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

DESCRIPTION: ZOTRIM®SUSPENSION Contains co-trimoxazole 240mg which is a synthetic antibacterial combination product, each containing 40mg Trimethoprim [2,4-diamino-5- (3,4,5-trimethoxybenyl-Pyrimidine] and 200mg of Sulphamethoxazole [5-methyl-3-Sulfanilamido-Isoxazole].

CLINICAL PHARMACOLOGY: Zotrim is an orally active antibiotic.The antimicrobial activity is that of a synergistic effect steming 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 exhibits folic acid synthesis. About 45 – 65% Plasma Protein bound. It is excreted mainly in the urine in 24hours with a larger proportion of Sulphamethoxazole as inactive metabolite.

MICROBIOLOGY:Invitro 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. Organisms susceptible include:

• Gram positive organisms such as Staphylococcus aureus, Str pyogenes, Str. Pnuemoniae, Str viridans, Enterococcus faecalis, Bacillus anthracis, Listeria, 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, salmonella, shigella, 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. Patients with severe hepatic failure. Patients with Glucose-6-Phosphate dehydrogenase deficiency.

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.

ADVERESE 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 erythomatosus, myocarditis,  serum sickness, Pseudomembranous colitis.

DOSAGE AND ADMINISTRATION:

In Adults: 960mg (2 table spoon) twice daily.

In Children: 

• 6 weeks – 5 months – 20mg(1/2 teaspoon  ) twice daily
• 6 months – 5 years – 240mg  (1 teaspoon  )twice daily
• 6 years – 12 years – 480mg (1 table spoon )  twice daily

In severe infections: 2.88g daily in 2 divided doses.

STORAGE:

Store below 300C in a cool dry place, protect from direct sunlight.

Keep out of the reach of children.