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  • Augmentin BID (875 mg Tablets)
    / GSK


    Active Ingredient *
    Amoxycillin (as trihydrate) 875 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    14 X 875 mg

    full basket chart 76015 1004

    Related information


    Dosage

    Dosage depends on the age, weight and renal function of the patient and the severity of the infection.
    Dosages are expressed throughout in terms of amoxicillin content except when doses are stated in terms of an individual component.
    – To minimise potential gastrointestinal intolerance, administer at the start of a meal.
    – The absorption of Amoxicillin-clavulanate is optimised when taken at the start of a meal.
    – Treatment should not be extended beyond 14 days without review.
    – Therapy can be started parenterally and continued with an oral preparation.
    – Amoxicillin-clavulanate 875 mg tablets -these tablets have a breakline, they can be broken in half for ease of dosing, but it’s important that both halves must be used for the same dose, i.e they cannot be broken to have one half now and one later.
    – Amoxicillin-clavulanate 250 mg and 500 mg tablets -these tablets do not have a breakline and must not be broken, as part of the dose may be lost as small fragments. GSK could not take any responsibility for such off-label use.
    – Amoxicillin-clavulanate 250 mg ,500 mg and 875 mg must not be crushed.
    Adults:  Two tablets Amoxicillin-clavulanate 250mg should not be substituted for one tablet Amoxicillin-clavulanate 500mg since they are not equivalent.
    Renal Impairment: Dosage adjustments are based on the maximum recommended level of amoxicillin.
    Creatinine clearance >30 mL /min No adjustment necessary.
    Creatinine clearance 10-30 mL /min 1 tablet 500mg given b.i.d.; OR
    1-2 tablets 250 mg, depending upon severity of infection, given b.i.d.(*)
    Creatinine clearance <10 mL /min 1 tablet 500 mg given o.d; OR
    1-2 tablets 250 mg; depending upon severity of infection, given o.d.(*)
    (*) The 875mg presentation should only be used in patients with a creatinine clearance of >30 mL /min.
    Haemodialysis: Adults: 1 tablet 500mg OR 2 tablets 250mg every 24 hours, PLUS 1 dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased) (*)
    (*) The 875mg presentation should only be used in patients with a creatinine clearance of >30 mL /min.
    Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals.
    There are, as yet, insufficient data on which to base a dosage recommendation.
    Elderly: No adjustment needed; dose as for adults. If there is evidence of renal impairment, dose should be adjusted as for renally impaired adults (see above).
    Children: Dosage should be expressed in terms of the age of the child and either in mg/kg/day or mL of suspension per dose or equivalent for other presentations.
    A. TID 4:1 Suspensions 125 mg amox/5 mL & 250 mg amox/5 mL
    For full details see subscribing information.
    Renal Impairment: Dosing adjustments are based on the maximum recommended level of amoxicillin.
    For full details see subscribing information.


    Indications

    Amoxicillin-clavulanate 250MG Tablets; Amoxicillin-clavulanate 500MG Tablets. Amoxicillin-clavulanate 125MG Suspension; Amoxicillin-clavulanate 250MG Suspension; For the treatment of lower respiratory tract infections, otitis media infection, sinusitis infections, acute pharyngitis, skin and soft tissues infections and urinary tract infections caused also by beta-lactamase producing organisms which are susceptible to Amoxicillin-clavulanate and are resistant to other beta-lactam antibiotics.
    Amoxicillin-clavulanate 400MG Suspension: Otitis media, sinusitis, respiratory tract infections e.g. recurrent tonsilitis.
    Amoxicillin-clavulanate 875MG Tablets: Short term treatment of bacterial infections at the following sites: upper/lower respiratory tract infections, genito-urinary tract infections, skin and soft tissue infections, bone and joint infections, dental infections and other infections.


    Contra-Indications

    In patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins, in patients with a previous history of Augmentin-associated jaundice/hepatic dysfunction.


    Special Precautions

    Before initiating therapy with Amoxicillin-clavulanate, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
    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. If an allergic reaction occurs, Amoxicillin-clavulanate therapy should be discontinued and appropriate alternative therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required.
    Amoxicillin-clavulanate should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
    Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
    In general Amoxicillin-clavulanate is well tolerated and possesses the characteristic low toxicity of the penicillin group of antibiotics. Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy.
    Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin-clavulanate and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Amoxicillin-clavulanate should be used with caution in patients with evidence of hepatic dysfunction.
    In patients with renal impairment, dosage should be adjusted according to the degree of impairment.
    Cholestatic jaundice, which may be severe, but it usually reversible, has been reported rarely. Signs and symptoms may not become apparent for several weeks after treatment has ceased.
    In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. Amoxicillin-clavulanate Suspensions contain aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
    Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin.


    Side Effects

    Mainly of a mild and transitory nature: Angioneurotic edema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis. Skin rash, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP). Interstitial nephritis. Diarrhea, nausea, vomiting, indigestion, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis).
    See prescribing information for full details.


    Drug interactions

    Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with Amoxicillin-clavulanate may result in increased and prolonged blood levels of amoxicillin, but not of clavulanic acid.
    Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Amoxicillin-clavulanate and allopurinol.
    In common with other broad-spectrum antibiotics, Amoxicillin-clavulanate may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
    In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.


    Pregnancy and Lactation

    Pregnancy: Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and parenterally administered Amoxicillin-clavulanate have shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with Amoxicillin-clavulanate may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, unless considered essential by the physician.
    Lactation: Amoxicillin-clavulanate 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 known detrimental effects for the breast-fed infant.


    Overdose

    Symptoms & Signs: Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. Amoxicillin-clavulanate can be removed from the circulation by haemodialysis.
    Treatment: GI symptons may be treated symptomatically, with attention to the water/electrolyte balance. Amoxicillin-clavulanate can be removed from the circulation by haemodialysis
    Children: A prospective study of 51 paediatric patients at a poison control centre suggested that overdoses of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
    Drug abuse & dependence: Drug dependency, addiction and recreational abuse have not been reported as a problem with this compound.


    Manufacturer
    GlaxoSmithKline Pharmaceuticals, Poland
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