Augmentin S Suspension

AUGMENTIN formulations are indicated for the treatment of infections caused by amoxicillin-resistant organisms producing β-lactamases sensitive to clavulanic acid:

• Upper respiratory tract infections, such as sinusitis, otitis media, recurrent tonsillitis.
• Lower respiratory tract infections, such as acute exacerbations of chronic bronchitis (caused by amoxicillin-resistant β-lactamase producing Escherichia coli, Haemophilus influenzae and Haemophilus parainfluenzae), bronchopneumonia.
• Genito-urinary tract infections, such as cystitis, urethritis, pyelonephritis.
• Skin and soft tissue infections.

AUGMENTIN formulations will also be effective in the treatment of infections caused by amoxicillin-sensitive organisms at the appropriate amoxicillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect.

Contra-indications:

In patients with a history of hypersensitivity to β-lactams e.g. penicillins and cephalosporins. AUGMENTIN is contra-indicated in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction. Safety in children under 2 months of age has not been established.

Warnings and special precautions:

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity, who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with AUGMENTIN, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, AUGMENTIN should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required.

Since AUGMENTIN contains amoxicillin, an aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used. AUGMENTIN should be avoided if infectious mononucleosis is suspected.

Changes in liver function tests have been observed in some patients receiving AUGMENTIN. Hepatic function should be monitored at regular intervals. Transient hepatitis and cholestatic jaundice have been reported. AUGMENTIN should be used with caution in patients with evidence of hepatic dysfunction.

In patients with renal impairment, dosages should be adjusted according to the degree of impairment. (See DOSAGE AND DIRECTIONS FOR USE.) Prolonged use may also occasionally result in overgrowth of non-susceptible organisms. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), AUGMENTIN should be discontinued and/or appropriate therapy instituted.

The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy. Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function, is advisable during prolonged therapy. AUGMENTIN should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxicillin induced skin rashes. AUGMENTIN suspensions contain aspartame and should be used with caution in patients with phenylketonuria.

AUGMENTIN Suspensions should be taken immediately before a meal. Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.

Dosage:

General Information: For infections caused by amoxicillin-sensitive organisms the dosage is that approved for amoxicillin as the clavulanic acid component does not contribute to the therapeutic effect. Dosage depends on the age, weight and renal function of the patient and the severity of the infection.

Children 2-12 years: The dose of AUGMENTIN in children is 25-50 mg/kg/day of the 4 parts amoxicillin, 1 part clavulanic acid preparations (which corresponds to a daily dosage of the equivalent of 20-40 mg/kg of amoxicillin and 5-10 mg/kg of clavulanic acid) to be taken in divided doses every eight hours, at the start of a meal.

The dose of AUGMENTIN BD in children is 28,6-51,4 mg/kg/day of the 7 parts amoxicillin, 1 part clavulanic acid preparations (which corresponds to a daily dosage of the equivalent of 25-45 mg/kg of amoxicillin and 3,6-6,4 mg/kg of clavulanic acid) to be taken in divided doses every twelve hours, at the start of a meal.

Data from large clinical trials was used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e those occurring at <1/10 000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency. The following convention has been used for the classification of frequency: very common ≥ 1/10 common ≥ 1/100 and <1/10 uncommon ≥ 1/1 000 and <1/100 rare ≥ 1/10 000 and <1/1 000 very rare <1/10 000.

Infections and infestations:

Common: Mucocutaneous candidiasis (including vaginitis).

Blood and lymphatic system disorders:

Rare: Reversible leucopenia (including neutropenia) and thrombocytopenia. Very rare: Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (see WARNINGS AND SPECIAL PRECAUTIONS). Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly.

Immune system disorders:

Very rare: Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis.

Nervous system disorders:

Uncommon: Dizziness, headache. Very rare: Reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders:

Common: Diarrhoea, nausea, vomiting. Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMENTIN at the start of a meal. Uncommon: Indigestion. Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). Superficial tooth discolouration has been reported which can usually be removed by brushing. Abdominal pain, gastritis, stomatitis, glossitis, black “hairy” tongue, abnormal taste, tiredness and hot flushes have been reported.

Hepatobiliary disorders:

Uncommon: A moderate rise in AST and/or ALT has been noted in patients treated with β-lactam class antibiotics, but the significance of these findings is unknown. Very rare: Hepatitis and cholestatic jaundice. These events have been noted with other penicillins and cephalosporins. Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. Signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe and in extremely rare circumstances deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.

Skin and subcutaneous tissue disorders:

Uncommon: Skin rash, pruritus, urticaria. Rare: Erythema multiforme. Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP). If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin (see WARNINGS AND SPECIAL PRECAUTIONS).

Renal and urinary disorders:

Very rare: Interstitial nephritis, crystalluria.

AUGMENTIN preparations should be stored in a cool, dry place below 25 °C. AUGMENTIN suspensions, once reconstituted, should be kept in a refrigerator (2 °C to 8 °C) and used within 7 days. Do not freeze. KEEP OUT OF REACH OF CHILDREN.