Trimethoprim 100 mg tablets

1. Name Of The Medicinal Product

Trimethoprim 100mg Tablets

2. Qualitative And Quantitative Composition

Trimethoprim 100.00 mg

For excipients, see 6.1

3. Pharmaceutical Form

Tablet; white coloured flat bevelled edged tablets engraved with 'MT100'.

Slight characteristic odour.

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 pneumonia, Staphylococcus aureus, Escherichia 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.

Route of administration: Oral

4.2 Posology And Method Of Administration

Adults: treatment of urinary tract infections and all other susceptible infections: 200mg twice daily.

Long-term prophylaxis of recurrent urinary tract infections: 100mg at night before bed-time.

Children: 4 months to 12 years of age:- treatment of urinary tract infections and all other susceptible infections: 6mg/kg bodyweight daily, sub-divided into 2 equal doses.

Long-term prophylaxis of recurrent urinary tract infections: 2.5mg/kg body weight daily given as a single dose before bedtime.

Elderly: treat as for adults.

4.3 Contraindications

Hypersensitivity to Trimethoprim or to any other component of the formulation. 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.

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

Trimethoprim may potentiate the anticoagulant effects of warfarin.

4.6 Pregnancy And Lactation

Trimethoprim should not be administered to pregnant women. Trimethoprim is not contraindicated for short-term use in lactating mothers, although the drug is excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nausea, vomiting, gastro-intestinal disturbance, headache are rare. Skin rash, pruritus and urticaria have been reported occasionally. 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. More severe skin sensitivity reactions like erythema multiforme, Stevens Johnson syndrome and epidermal necrolysis have been reported rarely. Aseptic meningitis has been reported.

Anaphylactic reactions, anaphylactoid reactions and angioedema have been reported rarely.

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 the unchanged drug.

Trimethroprim may cause an apparent rise in serum creatinine levels due to competition in the tubular secretory mechanisms.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Povidone 25cps

Crospovidone

Sodium starch glycollate

Magnesium stearate

Industrial methylated spirit

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original container.

6.5 Nature And Contents Of Container

High density polystyrene with polythene lids and/or polypropylene containers with polythene lids and polyurethane or polythene inserts.

Blister pack - 25 micron PVC glass-clear/bluish rigid PVC (pharmaceutical grade) 20 micron hard-tempered aluminium foil coated on the pull side with 6-7gsm heat seal lacquer and printed on the bright side.

Pack sizes: 50,100, 500, 1000, 5000, 28 (blister pack)

6.6 Special Precautions For Disposal And Other Handling

No special instructions

7. Marketing Authorisation Holder

Milpharm Limited,

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 16363/0023

9. Date Of First Authorisation/Renewal Of The Authorisation

8 March 2001

10. Date Of Revision Of The Text

28/05/2007