MACRODANTIN Capsules Hard 100 Milligram
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
24-05-2024
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Ingredient activ:
NITROFURANTOIN
Disponibil de la:
PCO Manufacturing
Dozare:
100 Milligram
Forma farmaceutică:
Capsules Hard
Data de autorizare:
2009-08-28
Caracteristicilor produsului
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withdrawn.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
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