PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER             (PDF DOWNLOAD)

DESCRIPTION: ZOTRIM® is a brand of co-trimoxazole, which is a synthetic antibacterial combination product comprising of 160mg Trimethoprim [2,4-diamino-5- (3,4,5-trimethoxybenyl)Pyrimidine] and 800mg of Sulphamethoxazole [5-methyl-3-Sulfanilamido-Isoxazole. 

 

CLINICAL PHARMACOLOGY: ZOTRIM® is an orally active antibiotic. The antimicrobial activity is that of a synergistic effect stemming from the combination of the individual actions of Trimethoprim and Sulphamethoxazole. Sulphamethoxazole blocks thymidine and purine synthesis by inhibiting microbial folic acid synthesis. Trimethoprim also inhibits folic acid synthesis. It is excreted mainly in the urine in 24 hours with a larger proportion of Sulphamethoxazole as inactive metabolite.

 

MICROBIOLOGY: In-vitro studies demonstrate that Co-trimoxazole exhibits a wide bactericidal activity against a wide range of Gram-positive and Gram-negative organisms as well as protozoa. Susceptible organisms include:

• Gram-positive organisms such as Staphylococcus aureus, Str pyogenes, Str. pnuemoniae, Str viridans, Enterococcus faecalis, Bacillus anthracis, Listeria spp, Corynebacterium diphtheriae, Clostridium perfringes.
• Gram-negative organisms such as E. coli, Klebsiella spp, Proteus mirabilis, Salmonella spp, Enterobacter, Shigella, Haemophilus influenzae, H. ducreyi, Vibrio cholerae, Legionella.
• Other organisms include Naegleria, Plasmodium, Toxoplasma, Pneumocystis carinii, Brucella, Chlamydia. 

 

INDICATIONS: ZOTRIM® is indicated for the following:

• Urinary tract infections.
• Biliary tract infection.

–       Exacerbations of chronic bronchitis 

• Various forms of gastro-enteritis including cholera, shigellosis, as well as AIDS-related diarrhoea.
• Others include acute otitis media, Pertussis, Brucellosis, Chancroid, Cystic fibrosis. 
• Pneumocystis carinii pneumonitis.

 

CONTRA-INDICATIONS: ZOTRIM® is contra-indicated in patients that are hypersensitive to any component of the formulation as well as in patients with severe hepatic failure or with Glucose-6-Phosphate dehydrogenase deficiency.

INTERACTION: Care should be exercised when giving Co-trimoxazole to patients receiving  ACE 

Inhbitors, Anaesthetics, Antiarrhythmics, Antibacterials, Anticoagulants, Antidiabetics, Antiepileptics, 

Antifolates, Antimalarials, Antivirals, Cations at physiological pH, Clozapine, Cytotoxics, Digoxin, 

Diuretics, Immunosuppressants, Potassium aminobenzoate.

 

Labratory tests of trimethoprim and sulphonamides have been reported to interfere with diagnostic 

tests, including serum-methotrexate and serum-plasma creatinine levels, also urea, urinary glucose 

and urobilinogen tests.

 

PRECAUTIONS:

• Patients should have adequate fluid intake during administration of the drug.
• Patients susceptible to foliate deficiency should be monitored.
• Treatment should be discontinued in the presence of rash because of the danger of severe allergic reaction such as Stevens-Johnson syndrome.

 

ADVERSE EFFECTS:   

Nausea, vomiting, anorexia, diarrhoea, allergic skin reactions such as rash and urticaria, Stevens-Johnson Syndrome, exfoliative dermatitis, photosensitivity reactions, neutropenia, thrombocytopenia, rarely agranulocytosis and purpura, systemic lupus erythematosus, myocarditis, serum sickness. Pseudomembranous colitis may occur.

OVERDOSE AND ANTIDOTE: Symptoms of overdosage may include dizziness, nausea, vomiting, rashes, headache, ataxia, drowsiness, dysuria, swelling of the face, weakness and confusion. Bone marrow depression has been reported in acute trimethoprim overdosage. Treatment is symptomatic. Observe the patient for at least four hours and monitor U&Es and full blood count in symptomatic cases. Give fluids to maintain a good urine output, increased fluid intake will increase the elimination of sulfamethoxazole, but decrease that of trimethoprim. Calcium Leucovirin 5-10mg daily will counteract any adverse effects of trimethoprim on bone marrow or calcium folinate 3-6mg of 5-7 days by mouth or IM. Other measures as indicated by the patients clinical condition.

 

DOSAGE AND ADMINISTRATION: Adults:  960mg (1 tablet) twice daily. 

PRSENTATION: ZOTRIM® 960mg caplets is packed as by 500’s in an HDPE jar.

STORAGE: Store below 300C in a dry place. Protect from direct sunlight.

