AMOKLAVIN DUO 400/57 SUSPENSION
(Amoxicillin Trihydrate and Potassium Clavulanate)
NAME OF THE MEDICINE
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) is a combination product containing
the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the β-lactamase inhibitor, potassium
clavulanate (as the potassium salt of clavulanic acid). Chemically, amoxicillin is D-(-)-α-amino-p-
hydroxybenzylpenicillin. It is susceptible to hydrolysis by β-lactamases. Amoxicillin trihydrate may
be represented structurally as:
(Chemical formula: C
O; Molecular weight: 419.4; CAS – 61336-70-7)
Clavulanic acid is produced by the fermentation of
. It is an irreversible
inhibitor of many β-lactamase enzymes except type 1 (Richmond). It is a β-lactam compound with
only weak antibacterial activity. Chemically potassium clavulanate is potassium
hydroxyethylidene) clavam-2-carboxylate, and may be represented structurally as:
(Chemical formula: C
; Molecular weight: 237.3; CAS – 61177-45-5)
Amoxicillin trihydrate is a white or almost white, crystalline powder and is slightly soluble in water.
A 0.2% solution in water has a pH of 3.5 to 5.5.
Potassium clavulanate is supplied in diluted potassium clavulanate, a dry mixture of potassium
clavulanate and silicon dioxide. Potassium clavulanate is a white or almost white, hygroscopic,
crystalline powder and is freely soluble in water and has a pKa of 2.7 (clavulanic acid). Its
experimental partition coefficient is -1.5. A 1% solution in water has a pH of 4.8 to 8.0.
anhydrous (Aerosil 200), saccharin sodium, silicon dioxide (Syloid AL-1 FP), xanthan gum, methyl
hydroxybenzoate, succinic acid, Golden Syrup Flavour 501118 AP0551 and Orange 51941
The powder in a bottle is diluted with 52 mL water to make up to 60 mL suspension. Each 5 mL of
suspension contains 400 mg amoxicillin and 57 mg clavulanic acid. It also contains 0.29 mmol of
Amoxicillin is stable in the presence of gastric acid. The two components in oral suspension
(amoxicillin and clavulanic acid) are rapidly absorbed if administered before or with a meal, but if
given after meals, the serum levels of clavulanic acid are significantly reduced. To optimise
absorption of clavulanic acid, amoxicillin/clavulanic acid oral suspension should be administered
at the start of a meal. The pharmacokinetics of amoxicillin are not affected by food.
In children aged 2 - 12 years, oral administration of amoxicillin and clavulanic acid oral suspension
(7:1 ratio) every 12 hours (q12h) at a dose of 45mg/kg/day amoxicillin (6.4mg/kg/day clavulanic
acid) was compared to amoxicillin and clavulanic acid oral suspension (4:1 ratio) every 8 hours
(q8h) at a dose of 40mg/kg/day amoxicillin (10mg/kg/day clavulanic acid), either immediately prior
to the start of a meal or at least three hours after a meal.
In this study, the following mean pharmacokinetic parameters were observed for amoxicillin for
amoxicillin and clavulanic acid oral suspension (40mg/kg/day) taken every 8 hours respectively:
peak plasma concentration (C
) of 12.0 and 7.33μg/mL, area under the plasma concentration-time
curve between 0 and 24 hours after the first dose (AUC
) of 35.2 and 18.6μg.h/mL, half life
(t½) of 1.22 and 1.02 hours, median time to peak plasma concentration (T
) of 1.0 and 2.1 hours
and the mean predicted time above the minimum inhibitory concentration (T
24 hours) of 12.3
hours and 14.0 hours.
The following pharmacokinetic parameters were observed for clavulanic acid for amoxicillin and
clavulanic acid oral suspension (45mg/kg/day) taken every 12 hours and amoxicillin and clavulanic
acid oral suspension (40mg/kg/day) taken every 8 hours respectively: C
of 5.49 and 2.66 μg /mL,
of 13.3 and 5.51 μg.h/mL, t½ of 0.99 and 0.94 hours and median T
of 1.0 and 1.6
hours, and mean predicted T
24 hours of 9.80 hours and 9.81 hours.
The clinical efficacy of amoxicillin and clavulanic acid (7:1 ratio) and amoxicillin and clavulanic
acid (4:1 ratio) have been shown to be comparable in the approved indications, despite the
differences in some pharmacokinetic parameters.
