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CO-TRIMOXAZOLE is a brand name for Trimethoprim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Co-trimoxazole Tablets are indicated in children (>12 to <18 years old) and adults (>18 years old) for treatment of the following infections when owing to sensitive organisms (see section 5.1): • Treatment and prophylaxis of Pneumocystis jirovecii pneumonia (PJP). • Treatment and prophylaxis of toxoplasmosis •…
Verbatim from this product's MHRA label. Tap a section to expand.
e 80 mg Trimethoprim BP and 400 mg Sulfamethoxazole BP. If other formulations are to be used appropriate adjustment should be made.
Standard dosage recommendation 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 (2) 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 2 tablet 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.
2 for the pharmacokinetics in the paediatric population with normal renal function of both components of FECTRIM/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 Fectrim/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 bodyweight per day in 2 or more divided doses for 2 weeks. The aim is to obtain peak plasma or serum level of Trimethoprim greater than or equal to 5 micrograms per ml (verified in patients receiving 1- hour infusions of intravenous Co-Trimoxazole).
).
Prevention:
Adults (>18 years old): The following dosing schedules may be used: - 160 mg trimethoprim/800 mg sulfamethoxazole daily, 7 days per week. - 160 mg trimethoprim/800 mg sulfamethoxazole three times a week on alternate days. - 320 mg trimethoprim/1600 mg sulfamethoxazole per day in two divided doses three times a 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 to < 18 years old 2 tablet every 12 hours, seven days per week >12 to to < 18 years old 2 tablet every 12 hours, three time per week on alternative days >12 to to < 18 years old 2 tablet every 12 hours, three times per week on consecutive days >12 to 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.
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.
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.
• Life-threatening cutaneous reactions including Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms have been reported with the use of Fectrim/Co-Trimoxazole • 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). • The best results in managing SJS and 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 Fectrim Forte, Fectrim Forte 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, cotrimoxazole 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. o Co-Trimoxazole should not be given to patients with severe impairment of liver function. o Contra-indicated in patients with severe renal insufficiency where repeated measurement of the plasma concentration cannot be performed. o Co-trimoxazole is contra-indicated in patients with megaloblastic anaemia due to folate deficiency.
o Co-trimoxazole should not be given to infants during the first 6 weeks of life. o Co-Trimoxazole should not be given to patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulphonamides.
o Co-Trimoxazole should not be given to patients with acute porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8 Undesirable effects).
Prevention:
Adults (>18 years old): The following dosing schedules may be used: - 160 mg trimethoprim/800 mg sulfamethoxazole daily, 7 days per week. - 160 mg trimethoprim/800 mg sulfamethoxazole three times a week on alternate days. - 320 mg trimethoprim/1600 mg sulfamethoxazole per day in two divided doses three times a 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 to < 18 years old 2 tablet every 12 hours, seven days per week >12 to to < 18 years old 2 tablet every 12 hours, three time per week on alternative days >12 to to < 18 years old 2 tablet every 12 hours, three times per week on consecutive days >12 to 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.
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.
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 Fectrim/Co-Trimoxazole with some food or drink to minimise the possibility of gastro-intestinal disturbances.
Method of administration:
Oral. It may be preferable to take Fectrim/Co-Trimoxazole with some food or drink to minimise the possibility of gastro-intestinal disturbances. 1. o Co-Trimoxazole should not be given to patients with severe impairment of liver function.
o Contra-indicated in patients with severe renal insufficiency where repeated measurement of the plasma concentration cannot be performed. o Co-trimoxazole is contra-indicated in patients with megaloblastic anaemia due to folate deficiency.
o Co-trimoxazole should not be given to infants during the first 6 weeks of life. o Co-Trimoxazole should not be given to patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulphonamides.
o Co-Trimoxazole should not be given to patients with acute porphyria. 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.
• Life-threatening cutaneous reactions including Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms have been reported with the use of Fectrim/Co-Trimoxazole • 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). • The best results in managing SJS and 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 Fectrim Forte, Fectrim Forte 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, cotrimoxazole 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 […]
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 sulfonamide 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 FECTRIM/Co- Trimoxazole is given for long periods, or to folate deficient patients or to the elderly; 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 Haemolysis may occur in glucose-6-phosphate dehydrogenase (G-6-PD) deficiency patients. Patients with severe atopy or bronchial asthma Fectrim/Co-trimazole should be given with caution in patients with severe atopy or bronchial asthma.
Treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci Fectrim/Co-trimaxole should not be use 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 phenylketonuria patients on appropriate dietary restriction. Patients with or at risk of porphyria The administration of Fectrim/Co-Trimoxazole to patients known or suspected to be at risk of acute porphyria should be avoided.
Both trimethoprim and sulfonamides (although not specifically sulfamethoxazole) have been associated with clinical exacerbation of porphyria. Patients with hyperkalaemia and hyponatraemia Close monitoring of serum potassium is warranted in patients at risk of hyperkalaemia.
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). Fectrim/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 Fectrim/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.