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KLAVOX ®amoxycillin
+ clavulanate-potassium
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PRESENTAION
KLAVOX 375mg tablets:
White oval film-coated tablets engraved.KLAVOX on one side. Each
tablets contains 250mg amoxycillin and 125 mg clavulanic acid.
KLAVOX 625mg tablets : White oval film-coated tablets engraved.KLAVOX
Each tablet contains 500mg amoxycillin and 125mg clavulanic acid.
KLAVOX 156mg syrup : Bottles of powder for the
preparation fruit flavoured syrup. When
reconstituted each 5ml contains 125mg amoxycillin
and 31.25mg clavulanic acid.
KLAVOX 312mg syrup : Bottles of powder for the
preparation of fruit flavoured syrup. When
reconstituted each 5ml contains 250mg amoxycillin
and 62.5mg clavulanic acid. The amoxycillin is
present as amoxycillin trihydrate and the
clavulanic acid is present as potassium
clavulanate.
KLAVOX 156mg and 312mg syrups contain aspartame.
KLAVOX presentations do not contain sucrose,
tartrazine or any other azo dyes and KLAVOX
Syrups do not contain preservatives.
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USES
KLAVOX
is an antibiotic agent with a notably broad
spectrum of activity against commonly occurring
bacterial pathogens in general practice and
hospital. The b-lactamase inhibitory action of
clavulanate extends the spectrum of amoxycillin
to embrace a wider range of organisms, including
many resistant to other b-lactam antibiotics.
KLAVOX oral preparations are indicated for short-term
treatment of bacterial infections at the
following sites:
Upper respiratory tract infections (including ENT)
e.g. tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections e.g. acute and
chronic bronchitis, lobar and bronchopneumonia.
Genito-urinary tract infections e.g. cystitis,
urethritis, pyelonephritis.
Skin and soft tissue infections, e.g. boils,
abscesses, cellulitis, wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess.
Other infections e.g. septic abortion, puerperal
sepsis, intra-abdominal sepsis.
KLAVOX is bactericidal to a wide range of
organisms including:
Gram-positive : Aerobes: Enterococcus
faecalis, Streptococcus pneumoniae, Streptococcus
pyogenes, Streptococcus viridans, *Staphylococcus
aureus, *Coagulase negative staphylococci (including
staphylococcus epidermidis), Corynebacterium
species, Bacillus anthracis, Listeria
monocytogenes.
Anaerobes: Clostridium species, Peptococcus
species, Peptostreptococcus.
Gram-negative :
Aerobes: *Haemophilus influenzae, *Escherichia
coli, *Proteus mirabilis, *Proteus vulgaris, *Klebsiella
species,*Moraxella catarrhalis, *Salmonella
species, *Shigella species, Bordetella pertussis,
Brucella species, *Neisseria gonorrhoeae,
Neisseria meningitidis, Vibrio cholerae,
Pastuerella multocida.
Anaerobes : *Bacteroides spp. including B.
fragilis
* including b-lactamase producing strains
resistant to ampicillin and amoxycillin.
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DOSAGE and
ASMINISTRATION
Usual
dosages for the treatment of infection
Adults and children over 12 years Mild - Moderate
infections
One KLAVOX 625mg tablet three times a day
Severe infections:
One KLAVOX 625mg tablet three times a day. Where
the 625mg tablet is not available, a dose of
two KLAVOX 375mg tablets three times a day may be
taken. Therapy can be started parenterally and
continued with an oral preparation.
Children: The usual recommended daily dosage is
25mg/kg/dayo in divided doses every eight hours.
The table below presents guidance for children.
Under 1 year 25mg/kg/day, for example a 7.5kg
child would require 2ml.
KLAVOX 156mg syrup three times a day.
1 - 6 year (10-18kg) 5ml KLAVOX 156mg syrup three
times a day.
Over 6 years (18-40kg) 5ml KLAVOX 312mg syrup
three times a day.
In more serious infections the dosage may be
increased up to 50mg/kg/day in divided doses
every eight hours.
* Each 25mg KLAVOX provides 20mg amoxycillin and
5mg clavulanic acid.
KLAVOX 375mg and 625mg tablets are not
recommended in children of 12 years and under.
Dosage in dental infections (e.g. dentoalveolar
abscess)
Adults and children over 12 years : One KLAVOX
375mg tablet three times a day for five days.
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DOSAGE IN
REALNAL IMPAIRMENT
Adults:
Mild Impairment Moderate Impairment Severe
Impairment
(Creatinine clearance > 30 ml/min) (Creatinine
clearance 10-30 ml/min) (Creatinine clearance <10ml/min)
No
change in dosage One 375 mg tablet or Not more
than one 375 mg tablet every12 hours;
one 625 mg tablet 12 hourly 625 mg tablets are
not recommended
Children: Similar reductions in dosage should be
made for children.
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Dosage in
hepatic impairment
Dose
with caution; monitor hepatic function at regular
intervals.
Each KLAVOX 375mg tablet contains 0.63mmol (25mg)
of potassium. Oral Administration.
To minimise potential gastrointestinal
intolerance, administer at the start of a meal.
The absorption of KLAVOX is optimised when taken
at the start of a meal.
Treatment should not be extended beyond 14 days
without review.
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Contra-indications
Penicillin
hypersensitivity.
Attention should be paid to possible cross-sensitivity
with other B-lactam antibiotics, e.g.
cephalosporins.
A previous history of KLAVOX - or penicillin-associated
jaundice/hepatic dysfunction.
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Precautions
Changes
in liver function tests have been observed in
some patients receiving KLAVOX. The clinical
significance of these changes is uncertain but
KLAVOX should be used with caution in patients
with evidence of hepatic dysfunction. Cholestatic
jaundice, which may be severe, but is usually
reversible, has been reported rarely. Signs and
symptoms may not become apparent for up to six
weeks after treatment has ceased. In patients
with moderate or severe renal impairment KLAVOX
dosage should be adjusted as recommended in the
Dosage and administration section. 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
penicillin hypersensitivity (see Contra-indications).
Erythematous rashes have been associated with
glandular fever in patients receiving amoxycillin.
Prolonged use may also occasionally result in
overgrowth of non-susceptible organisms. KLAVOX
Suspensions contain 12.5mg aspartame per 5ml dose
and therefore care should be taken in
phenylketonuria.
Interactions:
Prolongation of bleeding time and prothrombin
time have been reported in some patients
receiving KLAVOX. KLAVOX should be used with care
in patients on anti-coagulation therapy. In
common with other broad-sp
ectrum antibiotics, KLAVOX may reduce the
efficacy of oral contraceptives and patients
should be warned accordingly.
Use in pregnancy and lactation:
Reproduction studies in animals (mice and rats) with orally and
parenterally administered KLAVOX have shown no teratogenic effects.
There is limited experience of the use of KLAVOX in human pregnancy.
As with all medicines, use should be avoided in pregnancy, especially
during the first trimester, unless considered essential by the physician.
KLAVOX may be administered during the period of lactation. With
the exception of the risk of sensitization, associated with the
excretion of trace quantities in breast milk, there are no detrimental
effects for the infant.
SIDE
EFFECTS:
Side effects, as with amoxycillin, are uncommon and mainly of a
mild and transitory nature. Diarrhoea, indigestion, nausea, vomiting,
pseudomembranous colitis, and candidiasis have been reported. Nausea,
although uncommon, is more often associated with higher oral dosages.
If gastrointestinal side effects occur with oral therapy they may
be reduced by taking KLAVOX at the start of meals. A moderate rise
in AST and/or ALT has been noted in patients with semi-synthetic
penicillins but the significance of these findings is unknown. Hepatitis
and cholestatic jaundice have been reported rarely with KLAVOX.
They may however be severe and continue for several months. They
are reported as occuring predominantly in adult or elderly patients
and slightly more frequently in males. Signs and symptoms may occur
during treatment but are more frequently reported after cessation
of therapy with a delay of up to six weeks. The hepatic events are
usually reversible. However, in extremely rare circumstances, deaths
have been reported. These have almost always been cases associated
with serious underlying disease or concomitant medications. Urticarial
and erythematous rashes sometimes occur. Rarely erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative
dermatitis have been reported. Treatment should be discontinued
if one of these types of rash appears. In common with other  -lactam
antibiotics angioedema and anaphylaxis have been reported. Interstitial
nephritis can occur rarely. As with other antibiotics the incidence
of gastrointestinal side effects may be raised in children under
2 years. In clinical trials, however, only 4% of children under
2 years were withdrawn from treatment. As with other
-lactams transient leucopenia, thrombocytopenia and haemolytic anaemia
have been reported rarely.
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Overdosage
Problems
of overdosage with KLAVOX are unlikely to occur;
if encountered 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. KLAVOX may be removed from
the circulation by haemodialysis
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Pharmaceutical
precautions
KLAVOX
oral presentations should be stored in a dry
place at 25_C or below. Once reconstituted,
KLAVOX syrup must be stored in a refrigerator (but
not frozen) and used within 7 days.
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Further
information
Resistance
to many antibiotics is caused by bacterial
enzymes which destory the antibiotic before it
can act on the pathogen. The clavulanate in
KLAVOX anticipates this defence mechanism by
blocking the B-lactamase enzymes, thus rendering
the organisms sensitive to amoxycillin's rapid
bactericidal effect at concentrations readily
attainable in the body. Clavulanate by itself has
little antibacterial activity; however, in
association with amoxycillin as KLAVOX it
produces an antibiotic agent of broad spectrum
with wide application in hospital and general
practice. The pharmacokinetics of the two
components of KLAVOX are closely matched. Peak
serum levels of both occur about 1 hour after
oral administration. Absorption of KLAVOX is
optimised at the start of a meal. Both
clavulanate and amoxycillin have low levels of
serum binding; about 70% remains free in the
serum. Doubling the dosage of KLAVOX
approximatedly doubles the serum levels achieved.
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STORAGE
Store
between 2° and 30°C.
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