Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NITROFURANTOIN
PCO Manufacturing
100 Milligram
Capsules Hard
2009-08-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Macrodantin 100mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Macrodantin 100 mg capsules contain 100 mg Nitrofurantoin in macrocrystalline form. Excipient : Contains lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard _Product imported from the UK:_ Hard gelatin capsule with an opaque yellow cap and body, containing a pale yellow odourless powder. The capsules are printed with the logo ‘Eaton 009’ in edible black ink on both the body and cap. 4 CLINICAL PARTICULARS 4.1 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 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. Macrodantin is not indicated for the treatment of associated renal cortical or perinephric abscesses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION See precautions and warnings section for risks associated with long-term therapy ADULTS AND CHILDREN OVER TEN YEARS OF AGE The dose should be taken with food or milk (e.g. at meal times). Acute Uncomplicated Urinary Tract Infections: 50 mg four times daily for seven days. Severe chronic recurrent infections: 100 mg four times daily for seven days. In the event of severe nausea the dose may be reduced, but not below the adult equivalent of 200 mg/day. Should nausea persist the drug should be withdrawn. Long term suppressive therapy: 50-100 mg once a day at bedt Read the complete document