Active substance(s): TRIMETHOPRIM
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimethoprim BP 100 mg.
Treatment of susceptible infections caused by Trimethoprim sensitive
organisms, including most Gram-positive and Gram-negative aerobic
organisms, including Haemophilus influenzae, Streptococcus pneumoniae,
Klebsiella pneumoniae, Staphylococcus aureus, E. Coli, Enterobacter, Proteus
and Streptococcus faecalis.
Exceptions include anaerobic bacteria. Mycobacterium tuberculosis, Neisseria
gonorrhoea, Pseudomonas auruginosa and Treponema pallidum.
Prophylaxis of recurrent urinary tract infections.
Posology and method of administration
Adults: Treatment of urinary tract infections and all other susceptible
infections: 200 mg twice daily.
Long term prophylaxis of recurrent urinary tract infections: 100 mg at night
Children: 4 months to 12 years of age.
Treatment of urinary tract infections and all other susceptible infections:
6mg/kg bodyweight daily, subdivided into 2 equal doses.
Long term prophylaxis of recurrent urinary tract infections: 2.5mg/kg
bodyweight daily given as a single dose before bedtime.
Elderly: Treat as adults.
Route of Administration: Oral.
Severe hepatic insufficiency. Severe renal insufficiency. Megaloblastic
anaemia and other blood dyscrasias. Trimethoprim should not be administered
to premature infants or children under 4 months of age. Pregnancy Trimethoprim should not be administered to pregnant women.
Special warnings and precautions for use
Patients with marked impairment of renal function; care should be taken to
avoid accumulation and resulting adverse hepatological effects.
Regular haematological tests should be undertaken in patients receiving longterm treatment and those predisposed to folate deficiency. The elderly may be
more susceptible to folate deficiency and a lower dose may be advisable.
Patients and their carers should be told how to recognise signs of blood
disorders and advised to seek immediate medical attention if symptoms such
as fever, sore throat, rash, mouth ulcers, purpura, bruising or bleeding develop.
Particular care should be exercised in the haematological monitoring of
children on long-term therapy. Porphyria.
Interaction with other medicinal products and other forms of interaction
The plasma concentration of procainamide is increased with concomitant use
of trimethoprim. The plasma concentration of dioxin is also possibly
Antiepileptics: plasma concentration and antifolate effect of phenytoin
Antimalarials: Increased risk of antifolate effect with pyrimethamine.
Ciclosporin may increase the nephrotoxicity of trimethoprim.
Cytotoxics: Increased risk of haematological toxicity with azathioprine and
mercaptopurine. Avoid concomitant use with methotrexate.
Trimethoprim may potentiate the anticoagulant effect of warfarin.
Pregnancy and lactation
The usual caution in prescribing any drug for women of child-bearing age
should be exercised with Trimethoprim. Trimethoprim is not contra-indicated
for short-term use in lactating mothers, although the drug is excreted in breast
Effects on ability to drive and use machines
Does not affect.
Gastro-intestinal disturbances including nausea and vomiting, headache, skin
rashes, pruritus and urticaria have been reported occasionally. Hyperkalaemia
and depression of haematopoiesis have also occurred. Erythema multiforme,
toxic epidermal necrolysis, photosensitivity and other allergic reactions
including angioedema and anaphylaxis have been reported rarely. Aseptic
meningitis has also been reported.
Cases of Megaloblastic anaemia during prolonged therapy with Trimethoprim
in doses higher than those recommended rarely occur but are reversible with
discontinuation of therapy and administration of folinic acid.
Treat symptomatically, gastric lavage and forced diuresis can be used.
Depression of haematopoiesis by Trimethoprim can be counteracted by
intramuscular injections of calcium folinate.
Trimethoprim has potent anti-microbial activity through its selective inhibition
of bacterial dihydrofolate reductase. It is effective against most gram-positive
and gram-negative aerobic organisms.
Absorption is by the oral route. Peak plasma levels are reached in about one
hour but significant plasma levels are obtained within half-an-hour.
Excretion is mainly in the urine in the form of unchanged drug. Trimethoprim
may cause an apparent rise in serum creatinine levels due to competition in the
tubular secretory mechanisms.
Preclinical safety data
List of excipients
Sodium starch glycollate
There are no major incompatibilities.
36 months all pack sizes.
Special precautions for storage
Store in a dry place below 25°C.
Keep container well closed.
Nature and contents of container
Polypropylene or high density polystyrene with polythene closures and
polyurethane wads or polythene inserts.
Pack sizes: 50, 100, 500, 1000, 5000
250 micron PVC glass-clear/bluish rigid PVC (Pharmaceutical grade).
20 micron hard-tempered aluminium foil coated on the dull side with
6-7 gsm heat seal lacquer and printed on the bright side.
Pack sizes: 28
Special precautions for disposal
No special instructions
MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT