/200 mg (1.2 g) and 500/100 mg (600
mg) may be added to pre-refrigerated infusion bags which may be stored for up to 8 hours.
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Thereafter, the infusion should be administered immediately after reaching room
temperature.
Intravenous Infusion Stability Period 5°C
Water for Injections B.P. 8 hr
Sodium Chloride Intravenous infusion B.P. (0.9% w/v) 8 hr
Amoxicillin-clavulanate is less stable in infusions containing glucose, dextran or bicarbonate.
Reconstituted solutions of Amoxiclav multichem may be injected into the drip tubing over a
period of 3-4 minutes.
Amoxiclav multichem vials are not suitable for multi-dose use.
Any residual antibiotic solutions should be discarded.
Any unused medicine should be disposed of in accordance with local requirements.
7. MEDICINE SCHEDULE
Prescription medicine.
8. SPONSOR
Multichem NZ Ltd
Private Bag 93527
Takapuna
AUCKLAND 0740
Telephone: (09) 488 0330
9. DATE OF FIRST APPROVAL
20 September 2006
10. DATE OF REVISION OF THE TEXT
25 March 2020
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SUMMARY TABLE OF CHANGES
Section CHANGE
4.8 Minor editorial changes and addition of aseptic meningitis as a new adverse reaction
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