Summary of product characteristics

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1. Name of the Medicinal Product
Product name: MOXIPIL CV 156 (Co-amoxiclav Oral Suspension BP 156.25mg/5ml)
Strength: 156.25mg/5ml
Pharmaceutical Form: Powder for oral suspension

2. Quality and Quantitative Composition

Each 5ml of reconstituted suspension contains:
Amoxicillin Trihydrate BP
Equivalent to Amoxicillin 125mg
Diluted Potassium Clavulanate BP
Equivalent to Clavulanic acid 31.25mg
Colour: Sunset Yellow FCF

Excipients with known effect:

Each 5ml of reconstituted suspension contains: 974.74mg of Sucrose, 8 mg of Aspartame, 0.5 mg of
Colour Tartrazine
For full list of excipients , see section 6.1

3. Pharmaceutical form
Powder for oral Suspension
Description: Off white granular powder having orange colour suspension after reconstitution

4. Clinical Particulars
4.1 Therapeutic Indications
Co-amoxiclav Oral Suspension is indicated for the treatment of the following infections in adults and
children:
 Acute bacterial sinusitis (adequately diagnosed)
 Acute otitis media
 Acute exacerbations of chronic bronchitis (adequately diagnosed)
 Community acquired pneumonia
 Cystitis
 Pyelonephritis
 Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with
spreading cellulitis.
 Bone and joint infections, in particular osteomyelitis.

4.2 Posology and Method of Administration

Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are
stated in terms of an individual component.
The dose of Co-amoxiclav that is selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to antibacterial agents
• The severity and the site of the infection
• The age, weight and renal function of the patient as shown below.

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 The use of alternative presentations of amoxicillin/clavulanic acid (e.g. those that provide higher doses
of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as
necessary.
For adults and children ≥ 40 kg, this formulation of Co-amoxiclav provides a total daily dose of 1500
mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children < 40
kg, this formulation of Co-amoxiclav provides a maximum daily dose of 2400 mg amoxicillin/600 mg
clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose
of amoxicillin is required, it is recommended that another preparation of Co-amoxiclav is selected in
order to avoid administration of unnecessarily high daily doses of clavulanic acid.
The duration of therapy should be determined by the response of the patient. Some infections (e.g.
osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days
without review.
Adults and children ≥ 40 kg
One 500 mg/125 mg dose taken three times a day.
Children < 40 kg
20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.
Children may be treated with Co-amoxiclav tablets, suspensions or paediatric sachets. Children aged 6
years and below should preferably be treated with Co-amoxiclav suspension or paediatric sachets. No
clinical data are available on doses of Co-amoxiclav 4:1 formulations higher than 40 mg/10 mg/kg per
day in children under 2 years.
Elderly
No dose adjustment is considered necessary.
Renal impairment
Dose adjustments are based on the maximum recommended level of amoxicillin.
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.
Adults and children ≥ 40 kg
CrCl: 10-30 ml/min 500 mg/125 mg twice daily
CrCl < 10 ml /min 500 mg/125 mg once daily
Haemodialysis 500 mg/125 mg every 24 hours, plus 500 mg/125 mg during dialysis, to be
repeated at the end of dialysis (as serum concentrations of both amoxicillin and
clavulanic acid are decreased)
Children < 40 kg
CrCl: 10-30 ml/min 15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily).
CrCl < 10 ml /min 15 mg/3.75 mg/kg as a single daily dose (maximum 500 mg/125 mg).
Haemodialysis 15 mg/3.75 mg/kg per day once daily.
Prior to haemodialysis 15 mg/3.75 mg/kg. In order to restore circulating drug
levels, 15 mg/3.75 mg per kg should be administered after haemodialysis.
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals.
Method of administration
Co-amoxiclav is for oral use.
Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise
absorption of amoxicillin/clavulanic acid.
Space the doses evenly during the day, at least 4 hours apart.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.