Following oral administration, both amoxicillin and clavulanic acid have been shown to diffuse in
significant concentrations into pus, bile, pleural, synovial and peritoneal fluids. Therapeutic
concentrations of both compounds have been detected in gall bladder, abdominal tissue, skin fat,
and muscle tissues. Both penetrate poorly into the CSF when the meninges are normal. Amoxicillin
penetrates into the CSF better through inflamed meninges but the maximum concentrations are still
much lower than the peak serum levels. There are no data at present on the CSF penetration of
clavulanic acid in patients with meningeal inflammation.
Neither amoxicillin nor clavulanic acid is highly protein bound. Clavulanic acid has been variously
reported to be bound to human serum in the range of 9 - 30% and amoxicillin approximately 20%
bound. From animal studies, there is no evidence to suggest either component accumulates in any
As with other penicillins, renal excretion is the major route of amoxicillin clearance, while
clavulanate clearance is via both renal and non-renal mechanisms. Approximately seventy percent
of the dose of amoxicillin is excreted in urine as amoxicillin. For clavulanic acid, following the
administration of 125mg of radiolabelled potassium clavulanate orally to normal volunteers 68% of
the administered radioactivity was recovered in the urine in 24 hours. Of this, 34% (ie. 23% of the
administered dose) represented unchanged clavulanic acid. 2,5-Dihydro-4-(2-hydroxyethyl)-5-oxo-
accounted for a further 23% and 12% (ie. 16% and 8% respectively of the administered dose). Small
amounts of other yet unidentified metabolites were also present. These metabolites were also
present in the urine of rat and dog. The extent of urinary excretion of clavulanic acid and its
metabolites is lower in rat urine than in dog and human urine.
Concurrent administration of probenecid delays amoxicillin excretion but does not notably delay
renal excretion of clavulanic acid.
Similar amoxicillin and clavulanic acid elimination pharmacokinetics occur in adults, children and
infants with mature renal function.
A randomised, single-blind study in 868 children aged 2 months to 12 years with acute otitis media
compared the efficacy of l amoxicillin and clavulanic acid oral suspension 45mg/kg/day amoxicillin
(6.4mg/kg/day clavulanic acid) administered q12h for 5 days (n= 293) or 10 days (n=287) with
amoxicillin and clavulanic acid 40mg/kg/day amoxicillin (10mg/kg/day clavulanic acid) given q8h
for 10 days (n=288). At the end of therapy (days 12 to 14) equivalent per protocol clinical success
rates of 78.8% (n=189) and 86.5% (n=178) respectively were demonstrated for the q8h and q12h
10 day treatment groups, compared with a 71.1% (n=197) success rate for the q12h 5 day treatment
group. At 32 to 38 days follow up, equivalent success rates were demonstrated for q8h and q12h 10
day regimens of 64.2% and 63.1% respectively, compared with a 57.8% success rate for the q12h
5 day treatment group.
Like other penicillins, amoxicillin has a bactericidal effect on sensitive organisms during the stage
of active multiplication. However, amoxicillin is susceptible to hydrolysis by β-lactamases and the
addition of clavulanic acid in amoxicillin and clavulanic acid oral suspension extends the
antimicrobial spectrum of amoxicillin to include organisms normally resistant to amoxicillin due to
beta lactamase production.
studies have demonstrated the susceptibility of most strains of
the following organisms:
Table 1 – Acquired resistance data for amoxicillin/clavulanic acid in Australia according
to NCCLS guidelines (M100-S10) for amoxicillin/clavulanic acid
Percentage of Strains
Number of Pathogens (n)
Streptococcus pneumoniae *
Haemophilus influenzae #
*: - Data collected between March to November 1997.
#: - Data collected in 1999.
Table 2 – MIC Distribution for Sensitive/intermediate/resistant S. pneumoniae Isolates
MIC ≤2 mcg/ml
MIC =4 mcg/ml
MIC ≥ 8mcg/ml
Table 3– Acquired resistance data for amoxicillin/clavulanic acid from other countries
Sensitive aerobe gram positive
Coagulase negative staphylococci
Sensitive aerobe gram negative
Bacteroides fragilis group
Intermediate aerobe gram negative
Resistant aerobe gram positive
Resistant aerobe gram negative
The percent acquired resistance data provided in the above table has been collected from the following countries during the time period
specified: US, 1996; Canada, 1993-1994; US/Canada, 1996-1997; France, 1994-1995; US, Arabia, 1994-1995; US, 1996-1997; US, 1991-
1993; Belgium, 1993-1994; UK, Netherlands, 1989-1995.
Note: Resistance can vary from region to region and information on local resistance should be taken into account.
in vitro data
are available but their clinical significance is unknown.
Table 4- In Vitro Activity of amoxicillin/clavulanic acid
MIC 90 (μg/mL)
GRAM POSITIVE AEROBES:
Coagulase negative staphylococci
GRAM NEGATIVE AEROBES:
GRAM POSITIVE ANAEROBES:
GRAM NEGATIVE ANAEROBES
Bacteroides fragilis group
Other Bacteroides sp. of
B. fragilis group
Bacteroides fragilis group
Prevotella, Porphyromonas and Bacteroides sp.
* Methicillin resistant strains are resistant to amoxicillin/clavulanic acid.
and Klebsiella species may not be susceptible to amoxicillin/clavulanic acid at
concentrations of amoxicillin and clavulanic acid achievable in the urine the majority of strains are
Dilution or diffusion techniques - either quantitative (MIC) or breakpoint - should be used following
a regularly updated, recognised and standardised method (eg. NCCLS). Standardised susceptibility
test procedures require the use of laboratory control micro-organisms to control the technical
aspects of the laboratory procedures.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial
compound in the blood reaches the concentrations usually achievable. A report of "Intermediate"
indicates that the result should be considered equivocal, and if the micro-organism is not fully
susceptible to alternative clinically feasible drugs, the test should be repeated. This category implies
possible clinical applicability in body sites where the drug is physiologically concentrated, or in
situations where high dosage of drug can be used. This category also provides a buffer zone, which
prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A
report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial
compound in the blood reaches the concentrations usually achievable; other therapy should be
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) oral suspension is indicated in the
short term treatment of the following bacterial infections when caused by sensitive organisms (see
Skin and Skin Structure Infections
Urinary Tract Infections (complicated and uncomplicated)
Upper Respiratory Tract Infections including sinusitis and otitis media
Lower Respiratory Tract Infections including acute exacerbations of chronic bronchitis and
community acquired pneumonia
Appropriate culture and susceptibility studies should be performed to identify the causative
organism(s) and determine its (their) susceptibility to AMOKLAVIN DUO 400/57. However, when
there is reason to believe an infection may involve any of the β-lactamase producing organisms
listed above, therapy may be instituted prior to obtaining the results from bacteriological and
susceptibility studies. Once these results are known, therapy should be adjusted if appropriate.
The treatment of mixed infections caused by amoxicillin susceptible organisms and β-lactamase
producing organisms susceptible to AMOKLAVIN DUO 400/57, should not require the addition
of another antibiotic due to the amoxicillin content of AMOKLAVIN DUO 400/57.
A history of allergic reaction to β-lactams (eg. penicillins or cephalosporins) is a contraindication.
AMOKLAVIN DUO 400/57 is contraindicated in patients with a previous history of
amoxicillin/clavulanic acid -associated jaundice/hepatic dysfunction.
Before initiating therapy with amoxicillin-clavulanate, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.
REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF
PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE
ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF
PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS
WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH ANY
HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER
MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including
amoxicillin. A toxin produced by
appears to be the primary cause. The severity
of the colitis may range from mild to life-threatening. It is important to consider this diagnosis in
patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to
discontinuation alone. However in moderate to severe cases appropriate therapy with a suitable oral
antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and
protein replacement should be provided when indicated. Drugs which delay peristalsis, eg. opiates
and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic
and hematopoietic function is advisable during prolonged therapy.
Since AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) contains amoxicillin, an
aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis
because of the possibility that the underlying cause is infectious mononucleosis, in the presence of
which there is a high incidence of rash if amoxicillin is used.
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) should be given with caution to
patients with lymphatic leukemia since they are especially susceptible to amoxicillin induced skin
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) 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.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients
receiving amoxicillin-clavulanate and oral anticoagulants. Appropriate monitoring should be
undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral
anticoagulants may be necessary to maintain the desired level of anticoagulation.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during
therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug
should be discontinued and/or appropriate therapy instituted.
