Amoxicillin is indicated for the treatment of the following bacterial infections caused by
amoxicillin-sensitive gram-positive and gram-negative pathogens (see section 5.1):
 Infections of the upper respiratory tract, including infections of the ears, nose and
throat: Acute otitis media, acute sinusitis and bacterial pharyngitis.
 Infections of the lower respiratory tract: Acute exacerbation of chronic bronchitis,
community-acquired pneumonia.
 Infections of the lower urinary tract: Cystitis.
 Prophylaxis of endocarditis in patients at risk i.e. surgery in the oral cavity or upper
airways
Consideration should be given to official guidance on the appropriate use of antibacterial
agents.
Susceptibility of the causative organism to the treatment should be tested (if possible),
although may be initiated before the results are available.

The dosage of amoxicillin is dependent on age, bodyweight and renal function of the patient,
on the seriousness and localisation of the infection and on the expected or proved causative
agent.
Standard dosage
Adult and adolescents (> 40 kg body weight):
The usual dosage covers a range from 750 mg to 3g amoxicillin daily in divided doses. In
some areas 1500 mg amoxicillin daily in divided doses are recommended as the upper usual
dose.
Special dosage recommendation
Acute exacerbation of chronic bronchitis in adults: 2 x 1 g per day

Children’s dosage (under 40 kg)
The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not
exceeding 3 g/day) depending on the indication, the severity of the disease and the
susceptibility of the pathogen (see special dosage recommendations below and sections 4.4,
5.1 and 5.2).
*PK/PD data indicate that dosing three times daily is associated with enhanced efficacy,
thus twice daily dosing is only recommended when the dose is in the upper range.
Children weighing more than 40 kg should be given the usual adult dosage.
Special dosage recommendation
Tonsillitis: 50 mg/kg/day in two divided doses.
Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility
to penicillins, dosage regimens should be guided by national/local recommendations.
Dosage for the prevention of endocarditis
For the prevention of endocarditis, in patients not having general anaesthetic, 3 g
amoxicillin are given orally in the hour preceding the surgical procedure, followed by (6
hours later) a further 3 g dose, if considered necessary.
For children: 50 mg amoxicillin/kg body weight given as a single dose one hour preceding
the surgical procedure.
For further details and description of patients at risk local official guidelines for the
prevention of endocarditis should be consulted.

Dosage in patients with impaired renal function:
The dose should be reduced in patients with severe renal function impairment.
In patients with a renal clearance of less than 30 ml/min an increase in the dosage interval
and a reduction in the total daily dose is recommended (see section 4.4 and 5.2).
Adults (including older patients):
Creatinine clearance
ml/min
Dose
Interval between
administration
>30 No adjustment necessary -
10-30 500 mg 12 h
< 10 500 mg 24 h

In case of hemodialysis: 500 mg should be administered at the end of the procedure.
Renal impairment in children under 40 kg:
Creatinine clearance
ml/min
Dose
Interval between
administration
>30 Usual dose No adjustment necessary
10-30 Usual dose
12 h (corresponding to 2/3
of the dose)
< 10 Usual dose
24 h (corresponding to 1/3
of the dose)

Dosage in patients with impaired hepatic function
No dose reduction is necessary as long as the renal function is not impaired.
Duration of therapy:
In general the therapy should be continued for 2 to 3 days following the disappearance of
symptoms. In β-haemolytic streptococcal infections the duration of therapy should be 6-10
days in order to achieve eradication of the organism.
Method of administration:
The preparation is administered orally with a measuring spoon. The measuring spoon is
included in the package. The ready-for-use suspension should be taken with a glass of
water.
The absorption of amoxicillin is not reduced by food intake.
Administration to babies: The prescribed dosage is administered undiluted to the baby; milk
or tea should be given afterwards.

Before initiating therapy with amoxicillin, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins and cephalosporins. The possibility of crosshypersensitivity
(10 % - 15 %) with cephalosporins should be taken into account.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported
in patients on penicillin therapy. These reactions are more likely to occur in individuals with
a history of hypersensitivity to beta-lactam antibiotics.
In patients with renal function impairment the excretion of amoxicillin will be delayed and,
depending on the degree of the impairment, it may be necessary to reduce the total daily
dosage (see section 4.2.).
The prolonged use of amoxicillin may occasionally result in an overgrowth of nonsusceptible
organisms or yeasts. Patients should therefore carefully be watched for super
infections.
The occurrence of anaphylactic shock and other severe allergic reactions is rare following
the oral administration of amoxicillin. However, if such reactions occur, appropriate
emergency treatment measures must be taken.
The presence of high urinary concentrations of amoxicillin can cause precipitation of the
product in urinary catheters. Therefore, catheters should be visually inspected at intervals.
At high doses, adequate fluid intake and urinary output must be maintained to minimise the
possibility of amoxicillin crystalluria.
Amoxicillin should not be used for the treatment of bacterial infections in patients with viral
infections, acute lymphatic leukaemia, or infectious mononucleosis as erythematous
(morbilliform) rashes have been associated with glandular fever in patients receiving
amoxicillin. Antibiotics-associated colitis has been reported with nearly all antibacterial agents and may
range in severity from mild to life threatening (see section 4.8). 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
should immediately be discontinued, a physician be consulted and an appropriate therapy
initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.
As with other beta-lactums, the blood formula should be checked regularly during high-dose
therapy.
Periodic assessment of organ system functions, including renal, hepatic and haematopoietic
functions is advisable during prolonged therapy.
High dose therapy with beta-lactums for patients with renal insufficiency or seizures history,
treated epilepsy and meningal affection, could be exceptionally lead to seizures.
The occurrence of a generalised erythema with fever and pustules at the beginning of
treatment should make suspect a generalised acute exanthamatic pustulosis: this
necessitates the interruption of therapy and contraindicated any further administration of
amoxicillin.

Concomitant use not recommended
Allopurinol
Concomitant administration of allopurinol may promote the occurrence of allergic cutaneous
reactions and is therefore not advised.
Digoxin
An increase in the absorption of digoxin is possible on concurrent administration with
amoxicillin. A dose adjustment of digoxin may be necessary.
Anticoagulants
Concomitant administration of amoxicillin and anticoagulants from the coumarin class, may
prolong the bleeding time. A dose adjustment of anticoagulants may be necessary. A large
number of cases showing an increase of oral anticoagulant activity have been reported in
patients receiving antibiotics. The infectious and inflammatory context, age and the general
status of the patient appear as risk factors. In these circumstances, it is difficult to know the part of the responsibility between the
infectious disease and its treatment in the occurrence of INR disorders. However, some
classes of antibiotics are more involved, notably fluoroquinolones, macrolides, cyclines,
cotrimoxazole and some cephalosporins
Methotrexate
Interaction between amoxicillin and methotrexate leading to methotrexate toxicity has been
reported. Serum methotrexate levels should be closely monitored in patients who receive
amoxicillin and methotrexate simultaneously. Amoxicillin decreases the renal clearance of
methotrexate, probably by competition at the common tubular secretion system.
Caution is recommended when amoxicillin is given concomitantly with:
Oral hormonal contraceptives
Administration of amoxicillin can transiently decrease the plasma level of estrogens and
progesterone, and may reduce the efficacy of oral contraceptives. It is therefore
recommended to take supplemental nonhormonal contraceptive measures.
Other forms of interactions:
 Forced diuresis leads to a reduction in blood concentrations by increased elimination
of amoxicillin.
 It is recommended that when testing for the presence of glucose in urine during
amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to
the high urinary concentrations of amoxicillin, false positive readings are common
with chemical methods.
 Amoxicillin may decrease the amount of urinary estriol in pregnant women.
 At high concentrations, amoxicillin may diminish the results of serum glycemia
levels.
 Amoxicillin may interfere with protein testing when colormetric methods are used.

Pregnancy
Amoxicillin passes the placenta and foetal plasma concentrations are approximately 25-30%
of the maternal plasma concentrations. Data on a limited number of exposed pregnancies indicate no adverse effects of amoxicillin
on pregnancy or on the health of the foetus/new-born child. To date, no other relevant
epidemiological data are available. Animal studies do not indicate direct or indirect harmful
effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal
development. Caution should be exercised when prescribing to pregnant women.
Breast-feeding
Amoxicillin is excreted into breast milk (approx. 10% of the corresponding serum
concentration). So far no detrimental effects for the breast-fed infant have been reported
after taking amoxicillin. Amoxicillin can be used during breast-feeding.
However, breast-feeding must be stopped if gastrointestinal disorders (diarrhoea, candidosis
or skin rash) occur in the new born.
4.6 Effects on ability to drive and use machines:
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 (see section 4.8).

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
Very rare <1/10,000

In this section undesirable effects are defined as follows:
Not known (cannot be estimated from the available data)
Infections and infestations
Uncommon
Superinfections and colonization with resistant organisms or yeasts such as oral and vaginal
candidiasis after prolonged and repeated use of amoxicillin Blood and the lymphatic system disorders
Rare
Eosinophilia and haemolytic anaemia.
Very rare
Leucopenia, neutropenia, granulocytopenia, thrombocytopenia, pancytopenia, anaemia,
myelosuppression, agranulocytosis, prolongation of bleeding time, and prolongation of
prothrombin time. All were reversible on discontinuation of therapy.

Immune system disorders
Rare
Laryngeal oedema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic shock.
Nervous system disorders
Rare
CNS effects including hyperkinesia, dizziness and convulsions. Convulsions may occur in
patients with impaired renal function, epilepsy, meningitis or in those receiving high doses.
Gastrointestinal disorders:
Common
Gastric complaints, nausea, loss of appetite, vomiting, flatulence, soft stools, diarrhoea,
enanthemas (particularly in the region of the mouth), dry mouth, taste disturbances. These
effects on the gastrointestinal system are mostly mild and frequently disappear either
during the treatment or very soon after completion of therapy. The occurrence of these side
effects can generally be reduced by taking amoxicillin during meals.
Rare
Superficial discoloration of the teeth (especially with the suspension). Usually the
discoloration can be removed by teeth brushing.
Very rare
If severe and persistent diarrhoea occurs, the very rare possibility of pseudomembranous
colitis should be considered. The a

Hepato-biliary disorders:
Uncommon
Moderate and transient increase of liver enzymes.
Rare
Hepatitis and cholestatic jaundice.
Skin and subcutaneous tissue disorders:
Common
Cutaneous reactions such as exanthema, pruritus, urticaria; the typical morbilliform
exanthema occurs 5 - 11 days after start of therapy. Immediate appearance of urticaria
indicates an allergic reaction to amoxicillin and therapy should therefore be discontinued.
Rare (see also section 4.4).
Angioneurotic oedema (Quincke's oedema), erythema multiforme
exsudativum, acute generalized pustulosis, Lyell’s syndrome, Stevens-Johnson syndrome,
toxic epidermal necrolysis, bullous and exfoliative dermatitis.
Renal disorders
Rare
Acute interstitial nephritis. Crystalluria.
General disorders and administration site conditions
Rare
Drug fever.dministration of antiperistaltic drug is contraindicated.
Development of a black tongue.

Hepato-biliary disorders:
Uncommon
Moderate and transient increase of liver enzymes.
Rare
Hepatitis and cholestatic jaundice.
Skin and subcutaneous tissue disorders:
Common
Cutaneous reactions such as exanthema, pruritus, urticaria; the typical morbilliform
exanthema occurs 5 - 11 days after start of therapy. Immediate appearance of urticaria
indicates an allergic reaction to amoxicillin and therapy should therefore be discontinued.
Rare (see also section 4.4).
Angioneurotic oedema (Quincke's oedema), erythema multiforme
exsudativum, acute generalized pustulosis, Lyell’s syndrome, Stevens-Johnson syndrome,
toxic epidermal necrolysis, bullous and exfoliative dermatitis.
Renal disorders
Rare
Acute interstitial nephritis. Crystalluria.
General disorders and administration site conditions
Rare
Drug fever.

Symptoms of overdose:
Amoxicillin is not generally associated with acute toxic effects, even when accidentally
consumed in high doses. Overdosage can lead to symptoms such as gastrointestinal renal
and neuro-psychic disturbances and fluid and electrolyte imbalance. In patients with
severely impaired renal function, large overdoses can result in signs of renal toxicity;
crystalluria is possible.Management of overdose:
There is no specific antidote for an overdose of amoxicillin.
Treatment consists primarily of administration of activated charcoal (a gastric lavage is
usually not necessary), or symptomatic measures. Particular attention should be paid to the
water and electrolyte balance of the patients.
Amoxicillin can be eliminated via haemodialysis.

5. Pharmacological Properties:
5.1. Pharmacodynamics:
ATC-Code: J01CA04
Pharmacotherapeutic group: Beta-lactam antibacterials, Penicillins with extended spectrum.
Mode of action
Amoxicillin is an aminobenzyl penicillin that has a bactericidal action due to its inhibition of
the synthesis of the bacterial cell wall.
PK/PD relationship
For amoxicillin, time above MIC (T>MIC) is the key pharmacodynamic parameter in
predicting a successful clinical and bacteriological outcome.
Mechanism of resistance
Bacteria may be resistant to amoxicillin due to production of beta-lactamases which
hydrolyse aminopenicillins, due to alteration in penicillin-binding proteins, due to
impermeability to the drug, or due to drug efflux pumps. One or more of these mechanisms
may co-exist in the same organism, leading to a variable and unpredictable cross-resistance
to other beta-lactams and to antibacterial drugs of other classes.
Breakpoints (EUCAST)

Organism Susceptibility Breakpoints (μg/ml)
Susceptible Intermediate Resistant
Haemophilus influenzae ≤ 1 -- > 1
Moraxella catharrhalis ≤ 1 -- > 1
Enterococcus ≤ 4 8 > 8
Streptococcus A, B, C, G1 ≤ 0.25 -- > 0.25
Streptococcus pneumoniae2 ≤ 0.5 1-2 > 2

- 18 -
Organism Susceptibility Breakpoints (μg/ml)
Susceptible Intermediate Resistant
Enterobacteriaceae,3 -- -- > 8
Gram-negative anaerobes ≤ 0.5 -- > 2
Gram-positive Anaerobes ≤ 4 8 > 8
Non-species related breakpoints ≤ 2 4-8 > 8
1 Breakpoint values in the table are based on Benzyl penicillin breakpoints.
2 Breakpoint values in the table are based on ampicillin breakpoints.
3 The resistant breakpoint of R>8 mg/L ensures that all isolates with resistance
mechanisms are reported resistant.

Susceptibility:
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
Corynebactierum diphteriae
Enterococcus faecalis $
Listeria monocytogenes
Streptococcus agalactiae
Streptococcus bovis
Streptococcus pyogenes *
Aerobic Gram-negative
Helicobacter pylori
Anaerobes
Peptostreptococci
Others
Borrelia

Species for which acquired resistance may be a problem
Aerobic Gram-positive
Corynebacterium spp
Enterococcus faecium $
Streptococcus pneumoniae * +
Streptococcus viridans
Aerobic Gram-negative
Escherichia coli +
Haemophilus influenzae *
Haemophilus para-influenzae *
Moraxella catarrhalis +
Proteus mirabilis
Anaerobes
Prevotella
Fusobacterium spp
Inherently resistant organisms
Aerobic Gram-positive
Staphylococcus aureus
Aerobic Gram-negative
Acinetobacter spp
Citrobacter spp
Enterobacter spp
Klebsiella spp
Legionella
Morganella morganii
Proteus vulgaris
Providencia spp
Pseudomonas spp
Serratia spp
Anaerobes
Bacteroides fragilis

Others
Chlamydia
Mycoplasma
Rickettsia
* Clinical efficacy has been demonstrated for susceptible isolates in approved clinical
indications
+ pathogens resistance prevalence is > 50%
$ Naturally intermediate species

Absorption:
The absolute bioavailability of amoxicillin depends on the dose and ranges between 75 and
90%. In the dose range between 250 mg and 1000 mg the bioavailability (parameters: AUC
and Cmax) is linearly proportional to the dose. At higher doses the extent of absorption
decreases. The absorption is not affected by concomitant food intake. Oral administration of
a single dose of 500 mg amoxicillin results in plasma concentrations of 6 - 11 mg/l. After
administration of a single dose of 3 g amoxicillin, the plasma concentrations reach 27 mg/l.
Peak plasma concentrations are present about 1-2 hours after administration.
Distribution:
Protein binding for amoxicillin is approximately 17%. Therapeutic drug levels are rapidly
achieved in serum, lung tissue, bronchial secretions, middle ear fluid, bile and urine. In
healthy meninges amoxicillin diffuses badly in liquor cerebrospinalis. Amoxicillin crosses the
placenta and a small percentage is excreted into the breast milk.
Biotransformation and elimination:
The main route of excretion of amoxicillin is the kidney. About 60-80% of an oral dose of
amoxicillin is excreted in unchanged active form in the urine within 6 hours of
administration, and a small fraction is excreted in the bile. Approximately 7 - 25% of the
administered dose is metabolised to inactive penicilloic acid. The serum half-life in patients
with normal renal function is approximately 1 – 1,5 hour. In patients with end-stage renal
failure the half-life ranges between 5 to 20 hours. The substance is haemodialysable. Pediatric population
In preterm infants with gestational age 26-33 weeks, the total body clearance after
intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very
similar to the inulin clearance (GFR) in this population.
Following oral administration, the absorption pattern and the bioavailability of amoxicillin in
small children may be different to that of adults. Consequently, due to the decreased CL,
the exposure is expected to be elevated in this group of patients, although this increase in
exposure may in part be diminished by decreased bioavailability when given orally.

Preclinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

S. No. Ingredient mg/5 ml Function
EXCIPIENTS
1. Sucrose BP 2073.11 Sweetening agent
2. Sodium Benzoate BP 5.00 Preservative
3. Carmellose Sodium BP 36.25 Thickening agent
4. Sodium Citrate BP 15.00 Buffering agent
5. Citric Acid BP 0.50 Buffering agent
6. Carmoisine 0.75 Colour
7. Colloidal Anhydrous Silica BP 13.75 Glidant
8. Tutti Frutti Flavor 40.00 Flavour

None

Before constitution keep in a dry place below 25C
Once constituted, the suspension must be stored in a refrigerator and used within 14 days.
Do not freeze.

Pack Size: 100 ml
Amber glass bottle sealed with child resistant cap.

None