Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. It is indicated in adults, children and infants over 12 years of age.
Macrobid is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.
Most strains of Proteus and Serratia are resistant. All Pseudomonas strains are resistant.
Macrobid is not indicated for the treatment of associated renal cortical or perinephric abscesses.
The dose should be taken with food or milk (e.g. at meal times).
Acute or recurrent uncomplicated UTI and pyelitis: 100mg twice daily for seven days.
Surgical Prophylaxis: 100 mg twice daily on the day of the procedure and 3 days thereafter.
Provided there is no significant renal impairment, in which nitrofurantoin is contraindicated, the dosage should be that for any normal adult.
See precaution and risks to elderly patients associated with long term therapy (see section 4.8).
Macrobid is a fixed dosage and is therefore not suitable for children under 12 years.
Nitrofurantoin is contraindicated in patients with renal dysfunction and in patients with an eGFR of less than 45 ml/minute (see sections 4.3 & 4.4).
For oral use.
Symptoms and signs of overdose include gastric irritation, nausea and vomiting.
There is no specific antidote. However, Nitrofurantoin can be haemodialysed. Standard treatment is by induction of emesis or by gastric lavage in cases of recent ingestion. Monitoring of full blood count, liver function tests and pulmonary function, are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.
The expiry date for the product should not exceed 2 years from the date of its manufacture.
Capsules should be stored in light and moisture resistant containers.
Storage temperature should not exceed 30°C (aluminium/ aluminium).
Do not store above 25°C (For PVC/ polyethylene/aclar/aluminium blisters).
There are two pack sizes, one consists of 14 capsules and the other is a sample pack containing 2 capsules. Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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