The active ingredients in Avrotrim are:
Trimethoprim (2, 4 – diamino – 5 – (3, 4, 5- trimethoxybenzyl-Pyrimidine).
Sulphamethoxazole (5-methyI-3-sulfanilamido – isoxazole)
Avrotrim tablets: Each contains 80mg.
Trimethoprim B.P and 400mg Sulphamethoxazole B.P
Avrotrim Suspension: Each 5ml of flavoured suspension contains 40mg Trimethoprim B.P and 200mg Sulphamethoxazole B.P
Avrotrim’s antibacterial effect covers a wide range of gram-positive and gram negative organisms such as Staphylococci, Pneumococci, Haemophilius, Streptococci, Neissena, E.coli, Proteus mirabilis, Proteus vulgaris, Bordetella, Salmonella, Kiebsiela-Aerobacter, Shigelia, Vibro cholerae, Brucella, Pneumocystis, carinii, Serrata, Marcescen, Yersinia and Nocardia.
Avrotrim is indicated for the treatment of sensitive bacterial infections of the:
Respiratory Tract: Acute and chronic bronchitis, Pneumonia, Pneumocystis carinii, pneumonitis, bronchiectasis, otitis media, sinusitis, Pharyngitis.
Urinary Tract: Acute and chronic cystitis, Pyelonephritis, Urethritis, Prostatis. Acute upper and lower urinary tract infections. Long-term prophylaxis of recurrent or suppression of chronic infections following sterilization of the urine.
Genital Tract: Oro-pharyngeal and ano-rectal gonorrhoea infection, gonococcal urethritis, salpingitis, chancroid, lymphogranuloma venereum and granuloma inguinale venereum.
Gastrointestinal Tract: Thyphoid and Parathyroid fever, thyroid carrier state and bacillary dysentery cholera (as an adjunct to fluid and electrolyte replacement). Shigellosis, gastroenteritis due to entero-pathogens and biliary tract infections
Skin and Soft Tissues: Pyodema furuncles, abscesses and infected wounds.
Adults and Children over 12 years: morning 2 tablets, evening 2 tablets (2 tablets every 12 hours)
Children 6-12 years: morning 1 tablet, evening 1 tablet (1 tablet every 12 hours)
Children 6-12 years: morning 2 teaspoonful, evening 2 teaspoonful (2 teaspoonful every 12 hours-10ml)
Children 6 months-5 years: morning 1 teaspoonful, evening 1 teaspoonful (1 teaspoonful every 12 hours-5ml)
Children 6 weeks-5 months: morning ½ teaspoonful, evening ½ teaspoonful ( ½ teaspoonful every 12 hours-2.5ml)
The above Dosage regimen corresponds approximately to an average dose of 6mg Trimethoprim and 30mg SulphathoxazoIe per kilogram body weight per 24 hours. For severe Infections, the dosage shown may be increased by 50%.
Treatment should be continued until the patient has been symptom free for 2 days; majority will require treatment for at least 5 days.
SPECIAL DOSAGE RECOMMENDATIONS
Unless otherwise specified, standard dosage applies.
It may be advisable to use a higher than standard dosage initially. The course of treatment should last for three months to reduce the risk of relapse.
Pneumocytis carinii pneumonitis:
Treatment: 20mg Trimethoprim and 100mg Sulphamethoxazole per kilogram body weight per day in two or more divided doses for two weeks.
Prevention: Standard dosage for the duration of the period at risk.
Dosage restricted to adults only.
Uncomplicated cases: 4 tablets every 12 hours for two days or 5tablets followed by a further dose of 5 tablets eight hours later.
If poor patient compliance is expected a single dose of 8 tablets taken under supervision may be employed.
Oro-pharygeal gonococcal infection: 2 tablets three times daily for seven days or 9 tablets daily for five days.
Chancroid: Standard dosage should be continued for 10-15 days.
Granuloma Ingulnale: Standard dosage should be continued for up to 2 weeks.
Acute Brucellosis: A higher than standard dosage should be used initially and treatment continued for a period of at least four weeks and may be repeated.
Malaria due to P. Falclparum: Four tablets twice daily for two days may be given as an alternative regimen for adults. Children would require a reduced dose.
Typhoid and paralyphoid carrIage: Standard dosage treatment should be continued for at least 1- 3 months.
