Trimethoprim Tablets 200mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TIEMPE/Trimethoprim 200mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimethoprim BP 200 mg.
3 PHARMACEUTICAL FORM
Tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 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 before bedtime.
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.
4.3 Contraindications
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.
4.4 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 long-term treatment and those pre-disposed to folate deficiency. Particular care should be exercised in the haematological monitoring of children on long-term therapy.
4.5 Interaction with other medicinal products and other forms of interaction
No known interactions.
4.6 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 milk.
Effects on ability to drive and use machines
4.7
Does not affect.
4.8 Undesirable effects
Nausea, vomiting, gastro-intestinal disturbance, headache, skin rashes and pruritus. All these are rare.
Cases of Megaloblastic anaemia during prolonged therapy with Trimethoprim in doses higher then those recommended rarely occur but are reversible with discontinuation of therapy and administration of folinic acid.
4.9 Overdose
Treat symptomatically, gastric lavage and forced diuresis can be used. Depression of haematopoiesis by Trimethoprim can be counteracted by intramuscular injections of calcium folinate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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.
5.3
Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Povidone
Crospovidone
Sodium starch glycollate
Magnesium stearate
Industrial methylated spirit
Purified water
6.2 Incompatibilities
There are no major incompatibilities.
6.3 Shelf life
36 months all pack sizes.
6.4 Special precautions for storage
Store in a dry place below 25 °C. Keep container well closed.
6.5 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
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0118
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT