TRIMOPTIN Tablet Ref.[108381] Active ingredients: Trimethoprim

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Athlone Pharmaceuticals Limited, Connaught House, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

4.1. Therapeutic indications

Treatment of infections caused by trimethoprim-sensitive organisms including urinary and respiratory tract infections and prophylaxis of recurrent urinary tract infections.

4.2. Posology and method of administration

Trimoptin 100mg tablets are not recommended for use in children under 12 years of age. Other suitable dosage forms are available for this patient population.

1. Treatment of respiratory and urinary tract infections

Adults

200mg twice daily for 7-10 days.

The first dosage on the first day can be doubled.

Children

Over 12 years: same as adult dose.

Not recommended for use in children under 12 years.

2. Prophylaxis of recurrent urinary tract infection

Adults

The usual dose is 100mg at night. An extra 100mg may be taken in the morning if necessary.

Children

Over 12 years: same as adult dose.

Not recommended for use in children under 12 years.

3. Dosage in renal impairment

Creatinine Clearance (ml/sec) Plasma creatinine
(micromole/l)
Dosage advised
Over 0.45 Men <250
Women <175
Normal
0.25-0.45 Men 250-600
Women 175-400
Normal for 3 days then half dose
Under 0.25 Men ˃600
Women >400
Half the normal dose

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

Route of administration: Oral.

4.9. Overdose

Treat symptomatically, gastric lavage and forced diuresis can be used.

Depression of haematopoiesis by Trimoptin can be counteracted by intramuscular injections of calcium folinate.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Store in the original package. Protect from light.

6.5. Nature and contents of container

Polypropylene tablet container of 15, 18, 20, 21, 28, 30, 100 or 500 tablets with a high-density/low-density polyethylene blend cap and low-density polyethylene snap filler. Also available in a PVC blister with aluminum lidding foil containing 28 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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