Source: Registered Drug Product Database (NG) Publisher: Avro Pharma Limited, Daid House Plot 2, Block J, Limca Way, Isolo Industrial Estate, Oshodi-Apapa Expressway, Isolo, Lagos State, Nigeria, Tel: +234(1)2913955, Email: avro@rumon-org.com
Avrotrim Paediatric Suspension is indicated in children aged 12 years and under (infants (>6 weeks to <2 years old) and children (>2 to <12 years old) for the treatment of the following infections when owing to sensitive organisms (see section 5.1):
The following infections may be treated with Co-Trimoxazole where there is bacterial evidence of sensitivity to Co-Trimoxazole and good reason to prefer the combination of antibiotics in Co-Trimoxazole to a single antibiotic:
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The standard dosage for children is equivalent to approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg body weight per day, given in two equally divided doses. The schedules for children are according to the child’s age and provided in the table below:
| STANDARD DOSAGE | |
|---|---|
| Age | Paediatric Suspension |
| 6 to 12 years | 10 ml every 12 hours |
| 6 months to 5 years | 5 ml every 12 hours |
| 6 weeks to 5 months | 2.5 ml every 12 hours |
Treatment should be continued until the patient has been symptom free for two days; acute infections will require treatment for at least 5 days. If clinical improvement is not evident after 7 days therapy, the patient should be reassessed.
As an alternative to standard dosage for acute uncomplicated lower urinary tract infections, short-term therapy of 1 to 3 days' duration has been shown to be effective.
No data are available relating to dosage in patients with impaired hepatic function.
Adults (>18 years old) and children over 12 years old (>12 to <18 years old):
| Creatinine Clearance (ml/min) | Recommended Dosage |
|---|---|
| >30 | 10 ml every 12 hours |
| 15 to 30 | 5 ml every 12 hours |
| <15 | Not recommended |
No information is available for children aged 12 years and under with renal failure. See section 5.2 for the pharmacokinetics in the paediatric population with normal renal function of both components of trimethoprim-sulfamethoxazole.
Measurements of plasma concentration of sulfamethoxazole at intervals of 2 to 3 days are recommended in samples obtained 12 hours after administration of co-trimoxazole. If the concentration of total sulfamethoxazole exceeds 150 micrograms/ml then treatment should be interrupted until the value falls below 120 micrograms/ml.
A higher dosage is recommended using 20 mg trimethoprim and 100 mg sulfamethoxazole per kg of body weight per day (see table below) in two or more divided doses for two weeks. The aim is to obtain peak plasma or serum levels of trimethoprim of greater than or equal to 5 microgram/ml (verified in patients receiving 1-hour infusions of intravenous co-trimoxazole) (See section 4.8).
| Age | Paediatric Suspension |
|---|---|
| 6 to 12 years | 10 ml every 12 hours, seven days per week |
| 6 to 12 years | 10 ml every 12 hours, three times per week on alternative days |
| 6 to 12 years | 10 ml every 12 hours, three times per week on consecutive days |
| 6 to 12 years | 20 ml once a day, three times per week on consecutive days |
| 6 months to 5 years | 5 ml every 12 hours, seven days per week |
| 6 months to 5 years | 5 ml every 12 hours, three times per week on alternative days |
| 6 months to 5 years | 5 ml every 12 hours, three times per week on consecutive days |
| 6 months to 5 years | 10 ml once a day, three times per week on consecutive days |
| 6 weeks to 5 months | 2.5 ml every 12 hours, seven days per week |
| 6 weeks to 5 months | 2.5 ml every 12 hours, three times per week on alternative days |
| 6 weeks to 5 months | 2.5 ml every 12 hours, three times per week on consecutive |
| 6 weeks to 5 months | 5 ml once a day, three times per week on consecutive days |
The daily dose given on a treatment day approximates to 150 mg trimethoprim/m²/day and 750 mg sulfamethoxazole/m²/day. The total daily dose should not exceed 320 mg trimethoprim and 1600 mg sulfamethoxazole.
There is no consensus on the most appropriate dosage. Adult doses of 480 mg trimethoprim/2400 mg sulfamethoxazole to 640 mg trimethoprim/3200 mg sulfamethoxazole daily for up to three months have been used.
It may be advisable to use a higher than standard dosage initially. Treatment should continue for a period of at least four weeks and repeated courses may be beneficial. co-trimoxazole should be given in combination with other agents in line with national treatment guidelines.
There is no consensus on the most appropriate dosage for the treatment or prophylaxis of this condition. The decision should be based on clinical experience. Doses of 480 mg or 960 mg of trimethoprim – sulfamethoxazole twice daily for three months have been used for prophylaxis and 40 mg/kg/day or 120 mg/kg/day for a mean of 25 days for the treatment of toxoplasmosis in patients with HIV.
Oral use.
It may be preferable to take Avrotrim with some food or drink to minimise the possibility of gastrointestinal disturbances.
Nausea, vomiting, dizziness and confusion are likely signs/symptoms of overdosage. Bone marrow depression has been reported in acute trimethoprim overdosage.
If vomiting has not occurred, induction of vomiting may be desirable. Gastric lavage may be useful, though absorption from the gastrointestinal tract is normally very rapid and complete within approximately two hours. This may not be the case in gross overdosage. Dependant on the status of renal function administration of fluids is recommended if urine output is low.
Both trimethoprim and active sulfamethoxazole are moderately dialysable by haemodialysis. Peritoneal dialysis is not effective.
3 years.
Store below 30°C. Protect from light.
Amber glass bottles, with aluminium Ropp Screw cap and a calibrated measuring cup.
Pack size: 50 ml.
No special requirements.
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