Ampiclox

                                Ampiclox

Ampiclox
Ampicillin sodium trihydrate - cloxacillin
sodium monohydrate
OOMPOSITION
Capsules:
Capsules 250 mg (ampicillin sodium trihydrate - rloxaclllin sodium monohydrate) contain 125 mg arripicillin and 125 mg cloxacillin.
Capsules 500 mg (ampicillin sodium trihydrate e cloxacillin sodium monohydrate) contain 250 mg ampicillin and 250 mg cloxacillin.
Mennafil Suspension:
Dry powder suspension 90 mg/0.6 ml (ampicillin sodium tnhydrate ~ oloxacillln sodium monohydrate) contains 60 mg ampicillin and
30 mg cloxacillin
Syrmrr
Syrup 250 mg/5 ml (ampicillin sodium trihydrate e cloxacillin sodium monohydrate) Contains 125 mg ampicillin and 125 mg
cloxacillin.
Syrup 500 mg/5 ml (arnplcillin sodium trihydrate — cloxacillin sodium monohydrate) contains 250 mg ampicillin and 250 mg
cloxacillin.
Iiriecflon:
lfials 75 mg (ampicillin sodium trihydrate e cloxacillin sodium monohydrate) contain 50 mg ampicillln and 25 mg cloxacillin.
Vials 250 mg (ampicillin sodium trihydrate e cloxacillin sodium monohydrate) contain 125 mg amplcillin and 125 mg cloxacillin.
fits 500 mg (ampicillin sodium trihydrate - ctoxacillin sodium monohydrate) contain 250 mg ampiclllin and 250 mg cloxacillin.
n ications
AMPIQDX is indicated for the treatment of severe bacterial infections before the infecting organism is identified, and for mixed
Gram-posffive (except MHSA and MRSE) and Gram-negative infections. Typical infections include:
Surgery post-operative wound infections, post-operative pulmonary infections, acute post-operative enterocolitis, inti-a-abdominal
abscesses as a oomptlcation of operations.
Respiratory iirfecbbris bronchoprieumonia, acute exacerbabons of chronic bronchitis.
Ubstetrics septic abortion, puerperal fever
Odierihlecbbris such as septicaemia, bone infections e.g. osteomyelitis, E.N.T. infections requiring urgent treatment.
AMPrt1DX neonatal suspension and injection are indicated for the prophylaxis or treatment of bacterial infections in premature
babies or neonates.
Dosage and Mlriinlstntlon
oute r)\BIQ2
IIIB flttd Elderly
ml |1to2gevery6hours
.m. injection I500 mg to lg every 4 to e hours
.v. injection lsoo mg to 1 g every 4 to 6 hours
e dose of AMPIKIOX may be increased for the treatment of severe infections.
ildrln I
to 12 years
ral |'la|fadultdose.5to1Dmlsyi'iipevery6l'iours
lo‘ le itlalf adult dose: 250 mg every B hours
Neonates to 2 years I
Neonatal suspension 6 ml (90 mg) of reconstituted suspension every 4 hours
dminister 0/5 to 1 hour pnortn feeding
ln'ectlon lone quarter adult dose: 75 mg every 8 hours
Renal impairment _
In cases of renal failure, the dosage should be adapted in accordance with the following:
Creatinine dearance greater than 50 mumirr normal dose according to indication
Crealinihe clearance between 50 and 10 mVmi'rz
- dosage (oral or parenteral administration) initial dose: nonnal dose (according to indication).
e dosage (oral or parenteral administration) maintenance dose. the normal unit dose (AMPll)Ll7X5l10 mg orally, up to 1 g
i m or i.v) three times daily.
Creatinfne clearance below 10 mumirz
e dosage (oral or parenteral adminishation) initial dose: normal dose (according to indication).
- dosage (oral or parenteral administration) maintenance dose: the normal unrt dose twice or once daily.
In cases of dialysis, an additional nonnal unit dose (AMPlL‘LOX50U mg orally, up to 1 g i ni or ill) loin be administered after the
procedure.
Hepatic Impairment
Reduce ff€t]U0flQ] of administration depending on the severity of the condition.
MODE OF ADMINISTRATION
0rlI Mm:
AMPICLUX should be administered 0.5 to 1 h before meals.
Parmfenl mum: .
Administer by slow i.v. ll'l]EC1l0fl (3 to 4 minutes). AMPl0LOX may also be added to lnfusion tluids("wl1tftir fl|Yii"°<J|Yl>\1$il19$,arriiri0
acid solutions, fat emulsions and blood), and can, therefore, be administered simultaneously with these forms nr treatment or
injected, suitably diluted, intothe dmg tube over a period of 3 to 4 minutes.
AMPICLOX should not be given to patients with a history of hypersensitivity to beta-lactani antllltotlis (e.g. penicillins,
cephatosporins) or excipients.
AMPICLOX is coritrairidiwted for ocular administration.
Warnings and Precautions
Caution should be observed when administering AMPll2LlJX neonatal suspension to babies while mothers are hypersensitive to
penicillin. _ _
Before initiating therapy with AMPICLOX, careful inquiry should be made concerning pr6Vl0lJ5 "Mreerislhvity reactions to
beta-lactams.
Crosssensrtivity between penicillins and cephalosponns is well documented
Serious and occasionally fahl hypersensitivity reactions (anapnyiaxg ripen been reported in patients receiving par;-larimrri
antibiotics. Alttioughanaphylaios is more frequent following p3reqtg:| lriprapy, it has occurred in patients on oral pemoiltins.These
 M. ,.......
3" it efgic rea n occurs, be isoontinued ate altemalive i ' .
reactions should be tmted symptomalically. and M r r y All Mme
AMPICLDX should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The
occunence of a skin rash has been mociated with these conditions fplmring the administration of ampicillin.
Prolonged use may occasionally resutt in overgrowth of non-susceptible organisms.
Dosage should be adjusted in patients with renal impalrrrient. '
Cloxacillin can displace bilirubin from protein-binding sites. Normal mutton should therefore be exercised in the treatment of
iaundiced neonates.
AMPlCLOX neonatal suspension and syrup contain sodium benzoate which is a mild initant to the skin, eyes and mucous
membrane. it may increase the nsk of jaundice in nevrbom babies.
The sodium content of the fonnulatron must be included in the daily allowance of pahents on sodium restricted diets
Each AMPlCLOX 500 mg vial contains 30.4 mg of sodium.
Each AMPICLOXZSO mg vial contains 15.2 mg of sodium.
Each AMPICLOX 75 mg vial contains 4.73 mg of sodium.
Each AMPICLOX 500 mg capsule contains 13.2 mg of sodium.
Each AMPI(,‘LOX250 mg capsule contains 6.6 mg of sodium.
AMPICLOXsyrup 500 mg contains 26.4 mg sodium per 5 ml dose
AMPfCLDX syrup 250 mg contains 13.2 mg sodium per 5 ml dose.
AMPICLUX Neonatal Suspension contains 2.5mg sodium per 0.fiml dose.
interactions
Probenecid decreases the renal tubular excretion of AMPICLOX. Concurrent use with AMPlCl.l7X mail result m increased and
prolonged blood levels of AMPICLOX.
In common with other antibiotics, AMPICLUX may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy
oi combined oral contraceptives.
Sulphonamides and acetylsaliqlic acid inhibit serum protein binding of otoxacillin in vitro. This may result in increased levels ot free
cloxacillin in serum in viva.
Bacteriostatic drugs may interfere with the bactericidal action of AMPf(,‘LtU(.
Concurrent administration of allopurinol during treatment with AMPIDLUX can increase the likelihood of allergic skin reactions.
Pregnancy and Lactation
Adequate human data on use during pregnancy are not available. However, animal studies have not identmed any risk to pregnancy
or embryo-toetal development.
Adequate human and animal data on use during lactation are not available.
Ability hi perform task: that require iudgoment, motor or cognitive skills
No adverse effects on the ability to drive or operate machinery have been observed.
Adverse Reactions
Adverse reactions are listed below by system organ class and frequericy. Frequencies are defined as: very common (>1/1 U),
common (>1/100, <1/111), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000), including isolated
reports. Common and uncommon adverse reactions were generaltyibtermined from pooled safety data from a clinical trial
population of 1210 treated patients. Rare and very iare adverse readliris were generally delenriined from more than 32 years of
post-marketing experience data and refer to reporting rate rather up true frequency.
Blood and lymphatic system disorihs > ‘Y '
Very rare: Haemotytic anaemia, teulipenta, t.ttIVJt’t‘lD0l5Yt0l)Bfltfl, rihiuinq-mos
Immune syshm itbordur: " =1‘ V
Very rare: Anaphylaxis and other hypersensitivity reactions
Skin disorders and interstitial nephritis have been reported as hypeiiaitivity reactions.
h any hypersensitivity reaction occurs, the treatment should be disoiirtlnued,
Nervous system disorders -
Very rare: Mydclonus and convulsions. ~
 | disorders
Common: Diarrhoea and nausea.
Uncommon: Vomiting,
Very rare: Pseudomembranous colitis and liaemorrhagic colitis.
Heoato-biliary disorders l ‘—
Very rare: Hepatitis and cholestabc jaundice. A moderate and trarueritiricrease in transaminases.
Skin and subcutaneous tissue disorders .
Common: Skin rash, urticaria and pnintus. -
The incidence of skin rash, pnintus and urticaria l5 higher in patients suffering from infectious mononucleosis and acute or chronic
leukaemia of lymphoid origin.
Very rare: Bullous reacbons (including erythema multitorme, Stevere-Johnson syndrome and toxic epidermal necrolysis),
exfoliative dermatitis and purpiira.
Skin disorders have also been reported as hypersensitivity reactions
Retrial arid urinary disorders
Very rare‘ interstitial nephritis.
overdose
Overdosage with oml AMPICLOX is unlikely to cause serious reactions if renal ninciion is nonnal. Very high dosage of i v.
administered ampicillin and/or high dosage
of cloxacillin in renal failure may provoke neurotpxic reactions simililrh ttttfie seen with benzylpenicillin in excess.
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident. These symptoms should be treated
symptomattcally,
PHARMADOLOEICAL PROPETIIES V
Phamiaoodynamios _
AMPICLUX is a combination of ampicillin and cloxacillin. Cloxacillin SHIIIIVW-Sp9Ctt1|I'|1 antibiotic of the isoxazolyl penicillin group,
it is not inactivated by maphylococcal betaelactamases Ampicillin is iltrodil-spectrum antibiotic of the aminooenicillin groi-ill; It '5
not resistam to belalactamases. y
Botti ampicillin and cloxacillin are bactericidal antibiotics and act by interfering with the formation of nevi bacterial cell wall by
dividing organisms.
Strains of the following organisms are generally susceptible to the bactericidal actions of AMPICLOX. lfl vitm.
rganism
Staphylococcus aureus (betaelactamase positive)
S. aureus (penicillin sensitive)
tococcus pyogenes
lfin'dens~fype streptococcus 2
Strep. pneumoniae
Neiweria gorlorrrreae
N. meningitriris e
Haemoptiilus influenzae
Escherichia coll
Salmonella lyplli _
Proteus mirabifis
Methicillinresistant S. aureus lMRSA) and S. epiLlenni'di's(MRSE) 3"! lB8'St3rit lb AMPICLUX
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Phuniieooltlriottia
lbniirpllon _
Betti ernptdlltii and otofiadllin are Sit!“ I" the gastric environment resuiting in good absorption. Notifier component of the
gninningiinn of amptoillin mil plrixiicillin interferes with the absorption or excretion of the other.
The Mel qiiarittty absorbed by the oril mute represents 50% (ctoxacillin) end 40% (ampicillin) of the quantity administered.
thepreseiioeoffood tnfhestoittwtl "lav depress oral absorption andAMHOf.0Xsiioulditiereforebetaken 0.5to1 h before
meets
btetrliutlon _ _
AMH0l0\'d1tli.ises well Into most N188 and My fluids including, among others, bronchial secretiom, sinuses, saliva,
oerebioepiml mid (verldtle porwilfllte depending on the degree of meriirgeal inflammation), bile, serous mernbrenos and middle
ear.
cmgm mmqlingql union AMPIELOXdiffuses in only small proportion into the cerobrospinal fluid of subjects whose
mefliriow are not WM 2 .
