Ranceph 125 mg/5 ml/250 mg Suspension

RANCEPH SUSPENSION is indicated for the treatment of the following infections caused by susceptible micro-organisms:

• Respiratory tract infections caused by Streptococcus pneumonia and group A u00df- 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 cefalexin. Renal function studies should be performed when indicated.

Posology

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 SUSPENSION 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 25mg/kg/day to 50mg/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 67 ml water in two portions to the dry mixture in the bottle. Shake well after each addition.

Method of administration: Oral administration.

RANCEPH SUSPENSION is contra-indicated in:

• RANCEPH SUSPENSION should not be used in patients with known hypersensitivity to the cefalexin or any of the excipients of RANCEPH SUSPENSION (listed in section 6.1).
• Patients with known allergy to the cefalosporin group of antibiotics. (See Section 4.4).
• Pregnancy and lactation (see Section 4.6)

Before therapy with RANCEPH SUSPENSION is started, careful enquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins or other medicine. RANCEPH SUSPENSION should be administered with caution to penicillin-sensitive patients. There is evidence of cross-allergenicity between the penicillins and cefalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both.

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous reactions) have been reported in patients on penicillin therapy. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see section 4.8).

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 RANCEPH SUSPENSION.

RANCEPH SUSPENSION should be administered with caution in the presence of impaired renal function; dosage reduction may be necessary. Renal and haematological status should be monitored especially during prolonged and high-dose therapy.

RANCEPH SUSPENSION 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 direct Coombsu2019 (antiglobulin) have been reported during treatment with the cefalosporin antibiotics and these can interfere with blood cross-matching. A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets.

The concomitant use of nephrotoxic medicines such as the aminoglycosides gentamicin and tobramycin may increase the risk of kidney damage with RANCEPH SUSPENSION. There is also evidence for enhanced nephrotoxicity with the loop diuretic furosemide.

The renal excretion of RANCEPH SUSPENSION is inhibited by probenecid. There may be antagonism between RANCEPH SUSPENSION and bacteriostatic antibacterials. RANCEPH SUSPENSION may decrease the efficacy of oestrogen containing contraceptives.

The safety in pregnancy and lactation has not been established.

RANCEPH SUSPENSION may cause dizziness or drowsiness. Patients should therefore be advised not to drive or operate machinery until their individual susceptibility is known. RANCEPH SUSPENSION contains sugar. Patients with rare hereditary problems of fructose intolerance insufficiency should not take RANCEPH SUSPENSION.

System Organ Class

Frequent

Less frequent

Frequency Unknown

Blood and the lymphatic system disorders

Eosinophilia.

Haemolytic anaemia, neutropaenia and thrombocytopenia.

Immune system disorders

Hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis.

Nervous system disorders

Headache.

Dizziness and drowsiness. Convulsions and confusion have been associated with high doses, especially in patients with renal impairment.

Gastro-intestinal disorders

Nausea, vomiting and diarrhoea.

Abdominal cramps, pseudomembranous colitis and overgrowth of non-susceptible organisms have been reported.

Hepato-biliary disorders

Hepatitis and cholestatic jaundice.

Renal and urinary disorders

Nephrotoxicity, acute renal tubular necrosis, acute interstitial nephritis

Reproductive system and breast disorders

Vulval candidiasis.

Skin and subcutaneous tissue disorders

Linear IgA disease

Cardiac disorders

Kounis syndrome

General disorders and administration site conditions

Fatigue.

Investigations

Positive response to the Coombsu2019 (antiglobulin) test; transient increases in liver enzyme values.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued 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 Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

See Section 4.8. Treatment is symptomatic and supportive. Cefalexin is removed by haemodialysis and peritoneal dialysis.