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4.3 Contraindications
 Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients listed in
section 6.1.
 History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam
agent (e.g. a cephalosporin, carbapenem or monobactam).
 History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid

4.4 Special warning and precautions for use

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.
Serious and occasionally fatal hypersensitivity 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 and in
atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be
discontinued and appropriate alternative therapy instituted.
Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving
amoxicillin/clavulanate (seesection 4.8). DIES is an allergic reaction with the leading symptom of
protracted vomiting (1-4 hours after drug use) inthe absence of allergic skin or respiratory symptoms.
Further symptoms could comprise abdominal pain, diarrhoea,hypotension or leucocytosis with
neutrophilia. There have been severe cases including progression to shock.
In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then
consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in
accordance with official guidance.
This presentation of Co-amoxiclav is not suitable for use when there is a high risk that the presumptive
pathogens have reduced susceptibility or resistance to beta-lactam agents that is not mediated by beta-
lactamases susceptible to inhibition by clavulanic acid. This presentation should not be used to treat
penicillin-resistant S. pneumoniae.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Amoxicillin/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.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of
allergic skin reactions.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula
may be a symptom of acute generalised exanthemous pustulosis (AGEP). This reaction requires Co-
amoxiclav discontinuation and contraindicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic
impairment.
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. In all populations,
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

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always occurred in patients with serious underlying disease or taking concomitant medications known
to have the potential for hepatic effects.
Antibiotic-associated colitis has been reported with nearly all antibacterial agents including
amoxicillin and may range in severity from mild to life threatening. Therefore, it is important to
consider this diagnosis in patients who present with diarrhoea during or subsequent to the
administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin/clavulanic acid
should immediately be discontinued, a physician be consulted and an appropriate therapy initiated.
Anti-peristaltic medicinal products are contraindicated in this situation.
Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is
advisable during prolonged therapy.
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic
acid. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly.
Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of
anticoagulation
In patients with renal impairment, the dose should be adjusted according to the degree of impairment.
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 crystalluria. In
patients with bladder catheters, a regular check of patency should be maintained.
During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever
testing for the presence of glucose in urine because false positive results may occur with non-
enzymatic methods.
The presence of clavulanic acid in Co-amoxiclav may cause a non-specific binding of IgG and
albumin by red cell membranes leading to a false positive Coombs test.
There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus
EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of
Aspergillus infection. Cross-reactions with non-Aspergilluspolysaccharides and polyfuranoses with
Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results
in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by
other diagnostic methods.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance
should not take this medicine.
This medicinal product contain aspartame which is source of phenylalanine may be harmful for patient
having phenylketonuria (PKU).
This medicinal product contain Colour Sunset Yellow, may cause allergic reaction.

4.5 Interaction with other medicinal products and other forms of interaction
Oral anticoagulants
Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of
interaction. However, in the literature there are 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. Moreover, adjustments in the dose of oral
anticoagulants may be necessary.
Methotrexate
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

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Probenecid
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion
of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of
amoxicillin but not of clavulanic acid.
Mycophenolate mofetil
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active
metabolite mycophenolic acid (MPA) of approximately 50% has been reported following
commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not
accurately represent changes in overall MPA exposure. Therefore, a change in the dose of
mycophenolate mofetil should not normally be necessary in the absence of clinical evidence of graft
dysfunction. However, close clinical monitoring should be performed during the combination and
shortly after antibiotic treatment.

4.6 Fertility, Pregnancy and lactation

Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal/foetal development, parturition or postnatal development. Limited data on the use of
amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital
malformations. In a single study in women with preterm, premature rupture of the foetal membrane it
was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an
increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless
considered essential by the physician.
Lactation
Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the
breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes are
possible in the breast-fed infant, so that breast-feeding might have to be discontinued. The possibility
of sensitisation should be taken into account. Amoxicillin/clavulanic acid should only be used during
breast-feeding after benefit/risk assessment by the physician in charge.
Fertility
There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals
have shown no teratogenic effects on fertility.

