AUGMENTIN® INFANT DROPS I 32 59 QUALITATIVE AND QUANTITATIVE COMPOSITION AUGMENTIN infant drops contain 50 mg amoxiciliin (as amoxlcillin trihydrate) and 12.5 mg clavulanic acid (as potassium clavulanate) per 1 ml. PHARMACEunCAlFOR [)()w:ler '8CQ<"'S: t "ca:er, at me of dispensu1Q.to form an oral '-free SUSpension. CU ICAl PARTlCUlARS Indications AUGMENTI 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, sinusrts. outis media. Lower respiratory tract mfecbons e.g. acute exacerbation of chroruc bronch' IS,lobar and bronchopnetnlOO.a Genrto-unnary tract mfectKlns e.g. cys s, urethritis, pyelonephntls. SIan and soft tissue infections, e.g. bolls, abscesses, cellulrtls, wound infections Bone 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 orgatllSlTlSareamenable 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. For booy 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"d to the w"!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)of AUGMENTIN 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 1.34 infant 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 daily i.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 impairment Dosew caut rtor hepatic function at regular interva.s Administration To minimise potential gastrointestinal intolerance, administer at the Duration of therapy should be appropriate to the indication and Contraindication. 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 Precautions Before inrtiating therapy with AUGMENnN, careful enquiry should be ~ allergens. Serious and occaSionally fatal hypersens. an In i dlVlduals h a history of per1IO hype _ AUGMENTIN should be avoided Infectious monon following 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. Appropriate monrtoring should be undertaken when anticoagulants are prl>SCribedconcurren 'Y.Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired 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 AUGME should be used Withcaunon 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 SIXweeks afier 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 of I 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>nsvrtyreactions 0 pe/1lCl ,cephaJosponnsor other reactons are more 'kely to occur form rash has been associated with this coodition AUGMENnN SUSpenSIOns contao 25 mg aspa.'la"'" per ~ sa SOOfCeof -".. aa" "<! and --e",'O'l! '" be used - ca.." pa~eots phenylketonuna. Interactions ConcomItant use of probenl>Clds In Increased and prolonged blOod Concomitant use of allopunoo due AUGMENnN and allopurinol. In common wrth other an bJOtJcs. AUGME contraceptives. In the literature there are rare cases of Increased mernanona norr.-a.se<lra:", 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 of AUGMENTIN. Pregnancy and Lactation Reproduction studies in animals (mice and rats) with orally and parenterally admln.stered AUGMENTIN have shown no teratogenic effects. In a single study in women wijh preterm, premature rupture of the foetal membrane (pPROM),rt was reported that prophylactic treatment wrth AUGMENTIN may be associated Withan Increased risk of necrotlslng enterocouns in neonates. As wrth all medicines, use should be avoided in pregnancy, especially dunng the first tnmester, unless considered essenbal 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 quamrtes breast milk, there are no detnmental effects for the infant. Effects on Ability to Drive and Use Machines Adverse effects on the abl ity to dnve or operate machinery have not been observed. Adverse Reactions Data 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 e effects 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 >1110 common >1/100 and <1/10 uncommon >111000 and <1/100 rare >1110,000 and <111000 very rare <1/10,000. Infections and infestations Common Mucocutaneous candidiasis Blood and lymphatic system disorders Rare Reversible leucopenia (including neutropenia) and th bocytopenia Very rare Reversible agranulocytosis and h.emolytic anaemia. Prolongation of blE>edlng time and prothrombin time Immune system disorders Ve 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::1 a!'._,..~;oCS<.:" :!O!I:':o;'S rray affect the g