TRIMETHOPRIM DAWA

g. uncomplicated bacterial cystitis in women) and two weeks according to the nature and severity of infection. The first dose can be doubled. • Adults and children over 12 years: 200mg twice daily. • Children 6-12 years: 100mg twice daily.

• Children under 6 years of age: Not recommended; a more suitable dosage form should be used this age group. • Elderly: Dosage is dependent upon kidney function; see special dosage schedule. Long-term treatment and prophylactic therapy: • Adults and children over 12 years: 100mg at night.

• Children 6-12 years: 50mg at night. Where a single daily dose is required, dosage at bedtime may maximize urinary concentrations. The approximate dosage in children is 2mg trimethoprim per kg body weight per day. • Elderly: Dosage is dependent upon kidney function; see special dosage schedule Advised dosage schedule where there is reduced kidney function: eGFR (ml/min) Dosage advised Over 30 Normal 15-30 Normal for 3 days then half dose Under 15 Half the normal dose Monitoring of renal function and serum electrolytes should be considered particularly with longer term use, in patients with impaired renal function.

Trimethoprim should only be initiated and used in dialysis patients under close supervision from specialists in both infectious disease and renal medicine. Trimethoprim is removed by dialysis. Monitoring trimethoprim plasma concentration may be considered with long term therapy but should be discussed with specialists in infectious disease and renal medicine.

Route of administration:

Oral.

The most frequent adverse effects at usual doses are pruritus and skin rash (in about 3 to 7% of patients) and mild, gastrointestinal disturbances including nausea, vomiting and glossitis. The adverse affected are displayed by system organ class and frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), (and not known (cannot be estimated from the available data).

System organ class Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Infections and infestations Monilial overgrowth Blood and lymphatic system disorders1 Leucopenia, thrombocytopenia, agranulocyctosis, neutropenia, pancytopaenia, bone marrow depression, aplastic anemia, haemolytic anemia, eosinophilia, purpura, haemolysis Megaloblastic anaemia, methaemoglobinaemia.

Trimethoprim therapy may affect haematopoiesis Immune system disorders Hypersensitivity, anaphylaxis, anaphylactoid reaction, drug fever, allergic vasculitis resembling Henoch-Schoenlein purpura, periarteritis nodosa, systemic lupus erythematosus Metabolism and nutrition disorders Hyperkalemia (particularly in The elderly and in HIV patients), Hypoglycemia, hyponatraemia2, anorexia Psychiatric disorders Depression, Hallucinations, confusional states, agitation, anxiety, abnormal behavior, insomnia and nightmares Nervous system disorders Headache.

Dyskinesias, aseptic meningitis3, tremor, ataxia, dizziness, lethargy, syncope, paraesthesiae, convulsions, peripheral neuritis, vertigo, tinnitus Eye disorders Uveitis Respiratory, Thoracic and mediastinal disorder Cough, shortness of breath, wheeze, epistaxis Gastrointestinal disorders Nausea, vomiting, diarrhoea Glossitis, constipation, stomatitis, pseudomembranous colitis, pancreatitis Gastrointestinal disturbances, sore mouth Hepatobiliary disorder Disturbances in liver enzyme values, elevation of serum transaminases, elevation of bilirubin levels, cholestatic jaundice, hepatic necrosis4 Skin and subcutaneous disorder Skin rashes, urticaria Exfoliative dermatitis, photosensitivity, angioedema, erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis5, fixed drug eruption, erythema nodusum, bullous dermatitis, purpura Pruritus, Drug reaction with eosinophilia and systemic symptoms (DRESS).

Musculoskeletal and connective tissue disorders Myalgia. 3 Contraindications), however the majority of haematological changes are mild and reversible when treatment is stopped. 2 Close supervision is recommended when trimethoprim is used in elderly patients or in patients taking high doses as these patients may be more susceptible to hyperkalaemia and hyponatraemia 3 Aseptic meningitis was rapidly reversible on withdrawal of the drug, but recurred in a number of cases on re-exposure to either co-trimoxazole or to trimethoprim alone.

4 Cholestatic jaundice and hepatic necrosis may be fatal. 5 Lyell's syndrome (toxic epidermal necrolysis) carries a high mortality. 6 It is not known however, whether this represents inhibition of creatinine tubular secretion or genuine renal dysfunction.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

Administer with care to patients with impaired renal function. Monitoring of renal function and serum electrolytes should be considered particularly with longer term use. In patients with renal impairment, care should be taken to avoid accumulation.

Trimethoprim should only be initiated and used in dialysis patients under close supervision from specialists in both infectious disease and renal medicine. 8). Elevations in serum potassium have been observed in some patients treated with trimethoprim.

g. heparin). 5). Trimethoprim may cause depression of haemopoiesis. g. the elderly) to check for possible pancytopaenia and administration of folate supplement should be considered. Although an effect on folate metabolism is possible, interference with haematopoiesis rarely occurs at the recommended dose.

If any such change is seen, folinic acid should reverse the effect. Elderly people may be more susceptible and a lower dose may be advisable. If there is evidence of folic acid deficiency, calcium folinate should be administered and response checked by haematologic monitoring.

It may be necessary to discontinue trimethoprim. Particular care should be exercised in the haematological monitoring of children on long term therapy. 8). 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.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorbtion should not take this medicine. Trimethoprim has been associated with acute attacks of porphyria. Trimethoprim use in patients with acute porphyria is not recommended.

5)

Hypersensitivity to trimethoprim or any of the excipients. 6). Severe hepatic insufficiency. Megaloblastic anaemia and other blood dyscrasias. Trimethoprim should not be administered to premature infants or children under 4 months of age.