Bindoclav Suspension

BINDOCLAV SUSPENSION formulations are indicated for the treatment of infections caused by amoxicillin resistant organisms producing beta-lactamases sensitive to clavulanic acid: Upper respiratory tract infections, such as sinusitis, recurrent otitis media, tonsillitis. Lower respiratory tract infections, such as bronchitis and bronchopneumonia. Genito-urinary tract infections, such as cystitis, urethritis, pyelonephritis. Skin and soft tissue infections. BINDOCLAV SUSPENSION 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.

BINDOCLAV SUSPENSION should be taken immediately before a meal. 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. Children 2-12 years: The dose of BINDOCLAV SUSPENSION 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. Children weighing 40Kg and over should be dosed according to adult recommendations.

Hypersensitivity to penicillins or to cephalosporins. Cross-sensitivity between penicillins and cephalosporins is well documented. BINDOCLAV SUSPENSION is contra-indicated in patients with a previous history of amoxicillin/clavulanic-associated jaundice/hepatic dysfunction. Safety in children under 2 months of age has not been established.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Before initiating therapy with BINDOCLAV SUSPENSION, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. 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. If an allergic reaction occurs, (including hypersensitivity dermatitis) BINDOCLAV SUSPENSION should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment with epinephrine adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required. Prolonged use may result in overgrowth of non-susceptible organisms. Pseudomembranous enterocolitis has been reported and clostridium difficile associated diarrhea (CDAD) have been reported with amoxicillin contained in BINDOCLAV SUSPENSION. It may range in severity from mild to life threatening. Therefore it is important to consider this is patients who present with diarrhea during or subsequent to the administration of BINDOCLAV SUSPENSION. Prolongation of prothrombin time has been reported in patients receiving BINDOCLAV SUSPENSION. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Dose adjustment of the oral anticoagulants such as warfarin maybe necessary. Transient hepatitis and cholestatic jaundice has been reported. Changes in liver function tests have been observed in some patients receiving AUROXILSUSPENSION. It should be used with care in patients with evidence of severe hepatic dysfunction. The events may be severe, and occur predominantly in adult or elderly patients. 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. The hepatic effects are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication. A moderate raise in aspartate transaminase (AST) and/or alanine transaminase (ALT) has been noted in patients treated with amoxicillin/ clavulanic acid such as in BINDOCLAV SUSPENSION. BINDOCLAV SUSPENSION should be used with caution in patients with evidence of hepatic dysfunction. Periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged therapy. Caution is needed when administering BINDOCLAV SUSPENSION to patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients.

BINDOCLAV SUSPENSION may reduce the efficacy of oral contraceptives and patients should be warned accordingly. The concomitant administration of allopurinol and BINDOCLAV SUSPENSION substantially increases the incidence of skin rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. Co-administration of probenecid has little effect on the clavulanic acid component of BINDOCLAV SUSPENSION, but delays amoxicillin excretion. Tetracyclines and other bacteriostatic medicines may interfere with the bactericidal effects of amoxicillin. No information is available about the concurrent use of BINDOCLAV SUSPENSION and alcohol. However, the indigestion of alcohol whilst being treated with some other u03b2-lactam antibiotics has precipitated in disulfiram (Antabuse) like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with BINDOCLAV SUSPENSION.

Use in Pregnancy: The safety of BINDOCLAV SUSPENSION in pregnancy has not been established. There is limited information on the use of BINDOCLAV SUSPENSION in pregnancy and its use should be avoided in pregnancy, unless considered essential by the medical practitioner. In woman with pre-term, premature rupture of the foetal membrane (pPROM) prophylactic treatment with amoxicillin-clavulanate maybe associated with an increased risk of necrotising enterocolitis in neonates. Use in Lactation: Amoxicillin is distributed into breast milk. The use of BINDOCLAV SUSPENSION by mothers breast feeding their infants may lead to sensitisation, diarrhoea, candidiasis and skin rash in the infant. Mothers who are treated with BINDOCLAV SUSPENSION should not breastfeed their infants.

The use of BINDOCLAV SUSPENSION may cause dizziness. Caution must be exercised whilst driving or operating machinery. BINDOCLAV SUSPENSION contains aspartame and should be used with caution in patients with phenylketonuria.

The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose and can be minimised by administering BINDOCLAV SUSPENSION at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these gastrointestinal symptoms occur and a higher concentration of amoxicillin is required, consideration should be given to administering the additional amoxicillin separately. The following adverse reactions have been reported and may occur with BINDOCLAV SUSPENSION: Infections and infestations: Frequent: Mucocutaneous candidiasis (including vaginitis) Blood and lymphatic system disorders: Less frequent: Reversible leukopenia (including neutropenia) and thrombocytopenia, reversible agranulocytosis, haemolytic anaemia, prolongation of bleeding time and prothrombin time (see WARNINGS AND SPECIAL PRECAUTIONS). Immune system disorders: Less frequent: Serum sickness-like syndrome. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin (see WARNINGS AND SPECIAL PRECAUTIONS). Hypersensitivity vasculitis. Nervous system disorders: Less frequent: Dizziness, headache, reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses. Gastrointestinal disorders: Frequent: Nausea, vomiting, diarrhoea Less frequent: Glossitis The following side effects have been reported and frequencies are unknown: Indigestion, abdominal pain, gastritis, stomatitis, black u2018hairyu2019 tongue, enterocolitis, mucocutaneous candidiasis and antibiotic-associated colitis (including pseudomembranous colitis, Clostridium difficile associated diarrhoea (CDAD) and haemorrhagic colitis) and abnormal taste. Superficial tooth discolouration especially with the suspension formulations. It can usually be removed by brushing. If gastrointestinal reactions are evident, they may be reduced by taking BINDOCLAV SUSPENSION at the start of a meal. Hepato-biliary disorders: Less frequent: Hepatitis and cholestatic jaundice. Skin and subcutaneous tissue disorders: Less frequent: Skin rash, pruritus, urticarial, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP). If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued. Renal and urinary disorders: The following side effects have been reported and frequencies are unknown: Crystalluria, interstitial nephritis. Reproductive system and breast disorders: The following side effects have been reported and frequencies are unknown: Vaginitis.

Overdosage with amoxicillin is usually asymptomatic. However, gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water and electrolyte imbalance should be treated symptomatically. Adequate fluid intake and urinary output must be maintained to minimise the possibility of crystalluria. Amoxicillin may be removed from the circulation by haemodialysis. The molecular weight, degree of protein binding and pharmacokinetic profile of clavulanic acid together with information from a single patient with renal insufficiency all suggest that this compound may also be removed by haemodialysis.