(and dosage form):
Each tablet contains:
A 20.2 Antimicrobial agents other than antibiotics.
ACUCO is a combination of trimethoprim and sulphamethoxazole and results in synergistic effects causing a bactericidal action (in vitro). The action of cotrimoxazole is achieved by the sequential blocking of two enzymes essential in folinic acid synthesis in the organism.
The treatment of infections of the upper and lower respiratory tract, the urinary tract and the alimentary and genital tract in both sexes, and skin infections caused by sensitive organisms.
ACUCO is contra-indicated in patients with known sulphonamide or trimethoprim hypersensitivity or who are suffering from porphyria. It should not be used in patients suffering from liver parenchymal damage, or a severe renal insufficiency.
Co-trimoxazole should not be used during pregnancy and lactation. Use of the substance in premature or new-born infants during the first two months of life, is contra-indicated.
Should not be given to patients with megaloblastic anaemia or blood dyscrasias.
Contra-indicated in the presence of vitamin B12 and folic acid deficiency state.
Erythema multiforme, toxic dermal necrolysis and allergic vasculitis may occur.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children older than 12 years:
Two tablets every 12 hours for a period of 10 to 14 days.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Haematological changes such as anaemia (including aplastic, haemolytic and macrocytic), coagulation disorders, granulocytopenia, agranulocytosis, purpura, Henoch-Schönlein purpura; and sulphaemoglobinaemia may occur. Skin disorders e.g. reddening exanthema and itch may occur. Exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyells Syndrome) may occur.
When a rash appears, this medicine must be discontinued.
Megaloblastosis, leucopenia or thrombocytopenia may occur. Nausea and vomiting constitutes the bulk of gastro-intestinal reactions; diarrhoea may occur.
Glossitis and stomatitis are relatively common. Jaundice has been noted and appears to have the histological features of allergic cholestatic hepatitis. Central nervous system reactions consists of headache, depression and hallucinatory manifestations, dizziness, drug fever and psychosis.
Other adverse effects include: acidosis, anorexia, goitre, hypothyroidism, arthralgia, drowsiness, fatigue, insomnia, nightmares, confusion, vertigo, ataxia, tinnitus, peripheral neuritis and polyartheritis nodosa. Toxic nephrosis has been reported.
Direct exposure to sunlight should be avoided as it facilitates development of sensitisation dermatitis. ACUCO should be used with caution in patients with allergic conditions or bronchial asthma.
Pseudomembranous colitis and anaphylaxis have been reported.
Previous or simultaneous administration of diuretics with co-trimoxazole may cause an increased risk of thrombocytopenia, especially in elderly patients with heart failure; death may occur.
In patients with renal impairment, reduced or more widely spaced dosage is indicated to avoid accumulation in the blood. For such patients measurements of plasma concentration is advisable. Regular blood counts are advisable if cotrimoxazole is to be given for a long period.
Paraldehyde has been reported to increase the acetylation of sulphamethoxazole with subsequent increased risk of crystalluria.
ACUCO may be antagonized by p-aminobenzoic acid and compounds derived from it.
High doses of ACUCO may have a hypoglycaemic effect. Thyroid tests must be carried out in patients with thyroid disorders.
Sulphamethoxazole is strongly bound to proteins. Patients receiving anticoagulants of the coumarin group or methotrexate concomitantly should therefore be carefully monitored. Sulphamethoxazole increases the hypoglycaemic action of sulphonylureas in diabetic patients.
ACUCO should be used with caution in patients receiving pyremethamine or immunosuppressive therapy. Trimethoprim prolongs the half-life of phenytoin.
ACUCO may interact with the following medicines by interfering with their clearance: digoxin, procainamide and tolbutamide.
Sulphamethoxazole has been reported to interfere with some diagnostic tests including those for urea, creatinine, urinary glucose and urobilinogen.
Trimethoprim may interfere with some diagnostic tests including serum methotrexate assay and the Jaffé reaction for creatinine.
Adverse effects on the blood may be more severe and higher blood levels are reached in malnourished or elderly patients. Because of the risk of crystalluria, an adequate fluid intake should be maintained.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea, vomiting, cyanosis, haematuria, oliguria, or anuria and allergic skin reactions (skin rashes, anaphylaxis, etc.). Treatment is supportive and symptomatic.
White, round flat tablet bisected on the one side.
In amber PVC containers of 20, 100 and 500 tablets.
Store in a cool, dry place, below 25°C. Protect from light and heat.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Apotex S.A. (Pty) Ltd
C/o Watt and Fleming Streets
Meadowdale Ext. 1
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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