Monotrim

Treatment of susceptible infections caused by Monotrim sensitive organisms including most gram-positive and gram-negative aerobic organisms, including Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumonia, Staphylococcus aureus, Eschersichia coli, Enterobacter, Proteus and Streptococcus faecalis.

Exceptions include anaerobic bacteria. Mycobacterium tuberculosis, neisseria gonorrhoeae, pseudomonas aeruginosa and treponema pallidum.

Prophylaxis of recurrent urinary tract infections.

Consideration should be given to official guidance on the appropriate use of antibacterial agents

Posology

Acute infections:

Treatment should continue for a period of between three days (e.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 in 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 maximise urinary concentrations. The approximate dosage in children is 2mg Monotrim 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:

Monotrim is removed by dialysis. However, it should not be administered to dialysis patients unless plasma concentrations can be estimated regularly.

Route of administration: Oral

Hypersensitivity to Monotrim or any of the excipients. Pregnancy. Severe hepatic insufficiency. Severe renal insufficiency where blood levels cannot be regularly monitored. Megaloblastic anaemia and other blood dyscrasias. Monotrim should not be administered to premature infants or children under 4 months of age.

Administer with care to patients with impaired renal function. Regular haematological examination should be performed during long-term therapy.

Caution should be exercised in the administration of Monotrim to patients with actual or potential folate deficiency (e.g. the elderly) 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.

In patients with renal impairment, care should be taken to avoid accumulation.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorbtion should not take this medicine.

None known.

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. These effects are generally mild and quickly reversible on withdrawal of the drug.

Blood and lymphatic system disorders

Leucopenia, megaloblastic anaemia, thrombocytopenia, agranulocyctosis, hyperkalaemia (particularly in the eldery and in HIV patients), methaemoglobinaemia. Monotrim therapy may affect haematopoiesis

Nervous system disorders

Aseptic meningitis

Gastrointestinal disorders

Gastro-intestinal disturbances including nausea and vomiting, glossitis, sore mouth.

Hepatobiliary disorders

Disturbances in liver enzyme values, cholestatic jaundice.

Skin and subcutaneous tissue disorders

Pruritis, skin rashes, exfoliative dermatitis, urticaria.

More severe skin sensitivity reactions such as erythema multiforme, Stevens-Johnson Syndrome and ToxicEpidermal Necrolysis have been reported rarely.

Musculoskeletal and connective tissue disorders

Myalgia

General disorders and administration site conditions

Anaphylaxis, drug fever, headache.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal products is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Treat symptomatically, gastric lavage and forced diuresis may be used. Depression of haematopoiesis by Monotrim may be countered by intramuscular injections of calcium folinate.

Pharmacotherapeutic Group: Systemic antibacterial. ATC Code: J01EA01

Mechanism of action: Monotrim is a dihydrofolate reductase inhibitor which affects the nucleoprotein metabolism of micro-organisms by interference in the folic-folinic acid systems.

Monotrim is effective in vitro against a wide range of Gram-positive and aerobic Gram-negative organisms, including enterobacteria Escherica coli, Proteus, Klebsiella pneumoniae, Streptococcus pneumoniae, Streptococcus faecalis, Haemophilus influenzae and Staphylococcus aureus.

It is not effective against Anaerobes, Pseudomonas aeruginosa, Treponema pallidum, Mycobacteria, Nocardia species, Neisseria species and Brucella abortus.

Monotrim is rapidly and almost completely absorbed from the gastrointestinal tract and peak concentrations in the circulation occur about 1-4 hours after an oral dose. Peak plasma concentrations of about 1μg/ml have been reported after a single dose of 100mg. Approximately 40-70% is bound to plasma proteins. The half life is approximately 8-10 hours. About 40-60% of a dose is excreted unchanged in the urine within 24 hours, together with metabolites; hence, patients with impairment of renal function such as the elderly may require a reduction in dosage due to accumulation. It appears in breast milk.

There are no pre-clinical data of relevance to the prescriber additional to that included in other sections of the SmPC.

None known

No special requirements