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

Logo ADCO-CO-TRIMOXAZOLE

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ADCO-CO-TRIMOXAZOLE
TABLETS

COMPOSITION:
Each tablet contains
trimethoprim 80 mg and sulphamethoxazole 400 mg (the combination of trimethoprim and sulfamethoxazole is equal to co-trimoxazole).

PHARMACOLOGICAL CLASSIFICATION:       
A. 20.2 Antimicrobial agents other than antibiotics

PHARMACOLOGICAL ACTION:
Co-trimoxazole causes blockade of two consecutive steps in the synthesis of tetrahydrofolic acid:-
(i) Inhibition of bacterial synthesis of dihydrofolic acid from para-aminobenzoic acid.
(ii) Inhibition of the action of dihydrofolate reductase and thus the prevention of the synthesis of tetrahydrofolic acid from dihydrofolic acid.
Co-trimoxazole has a bactericidal action on certain organisms at concentrations at which the components trimethoprim and sulphamethoxazole alone are usually bacteriostatic. Co-trimoxazole is effective in-vitro against a range of Gram-positive and Gram-negative organisms. A synergistic interaction between the components of the preparation is apparent even when micro-organisms are resistant to sulphamethoxazole and moderately resistant to trimethoprim. However, a maximal degree of synergism occurs when micro-organisms are sensitive to both components.
Resistance may occur to co-trimoxazole.

INDICATIONS:
The treatment of infections caused by susceptible organisms.

CONTRA-INDICATIONS:
ADCO-CO-TRIMOXAZOLE
is contra-indicated in patients with a history of sensitivity to it or to the sulphonamides.
ADCO-CO-TRIMOXAZOLE should not be given to patients with megaloblastic anaemia, and should be avoided in those patients who may have megaloblastic bone-marrow changes or folic acid deficiency and also in patients receiving anticonvulsant medicines.
ADCO-CO-TRIMOXAZOLE is contra-indicated in patients with impaired hepatic function and in patients with severe renal insufficiency.
ADCO-CO-TRIMOXAZOLE is contra-indicated during pregnancy and should not be given to women prior to delivery (because of the danger of producing kernicterus in the infant), nor to nursing mothers. It is also contra-indicated in patients with porphyria.

WARNING:
Erythema multiforme, toxic epidermal necrolysis and allergic vasculitis may occur.

DOSAGE AND DIRECTIONS FOR USE:
Adult and children over 12 years: Two tablets twice a day, morning and evening, after meals.
Maximum dose (for severe cases): Three tablets twice a day.
Children from 6 to 12 years: One tablet twice a day, morning and evening, after meals.
The dosage must be reduced in patients with renal insufficiency and the preparation should not be administered if the creatinine clearance rate is less than 15 mL/minute.
Frequent haematological investigations are required during prolonged therapy.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, diarrhoea, headache, dizziness, drug fever and skin rashes can occur.
Cyanosis may occur due to methaemoglobinaemia or sulphaemoglobinaemia.
Bone marrow depression may occur.
Acidosis, anorexia, stomatitis, goitre, hypothyroidism, arthralgia, drowsiness, fatigue, insomnia, nightmares, confusion, depression, psychosis, vertigo, ataxia, tinnitus, peripheral neuritis, and polyarteritis nodosa can occur.
Allergic reactions can occur. Direct exposure to sunlight should be avoided during ADCO-CO-TRIMOXAZOLE therapy as this facilitates development of sensitisation dermatitis. It should not be used in patients with allergic conditions or bronchial asthma.
A severe form of erythema multiforme, the Stevens-Johnson syndrome, may occur.
Treatment should be discontinued immediately if a skin rash appears.
Epidermal necrolysis (Lyell's syndrome), lupus erythematosus and hepatitis have been reported.
Blood disorders have occurred and include agranulocytosis, aplastic anaemia and thrombocytopenia. Leucopenia and eosinophilia have been reported. Acute haemolytic anaemia can occur which may be associated with glucose-6-phosphate dehydrogenase deficiency or previous sensitisation to sulphonamides. Blood tests should be performed frequently, particularly during prolonged treatment. The appearance of a sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders. Adverse effects on the blood may be more severe in malnourished or elderly patients. Lumbar pain, dysuria, haematuria, oliguria and anuria may occur. Toxic nephrosis has been reported.
ADCO-CO-TRIMOXAZOLE should be used with caution and in reduced doses in patients with impaired renal function. Permanent impairment of renal function may follow the use of ADCO-CO-TRIMOXAZOLE in patients with renal disease, and reversible decrease in creatinine clearance has been noted in patients with normal renal function. Because of the risk of crystalluria an adequate fluid intake should be maintained and the administration of alkalis may be necessary if large doses are used.
ADCO-CO-TRIMOXAZOLE should be used with caution in patients receiving pyrimethamine or immunosuppressive therapy.
Previous or simultaneous administration of diuretics with ADCO-CO-TRIMOXAZOLE may carry an increased risk of thrombocytopenia.
The action of sulphamethoxazole may be antagonised by para-aminobenzoic acid and compounds derived from it, and they should therefore not be given concomitantly.
Sulphamethoxazole is strongly protein bound. Patients receiving anticoagulants of the coumarin type should therefore be carefully monitored. Sulphamethoxazole may also enhance the effects of methotrexate and warfarin.
High doses of sulphamethoxazole have been reported to have a hypoglycaemic effect; the anti-diabetic effects of the sulphonylurea compounds may be enhanced by concomitant administration of sulphonamides in diabetic patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea, vomiting, headaches, cyanosis, oliguria or anuria.
Treatment is symptomatic and supportive.

IDENTIFICATION:
White, flat faced tablets with bevelled edges, engraved "ADCO" on the one side.

PRESENTATION:
Securitainers of 20, 100 and 500 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from moisture. Keep out of reach of children.

REGISTRATION NUMBER:
L/20.2/226.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 February 1979.

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

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