1 NAME OF THE MEDICINAL PRODUCT Sutrim tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Sulfamethoxazole 400 mg and Trimethoprim 80mg. Excipients: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Scored uncoated tablets. White, flat rounded uncoated tablets, scored from one side. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Sutrim is an antibacterial agent. Sutrim is effective in vitro against a wide range of gram-positive and gram-negative organisms. It is not active against Mycobacterium tuberculosis, mycoplasma or Treponema pallidum, Pseudomonas aeruginosa is usually insensitive. Sutrim is indicated in adults and children (>12 to <18 years old) and adults (>18 years old). Sutrim tablets are indicated for the treatment of the following infections when owing to sensitive organisms (see section 5.1): o Treatment and prevention of Pneumocystis jiroveci pneumonitis or ‘PJP’. o Treatment and prophylaxis of toxoplasmosis o Treatment of nocardiosis. The following infections may be treated with Sutrim where there is bacterial evidence of sensitivity to Sutrim and good reason to prefer the combination of antibiotics in Sutrim to a single antibiotic: o Acute uncomplicated urinary tract infection o Acute otitis media o Acute exacerbation of chronic bronchitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology • The tablet should be taken as whole without division. • The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Dividing the tablets may not provide an exact "half" dose. Posology General Dosage Recommendations Where dosage is expressed as "tablets" this refers to the adult tablet, i.e. 80 mg Trimethoprim and 400 mg Sulfamethoxazole. If other formulations are to be used appropriate adjustment should be made. Standard dosage recommendations for acute infections 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; 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. Elderly patients: See Special Warnings and Precautions for Use (Section 4.4). Unless otherwise specified standard dosage applies. Impaired hepatic function: No data are available relating to dosage in patients with impaired hepatic function. Impaired renal function: Dosage recommendation: 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 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 Sutrim, 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 Sutrim. If the concentration of total sulfamethoxazole exceeds 150 microgram/ml then treatment should be interrupted until the value falls below 120 microgram/ml.
