Furadantin 25mg/5ml oral suspension

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Nitrofurantoin

Sẵn có từ:

Mercury Pharma Group Ltd

Mã ATC:

J01XE01

INN (Tên quốc tế):

Nitrofurantoin

Liều dùng:

5mg/1ml

Dạng dược phẩm:

Oral suspension

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 05011300

Đặc tính sản phẩm

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