Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Septrin tablets should only be used where, in the judgement of the physician, the benefit of treatment outweighs any possible risks, and where there is good reason to prefer the combination to a single antimicrobial agent.
Septrin tablets are indicated in children (>12 to <18 years old) and adults (>18 years old) for the treatment of the following infections when owing to sensitive organisms (see section 5.1):
Urinary tract infections: For simple urinary tract infections, trimethoprim alone or another single antimicrobial agent is the preferred treatment. Since trimethoprim is also as efficacious as Septrin for the prophylaxis of recurrent urinary tract infections, Septrin is not indicated for prophylactic use.
Respiratory tract infections: Septrin may be used as second line therapy in chronic obstructive airways disease or other respiratory tract infections, including acute otitis media where sensitivity has been demonstrated or is highly probable. (Septrin is not indicated for prophylactic or prolonged administration in otitis media).
Treatment and prevention of Pneumocystis jirovecii pneumonitis or 'PJP.'
Septrin may be used in the management of other serious conditions such as nocardiasis, toxoplasmosis and brucellosis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Where dosage is expressed as “tablets” this refers to the adult tablet, i.e. 80 mg Trimethoprim BP and 400 mg Sulfamethoxazole BP. If other formulations are to be used appropriate adjustment should be made.
Adults (>18 years old):
| STANDARD DOSAGE | |
|---|---|
| Age | Tablets |
| >18 years old | 2 tablets every 12 hours |
Children over 12 years old (>12 to <18 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:
| Age | Tablets |
|---|---|
| >12 to <18 years old | 2 tablets 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.
Treatment for acute brucellosis should be maintained for a period of at least 4 weeks, while nocardiosis requires longterm therapy.
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.
See section 4.4.
No data are available relating to dosage in patients with impaired hepatic function.
Children (>12 to <18 years old) and adults (>18 years old):
| Creatinine Clearance (ml/min) | Recommended Dosage |
|---|---|
| >30 | 2 tablets every 12 hours |
| 15 to 30 | 1 tablet 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 Septrin. 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 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 trimethoprim – sulfamethoxazole). (See section 4.8).
The following dose schedules may be used:
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 following dose schedules may be used for the duration of the period at risk:
| Age | Tablets |
|---|---|
| >12 to <18 years old | 2 tablets every 12 hours, seven days per week |
| >12 to <18 years old | 2 tablets every 12 hours, three times per week on alternative days |
| >12 to <18 years old | 2 tablets every 12 hours, three times per week on consecutive days |
| >12 to <18 years old | 4 tablets 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 6 to 8 tablets daily for up to 3 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. Septrin 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.
It may be preferable to take Septrin with some food or drink to minimise the possibility of gastrointestinal disturbances.
Nausea, vomiting, dizziness and confusion are likely signs/symptoms of overdose. Bone marrow depression has been reported in acute trimethoprim overdose.
Dependent 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.
In cases of known, suspected or accidental overdose, stop therapy.
Acidification of the urine will increase the elimination of trimethoprim. Inducing diuresis plus alkalinisation of urine will enhance the elimination of sulfamethoxazole. Alkalinisation will reduce the rate of elimination of trimethoprim. Calcium folinate (5 to 10 mg/day) will reverse any folate deficiency effect of trimethoprim on the bone marrow should this occur. General supportive measures are recommended.
5 years.
Do not store above 25°C.
Keep the blister in the outer carton in order to protect from light.
PVC/Aluminium foil blister packs.
Packs of 100 and 500 tablets.
No special requirements.
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