Augmentin/Augmentin ES Special Precautions

Before initiating therapy with Augmentin/Augmentin ES, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity (and more likely in individuals with a history of cephalosporin hypersensitivity because of cross-hypersensitivity - for Augmentin tablet only) (see Contraindications). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to AUGMENTIN/AUGMENTIN ES (see Adverse Reactions). If an allergic reaction occurs, Augmentin/Augmentin ES therapy must/should be discontinued and appropriate alternative therapy instituted.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous (i.v.) steroids and airway management, including intubation may also be required.
Augmentin/Augmentin ES 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 (super infection) that can occur with fungi, bacteria and virus.
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 investigated etiology for timely appropriated treatment/investigated further.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving Augmentin and oral anticoagulants. Monitoring INR/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).
Effects on ability to drive and use machines: Adverse effects on the ability to drive or operate machinery have not been observed.
Augmentin tablet and Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Changes in liver function tests have been observed in some patients receiving Augmentin. The clinical significance of these changes is uncertain but 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.
Augmentin tablet: In general Amoxicillin-clavulanate is well tolerated. In case of prolonged treatment, should asset the renal function, hepatic and blood counting is advisable before and during therapy for the proper adjusting and reducing the risk for neurotoxic.
In patients with renal impairment Augmentin dosage should be adjusted as recommended in Dosage & Administration.
Augmentin suspensions contain 12.5 mg aspartame per 5 ml dose, which is a source of phenylalanine, and therefore should be used with caution in patients with phenylketonuria.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: In patients with renal impairment Augmentin suspension 228 mg/5 mL and 457 mg/5 mL are not recommended.
Augmentin 228 mg/5 mL and 457 mg/5 mL suspensions contain aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
Augmentin ES suspension: In general Augmentin ES 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.
Augmentin ES should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairments, dosage of Augmentin should be adjusted according to the degree of impairment. No dosing recommendations can be made for Augmentin ES in renally impaired patients (see Dosage & Administration).
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.