Augmentin/Augmentin ES

Augmentin/Augmentin ES Special Precautions

amoxicillin + clavulanic acid




Full Prescribing Info
Special Precautions
Before initiating therapy with Co-amoxiclav (Augmentin), 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, Co-amoxiclav (Augmentin) therapy should be discontinued and appropriate alternative therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, IV steroids and airway management, including intubation may also be required.
Co-amoxiclav (Augmentin) 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.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
In general, co-amoxiclav 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.
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 (see Overdosage).
Augmentin: Changes in liver function tests have been observed in some patients receiving Co-amoxiclav (Augmentin). The clinical significance of these changes is uncertain but Co-amoxiclav (Augmentin) 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 renal impairment, dosage should be adjusted according to the degree of impairment (see Renal Impairment under Dosage & Administration).
Co-amoxiclav Suspensions/Sachets/Chewable tablets (where applicable), contains aspartame, which is a source of phenylalanine and should be used with caution in patients with phenylketonuria.
Augmentin ES: Co-amoxiclav (Augmentin ES) should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairment, dosage of Co-amoxiclav (Augmentin) should be adjusted according to the degree of impairment. No dosing recommendations can be made for Co-amoxiclav (Augmentin ES) in renally impaired patients (see Dosage & Administration).
Co-amoxiclav (Augmentin ES) contains aspartame (each 5 mL of suspension contains 7 mg of phenylalanine) and so should be used with caution in patients with phenylketonuria.
Effects on Ability to Drive and Use Machines: Adverse effects on the ability to drive or operate machinery have not been observed.
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