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Therapeutic indications
Co-Trimoxazole 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:
• Treatment and prevention of Pneumocystis jirovecii pneumonitis (PJP).
• Treatment and prophylaxis of toxoplasmosis.
• Treatment of nocardiosis.
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:
• Acute uncomplicated urinary tract infection.
• Acute otitis media.
• Acute exacerbation of chronic bronchitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology:
Standard dosage recommendations for acute infections
Children aged 12 years and under (infants (>6 weeks to <2 years old) and children (>2 to <12 years old)
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; the majority 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.
Impaired hepatic function:
No data are available relating to dosage in patients with impaired hepatic function.
Impaired renal function:
Dosage recommendation:
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. for the pharmacokinetics in the paediatric population with normal renal function of both components of Co-Trimoxazole TMP and SMZ.
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 microgram/ml then treatment should be interrupted until the value falls below 120 microgram/ml.
Pneumocystis jirovecii pneumonitis:
Treatment - Children aged 12 years and under (infants (>6 weeks to <2 years old) and children (>2 to <12 years old):
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) .
Prevention - Children aged 12 years and under (infants (>6 weeks to <2 years old) and children (>2 to <12 years old):
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 according to the child's age that may be used for the duration of the period at risk are provided in the table below:
|
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 days |
|
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.
Nocardiosis:
There is no consensus on the most appropriate dosage. Adult doses of 6 to 8 tablets daily for up to 3 months have been used (one tablet contains 400 mg sulfamethoxazole and 80 mg trimethoprim).
Toxoplasmosis:
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. For prophylaxis, however, the dosages suggested for prevention of Pneumocystis jirovecii pneumonitis may be appropriate.
Method of administration:
Oral
It may be preferable to take Co-Trimoxazole with some food or drink to minimise the possibility of gastrointestinal disturbances.
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