Loading…
CO-TRIMOXAZOLE is a brand name for Sulfamethoxazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Co-Trimoxazole Adult Suspension is 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): • Treatment and prevention of Pneumocystis jirovecii pneumonitis (PJP) • Treatment and prophylaxis of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Standard dosage recommendations for acute infections Adults (>18 years old): STANDARD DOSAGE Age Adult Suspension >18 years old 10 ml 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 Adult Suspension >12 to <18 years old 10 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.
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 10 ml every 12 hours 15 to 30 5 ml every 12 hours <15 Not recommended No information available for children aged 12 years and under with renal failure.
2 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 (>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 of body weight per day in two or more divided doses for two weeks. 8 Undesirable Effects).
).
Prevention - Adults (>18 years old):
The following dose schedules may be used: - 160 mg trimethoprim/800mg sulfamethoxazole daily 7 days per week. - 160 mg trimethoprim/800mg sulfamethoxazole three days per week on alternate days. - 320 mg trimethoprim/1600mg sulfamethoxazole per day in two divided doses three days 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 Adult Suspension >12 to <18 years old 10 ml every 12 hours, seven days per week >12 to <18 years old 10 ml every 12 hours, three times per week on alternative days >12 to <18 years old 10 ml every 12 hours, three times per week on consecutive days >12 to <18 years old 20 ml once a day, three times per week on consecutive days The daily dose given on a treatment day approximates to 150mg trimethoprim/m2/day and 750mg sulfamethoxazole/m2/day.
The total daily dose should not exceed 320 trimethoprim and 1600 mg sulfamethoxazole.
Nocardiosis:
This 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.
Life threatening adverse reactions Fatalities, although very rare, have occurred due to severe reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias and hypersensitivity of the respiratory tract.
8). • Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. g. 8) and an alternative treatment considered (as appropriate).
• The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. • If the patient has developed SJS, TEN or DRESS with the use of Co- Trimoxazole, the treatment must not be re-started in this patient at any time.
8); it requires cessation of treatment and contraindicates any new administration of Co-Trimoxazole alone or in combination with other drugs. Haemophagocytic lymphohistiocytosis (HLH) Cases of HLH have been reported very rarely in patients treated with co-trimoxazole.
g. fever, hepatosplenomegaly, hypertriglyceridaemia, hypofibrinogenaemia, high serum ferritin, cytopenias and haemophagocytosis). Patients who develop early manifestations of pathologic immune activation should be evaluated immediately.
If diagnosis of HLH is established, co-trimoxazole treatment should be discontinued. Respiratory toxicity Very rare, severe cases of respiratory toxicity, sometimes progressing to Acute Respiratory Distress Syndrome (ARDS), have been reported during co-trimoxazole treatment.
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function may be preliminary signs of ARDS. In such circumstances, co- trimoxazole should be discontinued and appropriate treatment given.
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. • Co-Trimoxazole should not be given to patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulphonamides.
• Co-Trimoxazole should not be given to patients with acute porphyria. • Co-Trimoxazole should not be given to infants during the first 6 weeks of life.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sulfamethoxazole in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Prevention - Adults (>18 years old):
The following dose schedules may be used: - 160 mg trimethoprim/800mg sulfamethoxazole daily 7 days per week. - 160 mg trimethoprim/800mg sulfamethoxazole three days per week on alternate days. - 320 mg trimethoprim/1600mg sulfamethoxazole per day in two divided doses three days 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 Adult Suspension >12 to <18 years old 10 ml every 12 hours, seven days per week >12 to <18 years old 10 ml every 12 hours, three times per week on alternative days >12 to <18 years old 10 ml every 12 hours, three times per week on consecutive days >12 to <18 years old 20 ml once a day, three times per week on consecutive days The daily dose given on a treatment day approximates to 150mg trimethoprim/m2/day and 750mg sulfamethoxazole/m2/day.
The total daily dose should not exceed 320 trimethoprim and 1600 mg sulfamethoxazole.
Nocardiosis:
This 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.
Method of administration:
Oral It may be preferable to take Co-Trimoxazole with some food or drink to minimise the possibility of gastrointestinal disturbances. 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.
• Co-Trimoxazole should not be given to patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulphonamides. • Co-Trimoxazole should not be given to patients with acute porphyria. • Co-Trimoxazole should not be given to infants during the first 6 weeks of life.
4 Special warnings and precautions for use Life threatening adverse reactions Fatalities, although very rare, have occurred due to severe reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias and hypersensitivity of the respiratory tract.
8). • Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. g. 8) and an alternative treatment considered (as appropriate).
• The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. • If the patient has developed SJS, TEN or DRESS with the use of Co- Trimoxazole, the treatment must not be re-started in this patient at any time.
8); it requires cessation of treatment and contraindicates any new administration of Co-Trimoxazole alone or in combination with other drugs. Haemophagocytic lymphohistiocytosis (HLH) Cases of HLH have been reported very rarely in patients treated with co-trimoxazole.
g. fever, hepatosplenomegaly, hypertriglyceridaemia, hypofibrinogenaemia, high serum ferritin, cytopenias and haemophagocytosis). Patients who develop early manifestations of pathologic immune activation should be evaluated immediately.
If diagnosis of HLH is established, co-trimoxazole treatment should be discontinued. Respiratory toxicity Very rare, severe cases of respiratory toxicity, sometimes progressing to Acute Respiratory Distress Syndrome (ARDS), have been reported during co-trimoxazole treatment.
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function may be preliminary signs of ARDS. In such circumstances, co- trimoxazole should be discontinued and appropriate treatment given.
g. impaired kidney and/or liver function and/or concomitant use of other drugs. 2). Urinary output An adequate urinary output should be maintained at all times. Evidence of crystalluria […]
g. impaired kidney and/or liver function and/or concomitant use of other drugs. 2). Urinary output An adequate urinary output should be maintained at all times. Evidence of crystalluria in vivo is rare, although sulphonamide crystals have been noted in cooled urine from treated patients.
In patients suffering from malnutrition the risk may be increased. Folate Regular monthly blood counts are advisable when Co-Trimoxazole is given for long periods, or to folate deficient patients or to older patients; since there exists a possibility of asymptomatic changes in haematological laboratory indices due to lack of available folate.
. 5). Patients with glucose-6-phosphate dehydrogenase deficiency In glucose-6-phosphate dehydrogenase deficient (G-6-PD) patients, haemolysis may occur. Patients with severe atopy or bronchial asthma Co-Trimoxazole should be given with caution to patients with severe atopy or bronchial asthma.
Treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci Co-Trimoxazole should not be used in the treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci; eradication of these organisms from the oropharynx is less effective than with penicillin.
Phenylalanine metabolism Trimethoprim has been noted to impair phenylalanine metabolism but this is of no significance in phenylketonuric patients on appropriate dietary restriction. Patients with or at risk of porphyria The administration of Co-Trimoxazole to patients known or suspected to be at risk of porphyria should be avoided.
Both trimethoprim and sulphonamides (although not specifically sulfamethoxazole) have been associated with clinical exacerbation of porphyria. Patients with hyperkalaemia and hyponatraemia Close monitoring of serum potassium and sodium is warranted in patients at risk of hyperkalaemia and hyponatraemia.
Metabolic acidosis Co-Trimoxazole has been associated with metabolic acidosis when other possible underlying causes have been excluded. Close monitoring is always advisable when metabolic acidosis is suspected. 8). Co-Trimoxazole has been given to patients receiving cytotoxic therapy with little or no additional effect on the bone marrow or peripheral blood.
The combination of antibiotics in Co-Trimoxazole 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.
Excipients […]