FECTRIM PAEDIATRIC

Children: 6-12 years: 4 tablets twice daily. 2-6 years: 2 tablets twice daily In the case of severe infections, the dosage may be increased by 50%. FECTRIM should be taken with a little food to avoid gastro-intestinal disturbances. The dosage regime should be continued for at least 5 days in acute infections or until the patient has become symptom-free for 2 days.

Long term prophylaxis of recurrent, or suppression of chronic infection following sterilisation of the urine. Children under 12: a single nightly dose equivalent to 2 mg Trimethoprim and 10 mg Sulphamethoxazole per kilo/body weight.

Treatment may be continued for 3-12 months or more as appropriate.

Pneumocystis carinii pneumonitis:

Treatment: 20 mg Trimethoprim and 100mg Sulphamethoxazole per kilo/body weight per day in two or more divided doses for 2 weeks. For maximum efficacy and minimum toxicity the steady state peak plasma or serum level of Trimethoprim should be maintained at 5 micrograms per ml.

Prophylaxis of Pneumocystis carinii pneumonia: 20 mg Trimethoprim and 100 mg Sulphamethoxazole per kilo/body weight per day in two or more divided doses (standard dose) for the duration of the period at risk. Therapy in all acute infections should be continued until the patient is symptom-free for 2 days or for a minimum of 5 days, whichever is the longer.

Method of administration:

Oral.

Blood dyscrasias must be considered such as thrombocytopenia, purpura, leucopenia, neutropenia and, rarely, agranulocytosis. The elderly are most susceptible to these blood dyscrasias. A blood count should be determined when treatment has continued for 4 weeks or longer.

Side effects reflect the components sulphonamide and trimethoprim in type and frequency.

Vascular disorders Not known:

Circulatory shock Skin: rashes, photosensitivity, severe reactions of exfoliative dermatitis, erythema multiform, Stevens Johnson syndrome, Lyell syndrome/toxic epidermal necrolysis, which has a high mortality. Allergic: serum sickness, anaphylaxis, allergic myocarditis, angioedema, drug fever, peri-arteritis nodosa, SLE.

Effects in treatment of Pneumocystis carinii pneumonitis may be more severe and severe hypersensitivity on re-exposure may occur. Haematological: less commonly megaloblastic anaemia, aplastic anaemia, haemolytic anaemia, methaemoglobinaemia.

Fatalities may occur. Haemolysis may occur in glucose-6-phosphate dehydrogenase deficiency. Gastro-intestinal: hepatic elevated transaminases and bilirubin. Rarely cholestatic jaundice and hepatic necrosis, which may be fatal. Nausea, vomiting, diarrhoea, glossitis, stomatitis, anorexia, pseudomembranous colitis and pancreatitis.

Neurological: aseptic meningitis which is reversible on withdrawal, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache, depression, dizziness, hallucinations. Genito-urinary: impaired renal function. Rarely interstitial nephritis.

Respiratory: cough, dyspnoea and pulmonary infiltrates, which suggest hypersensitivity, which may be fatal. Metabolic: hyperkalaemia and hyponatraemia. Musculoskeletal: arthralgia and myalgia. Miscellaneous: monilial overgrowth. Circulatory shock Cases of circulatory shock, often accompanied by fever and not responding to standard treatment for hypersensitivity, have been reported with sulfamethoxazole + trimethoprim, mainly in immunocompromised patients.

• An adequate urinary output should be maintained in cases with renal impairment, and a reduced or more widely spaced dosage interval should be used so as to avoid accumulation of the drug. • Hypersensitivity reactions may require treatment with steroids.

Calcium folinate, 3 to 6 mg intramuscularly for five to seven days may be given to counteract the effect of Trimethoprim on haemopoiesis • Fatalities may occur with Stevens Johnson syndrome, Lyell syndrome/toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias, hypersensitivity of respiratory tract.

• Care in folate deficient patients and the elderly, who may require folate supplements. • Haemolysis in glucose-6-phosphate dehydrogenase deficiency patients. • Caution in patients with severe allergy and bronchial asthma. • Do not use in Group A beta-haemolytic streptococci.

• May be used in phenylketonuria patients on diet. • Avoid in acute porphyria risk patients. • Regular blood counts are advised for patients on prolonged treatment; Respiratory toxicity Very rare, severe cases of respiratory toxicity, sometimes progressing to Acute Respiratory Distress Syndrome (ARDS), have been reported during co-trimoxazole treatment.

The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function may be preliminary signs of ARDS. In such circumstances, co-trimoxazole should be discontinued and appropriate treatment given.

Haemophagocytic lymphohistiocytosis (HLH) Cases of HLH have been reported very rarely in patients treated with co-trimoxazole. g. fever, hepatosplenomegaly, hypertriglyceridaemia, hypofibrinogenaemia, high serum ferritin, cytopenias and haemophagocytosis).

Patients who develop early manifestations of pathologic immune activation should be evaluated immediately. If diagnosis of HLH is established, cotrimoxazole treatment should be discontinued.

In patients exhibiting sensitivity to the product treatment should immediately be discontinued. A history of sulphonamide or trimethoprim sensitivity is a contra-indication. Treatment must be stopped on the appearance of a rash. Contra-indicated in blood dyscrasias or in patients showing marked liver parenchymal change.

Contra-indicated in renal insufficiency where measurement (repeated and regular) of the plasma concentration cannot be determined. The medicament should not be given to premature infants under 6 weeks except in the treatment of Pneumocystis carinii pneumonitis.