SEPTRIN SUSP; trimethoprim, sulphamethoxazole, antibacterials .
ACTIVE-INGREDIENT OF SEPTRIN SUSP
Septrin Pediatric Suspension 5 ml contains: Trimethoprim 40 mg. Sulfamethoxazole 200 mg .
INDICATION OF SEPTRIN SUSP
Septrin indicated for the treatment of the following infections when owing to sensitive organisms : – Treatment and prevention of Pneumocystis jiroveci (P. carinii) pneumonitis. – Treatment and prophylaxis of toxoplasmosis. – Treatment of nocardiosis. The following infections may be treated with Septrin where there is bacterial evidence of sensitivity to Septrin and good reason to prefer the combination of antibiotics in Septrin 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.
DOSAGE OF SEPTRIN SUSP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Method of administration : oral. It may be preferable to take Septrin with some food or drink to minimize the possibility of gastrointestinal disturbances. Standard dosage recommendations for acute infections: Pediatric Suspension: Children aged 12 years and under: In case of 6 to 12 years : 10 ml every 12 hours. In case of 6 months to 5 years : 5 ml every 12 hours. In case of 6 weeks to 5 months : 2.5 ml every 12 hours. This dosage approximates to 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per 24 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. The elderly : See special warnings and precautions for use. Unless otherwise specified standard dosage applies. Impaired hepatic function: No data available relating to dosage in patients with impaired hepatic function. Impaired renal function: Adults and children over 12 years; (no information is available for children under 12 years of age). In case of Creatinine clearance is (>30 ml/min) Standard dosage. In case of Creatinine clearance is (15 to 30 ml/min) Half the Standard dosage. In case of Creatinine clearance is (OVER-DOSAGE OF SEPTRIN SUSP
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 gross overdosage . 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.
CONTRA-INDICATION OF SEPTRIN SUSP
Septrin should not be given to patients with a history of hypersensitivity to sulphonamides, trimethoprim, co-trimoxazole or any excipients of Septrin. Contra-dicated in patients showing marked liver parenchymal damage. Contra-dicated in severe renal insufficiency where repeated measurments of the plasma concentration cannot be performed. Septrin should not be given to premature babies nor to full-term infants during the first 6 weeks of life except for the treatment /prophylaxis of PCP in infants 4 weeks of age or greater.
STORAGE OF SEPTRIN SUSP
Store below 25 °C. and protect from light. Keep container in the outer carton.
PACK OF SEPTRIN SUSP
Carton box containing a bottle of 60 and 120 ml suspension.
SEPTRIN SUSP MANUFACTURED BY
GlaxoSmithkine – El-salam city-cairo. A.R.E. under license from Aspen Pharma Trading Limited.