Augmentin Special Precautions

Before initiating therapy with AUGMENTIN 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 (see Contraindications). If an allergic reaction occurs, AUGMENTIN therapy must 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 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.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving AUGMENTIN 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.
Changes in liver function tests have been observed in some patients receiving AUGMENTIN. The clinical significance of these changes is uncertain. 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.
Tablet/Injection: In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in Dosage & Administration. (See Dosage & Administration).
Oral suspension: In patients with renal impairment AUGMENTIN suspension 228 mg/5 mL and 457 mg/5 mL are not recommended.
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).
Oral suspension: AUGMENTIN 228 mg/5 mL and 457 mg/5 mL suspensions contain 12.5 mg aspartame per 5 mL dose and therefore care should be taken in patients with phenylketonuria.
Injection: If the parenteral administration of high doses is necessary, the sodium content must be taken into account in patients on a sodium restricted diet.
The presence of clavulanic acid in AUGMENTIN may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
Effects on Ability to Drive and Use Machines: Adverse effects on the ability to drive or operate machinery have not been observed.