4.7 Effects on ability to drive and use machines

MOXIPIL CV 156 no studies on the effects on the ability to drive and use machines have been
performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions),
which may influence the ability to drive and use machines

4.8 Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with Co-amoxiclav, sorted by
MedDRA System Organ Class are listed below.
The following terminologies have been used in order to classify the occurrence of undesirable effects.
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)

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Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Infections and infestations
Mucocutaneous candidosis Common
Overgrowth of non-susceptible organisms Not known
Blood and lymphatic system disorders
Reversible leucopenia (including neutropenia) Rare
Thrombocytopenia Rare
Reversible agranulocytosis Not known
Haemolytic anaemia Not known
Prolongation of bleeding time and prothrombin Not known
time1
Immune system disorders10
Angioneurotic oedema Not known
Anaphylaxis Not known
Serum sickness-like syndrome Not known
Hypersensitivity vasculitis Not known
Nervous system disorders
Dizziness Uncommon
Headache Uncommon
Reversible hyperactivity Not known
2
Convulsions Not known
Aeseptic meningitis Not known
Cardiac Disorder
Kounis syndrome Not known
Gastrointestinal disorders
Diarrhoea Very common
3
Nausea Common
Vomiting Common
Indigestion Uncommon
4
Antibiotic-associated colitis Not known
Black hairy tongue Not known
11
Tooth discolouration Not known
Drug-induced enterocolitis syndrome Not known
Pancreatitis acute Not known
Hepatobiliary disorders
Rises in AST and/or ALT5 Uncommon
6
Hepatitis Not known
6
Cholestatic jaundice Not known
7
Skin and subcutaneous tissue disorders
Skin rash Uncommon
Pruritus Uncommon
Urticaria Uncommon
Erythema multiforme Rare
Stevens-Johnson syndrome Not known

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 Toxic epidermal necrolysis Not known
Bullous exfoliative-dermatitis Not known
9
Acute generalised exanthemous pustulosis (AGEP) Not known
Drug reaction with eosinophilia and systemic Not known
symptoms (DRESS)
Linear IgA disease Not known
Renal and urinary disorders
Interstitial nephritis Not known
8
Crystalluria Not known
1
See section 4.4
2
See section 4.4
3
Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they
may be reduced by taking amoxicillin/clavulanic acid with a meal.
4
Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4)
5
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.
6
These events have been noted with other penicillins and cephalosporins (see section 4.4).
7
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section
4.4).
8
See section 4.9
9
See section 4.4
10
See sections 4.3 and 4.4
11
Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may
help to preventtooth discolouration as it can usually be removed by brushing.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via EFDA yellow Card Scheme,
online at https://primaryreporting.who-umc.org/ET or toll free call 8482 to Ethiopian food and drug
authority (EFDA).

4.9 Overdose
Symptoms and signs of overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous
administration of large doses. A regular check of patency should be maintained.
Treatment of intoxication
Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte
balance.
Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.

5.0 Pharmacological Properties

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5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors;
ATC code: J01CR02.
Mechanism of action
Amoxicillin is semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes
(often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial
peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of
peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and
death.
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria 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 penicillins. It inactivates some beta-lactamase
enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a
clinically useful antibacterial effect.
Pharmacokinetic/Pharmacodynamic relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major
determinant of efficacy for amoxicillin.
Mechanisms of resistance
The two main mechanisms of resistance to amoxicillin/clavulanic acid are:
• Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid,
including class B, C and D.
• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance,
particularly in Gram-negative bacteria.
Breakpoints
MIC breakpoints for amoxicillin/clavulanic acid are those of the European Committee on
Antimicrobial Susceptibility Testing (EUCAST).
Organism Susceptibility Breakpoints (μg/ml)1
Susceptible Intermediate2 Resistant
Haemophilus influenzae 1
≤1 >1
Moraxella catarrhalis1 ≤1 - >1
Staphylococcus aureus 2
≤2 - ≥2
Coagulase-negative staphylococci 2
≤ 0.25 - >0.25
Enterococcus1 ≤4 8 ≥8
Streptococcus A, B, C, G5 ≤ 0.25 >0.25
Streptococcus pneumoniae3 ≤ 0.5 1-2 >2
Enterobacteriaceae1,4 -- >8
Gram-negative Anaerobes1 ≤4 8 >8
Gram-positive Anaerobes1 ≤4 8 >8
Non-species related breakpoints1 ≤2 4-8 >8

