Klafotaxim 500 mg.1000mg INJECTION

KLAFOTAXIM INJECTION is primarily indicated for genito-urinary tract infections, infections of the skin and soft tissues, respiratory tract infections, infections of the gastro-intestinal tract and meningitis in children due to the following susceptible strains of organisms:

Infections due to Streptococcus (Group D Streptococci and B-haemolytic Streptococci): Otitis media, sinusitis, pneumonia, pharyngitis, follicular tonsillitis, scarlet fever, urinary tract infections, (enterococci), meningitis in children, septic sore throat and cellulitis.

Infections due to Staphylococcus (Infections of non-penicillinase- and penicillinase producing strains included): Bronchitis, impetigo, furunculosis and abscess.

Infections due to Escherichia coli: Infections of the urinary tract, meningitis in paediatrics and lobar pneumonia.

Infections due to Haemophilius influenzae: Meningitis in paediatrics, otitis media and bronchitis of the larynx and trachea.

Gonococcal infections: Gonorrhoea.

Infections due to Neisseria meningitides: Paediatric meningitis.

Infections due to Salmonella: Enteritis.

Infections due to Shigella: Dysentery (Bacillus).

Pseudomonoas aeruginosa (Sensitive strains): Sepsis.

Infections due to Pneumococcus: Cellulitis, lobar pneumonia, otitis and bronchitis.

The causative organisms and its sensitivity to cefotaxime sodium must be determined by means of bacteriological studies.

Prophylactically: If administered peri-operatively in patients undergoing surgery, KLAFOTAXIM INJECTION may reduce the incidences of potentially contaminating post-operative infections. 1 g of KLAFOTAXIM INJECTION administered half-an-hour (30 mins) to one-and-a-half hours (90 mins) before surgery has been found to be the minimum effective dose.

Posology

Prophylactically: The minimum effective dose has been found to be 1 g KLAFOTAXIM INJECTION 30 u2013 90 minutes prior to surgery.

Adults: A 2 g dose per day is usually administered by means of two (2) by 1000 mg (1 g) injections in divided doses. Daily doses of 3 to 4 g in two (2) to four (4) administrations may be given in severe cases.

Paediatrics: Infants and Children: A daily dose of 50 - 100 mg/kg body mass in two (2) to four (4) injections is usually recommended. Up to 200 mg/kg body mass daily may be administered in exceptional cases.

Neonates: The recommended dosage regimen for neonates is as follows: 0 - 7 days (1 week) of age: 50 mg/kg IV at 12 hour intervals. 7 - 28 days (1 - 4 weeks) of age: 50 mg/kg IV at 8 hour intervals. The dosages above are applicable to both premature and full term infants.

Renal Failure: Half the recommended dosage of KLAFOTAXIM INJECTION should be administered to patients with creatinine clearances of 20 ml/minute. The dosage interval must not be changed.

Method of administration: For intravenous use.

• Hypersensitivity to cefotaxime sodium, or to any of the excipients of KLAFOTAXIM INJECTION listed in Section 6.1.
• KLAFOTAXIM INJECTION is contra-indicated in subjects allergic to cephalosporins.

KLAFOTAXIM INJECTION must be used with caution in patients allergic or sensitive to penicillin. Medical supervision (strict) should be exercised throughout therapy. Cefotaxime sodium should not be given to patients who are hypersensitive to it or to other cephalosporins. About 10 % of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain: great care should be taken if cefotaxime is to be given to such patients. Care is also necessary in patients with known histories of allergy. Cefotaxime sodium should be given with caution to patients with renal impairment: a dosage reduction may be necessary. Renal and haematological status should be monitored especially during prolonged and high-dose therapy.

KLAFOTAXIM INJECTION contains sodium. KLAFOTAXIM INJECTION 500: This medicinal product contains 24,12 mg sodium per 500 mg vial, equivalent to 1,2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. KLAFOTAXIM INJECTION 1000: This medicinal product contains 48,25 mg sodium per 500 mg vial, equivalent to 2,4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Cefotaxime may interfere with the Jaffu00e9 method of measuring creatinine concentrations and may produce falsely high values; this should be borne in mind when measuring renal function. Positive results to the direct Coombsu2019 test have been found during treatment with cefotaxime and these can interfere with blood crossmatching. The urine of patients being treated with cefotaxime may give false-positive reactions for glucose using copper-reduction reactions. The concomitant use of a nephrotoxic drug such as the aminoglycoside antibiotic gentamicin may increase the risk of kidney damage with cefotaxime. There is also some evidence for enhanced nephrotoxicity with a loop diuretic like frusemide. The renal excretion of cefotaxime is inhibited by probenecid. There may be antagonism between cefotaxime and bacteriostatic antibacterial agents.

General reactions: Skin eruptions, fever, eosinophilia and cases of diarrhoea, transient leucopaenia and temporary elevation of transaminases and alkaline phosphatases have been recorded.

INTERACTION WITH LABORATORY TESTS: A false positive reaction can occur on testing for glucose in the urine with reducing substances, but this can be avoided with the use of methods that are specific to gluco-oxidase (enzymatic methods).

It has not yet been established whether the product is safe in pregnancy, although animal studies have not shown any teratogenic effects.

KLAFOTAXIM INJECTION has been associated with dizziness, which may affect the ability to drive or operate machinery. High doses of KLAFOTAXIM INJECTION, particularly in patients with renal insufficiency, may cause encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions). Patients should be advised not to drive or operate machinery if any such symptoms occur.

System Organ Class

Frequent

Less frequent

Frequency unknown

Blood and lymphatic system disorders

• Eosinophilia, leucopenia, thrombocytopenia (reversible), bleeding complications related to hypoprothrombinaemia and/or platelet dysfunction
• Granulocytopenia, agranulocytosis, neutropenia, haemolytic anaemia

Immune system disorders

• Jarisch - Herxheimer reaction
• Anaphylactic reactions, angioedema, bronchospasm, anaphylactic shock

Cardiac disorders

• Arrhythmia following rapid bolus infusion through a central venous catheter

Nervous system disorders

• Convulsions
• Headache, dizziness, encephalopathy (e.g. impairment of consciousness abnormal movements)

Gastrointestinal disorders

• Diarrhoea, Nausea, vomiting, abdominal pain, pseudomembranous colitis

Hepatobiliary disorders

• Increase in liver enzymes and/or bilirubin
• Hepatitis, cholestatic jaundice

Renal and urinary disorders

• Decrease in renal function/increase of creatinine (particularly when co-prescribed with aminoglycosides)
• Interstitial nephritis, candidiasis

Skin and subcutaneous tissue disorders

• Hypersensitivity reactions including skin rashes and pruritus.
• Rash, pruritus, urticaria
• Erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis

General disorders and administration site condition

• Tenderness and pain at the injection site
• Fever, inflammatory reactions at the injection site, including phlebitis/thrombophlebitis

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continuing monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications. http://www.sahpra.org.za/Publications/Index/8

See u201cSection 4.4 Special warnings and precautions for use and 4.8 Undesirable effectsu201d. Treatment is symptomatic and supportive.