XEROPRIM Tablet Ref.[50586] Active ingredients: Sulfamethoxazole Trimethoprim

Erythema multiforme, toxic dermal necrolysis and allergic vasculitis may occur.

In patients with renal impairment, reduced or more widely spaced dosage is indicated to avoid accumulation in the blood. For such patients measurements of plasma concentration is advisable. Regular blood counts are advisable if XEROPRIM is to be given for a long period.

High doses of XEROPRIM may have a hypoglycaernic effect. Thyroid tests must be carried out in patients with thyroid disorders.

Paraldehyde has been reported to increase the acetylation of sulphamethoxazole with subsequent increased risk of crystalluria. Because of the risk of crystalluria, an adequate fluid intake should be maintained.

XEROPRIM may be antagonized by p-aminobenzoic acid and compounds derived from it.

Sulpharnethoxazole is strongly bound to proteins. Patients receiving anticoagulants of the coumarin group or methotrexate concomitantly should therefore be carefully monitored. Sulphamethoxazole increases the hypoglycaemic action of sulphonylureas in diabetic patients.

XEROPRIM should be used with caution in patients receiving pyrimethamine or immunosuppressive therapy. Trimethoprim prolongs the half-life of phenytoin.

XEROPRIM may interact with the following medicines by interfering with their clearance: digoxin, procainamide and tolbutamide.

Previous or simultaneous administration of diuretics with XEROPRIM may cause an increased risk of thrombocytopenia, especially in elderly patients with heart failure; death may occur.

XEROPRIM should not be used during pregnancy and lactation. Use of the substance in premature or new born infants during the first two months of life, is contra-indicated (See – CONTRAINDICATIONS).

Haematological changes such as anaemia (including aplastic, haemolytic and nacrocytic), coagulation disorders, granulocytopenia, agranulocytosis, purpura, henoch schöntein purpura; and sulphaermoglobinaemia may occur. Skin disorders e.g. Reddening exanthema and itch may occur. Exfoliative dermatitis, Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (Lyells Syndrome) may occur.

When a rash appears, this medicine must be discontinued. Megaloblastosis, leucopenia or thrombocytopenia ay occur. Nausea and vomiting constitutes the bulk of gastro intestinal reactions; diarrhoea may occur. Glossitis and stomatitis are relatively common.

Jaundice has been noted and appears to have the histological features of allergic cholestatic hepatitis. Central nervous system reactions consist of headache, depression and hallucinatory manifestations, dizziness, drug fever and psychosis.

Other adverse effects include: acidosis, anorexia, goitre, hypothyroidism, arthralgia, drowsiness, fatigue, insomnia, nightmares, confusion, vertigo, ataxia, tinnitus, peripheral neuritis and polyarteritis nodosa.

Toxic nephrosis has been reported. Direct exposure to sunlight should be avoided as it facilitates development of sensitisation dermatitis. XEROPRIM should be used with caution in patients with allergic conditions or bronchial asthma.

Pseudomembranous colitis and anaphylaxis have been reported.

Sulpharnethoxazole has been reported to interfere with some diagnostic tests including those for urea, creatinine, urinary glucose and urobilinogen.

Trimethoprim may interfere with some diagnostic tests including serum methotrexate assay and the jaffé reaction for creatinine.

Adverse effects on the blood may be more severe and higher blood levels are reached in malnourished or elderly patients.