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 1
The reported values are for Amoxicillin concentrations. For susceptibility testing purposes, the
concentration of Clavulanic acid is fixed at 2 mg/l.
2
The reported values are oxacillin concentrations.
3
Breakpoint values in the table are based on Ampicillin breakpoints.
4
The resistant breakpoint of R>8 mg/l ensures that all isolates with resistance mechanisms are
reported resistant.
5
Breakpoint values in the table are based on Benzyl penicillin breakpoints.
The prevalence of resistance may vary geographically and with time for selected species, and local
information on resistance is desirable, particularly when treating severe infections. As necessary,
expert advice should be sought when the local prevalence of resistance is such that the utility of the
agent in at least some types of infections is questionable.
Commonly susceptible species
Aerobic Gram-positive micro-organisms
Enterococcus faecalis
Gardnerella vaginalis
Staphylococcus aureus (methicillin-susceptible)£
Coagulase-negative staphylococci (methicillin-susceptible)
Streptococcus agalactiae
Streptococcus pneumoniae1
Streptococcus pyogenes and other beta-haemolytic streptococci
Streptococcus viridians group
Aerobic Gram-negative micro-organisms
Capnocytophaga spp.
Eikenella corrodens
Haemophilus influenzae2
Moraxella catarrhalis
Pasteurella multocida
Anaerobic micro-organisms
Bacteroides fragilis
Fusobacterium nucleatum
Prevotella spp.
Species for which acquired resistance may be a problem
Aerobic Gram-positive micro-organisms
Enterococcus faecium$
Aerobic Gram-negative micro-organisms
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
Proteus vulgaris
Inherently resistant organisms
Aerobic Gram-negative micro-organisms
Acinetobacter sp.
Citrobacter freundii
Enterobacter sp.
Legionella pneumophila

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Morganella morganii
Providencia spp.
Pseudomonas sp.
Serratia sp.
Stenotrophomonas maltophilia
Other micro-organisms
Chlamydophila pneumoniae
Chlamydophila psittaci
Coxiella burnetti
Mycoplasma pneumonia
$
Natural intermediate susceptibility in the absence of acquired mechanism of resistance.
£
All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid
1
Streptococcus pneumonia that are resistant to penicillin should not be treated with this presentation of
amoxicillin/clavulanic acid (see sections 4.2 and 4.4).
2
Strains with decreased susceptibility have been reported in some countries in the EU with a frequency
higher than 10%.

5.2 Pharmacokinetic Properties

Absorption
Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH. Both
components are rapidly and well absorbed by the oral route of administration. Following oral
administration, amoxicillin and clavulanic acid are approximately 70%bioavailable. The plasma
profiles of both components are similar and the time to peak plasma concentration (T max) in each case
is approximately one hour.
The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (500 mg/125 mg tablets
three times daily) was administered in the fasting state to groups of healthy volunteers, are presented
below.

Mean (± SD) pharmacokinetic parameters

Active substance(s) Dose Cmax Tmax * AUC (0-24h) T 1/2
administered (mg) (μg/ml) (h) (μg.h/ml) (h)
Amoxicillin
AMX/CA 500 7.19± 2.26 1.5 (1.0-2.5) 53.5 ± 8.87 1.15 ± 0.20
500/125 mg
Clavulanic acid
AMX/CA 125 2.40± 0.83 1.5 (1.0-2.0) 15.72 ± 3.86 0.98 ± 0.12
500 mg/125 mg
AMX-Amoxicillin, CA-Clavulanic acid
* Median (range)
Amoxicillin and clavulanic acid serum concentrations achieved with amoxicillin/clavulanic acid are
similar to those produced by the oral administration of equivalent doses of amoxicillin or clavulanic
acid alone.
Distribution
About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein.
The apparent volume of distribution is around 0.3-0.4 l/kg for amoxicillin and around 0.2 l/kg for
clavulanic acid.