Cholestatic hepatitis, which may be severe but is usually reversible, has been reported rarely. Signs
and symptoms may not become apparent until several weeks after treatment has ceased. In most
cases resolution has occurred with time. However, in extremely rare circumstances, deaths have
been reported. These have almost always been cases associated with serious underlying disease or
concomitant medications. Hepatic events subsequent to amoxicillin/clavulanic acid have occurred
predominantly in males and elderly patients and may be associated with prolonged treatment. These
events have been very rarely reported in children. AMOKLAVIN DUO 400/57 (amoxicillin and
clavulanic acid) should be used with care in patients with evidence of hepatic dysfunction.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly
with parenteral therapy. During the 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
In children with renal impairment, dosage should be adjusted according to degree of impairment
using the alternative amoxicillin and clavulanic acid (4:1 ratio) 125mg/31.25mg or 250mg/62.5mg
formulations (available from other brand/s).
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid 400/57 mg in 5 mL) formulation is
not recommended for use in children with renal impairment.
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of
amoxicillin and clavulanic acid.
and clavulanic acid
chromosomal damage (mouse micronuclucleus test and a dominant lethal test) and gene conversion.
All were negative.
Effects on Fertility
Amoxicillin and clavulanic acid at oral doses of up to 1200 mg/kg/day had no effect on fertility and
reproductive performance in rats dosed with a 2:1 ratio formulation of amoxicillin and clavulanate.
Use in Pregnancy
Animal studies with orally and parenterally administered amoxicillin and clavulanic acid have
shown no teratogenic effects. There is limited experience of the use of amoxicillin and clavulanic
acid in human pregnancy. In women with preterm, premature rupture of the foetal membrane
(pPROM), prophylactic treatment with amoxicillin and clavulanic acid may be associated with an
increased risk of necrotising enterocolitis in neonates.
As with all medicines, use should be avoided in pregnancy, especially during the first trimester,
unless considered essential by the physician.
Use in Labor and Delivery
Oral ampicillin class antibiotics are generally poorly absorbed during labor. Studies in guinea pigs
have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of
contractions, height of contractions and duration of contractions. However, it is not known whether
the use of amoxicillin and clavulanic acid in humans during labor or delivery has immediate or
delayed adverse effects on the foetus, prolongs the duration of labor or increases the likelihood that
forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
Use in Lactation
Amoxicillin is excreted in milk. There are no data on the excretion of clavulanic acid in human or
administered to a nursing woman.
Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Effect on laboratory tests
Oral administration of amoxicillin and clavulanic acid will result in high urine concentrations of
amoxicillin. Since high urine concentrations of ampicillin may result in false positive reactions
when testing for the presence of glucose in urine using Clinitest, Benedict's Solution or Fehling's
Solution, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such
as Clinistix® or Testape®) be used.
concentration of total conjugated oestriol, oestriol-glucuronide, conjugated oestrone and oestradiol
has been noted. This effect may also occur with amoxicillin and therefore AMOKLAVIN DUO
400/57 (amoxicillin and clavulanic acid).
INTERACTIONS WITH OTHER MEDICINES
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular
secretion of amoxicillin but does not notably affect clavulanic acid excretion. Concurrent use with
amoxicillin and clavulanic acid oral suspension may result in increased and prolonged blood levels
of amoxicillin but not of clavulanic acid.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of
rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not
known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia
present in these patients. There are no data with amoxicillin and clavulanic acid and allopurinol
In common with other antibiotics, amoxicillin and clavulanic acid 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.
Amoxicillin and clavulanic acid oral suspension is generally well tolerated. The majority of events
were of a mild and transient nature.
The following adverse events reported in a pivotal clinical trial with amoxicillin and clavulanic
acid oral suspension (45/6.4mg/kg/day q12h for 10 days) and are compared to amoxicillin and
clavulanic acid oral suspension (40/10mg/kg/day q8h for 10 days).
The most frequently (≥1%) reported adverse experiences in decreasing order for the
BD 10 days regimen.
Total No. of Patients
TDS 10 days
BD 10 days
Dermatitis, contact *
Therapeutic response increased **
Respiratory disorder (Not specified)
Ear disorder (not specified)
* Diaper rash
** Accidental/intentional overdose
In addition, the following adverse reactions have been reported for ampicillin class antibiotics and
may occur with amoxicillin and clavulanic acid oral suspension:
very common ≥1/10
common ≥1/100 and <1/10
uncommon ≥1/1000 and <1/100
rare ≥1/10000 and <1/1000
very rare <1/10000
Infections and infestations:
: mucocutaneous candidiasis.
: gastritis, stomatitis, glossitis, black "hairy" tongue, enterocolitis. Antibiotic-associated colitis
(including pseudomembranous colitis and haemorrhagic colitis), See
: moderate rise in AST and/or ALT.
: Hepatitis, cholestatic jaundice which may be severe but is usually reversible.
Nervous system disorders:
: reversible hyperactivity, convulsions. Convulsions may occur in patients with impaired
renal function or those receiving high doses.
Haematopoietic and lymphatic systems:
: anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, reversible leukopenia
(including neutropenia or agranulocytosis) these are usually reversible on discontinuation of therapy
and are believed to be hypersensitivity phenomena, prolongation of bleeding time and prothrombin
Hypersensitivity and skin:
: skin rashes, pruritis, urticaria
: angioneurotic oedema, anaphylaxis, serum-sickness-like syndrome, erythema multiforme,
exfoliative dermatitis and acute generalised exanthematous putulosis (AGEP) have been reported
rarely. Whenever such reactions occur, amoxicillin/clavulanic acid oral suspension should be
discontinued, unless in the opinion of the physician no alternative treatment is available and
continued use of amoxicillin/clavulanic acid oral suspension is considered essential. Serious and
occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with
oral penicillins (See
Renal and urinary disorders:
: interstitial nephritis
crystalluria (see Overdosage)
superficial tooth discolouration which can usually be removed by brushing.
DOSAGE AND ADMINISTRATION
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) should be taken immediately before
or with the first mouthful of food,
to minimise potential gastrointestinal intolerance and to optimise
Children aged 2 months up to 12 years
For moderate to severe infections the dose should be 45 mg/kg/day, based on the amoxicillin
component, (or 6.4mg/kg/day clavulanic acid) in two divided doses every 12 hours.
The children's dosage is intended for individuals whose weight will not cause dosage to be
calculated greater than that recommended for adults. Children weighing 40 kg and more should be
dosed according to the adult recommendations for other amoxicillin/clavulanic acid preparations
(available from other brand/s).
There are no clinical data available for amoxicillin and clavulanic acid in infants with immature
renal function. The use of AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) in this
group cannot be recommended.
Use in Hepatic Impairment
Data is currently insufficient for a dosage recommendation. Dose with caution and monitor
hepatic function at regular intervals.
Use in Renal Impairment
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) is not recommended for use in
children with renal impairment or in haemodialysis. In children with renal impairment, dosage
should be adjusted according to degree of impairment using the alternative amoxicillin and
clavulanic acid (4:1 ratio) 125mg/31.25mg or 250mg/62.5mg formulations (available from other
Direction for reconstituting the oral suspension
Prepare the oral suspension at time of dispensing as follows: Tap bottle until all the powder flows
freely. Add approximately 1/2 of the total amount of water for reconstitution (see table below) and
shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AMOKLAVIN DUO 400/57
(amoxicillin and clavulanic acid)
400/57 mg in 5 mL oral suspension
Amount of water
Final volume of
100 mL (glass)
Shake oral suspension well before using. Reconstituted syrup must be stored under refrigeration
(2 -8°C) and discarded after 7 days.
Problems of overdosage with amoxicillin and clavulanic acid are unlikely to occur. If encountered,
gastrointestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They
may be treated symptomatically, with attention to the water/electrolyte balance.
Amoxicillin may be removed from the circulation by haemodialysis.
Contact the Poisons Information Centre (telephone 13 11 26) for advice on overdose management.
PRESENTATION AND STORAGE CONDITIONS
Store dry powder below 25°C. Under these conditions the shelf life is 18 months.
Store reconstituted suspension at 2-8°C in a refrigerator. Under these conditions the shelf life is 7
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) Oral Suspension: Each 5mL of
amoxicillin (as trihydrate) and 57 mg clavulanic acid (as the potassium salt). It is presented in 100
mL amber coloured glass bottles containing white to cream dry powder for reconstitution in water
to form 60 mL of an oral suspension with white, opaque child-resistant cap.
NAME AND ADDRESS OF THE SPONSOR:
Deva Holdings (Australia) Pty Ltd
30 Periwinkle Drive,
Cranbourne East, VIC 3977
POISON SCHEDULE OF THE MEDICINE:
DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC
GOODS (THE ARTG): 15 December, 2014
DATE OF MOST RECENT AMENDMENT: