AUGMENTIN® INFANT DROPSI

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QUALITATIVE AND QUANTITATIVE COMPOSITIONAUGMENTIN infant drops contain 50 mg amoxiciliin (as amoxlcillin trihydrate) and 12.5 mg clavulanic acid (as potassiumclavulanate) per 1 ml.PHARMACEunCAlFOR

[)()w:ler '8CQ<"'S: t "ca:er, at me of dispensu1Q.to form an oral '-free SUSpension.CU ICAl PARTlCUlARSIndicationsAUGMENTI drops are <Zed for short-term treatmern of bacterial infecbons at the following srtes:Upper respuatoty tract nfecr>ons line ud.ng ENT) e.g. recurrent tonsillrtis, sinusrt s. outis media.Lower respiratory tract mfecbons e.g. acute exacerbation of chroruc bronch' IS,lobar and bronchopnetnlOO.aGenrto-unnary tract mfectKlns e.g. cys s, urethritis, pyelonephntls.SIan and soft tissue infections, e.g. bolls, abscesses, cellulrtls, wound infectionsBone and joint infections e.g. osteomyelrtis.Other infectJOns e.g. intra-abdominal sepsis.A comprehensive list of susceptible orgamsms is provi in the PharmacodYnamicssection.Infections caused by amoxicillin-susceptible orgatllSlTlSare amenable to lW"GMENTINtreatment due to its amoxicillin content. Mixed Infections caused byamoxicillin-susceptible orgamsms I conj . - A JG'IENn. -suseep e B-lactamase prodUCingorganisms may therefore be treated WithAUGMENnN.Dosage and Ad . .s1ration......, A

_ e;- L"'S

correspond 0 the weight of the child. Forbooy 0 the synnge. The dose (equivalent

to 0.93 ~ s oe~rAaam n S:e<ea to the child. As m tar ose should be ear- :e-eo once I!'oe<)' e ~ hours.For 'nformatlon, me~ (, AUGME-m.N-",fant drops which COt'eS:>O"dto thew"!r.::-a•••.., s are snown ~IOW:Weight of child (1<g) 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 10

Volume (ml) ofAUGMENTIN 0.13 0.20 0.27 0.33 0.40 0.47 0.53 0.60 0.67 0.73 0.80 0.87 0.93 1.00 1.07 1.14 1.20 1.27 1.34infant drops •••• These doses may be doubled In cases of severe Infection.Dosage in renal impairment

Mild impairment (Creatinine clearance >30 mVmin) Moderate impairment Severe impairment(CreatinineClearance 10-30 mVmln) (Creatinine clearance <10 mVmin)

No change in dosage, The recommended dose given twice daily nstead The recommended dose given once dailyi.e. The recommended dose given three times daily# o three times per dayJi (maximum 10 ml twice daily) instead of three times per day# (maximum 10 mil

# In more$OnotJScases thiSdose may be dcubled.Dosage in hepatic impairmentDose w caut rtor hepatic function at regular interva.sAdministrationTo minimise potential gastrointestinal intolerance, administer at theDuration of therapy should be appropriate to the indication andContraindication.AUGMENTIN is contraindicated in patients wrth a history of hypersers , to beta- :ac-.a-s. ego penicillins and cephalosporins.AUGMENTIN is contraindicated in patients wrth a previous history 0' ~ ENTIN- assoca:ed jaundlce!hepatic dysfunction.Warnings and PrecautionsBefore inrtiating therapy with AUGMENnN, careful enquiry should be ~allergens.Serious and occaSionally fatal hypersens. anIn i dlVlduals h a history of per1IO hype _AUGMENTIN should be avoided Infectious mononfollowing the use of amoxicillin.Prolonged use may also occasionally result In overgrow1hof non-susceptible orga'llSnls.Abnormal prolongation of prothrombin time OncreasedINR)has been reported rar in patients reee AUGMENTIN and oral anticoagulants. Appropriatemonrtoring should be undertaken when anticoagulants are prl>SCribedconcurren 'Y.Adjustments in the dose of oral anticoagulants may be necessary to maintain thedesired level of anticoagulation.Changes In . er function tests have been observed in some patients receiving AUGMENnN. The chmcal significance of these changes is uncertai but AUGMEshould be used With caunon 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 SIXweeksafier treatment has ceased.In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in the Dosage and Administration section.In patie~ts ~i~h red~ced urine output, c:y~talluria ~ ~n observed very.rarely, p(edominantly with ~t,..aI therapy '.During the administration of hi h doses ofI r,OX,C,HIii, It is adVisable to n a ,.tlll" acfequafef'u:o teC<eeo d u ,ta::) ou.put ~ Olde: tcJ"edece &-e ooss:..,.iH) fA 81 OXIol1 .

:t a meal. The absoro:ion of AUGMENTIN is optimised when taken at the start of a meal.be extended beyond 14 days without review.

concelTllf'QprevI(MJShypersE>nsvrty reactions 0 pe/1lCl , cephaJosponns or other

reactons are more 'kely to occur

form rash has been associated with this coodition

AUGMENnN SUSpenSIOnscontao 25 mg aspa.'la"'" per ~ sa SOOfCeof -".. aa" "<! and --e",'O'l! '" be used - ca.." pa~eotsphenylketonuna.InteractionsConcomItant use of probenl>Cld sIn Increased and prolonged blOodConcomitant use of allopunoo dueAUGMENnN and allopurinol.In common wrth other an bJOtJcs.AUGMEcontraceptives.In the literature there are rare cases of Increased mernanona norr.-a.se<l ra:", in pat.~ ==""" or: """"""""- 0" warf3l'n and prescnoed a 0'arnoxlcjjm. If co-admimslTation ISnecessary, the prothromb n eo< mnal sed ra- a be care monrtored WI the addrtion or Withdrawal ofAUGMENTIN.Pregnancy and LactationReproduction studies in animals (mice and rats) with orally and parenterally admln.stered AUGMENTIN have shown no teratogenic effects. In a single study in womenwijh preterm, premature rupture of the foetal membrane (pPROM), rt was reported that prophylactic treatment wrth AUGMENTIN may be associated With an Increasedrisk of necrotlslng enterocouns in neonates. As wrth all medicines, use should be avoided in pregnancy, especially dunng the first tnmester, unless consideredessenbal by the phYS'Cian.AUGME"ITIN may be adrnm stered dunng the period of lactation. Wrth the exceptIOnof the risk of sensitisation, associated wrth the excretion 0 trace quamrtesbreast milk, there are no detnmental effects for the infant.Effects on Ability to Drive and Use MachinesAdverse effects on the abl ity to dnve or operate machinery have not been observed.Adverse ReactionsData from large clinical tnals were used to determine the frequency of very common to rare undesirable effects The f,eq ass.goed to 801 """'" tn""""h eeffects O.e.,those occumng at <1110,000) were mainly determined using post-mSJ1<etingdata and refer to a reporting rate rather than a true frequency.The following convention has been used for the classification of frequency:vetycommon >1110common >1/100 and <1/10uncommon >111000 and <1/100rare >1110,000 and <111000very rare <1/10,000.Infections and infestationsCommon Mucocutaneous candidiasisBlood and lymphatic system disordersRare Reversible leucopenia (including neutropenia) and th bocytopeniaVery rare Reversible agranulocytosis and h.emolytic anaemia. Prolongation of blE>edlngtime and prothrombin timeImmune system disordersVe rare An ioneuroticoedema, ana h laxls, serumsickness-like s drame h ersensitivit vasculitis

. rec<r.:~_ ed. Probenec o=eases the rera - _••• of a.'":"<lX but not 0' 0'" .e.

ea:roerr. - arnoxici ca., xrease the like "(xx: 1::1a!'._,..~;oCS<.:" :!O!I:':o;'S

rray affect the g

Nervous system disordersUncommon Dizziness, headacheVery rare Reversible hyperactivity and convulsions. Convulsions may occ,»Gastrointestinal disordersCommon Diarrhoea, nausea, vomitingNausea is more often associated w~h higher oral dosages. ~ gastrointestinal react s are evident, they may be reduced by taking AUGMENTIN at the start of a meal.Uncommon IndigestiooVery rare Antibiotic-associated colitis Oncludingpseudomembranous t.s and haemorrhagic colitis].

Black hairy tongueSuperficial tooth discolouration has been reported very rarely In children. Good oral hygiene may help to prevent tooth d'scolouratlon as rt canusually be removed by brustung.

Hepatobiliary disorderUncommon A moderate rise in AST and/or ALT has been noted in patients treated with beta-Iactam class antibiotics, but the significance of these findings is

unknownVery rare Hepatitis and cholestatic jaundice. These events have been noted W' otner penicillins and cephalosporins.Hepatic events have been reported predominantly in males and eldeny pabents and be associated Withprolonged treatment. These events have been very rarelyreported in children.Signs and symptoms usually occur during or shortly after treatment n some cases -'" cot become apparent until several weeks after treatment has ceased.These are usually reversible. Hepatic events may be severeand In extre<"'ey rare Clrcu-s-.ances deaths have been reported. These have almost always occurred inpatients w~h serious undertying disease or taking concomitant medica' known to e hoepotential fOi'hepatJceffects.Skin and subcutaneous tissue disordersUncommon Skin rash, pruritus, urticariaRare Erythema rnultiformeVet;'Iare Stevens-Johnson syndrome_toxic epidermal ecrolYSIS,buIIoo exl .at e-dermaf IS,acute generahsedexan emous pustulosis GEIf any hypersensltlvrty dermatitis reaction occurs, treatment should be discontinoed.Renal and urinary disordersVery rare Interstitial nephritis, crystalluria (seeOverdose)OvendoseGastrointestinal symptoms and disturbance of the flUidand electrolyte balancesattention to the water electrolyte balance.Arnoxicillin crystalluria, in some cases leading to renal failure, has been observeo seeWamings and Precautions).AUGMENTINmay be removed from the circulation by haernodialysis.PHARMACOLOGICAL PROPERTIESPhermacodynamicsResistance to many antibiotics is caused by bacterial enzymeswhich destroy the antibiotic before it can act on the pathogen. The clavulanate in AUGMENTIN infantdrops anticipates this defence mechanism by blocking the 8-lactamase enzymes. us rendering the organisms susceptible to arnoxiciUin'srapid bactericidal effect at,concentra s rea~~ a~ a~ ~ in the body.

