(and dosage form):
Each TRIMZOL tablet contains Sulphamethoxazole 400 mg and Trimethoprim 80 mg.
A 20.2.1. Sulphonamides.
Co-trimoxazole is a bactericidal chemotherapeutic agent. Its antimicrobial activity results from the sequential blockage of two enzymes intervening in the biosynthesis of tetrahydrofolic acid in the microorganism.
Its antibacterial activity in vitro covers a range of Gram-positive and Gram-negative organisms such as Strep. pneumoniae, C. diphtheria and N. meningitidis.
Some strains of Staph. aureus, Staph. epidermis, Strep. pyogenes, the viridans group of streptococci, Stre. faecalis, E. coli, Pr. mirabilis, Pr. morganii, Pr. rettgeri, Enterobacter species, Salmonella, Shigella, Pseud. Pseudomallei, Serratia and Alcaligenes species are inhibited in vitro.
Also in vitro are Klebsiella species, Brucella abortus, Pasteurella haemolytica, Yersinia pseudotuberculosis, Y. enterocolitica and Nocardia asteroides. Very few strains of Pseud. aeruginosa are sensitive. Methicillin resistant strains of Staph. aureus are usually susceptible to the combination.
Infections due to susceptible organisms such as:
Respiratory tract infections: Acute and chronic bronchitis, bronchiactasis, pneumonia, tonsillitis, acute otitis and acute maxillary sinusitis.
Infections by Pneumocystis carinii:
Genito-urinary tract infections: uncomplicated lower urinary tract infections, chronic and recurrent urinary tract infections. Bacterial prostatitis. Acute gonococcal urethritis in both sexes.
Gastrointestinal infections: Typhoid and paratyphoid fever, typhoid carrier state and bacilliary dysentery and shigellosis.
Skin infections: Abscesses and wound infections.
Other bacterial infections: Brucellosis.
TRIMZOL should not be given to patients with a history of sulphonamide or trimethoprim sensitivity. Contra-indicated in patients showing liver parenchymal damage, blood dyscrasias or renal insufficiency.
TRIMZOL should not be given to infants during the first 6 weeks of life. The product should not be given in pregnancy, lactation, in patients with megaloblastic anaemia or in the presence of vitamin B12 and folic acid deficiency states.
DOSAGE AND DIRECTIONS FOR USE:
Adults: 2 tablets twice daily.
Maximum dosage (for severe infections): 3 twice daily.
Children over 12 years: As for adults.
6 - 12 years: 1 tablet twice daily.
Dosage in gonorrhoea: In uncomplicated gonorrhoea 4 TRIMZOL tablets every 12 hours for 2 days or 5 tablets followed 8 hours later by a further dose of 5 tablets.
In treatment ofPneumocystis carinii pneumonitis dosage is 20 mg trimethoprim/100 mg sulphamethoxazole per kg per day in two divided doses for 2 weeks. Treatment should normally only be carried out when facilities for regular estimation of the sulphamethoxazole components are available.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal disorders may occur e.g. nausea, vomiting and diarrhoea. Haematological changes such as anaemia (including aplastic haemolytic and macrocytic), coagulation disorders, granulocytopenia, agranulocytosis, purpura, Henoch-Schölein purpura and sulphaemoglobinemia may occur, particularly in elderly patients or after long-term treatment, which regress after withdrawing the medicament.
Monitoring of the blood count is advisable during long-term therapy. Limited renal functions requires a reduction of the dose in order to prevent cumulation. In such cases the determination of plasma concentration should be carried out. Where there are thyroid disorders these should also be monitored. because of sulphonamide component simultaneous or alternate treatment with hexamethylene - tetramine containing preparations should be avoided. The same applies to infusions and teas that contain hexametylene - tetramine. Photosensitivity may occur.
Skin disorders e.g. reddening, exanthema and itch are possible. Exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyells Syndrome) may occur. Megaloblastosis, leucopenia or thrombocytopenia may occur in patients deficient in folate.
Glossitis and stomatitis are relatively common. Transient jaundice has been noted and appears to have the histological features of allergic cholestatic hepatitis. Most patients who have developed icterus have had as history of prior infectious hepatitis.
Central nervous system reactions consist of headaches, depression and hallucinatory manifestations known to be produced by sulphonamides.
Previous or simultaneous administration of diuretics with co-trimoxazole may carry an increased risk of thrombocytopenia especially in elderly patients with heart failure; death may occur.
It should be used with caution in patients receiving pyrimethamine or immunosuppressive therapy.
Sulphamethoxazole is strongly bound to proteins. Patients receiving anticoagulants of the coumarin group should therefore be carefully monitored. Co-trimoxazole has been shown to increase the hypoglycaemic actions of sulphonylureas in diabetic patients.
Because of the risk of crystalluria, an adequate fluid intake should be maintained.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms: Nausea and vomiting, headaches, hallucinations, cyanosis, haematuria, oliguria or anuria.
Treatment: Supportive and symptomatic.
Full blood counts twice a week and liver function tests once a week for three weeks.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
TRIMZOL tablets: White, scored, biconvex tablet.
TRIMZOL is available in containers of 1 000 tablets.
Store in a cool dry place (below 25°C)
KEEP OUT OF REACH OF CHILDREN.
Trimzol tablet: W/20.2.1/67
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo Schwulst Labs. Limited
1 Manchester Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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