Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Aurogen South Africa (Pty) Ltd, 53 Phillip Engelbrecht Avenue, Woodhill Office Park, Building 1, Meyersdal, Extension 12, 1448, Johannesburg, South Africa
REPOCEF is indicated for the treatment of patients with mild to moderately severe infections caused by susceptible strains of the designated micro-organisms listed below.
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. REPOCEF is effective in the eradication of Streptococcus pyogenes from the nasopharynx. However, substantial data establishing the efficacy of REPOCEF in the subsequent prevention of rheumatic feverare not available at present.
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
In the treatment of otitis media and sinusitis due to beta-lactamase producing organisms, REPOCEF had bacteriologic eradication rates somewhat lower than those observed with a product containing aspecific 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.
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.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes.
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.
REPOCEF SUSPENSION 125 mg/5 ml:
For reconstitution to 60 ml, add purified water to the graduation mark on the bottle, invert the bottle and shake well until all the powder is dispersed.
REPOCEF SUSPENSION 250 mg/5 ml:
For reconstitution to 60 ml, add purified water to the graduation mark on the bottle, invert the bottle and shake well until all the powder is dispersed.
REPOCEF 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.
The recommended dosing of REPOCEF 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: 7,5-15 mg/kg every 12 hours.
REPOCEF 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 ≤30 ml/min, 50% of the standard dose should be given at the standard dosing interval. REPOCEF is in part removed by hemodialysis; therefore, REPOCEF should be administered after the completion of hemodialysis.
No dosage adjustment is necessary for patients with impaired hepatic function.
(See SIDE-EFFECTS)
In case of severe overdosage, especially in patients with compromised renal function, haemodialysis will aid in the removal of REPOCEF from the body.
Store in a cool, dry place at or below 30ºC.
Storage for Reconstituted Suspension:
Once reconstituted, the suspension should be kept in a refrigerator (2 to 8ºC) and used within 14 days. SHAKE WELL BEFORE USE. Discard any unused solution. Keep the container well closed.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
The granules are packed in a colourless 115 ml HDPE translucent, round bottle with a 28 mm neck closed with a white opaque 28 mm child resistant closure with an induction sealing wad, together with a 20 ml measuring cup.
Pack size: 60 ml of suspension after reconstitution.
The granules are packed in a colourless 115 ml HDPE translucent, round bottle with a 28 mm neck closed with a white opaque 28 mm child resistant closure with an induction sealing wad, together with a 20 ml measuring cup.
Pack size: 60 ml of suspension after reconstitution.
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