patients with impaired renal function or in those receiving high doses.

PHARMACEUTICAL PARTICULARSList of ExcipientsXanthum gum, hydroxypropyl methylcellulose, aspartame. Slicon dioxide, colloida,Silica, succinic acid, raspberry, orange and golden syrup dry flavours.Special Precautions for StorageThe dry powder should be stored I unopened containers a dry place at be 25"CReconstituted suspensions should be stored In a refrigerator (2-8'C) and used Withinseven days.Nature and Contents of ContainerGlass bottles with screw caps, containing an off-white dry powder. A polystyrene syringe dosing device is also included. Some packs may contain an ampoule ofwater for use in reconstitution.Instructions for Use/HandlingIf the pack contains a water ampoule, then to reconstrtute, first shake the bettle to loosen the powder. Add the entire contents of the water ampoule and shake well.When first reconstituted, allow to stand fOi'5 minutes to ensure full disperson,If the pack does not contain a water ampoule, then to reconstitute, first shake the bett e to loosen e powder. Wa:er should be added un the I b e 00 the bettlelabel, and then shake the bettle well. Then top up with water until the evel of the fill hne s reached and shaKeag8Jn.When recons ed, a; ow to stand for 5minutes to ensure full dispersion.Once reconstituted, the syringe dOSingdevice should then be used In place of the screw cap. The devica ISused to dose patients under 2 years according to theschedule in the Dosage and Administration section.Not all presentations are available in every country.

a rag. ra om. oHfieGlaxoSm;!nRline group of comparileSC 2013, GlaxoSmithKline group of compames. All rights reserved.

y be evident. Gastrointestinal symptoms may be treated symptomatically with

as agent of broad spectrum wrthWideappllcaLon If1hospital and general p<8CceAUGMENTIN is bactericidal to a wide range of organisms ,nelGram-positiveAerobes: Enterococcus faecalis, Streptococcus pneumon:ae, S spyogenes S:reptococcus Vlridans, 'StaphylOCOCCUsaureus, 'coagulase nega"vestaphylococci ~ncluding Staphylococcus epidermidls), Coryne~ - species, Sa •• at" 'lICJS, Usteria monocytogenes.Anaerobes: Clostridium species, Peptococcus species, Pept~.Gram-negativeAerobes: 'Haemophilus influenzae, 'Escherichia coli, 'Proteus mlf3b 'Preteus vulgans 'Klebsiella species, 'Moraxena catarrtJaJlS,'SaJmone.",spec •••, 'Shtge.speCies,Bordetella pertussis, Brucella species, 'NeIsseriagonorrfJoeae, e sseriame tJdIs,Vibrio cholerae, Pasteurellamuffocida.Anaerobes: 'Bacteroides spp. including B. fragilis.• Some members of these species of bacteria produce B~lactamase,rendering tRam insensitiveto amoxicillinalone.Pharmacokineticse pharrnaco netics of the two components of AUGMENTINare closely matched. Peak serum levels of both occur about 1 hour after oral administration.

Abso<p' of AUGME .soptmrsed at the start of a meal.Dou ng:t>e dosage of AUGMENTIN approximately doubles the serum levels ach eved.EIe caw ana e and arnoxiCI In have low levels of serum binding; abeut 70% rems ns free in the serum.Pre-clinical Safety DataNo further Information of relevance.

Council of Arab Health MinistersUnion of Arab Pharmacists

INSTRUCTIONSTO THE PATIENTTHIS IS A MEDICAMENT- Medicament is a product which affects your health, and s consumption contrary to Instructions ISdangerous for you- Follow strictly the doctor's prescription, the method of se and the instruc:: 5 of the pharmacist who sold the medicament.- The Doctor and the Pharmacist are experts in mediCine. s benefits arid- Do not by yourself interrupt the period of treatment prescribed for you., Do not repeat the same prescription without consu~lng your doctor.r----------------------------------,

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

Version number: GDS19I1PI08Date of issue: 27 April 2009

Manufactured by: Sm~Kline Beecham pic.' Worthing, UKPacked by: Glaxo Saudi Arabia Ltd.', Jeddsh, KSA'member of GlaxOSm~hKlinegroup of companies

eGlaxoSmithKline

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