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Following intravenous administration, both amoxicillin and clavulanic acid have been found in gall
bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus.
Amoxicillin does not adequately distribute into the cerebrospinal fluid.
From animal studies there is no evidence for significant tissue retention of drug-derived material for
either component. Amoxicillin, like most penicillins, can be detected in breast milk. Trace quantities of
clavulanic acid can also be detected in breast milk.
Both amoxicillin and clavulanic acid have been shown to cross the placental barrier.
Metabolism
Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up
to 10 to 25% of the initial dose. Clavulanic acid is extensively metabolized in man and eliminated in
urine and faeces, and as carbon dioxide in expired air.
Elimination
The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by
both renal and non-renal mechanisms.
Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one hour and a mean
total clearance of approximately 25l/h in healthy subjects. Approximately 60 to 70% of the amoxicillin
and approximately 40 to 65% of the clavulanic acid are excreted unchanged in urine during the first 6
h after administration of single Co-amoxiclav 250 mg/125 mg or 500 mg/125 mg tablets. Various
studies have found the urinary excretion to be 50-85% for amoxicillin and between 27-60% for
clavulanic acid over a 24 hour period. In the case of clavulanic acid, the largest amount of drug is
excreted during the first 2 hours after administration.
Concomitant use of probenecid delays amoxicillin excretion but does not delay renal excretion of
clavulanic acid.
Age
The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and
older children and adults. For very young children (including preterm newborns) in the first week of
life the interval of administration should not exceed twice daily administration due to immaturity of
the renal pathway of elimination. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to monitor renal function.
Specific Population
Gender
Following oral administration of amoxicillin/clavulanic acid to healthy males and female subjects,
gender has no significant impact on the pharmacokinetics of either amoxicillin or clavulanic acid.
Renal impairment
The total serum clearance of amoxicillin/clavulanic acid decreases proportionately with decreasing
renal function. The reduction in drug clearance is more pronounced for amoxicillin than for clavulanic
acid, as a higher proportion of amoxicillin is excreted via the renal route. Doses in renal impairment
must therefore prevent undue accumulation of amoxicillin while maintaining adequate levels of
clavulanic acid.
Hepatic impairment
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular
intervals.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology,
repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

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Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric
irritancy and vomiting, and discoloured tongue.
Carcinogenicity studies have not been conducted with amoxicillin/clavulanic acid.

6.0 Pharmaceutical Particulars

6.1 List of Excipients

S. No. Ingredients
1 Sodium Benzoate
2 Succinic acid
3 Xanthan gum
4 Aspartame
5 Flavour Orange (Powder)
a) Maltodextrin
b) Natural Flavouring Substance
c) Emulsifier (INS 414)
d) Nature Identical Flavoring Substances
e) Antioxidant(INS 300)
6 Flavour Raspberry (Powder)
a) Emulsifier (INS 414)
b) Nature Identical Flavouring
c) Substances
Maltodextrin
d) Natural Flavoring Substances
e) Preservative (INS 211)
f) Artif
Artificial Flavouring Substances
7 Colloidal anhydrous silica
8 Col. Sunset Yellow FCF
9 Sucrose

6.2 Incompatibilities
Not applicable

6.3 Shelf Life

24 Months (once reconstituted 5 days)

6.4 Special Precautions for Storage

Store at a temperature not exceeding 25°C. Protect from light & moisture.
Reconstituted Suspension: used within 5 days & stored between 2°C-8°C in a refrigerator
If dilution of the reconstituted product is required, water should be used.

6.5 Nature and Contents of Container

100 ml amber glass bottle having ring mark with induction sealing along with plastic screw cap fitted with
measuring cup on cap, further labeled & packed in a carton with product leaflet.

6.6 Special precautions for disposal and other handling

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No special requirements. Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
Shake the bottle well to loosen Powder. Slowly add boiled and cooled water up to the ring mark on the
bottle and shake vigorously. Adjust the volume up to the mark by adding more water if necessary. This
makes 100ml suspension. The reconstituted suspension must be used within 5 days and stored between
2°C-8°C.

7. Marketing authorization holder

Name : PIL Pharmaceuticals Limited
Address: Plot No. 71 & 72, Sector-6A, IIE, SIIDCUL,
Haridwar-249403 (Uttarakhand) INDIA
www.pilindia.in
Tel: +91-01334-660800, +91-01334-660801
fax: +91-01334-660807
e-mail: [email protected]

8. Marketing Authorisation Number(S)

04627/3977/NMR/2017

9. Date of first authorization/renewal of the authorization

Date of first authorization: 16/09/2019

10. Date of revision of the text

07/2023

11. Reference
https://www.medicines.org.uk/emc/product/6671/smpc#gref

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