Long-term prophylaxis of recurrent or suppression of chronic infection following sterilization of the urine: Adults and children over 12 years: 1 tablet every night. Children aged 12 years and under: a single nightly dose of 2mg Trimethoprim and 10mg Sulphamethoxazole per kg body weight.
Other Bacterial infections: Acute and chronic osteomyelitis, acute brucellosis, septicaemia due to sensitive organisms, Nocardiosis, mycetoma, (except when caused by the true fungi).
Protozoal infections: MalarIa due to P. Falciparum.
Prophylaxis of infections in immune compromised patients.
MODE OF ACTION
The two components of Avrotrim interfere with the bacterial synthesis of tetrahydrofolic acid, an essential stage in the production of thymidine, purines and subsequently nucleic acids.
DOSAGE AND ADMINISTRATION
Avrotrim should be taken with food or drink to minimize the possibility of gastro-intestinal disturbances.
Treatment may be continued for 3 – 1 2 months or more as appropriate.
At the recommended dosage, Avrotrim is usually well tolerated. Of the reported adverse effects, most are mild and comprise nausea (with or without vomiting) and drug rashes. As with a great variety of other drugs, Avrotrim has in isolated cases been associated with the Steven-Johnson and Lyell’s syndromes.
Haematological changes have been reported, the form of luekaemia, neutropenia and thrombocytopenia. Very rarely agranulocytosis, megaloblastic anaemia and purpuna occurred.
PRECAUTIONS & WARNING
In patients with impaired renal function, the dosage of Avrotrim should be reduced or the interval between doses prolonged in order to prevent accumulation in the blood.
Determination of plasma drug concentrations is recommended in such patients. Especially in the elderly, there is the possibility of haematological changes indicative of folic acid deficiency; these are reversible by folinic acid therapy. Regular blood counts are advisable when Avrotrim Is given for prolonged periods.
An adequate urinary output should be maintained at all times during therapy and treatment should be discontinued immediately if a skin rash appears or blood disorder develops. An adequate fluid intake should be maintained to reduce the risk of crystalluria.
Avrotrim should not be administered to patients with a history of hypersensitivity to sulphonamides or trimethoprim. It is contraindicated in patients with marked liver parenchymal damage, severe renal insufficiency when repeated determinations of the plasma concentration cannot be made. Except in rare cases, Avrotrim should not be given to patients with serious haematological disorder. The combination has occasionally been administered to patients receiving cytotoxic agents for the treatment of leukaemias without evidence of any adverse effect of the-bone marrow or peripheral blood. It is-contraindicated in patients with megaloblastic anaemia due to folate deliciency.
For safety reasons, Avrotrim is contra-indicated during pregnancy. If pregnancy cannot be excluded, possible risks should be balanced against the expected therapeutic effect.
Avrotrim should not be given to premature infants and neonates during the first few weeks of age.
PREGNANCY AND LACTATION
The safety of Avrotrim in human pregnancy has not been established. Despite the excretion of trimethoprim and sulphamethoxazole into breast milk, the administration of Avrotrim to lactating women represents a negligible risk to the sucking infant.
Co-trimoxazole prolongs the half-life of phenytoin. Concurrent use of rifampicin and co-trimoxazole results in shortening of the plasma half life of trimethoprim after a period of about one week. Reversible deterioration in renal function has been observed in patients treated with co-trimoxazole and cyclosporine following renal transplantation.
Co-trimoxazole has been shown to potentiate the anticoagulant activity of warfarin via stereo-selective inhibition of its metabolism. In elderly patients concurrently receiving diuretics, mainly thiazides, there appears to be an increased risk of thrombocytopenia with or without purpuria.
Occasional reports suggest that patients receiving pyrimethamine for malaria prophylaxiss in doses exceeding 25mg weekly may develop megaloblastic anaemia if Avrotrim is prescribed concurrently.
• Adult Tablets: Store in a cool place. Protect from light.
• Paediatric Suspension: Store in a cool dry place. Protect from light.
Shake the bottle well before use.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Manufactured in Nigeria by
7/9 Sapara Street,
Avro Pharma Limited
Daid House,PIot 2, Block J, Limca Way.
Isolo Industrial Estate
Oshodi-Apapa Expressway, Isolo,