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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 adults and children over 12 years for the treatment of the following infections when owing to sensitive organisms (see section 5.1): - Treatment and prophylaxis of Pneumocystis jirovecii pneumonitis or “PJP” - Treatment and prophylaxis of toxoplasmosis. - Treatment of…
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 recommendations for acute infections Adults and children over 12 years: STANDARD DOSAGE: 2 tablets every 12 hours.
The standard dosage for children is equivalent to approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per day, given in two equally divided doses. 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.
Pneumocystis jirovecii pneumonitis:
Treatment Adults and children over 12 years: 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. 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 co-trimoxazole).
8 Undesirable Effects).
Prophylaxis - Adults and children over 12 years:
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.
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 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.
).
Prophylaxis - Adults and children over 12 years:
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.
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 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 prophylaxis of Pneumocystis jirovecii pneumonitis may be appropriate.
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 - Adults and children over 12 years: 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.
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.
• Patients should be advised of the signs and symptoms and monitored closely for skin reactions. • If signs and symptoms suggestive of these reactions appear, trimethoprim should be withdrawn immediately and an alternative treatment considered (as appropriate).
• If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of trimethoprim, the treatment must not be restarted in this patient at any time. • The best results in managing SJS, TEN and DRESS come from early diagnosis and immediate discontinuation of any suspect drug.
Early withdrawal is associated with a better prognosis. 8); it requires cessation of treatment and contraindicates any new administration of Co-Trimoxazole alone or in combination with other drugs. 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.
Haemophagocytic lymphohistiocytosis (HLH) Cases of HLH have been reported very rarely in patients treated with co- trimoxazole. , 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. g. impaired kidney and/or liver function and/or concomitant use of other drugs.
1. • Contra-indicated in patients showing marked liver parenchymal damage. • Contra-indicated in 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. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 prophylaxis of Pneumocystis jirovecii pneumonitis may be appropriate.
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 - Adults and children over 12 years: 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.
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 2–3 days are recommended in samples obtained 12 hours after administration of Co-trimoxazole.
If the concentration of total sulfamethoxazole exceeds 150 mcg/ml then treatment should be interrupted until the value falls below 120 mcg/ml. Route of administration Oral It may be preferable to take co-trimoxazole with some food or drink to minimise the possibility of gastrointestinal disturbances.
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 2–3 days are recommended in samples obtained 12 hours after administration of Co-trimoxazole.
If the concentration of total sulfamethoxazole exceeds 150 mcg/ml then treatment should be interrupted until the value falls below 120 mcg/ml. Route 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 showing marked liver parenchymal damage. • Contra-indicated in 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. 6). 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.
• Patients should be advised of the signs and symptoms and monitored closely for skin reactions. • If signs and symptoms suggestive of these reactions appear, trimethoprim should be withdrawn immediately and an alternative treatment considered (as appropriate).
• If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of trimethoprim, the treatment must not be restarted in this patient at any time. • The best results in managing SJS, TEN and DRESS come from early diagnosis and immediate discontinuation of any suspect drug.
Early withdrawal is associated with a better prognosis. 8); it requires cessation of treatment and contraindicates any new administration of Co-Trimoxazole alone or in combination with other drugs. 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.
Haemophagocytic lymphohistiocytosis (HLH) Cases of HLH have been reported very rarely in patients treated with co- trimoxazole. , 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. Elderly patients Particular care is always advised when treating elderly patients because, as a group, they are more susceptible to adverse reactions and more likely to suffer serious effects as a result […]
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 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 In glucose-6-phosphate-dehydrogenase (G-6-PD) deficient 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 The administration of 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.
Phenylalanine metabolism Trimethoprim has been noted to impair phenylalanine metabolism but this is of no significance in phenylketonuria patients on appropriate dietary restrictions. Patients with or at risk of porphyria 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.
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 Undesirable effects). 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.
This medicine contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase […]