1. NAME OF THE MEDICINAL PRODUCT Sutrim Forte. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 160 mg of trimethoprim and 800 mg of sulfamethoxazole For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM White rounded oblong biconvex tablet scored from one side.(non functional scoring ) (Tablets should be swallowed whole without division). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sutrim Forte should only be used where, in the judgement of the physician, the benefits of treatment outweigh any possible risks; consideration should be given to the use of a single effective antibacterial agent. Sutrim Forte is an antibacterial agent. Sutrim Forte 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 Forte is indicated for the treatment of adults (>18 years old) and adolescents and children from 12-18 years of age. Sutrim Forte is indicated for the treatment of the following infections when owing to sensitive organisms (see section 5.1): • Treatment and prophylaxis (primary and secondary) of Pneumocytosis jiroveci pneumonitis or PJP. • Treatment and prophylaxis of toxoplasmosis • Treatment of nocardoasis. The following infections may be treated with Sutrim Forte where there is bacterial evidence of sensitivity to Sutrim Forte and good reason to prefer the combination of antibiotics in Sutrim Forte to a single antibiotic. • Treatment of acute uncomplicated urinary tract infections • Treatment of acute exacerbation of chronic bronchitis • Treatment of acute otitis media Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology General dosage recommendations Where dosage is expressed as "tablets" this refers to the adult Forte tablet, i.e 160 mg Trimethoprim BP and 800 mg Sulfamethoxazole BP. 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 Forte tablets >18 years old 1 tablet 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 Forte tablets >12 to <18 years old 1 tablet 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 of 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 1 tablet every 12 hours 15 to 30 1 tablet per day <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 Forte, 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 Forte. If the concentration of total sulfamethoxazole exceeds 150 microgram/ml then treatment should be interrupted until the value falls below 120 microgram/ml. Pneumocytosis jiroveci pneumonitis: Treatment - Children (>12 to <18 years old) and adults (>18 years old): A higher dosage is recommended, using 20 mg trimethoprim and 100 mg sulfamethoxazole per kg 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 and sulfamethoxazole). (See section 4.8). Prevention - Adults (>18 years old): The following dose schedules may be used: • 160 mg trimethoprim/800 mg sulfamethoxazole daily 7 days per week. • 160 mg trimethoprim/800 mg sulfamethoxazole three times per week on alternate days. • 320 mg trimethoprim/1600 mg sulfamethoxazole per day in two divided doses three times per week on alternate days. Prevention - Children >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 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 Tablets >12 to <18 years old 1 tablet every 12 hours, seven days per week >12 to <18 years old 1 tablet every 12 hours, three times per week on alternative days >12 to <18 years old 1 tablet every 12 hours, three times per week on consecutive days >12 to <18 years old 2 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. Nocardiosis - Adults (>18 years old): 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 jiroveci, pneumonitis may be appropriate. Method of administration Oral. It may be preferable to take Sutrim Forte with some food or drink to minimise the possibility of gastrointestinal disturbances. Tablets should be swallowed whole without division. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substances sulphonamides, trimethoprim, Sutrim Forte or to any of the excipients listed in section 6.1. • Contra-indicated in patients with severe impairment of liver function. • Contra-indicated in patients with severe renal insufficiency where repeated measurements of the plasma concentration cannot be performed. • sulfamethoxazole ,trimethoprim.should not be given to infants during the first 6 weeks of life. • Sutrim Forte should not be given to patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulphonamides. • Sutrim Forte should not be given to patients with acute porphyria.
