INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BENCOLE Suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BENCOLE Suspension

COMPOSITION:
Each 5 mL of suspension contains:

Trimethoprim 40 mg
Sulphamethoxazole 200 mg
Preservatives: 
Methyl hydroxybenzoate 0,20% m/v
Propyl hydroxybenzoate 0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A. 20.2.1 Sulphonamides

PHARMACOLOGICAL ACTION:
Co-trimoxazole is a combination of trimethoprim and sulphamethoxazole resulting in a synergistic effect causing a bacterial action (in vitro). The action of co-trimoxazole is achieved by the sequential blocking of two enzymes essential in folinic acid synthesis in the organism.

INDICATIONS:
Infections caused by sensitive organisms of the upper and lower respiratory tract, the urinary tract and the alimentary and genital tract in both sexes, and skin infections.

CONTRA-INDICATIONS:
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 severe renal insufficiency. Co-trimoxazole should not be used during pregnancy or by lactating women. Use of the substance in premature or new-born infants as well as during the first two months of life, is contra-indicated.
Contra-indicated in the presence of vitamin B12 and folic acid deficiency state. Should not be given to patients with megaloblastic anaemia or blood dyscrasias or in patients receiving anticonvulsant medicines.

DOSAGE AND DIRECTIONS FOR USE:
Infants: 
        8 weeks to 5 months: Half medicine measure (2,5 mL) every 12 hours.
Children: 
        6 months to 5 years: One medicine measure (5 mL) every 12 hours.
        6 years to 12 years: Two medicine measures (10 mL) every 12 hours.

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 like reddening, exanthema pruritus and itch may occur. Exfoliative dermatitis, Steven Johnson syndrome and toxic epidermal necrolysis (Lyells syndrome) may occur.
When rash appears, Bencole must be discontinued. Cyanosis due to the formation of methaemoglobin may occur.
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 histological features of allergic cholestatic hepatitis. Central nervous system reactions consist of headache, depression, 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 polyarteritis nodosa. Toxic nephrosis has been reported.
Direct exposure to sunlight should be avoided as it facilitates development of sensitisation dermatitis. Bencole should be used with caution in patients with allergic conditions or bronchial asthma.
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 measurement of plasma concentration is advisable. Regular blood counts are advisable if co-trimoxazole is to be given for a long period. Sulpha-methoxazole may be antagonized by p-aminobenzoic acid and compounds derived from it. High doses of Bencole may have a hypoglycaemic effect. Thyroid tests must be carried out in patients with thyroid disorders.
Paraldehyde has been reported to increase the acetylation of sulphamethoxazole with subsequent increased risk of crystalluria. Bencole 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 Jaffe reaction for creatinine.
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. Bencole should be used with caution in patients receiving pyrimethamine, immunosuppressive therapy or phenytoin.
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). Treatment is supportive and symptomatic.

IDENTIFICATION:
Cream to light yellow suspension

PRESENTATION:
Bottles with 50 mL, 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/20.2.1/0391

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext.77
Private Bag X 69
Bryanston 2021.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 August 1993

New addition to this site: May 2004
Source: Pharmaceutical Industry

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