Crusim ‘nth-txeeet milk ,4ll#_'Ifi.l.1Xls excreted in small quantities in breast milk.
Phsma liatfditeforcloiiaotlliri 5 0.5tiit h and 1 to 1.5 h for ampicillin.
Protein binding: the scum prwln binding proportion is approximately 94% for ctoiiacillin and 15% for ampicillin.
llehbotlltn mit.EnriO
|n mm Nu,“  % (cloxacillinl and 40% (ampicillin) of ire dose administered is metabolised.
“numb giimgigpd marry ltniidh the kidney. Approximatehi 30% of the dou administered orally and over 60% of the
ampi;i||i|-y (gm ggmirrimrud pqlnhrally is eliminated in active forrri in the urine within 24 h. The equivalent percentages hir
doioicillin are  20% end 30% respectively A small proportion (10%) of the dose administered is excreted in bile.
PttAll!l|lB.IIDAL
Utt irl hfilerlt:
Blpuuhr ‘
Magnesium secrete
S . .
Xarrlhan gum
Sodium climb anhyitrous
Saocrarln aitfliim.
-‘WW0!
Sodium barizoetie
Dhflum Ifllilh
Melhyt potysiloxane
Sodium citrate arlhydtois
fiocharln sodium
Monmmrrieriium giycntiizinate
Merrttiol dry flavour
Tutee Fruity dry flavour
Blood orange dry flavour
Sucrose.
None.
incompatibilities _
AMPIELDX riiust not be dissolved in either protein or protein hydrolysata litutioris or in llpid solutiors or in blood or plasma.
When AMPICLUX is prescribed together with an aminoglycoside, the two antibiotics should not be mixed in the same container as
the one containing the infusion solution because a loss of activity may ouair. -
Shelf Life 1 ..
The expiry date is indicated on the packaging.
Special Precautions for Stomp!
AMPICLOX should be stored in a dry place below 25°C.
Do not use after the expiry date.
All medicines should be kept out of rcn of children.
Reconstitiitlon of AMPlL‘LOXin]ectioris and preparatioivii!lMPICLOX infusion solutions most be carried out under appropriate
aseptic conditions it extended storage periods are required.
ii.-mire and cormflaf container
Capsirles ‘
250 mg: black and amethyst capsule:
500 mg: black and amethyst capsiiles
Nearrvmwirspenslorr:
Neonatal drops: clear, glam bottles containing powder for reconstitution to 8 ml of 90 mg/0.6 ml
57"!!!-'
Clear, glass bottles conmining powderfor reconstitution to 100 ml oi 250 mg/5 ml syrup
Injection:
1 g, 500 mg; 75 mg: vmite powder in clear, glass vials.
lristnirztione for Uuohhiilhg
llfeomflf Silpnridrrrr:
Preparation of the stteporisiori:_8dnro dispensing this dmg, add 7 ml of distilled water to the powder and shake well. Before each
use, shake the bottle ootthirij ti! reconstituted mixture thoroughly.
Any residual antibiotic solution should be discarded
AMPICLOXvials are not suitable for multidose use.
Solubons should be administered immediately after reconstitution.
|Il|‘lIlIt|l$Gll|l|' rmita:AMPIl10X5oo rng. 250 mg and 75 mg
Solvent volume: 1.5 ml,1 ml and 0.5 ml
Solvent type: Water for injection.
Stability of the solution at room temperature. 30 min.
Intravenous mute: lnlision AMPICLOX 500 mg, 250 mg and 75 mg.
Solvent volume: 10 ml, 5 ml and 2 rril.
Solvent type: Water for injection.
Stability ofthe solution at room temperature 30 min.
Not all presentations are available in every country
Version Iiilllibbn GDS12llPll3
Date of lsue: 16 June HID
Manufactured by: Medical tfilion Palrrrriaceutica/s Co $.A.E. Abu Sir/mn, A.R.£ m
For: Blaxoimiflrklirre — Egypt \
Underlicence from; 6laxdSn|IWOr'ne - UK _
AMPICLUX is alare tradeirlaiti 01 the GlaxoSmithKline group of companies
@GlaxoSmith Kline
crseo/no/so