Furosemide Pinewood 20 mg Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Furosemide

제공처:

Pinewood Laboratories Ltd

ATC 코드:

C03CA01

INN (국제 이름):

Furosemide

약제 형태:

Tablet

치료 영역:

furosemide

승인 상태:

Not marketed

승인 날짜:

2023-10-20

제품 특성 요약

Health Products Regulatory Authority
20 October 2023
CRN00CQ58
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide Pinewood 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide Pinewood 20 mg Tablets each contain 20 mg Furosemide.
Excipient with known effect
Each tablet contains 52.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white, round tablets, (6.00mm±0.2mm) marked F 20 on one
side & plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Furosemide Pinewood 20 mg Tablets is used for the management of fluid
retention and for the management of mild to
moderate hypertension, either alone or as an adjunct.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_General_
The dose used must be the lowest that is sufficient to achieve the
desired effect.
Furosemide Pinewood 20 mg Tablets has an exceptionally wide
therapeutic range, the effect being proportional to the dosage.
Furosemide Pinewood 20 mg Tablets is best given as a single dose
either daily or on alternate days.
The usual initial daily dose is 40 mg. This may require adjustment
until the effective dose is achieved as a maintenance dose. In
mild cases, 20 mg daily or 40 mg on alternate days may be sufficient,
whereas in cases of resistant oedema, daily doses of 80
mg and above may be used as one or two doses daily, or intermittently.
Severe cases may require gradual titration of the
furosemide dosage up to 600 mg daily. The recommended maximum daily
dose of furosemide administration is 1500 mg.
_ _
_Children_
Oral doses for children range from 1 to 3 mg/kg body weight daily up
to a maximum total dose of 40 mg/day.
_ _
_Elderly_
The dosage recommendations for adults apply, but in the elderly
furosemide is eliminated more slowly in general.
Dosage should be titrated until the required response is achieved.
4.3 CONTRAINDICATIONS
Patients with hypovolaemia or dehydration, anuria or renal failure
with anuria not responding to furo