NITROFURANTOIN Tablet Ref.[7492] Active ingredients: Nitrofurantoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Dr Reddys Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

Therapeutic indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.

Posology and method of administration

Posology

Adults

Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days.

Severe Chronic Recurrence: 100mg four times a day for seven days.

Long Term Suppression: 50mg-100mg once a day.

Prophylaxis: 50mg four times daily for the duration of procedure and 3 days thereafter.

Paediatric population

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days.

Suppressive therapy: 1mg/kg/once a day.

Elderly

Provided there is no significant renal impairment in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precautions and risks to elderly patients associated with long term therapy (section 4.8).

Renal impairment

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).

Method of administration

For oral use. This medicine should be taken at meal times with food or milk.

Overdose

Symptoms

Symptoms and signs of overdose include gastric irritation, nausea and vomiting.

Management

There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

Shelf life

36 months.

Special precautions for storage

Do not store above 25˚C. Store in the original package. Keep blister in the outer carton/keep container tightly closed.

Nature and contents of container

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

Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000.

250 micron, pharmaceutical grade, green rigid PVC

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, 30, 50, 56, 60, 84, 100, 250, 500 & 1000.

Special precautions for disposal and other handling

None.

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