 

DESCRIPTION: ZOTRIM® is a brand of co-trimoxazole, which is a synthetic antibacterial combination product comprising of 80mg Trimethoprim [2,4-diamino-5- (3,4,5-trimethoxybenyl)Pyrimidine] and 400mg of Sulphamethoxazole [5-methyl-3-Sulfanilamido-Isoxazole. 

 

CLINICAL PHARMACOLOGY: ZOTRIM® is an orally active antibiotic. The antimicrobial activity is that of a synergistic effect stemming from the combination of the individual actions of Trimethoprim and Sulphamethoxazole. Sulphamethoxazole blocks thymidine and purine synthesis by inhibiting microbial folic acid synthesis. Trimethoprim also inhibits folic acid synthesis. It is excreted mainly in the urine in 24 hours with a larger proportion of Sulphamethoxazole as inactive metabolite.

 

MICROBIOLOGY: In-vitro studies demonstrate that Co-trimoxazole exhibits a wide bactericidal activity against a wide range of Gram-positive and Gram-negative organisms as well as protozoa. Susceptible organisms include:

• Gram-positive organisms such as Staphylococcus aureus, Str pyogenes, Str. pnuemoniae, Str viridans, Enterococcus faecalis, Bacillus anthracis, Listeria spp, Corynebacterium diphtheriae, Clostridium perfringes.
• Gram-negative organisms such as E. coli, Klebsiella spp, Proteus mirabilis, Salmonella spp, Enterobacter, Shigella, Haemophilus influenzae, H. ducreyi, Vibrio cholerae, Legionella.
• Other organisms include Naegleria, Plasmodium, Toxoplasma, Pneumocystis carinii, Brucella, Chlamydia. 

 

INDICATIONS: ZOTRIM® is indicated for the following:

• Urinary tract infections.
• Biliary tract infection.

–       Exacerbations of chronic bronchitis 

• Various forms of gastro-enteritis including cholera, shigellosis, as well as AIDS-related diarrhoea.
• Others include acute otitis media, Pertussis, Brucellosis, Chancroid, Cystic fibrosis. 
• Pneumocystis carinii pneumonitis.

 

CONTRA-INDICATIONS: ZOTRIM® is contra-indicated in patients that are hypersensitive to any component of the formulation as well as in patients with severe hepatic failure or with Glucose-6-Phosphate dehydrogenase deficiency.

INTERACTION: Care should be exercised when giving Co-trimoxazole to patients receiving  ACE 

Inhbitors, Anaesthetics, Antiarrhythmics, Antibacterials, Anticoagulants, Antidiabetics, Antiepileptics, 

Antifolates, Antimalarials, Antivirals, Cations at physiological pH, Clozapine, Cytotoxics, Digoxin, 

Diuretics, Immunosuppressants, Potassium aminobenzoate.

Labratory tests of trimethoprim and sulphonamides have been reported to interfere with diagnostic 

tests, including serum-methotrexate and serum-plasma creatinine levels, also urea, urinary glucose 

and urobilinogen tests.

 

PRECAUTIONS:

• Patients should have adequate fluid intake during administration of the drug.
• Patients susceptible to foliate deficiency should be monitored.
• Treatment should be discontinued in the presence of rash because of the danger of severe allergic reaction such as Stevens-Johnson syndrome.

 

ADVERSE EFFECTS:   

Nausea, vomiting, anorexia, diarrhoea, allergic skin reactions such as rash and urticaria, Stevens-Johnson Syndrome, exfoliative dermatitis, photosensitivity reactions, neutropenia, thrombocytopenia, rarely agranulocytosis and purpura, systemic lupus erythematosus, myocarditis, serum sickness. Pseudomembranous colitis may occur.

OVERDOSE AND ANTIDOTE: Symptoms of overdosage may include dizziness, nausea, vomiting, rashes, headache, ataxia, drowsiness, dysuria, swelling of the face, weakness and confusion. Bone marrow depression has been reported in acute trimethoprim overdosage. Treatment is symptomatic. Observe the patient for at least four hours and monitor U&Es and full blood count in symptomatic cases. Give fluids to maintain a good urine output, increased fluid intake will increase the elimination of sulfamethoxazole, but decrease that of trimethoprim. Calcium Leucovirin 5-10mg daily will counteract any adverse effects of trimethoprim on bone marrow or calcium folinate 3-6mg of 5-7 days by mouth or IM. Other measures as indicated by the patients clinical condition.

DOSAGE AND ADMINISTRATION: Adults:  480mg (2 tablets) twice daily. 

PRSENTATION: ZOTRIM® 480mg caplets is packed as by 10 Blisters x 10s.

STORAGE: Store below 300C in a dry place. Protect from direct sunlight.

Keep all medicines out of the reach of children.