Lizorp 125 mg/5 ml/250 mg Suspension

LIZORP is indicated for the treatment of patients with mild to moderately severe infections caused by susceptible strains of the designated micro-organisms listed below.

Upper respiratory tract: Pharyngitis/tonsillitis caused by Streptococcus pyogenes. The usual agent of choice in the treatment and prevention of Streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin. LIZORP is effective in the eradication of Streptococcus pyogenes from the nasopharynx. However, substantial data establishing the efficacy of LIZORP in the subsequent prevention of rheumatic fever are not available at present.

Otitis media: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenza and Moraxella (Branhamella) catarrhalis. In the treatment of otitis media and sinusitis due to beta-lactamase producing organisms, LIZORP had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific beta-lactamase inhibitor. In considering the use of LIZORP, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing beta-lactamase inhibitors.

Lower respiratory tract: Secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumonia, Haemophilus influenza (beta-lactamase positive and negative strains) and Moraxella (Branhamella) catarrhalis.

Skin and skin structure: Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes.

Urinary tract: Uncomplicated urinary tract infections including acute cystitis in women caused by Escherichia coli, Klebsiella pneumonia and Proteus mirabilis. Culture and susceptibility testing should be performed when appropriate to determine susceptibility of the causative organism to LIZORP.

Adults and children over 12 years: LIZORP is administered orally for a period of 10 days in the treatment of infections due to susceptible bacteria in the following:

• Upper respiratory infections 500 mg every 24 hours
• Lower respiratory infections 500 mg every 12 hours
• Sinusitis 250 mg every 12 hours or 500 mg every 12 hours
• Uncomplicated urinary tract infections 500 mg every 24 hours
• Skin & skin structure infections 250 mg every 12 hours or 500 mg every 12 or 24 hours

Children: The recommended dosing of LIZORP for children between 1 year and 12 years of age is the following:

• Upper respiratory tract infections, pharyngitis or tonsillitis: 7,5 mg/kg every 12 hours
• Otitis media: 15 mg/kg every 12 hours
• Skin and skin structure infections: 20 mg/kg once daily
• Sinusitis: 7,5 u2013 15 mg/kg every 12 hours

Renal Impairment: LIZORP may be administered to patients with impaired renal function. No dosage adjustment is necessary for patients with creatinine clearance values > 30 ml/min. For those with creatinine clearance values u226430 ml/min, 50 % of the standard dose should be given at the standard dosing interval. LIZORP is in part removed by hemodialysis; therefore, LIZORP should be administered after the completion of hemodialysis.

Hepatic Impairment: No dosage adjustment is necessary for patients with impaired hepatic function.

LIZORP is contraindicated in patients who have had previous hypersensitivity reactions to the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics or any component of the formulation.

Children below the age of 1 year. Pregnancy and lactation.

Before therapy with LIZORP is instituted, careful inquiry should be made to determine whether the patients have had previous hypersensitivity reactions to LIZORP, other cephalosporins, penicillins, or other medicine. If LIZORP is to be given to penicillin-sensitive patients, caution should be exercised because cross-sensitivity among beta-lactam antibiotics has been documented. If an allergic reaction to LIZORP occurs, discontinue LIZORP. Serious acute hypersensitivity reactions may require emergency treatment measures.

Pseudomembranous colitis can occur.

Paediatric Use: Safety and efficacy in children below the age of 1 year have not been established. Accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged medicine half-life in this age group) has been reported.

Evaluation of renal status before and during therapy is recommended, especially in seriously ill patients. In patients with known or suspected renal impairment (see u201cDOSAGE AND DIRECTIONS FOR USEu201d), careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of LIZORP should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses. Cephalosporins, including LIZORP, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.

Prolonged use of LIZORP may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Positive direct Coombs tests have been reported during treatment with cephalosporin antibiotics.

Phenylketonurics: LIZORP (125 mg/5 ml and 250 mg/5 ml) contains phenylalanine (from aspartame) 8,4 mg per 5 ml reconstituted suspension.

LIZORP can inhibit vitamin K synthesis by suppressing gut flora. Prophylactic vitamin K therapy is recommended when LIZORP are used for long periods in malnourished or seriously ill patients.

Concomitant administration of LIZORP and aminoglycoside antibiotics causes nephrotoxicity.

Laboratory Test Interactions: LIZORP may produce a false positive reaction for glucose in the urine with copper reduction tests (Benedictu2019s or Fehlingu2019s solution or with Clinitest tablets), but not with enzyme-based tests (glucose oxidase) for glycosuria. A false negative reaction may occur in the ferricyanide test for blood glucose. The presence of LIZORP in the blood does not interfere with the assay of plasma or urine creatinine by the alkaline picrate method.

Safety of use in pregnancy and lactation has not been established.

LIZORP may cause dizziness which may affect ability to drive or use machinery. These activities should not be performed until the influence of LIZORP on the individual has been determined.

Blood and the lymphatic system disorders: Frequent: Eosinophilia. Less frequent: Neutropenia, thrombocytopenia. Prolonged PT/INR has been observed.

Immune system disorders: Less frequent: Anaphylaxis, fever, serum sickness and pseudomembranous colitis. Frequency unknown: Angioedema.

Nervous system disorders: The following side effects have been reported and frequencies are unknown: Dizziness, hyperactivity, headache, nervousness, insomnia, confusion and somnolence.

Gastrointestinal disorders: Frequent: Nausea, vomiting, diarrhoea and abdominal pain.

Hepato-biliary disorders: Less frequent: Cholestatic jaundice. The following side effects have been reported and frequencies are unknown: Elevations of AST, ALT, alkaline phosphatase, bilirubin values.

Skin and subcutaneous tissue disorders: Less frequent: Erythema multiforme, Stevens - Johnson syndrome, superinfection, rash, urticaria.

Renal and urinary disorders: The following side effects have been reported and frequencies are unknown: Elevations in blood urea and serum creatinine.

Reproductive system and breast disorders: Less frequent: General pruritus and vaginitis.

(See SIDE-EFFECTS) In case of severe overdosage, especially in patients with compromised renal function, haemodialysis will aid in the removal of LIZORP from the body.