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RANCEPH SUSPENSION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RANCEPH SUSPENSION
        125 mg/5 mL
RANCEPH SUSPENSION
        250 mg/5 mL

COMPOSITION:
Ranceph Suspension 125 mg/5 mL:
Each 5 mL of the constituted suspension contains:
Cephalexin monohydrate
equivalent to cephalexin anhydrous 125 mg
Sodium Benzoate (as preservative) 0,11% m/v
Ranceph Suspension 250 mg/5 mL:
Each 5 mL of the constituted suspension contains:
Cephalexin monohydrate
equivalent to cephalexin anhydrous 250 mg
Sodium Benzoate (as preservative) 0,11% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Microbiology
Cephalexin is a broad spectrum bactericidal antibiotic. It acts by inhibiting bacterial cell-wall synthesis.
Cephalexin is active against the following organisms in vitro: Beta-haemolytic streptococci, staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae, Neisseria catarrhalis.
Most strains of enterococci (Streptococcus faecalis) and a few strains of staphylococci are resistant to cephalexin. It is not active against most strains of Enterobacter species, P. morganii and P. vulgaris. It has no activity against Pseudomonas or Herellea species. When tested by in vitro methods, staphylococci exhibit cross-resistance between cephalexin and methicillin-type antibiotics.
In vitro sensitivity does not necessarily imply in vivo efficacy.
Pharmacology:
It is rapidly absorbed from the upper gastrointestinal tract, giving peak levels at 1 hour and following food at 2 hours. Following doses of 250 mg and 500 mg average serum levels of about 9 and 18 mcg per mL respectively were obtained at one hour.
Over 90% is recovered unchanged in urine within 8 hours. Peak urine concentrations are 1000 mcg per mL during this period following a 250 mg dosage of cephalexin. The serum half life of cephalexin is 0,9 to 1,2 hours but is prolonged in neonates. In uremic patients the half life may increase to 5-30 hours.

INDICATIONS:
Ranceph is indicated for the treatment of the following infections caused by susceptible micro-organisms:

–	Respiratory tract infections caused by Streptococcus pneumonia and group A ß-haemolytic streptococci.
–	Otitis media due to Streptococcus pneumonia, H. influenzae, staphylococci, streptococci and N. catarrhalis.
–	Skin and soft tissue infections caused by staphylococci and/or streptococci.
–	Genito-urinary tract infections, including acute prostatitis caused by E. coli, P. mirabilis and Klebsiella.
–	Dental infections caused by staphylococci and/or streptococci.

Appropriate culture and susceptibility studies should be performed to determine susceptibility of causative organism to cephalexin. Renal function studies should be performed when indicated.

CONTRA-INDICATIONS:
Cefalexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics.
The safety in pregnancy and lactation, has not been established.

WARNINGS:
Before therapy with cephalexin is instituted, careful enquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins or other medicine. Cephalexin should be administered with caution to penicillin-sensitive patients. There is some evidence of cross-allergenicity between the penicillins and cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both.
The diagnosis of pseudomembranous colitis must be considered in patients who develop diarrhoea in association with its use. Such colitis may be life-threatening and appropriate measures should be taken, including discontinuation of cephalexin.

DOSAGE AND DIRECTIONS FOR USE:
Adults: The adult dosage ranges from 1-4 g daily in divided doses. The usual adult dosage is 250 mg every 6 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250 mg every 6 hours, or 500 mg every 12 hours.
Adults who are not able to take capsules may be given Ranceph Suspension.
For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Ranceph greater than 4 grams are required, parenteral cephalosporins, in appropriate doses, should be considered.
The elderly and patients with impaired renal function: As for adults. Reduce dosage if renal function is markedly impaired.
Children: The usual recommended dosage for children is 25 mg/kg/day to 50 mg/kg/day in divided doses every six hours.
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.

Directions for mixing:
Add 40 mL and 67 mL water for 60 mL and 100 mL pack respectively in two portions to the dry mixture in the bottle. Shake well after each addition.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects of Ranceph are gastro-intestinal disturbances and hypersensitivity reactions. Gastro-intestinal effects include: nausea, vomiting and diarrhoea.
The most common side-effects are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis. There may be a positive response to the Coomb's test although haemolytic anaemia occurs less frequently. Neutropenia and thrombocytopenia have occasionally been reported. Transient increase in liver enzyme values have been reported. Hepatitis and cholestatic jaundice have occurred less frequently with some cephalosporins. Convulsions and other signs of central nervous system toxicity have been associated with high doses, especially in patients with renal failure. Pseudomembranous colitis and overgrowth of non-susceptible organisms have been reported.
Other side-effects include vulval irritation, abdominal cramps, headache, dizziness, drowsiness and fatigue.
SPECIAL PRECAUTIONS:
Cephalexin should be administered with caution in the presence of impaired renal function.
Positive direct Coombs tests have been reported during treatment with thecephalosporin antibiotics. A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions.
Treatment is symptomatic and supportive. Cephalexin is removed by haemodialysis and peritoneal dialysis.

IDENTIFICATION:
Ranceph Suspension 125 mg/5 mL:
Off-white powder forming an orange syrupy suspension on constitution with water. The resulting suspension has a characteristic flavour of orange.
Ranceph Suspension 250 mg/5 mL:
Off-white powder forming an orange syrupy suspension on constitution with water. The resulting suspension has a characteristic flavour of orange.

PRESENTATION:

Ranceph Suspension 125 mg/5 mL	HDPE bottles of 60 mL and 100 mL
Ranceph Suspension 250 mg/5 mL	HDPE bottles of 60 mL and 100 mL

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
After reconstitution, the product must be stored at 2–8°C in a refrigerator.
The prepared suspension should be consumed within one week of preparation.
Discard any unused portion of the reconstituted suspension after one week.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Ranceph Suspension 125 mg/5 mL:        32/20.1.1/0214
Ranceph Suspension 250 mg/5 mL:        32/20.1.1/0215

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (Pty) Ltd.
Lincoln House
Epsom Downs Office Park
13 Sloane Street
Epsom Downs
Bryanston

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1999

65398.pm6        2        11/3/98, 12:52 PM

Updated on this site: January 2000
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