Country: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitrofurantoin
Mercury Pharma Group Ltd
J01XE01
Nitrofurantoin
5mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011300
OBJECT 1 FURADANTIN 25MG/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 16-Apr-2018 | Concordia International - formerly AMCo 1. Name of the medicinal product Furadantin 25mg/5ml Oral Suspension OR Nitrofurantoin 25mg/5ml Oral Suspension 2. Qualitative and quantitative composition Contains 25mg Nitrofurantoin Ph. Eur. per 5ml Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. Pharmaceutical form An opaque yellow liquid with a lemon/apricot charateristic odour. 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. It is indicated in adults and children over 3 months of age. Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of _Escherichia coli_, _Enterococci_, _Staphylococci_, _Citrobacter_, _Klebsiella_ and _Enterobacter_. 4.2 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: 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 precaution and risks to elderly patients associated with long term therapy (see 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 4.3 Contraindications • Hypersensitivity to nitrofurantoin সম্পূর্ণ নথি পড়ুন