FISAT
Presentation
FISAT Tablets: White, scored, circular tablets engraved with ‘FISAT’; each tablet contains 80 mg
trimethoprim BP and 400 mg sulphamethoxazole BP. FISAT Suspension: White coloured, banana
flavoured suspension; each 5 ml suspension contains 40 mg trimethoprim BP and 200 mg
sulphamethoxazole BP.
Uses
FISAT is an antibacterial agent effective against a wide range of Gram-positive and Gram-negative organisms. It is indicated in: Respiratory tract infections: Acute and chronic bronchitis, bronchiectasis, lobar and bronchopneumonia, pneumocystis carinii pneumonitis, otitis media and sinusitis. Genito-urinary infections: Urethritis, cystitis, pyelitis, pyelonephritis, prostatitis, and male and female gonorrhoea. Gastro-intestinal infections:Typhoid and paratyphoid fever, chronic carriage of Salmonella typhi and paratyphi, cholera and shigellosis. Skin infections: Pyoderma, abscesses and wound infections. Other bacterial infections: Acute and chronic osteomyelitis, acute brucellosis, septicaemias and other infections caused by sensitive organisms.
Dosage and administration
Adults and children over 12 years: The usual daily dosage is 2 tablets twice daily at an interval of 12 hours. Maximum dosage: 3 tablets twice daily. Long-term treatment (more than 14 days): 1 tablet in the mornings, 1 tablet in the evenings. The tablets should be taken after meals with a little fluid. Children: Unless otherwise prescribed, children receive the following daily dosage.
Age
|
weight (kg)
|
Measuring spoon (5ml )of
suspension
|
6 weeks to 6 months.
|
4 to 7
|
½ spoonful twice daily
|
6 months to 6 years
|
8 to 20
|
1 spoonful twice daily
|
6 years to 12 years
|
20 to 40
|
2 spoonful twice daily
|
Specific dosage recommendations for adults: Acute uncomplicated urinary tract infections :A single dose of 4 tablets (1.92 g of co-trimoxazole). Gonorrhoea: In uncomplicated cases 4 tablets every 12 hours for two days or 5 tablets followed by a further dose of 5 tablets eight hours later. FISAT may also be used as prophylaxis of recurrent urinary tract infection in the following dosages: Adults and children over 12 years: 1 tablet nightly. Children under 12 years: A single nightly dose of 2 mg trimethoprim and 10 mg ulphamethoxazoie per kg body weight. Treatment may be continued for 3 to 12 months or more as suggested by the physician. Before using FISAT as a prophylactic agent, the urine needs to be sterilized by giving appropriate treatment of urinary tract infection. When renal performance is reduced the dosage must be adjusted to the renal function. In long-term therapy (longer than 14 days), the average daily dosage is halved. The suspension can be diluted with milk or fennel tea but not with acidic beverages e.g., fruit juices or mineral water containing carbonic acid. The duration of treatment depends on the response of the pathogen and the clinical picture in each case. Acute infections should be treated for at least 5 days or at least until the patient has been symptom-free for 2 days
Contra-indications, warnings, etc.
Contra-indications: Blood d to(als yscrasias. Hypersensitivity to sulphonamides (also consider allergy sulphonylurea antidiabetic agents and diuretic sulphonamide derivatives). Severe liver and kidney damage. Erythema multiforme-also in the patient’s medical history. Co-trimoxazole should not be given to premature or newborn babies or to infants under six weeks of age. It should not be administered in jaundice and also when conditions of vitamin B12 and folic acid deficiency exist. Use in pregnancy and lactation: Co-trimoxazole should not be given during pregnancy as folate antagonists may have teratogenic effects. Co-trimoxazole is unlikely to cause any harm to the normal infant, so can be given to lactating mothers if essential. Precautions: In long-term therapy (more than 14 days), regular checks on the blood picture, including thrombocyte counts, are indicated. Renal impairment necessitates a dosage reduction in order to avoid cumulation. In such cases, determinations of the plasma concentration of sulphamethoxazole should be carried out. This should not exceed 120 mcg/mi. In functional disorders of the thyroid gland, use should be subject to medical supervision. If symptoms such as sore throat, fever or influenza- like complaints occur during the treatment, then the blood picture should be checked immediately. Side-effects: In occasional cases, exanthema can occur as can also nausea, vomiting and diarrhea. Haematological changes have been observed particularly in elderly patients. The symptoms were generally slight and regressed upon withdrawal of the preparation. Thrombopenia leucopenia and neutropenia have been described, and more rarely megaloblastic anaemia, purpura or agranulocytosis. Drug interactions: During concomitant therapy with sulphonylureas, the hypoglycaemic effect can be enhanced. This should be taken into account when setting the dosage of these substances. Benzocaine, procaine and tetracaine can reduce the effect of the sulphonamide. The action of methotrexate and anticoagulants can be intensified. Because of FISATs sulphonamide component, simultaneous or alternating treatment with preparations containing hexamethylenetetramine should not be carried out. The same applies to and teas containing hexamethylenetetramine. Overdosage: Symptoms of acute overdosage are likely to be nausea, vomiting, abdominal pain, dizziness and confusion. Treatment should consist of gastric lavage if within an hour of ingestion, and may include forced diuresis. Hypersensitivity reactions may require treatment with steroids. Calcium folinate, 3 to 6 mg intramuscularly for five to seven days may be given to counteract the effect of trimethoprim on haemopoiesis.
Pharmaceutical precautions
Storage: FISAT tablets and suspension should be stored in a cool dry place protected from light.
Package quantities
FISAT Tablets: Cartons of 100 tablets in strip. FISAT Suspension: Bottles of 60 ml.
