LASIX HIGH DOSE furosemide (frusemide) 250 mg/25 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

furosemide, Quantity: 10 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; mannitol; sodium hydroxide

Administration route:

Intravenous

Units in package:

5x25mL, 6x25mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Frusemide high dosage formulations are intended exclusively for patients with severely impaired renal function. Use under strict medical supervision only within a hospital setting (see Dosage and Administration). High doses of frusemide may be used as an adjuvant treatment of oliguria and in the promotion of diuresis in the treatment of oedema; in selected patients with acute renal failure, e.g. in the post-operative phase and in association with septic infections; in selected patients with chronic renal failure with fluid retention, both in the pre-dialysis phase and when dialysis has become unavoidable, especially in the presence of acute pulmonary oedema; in selected patients with the nephrotic syndrome with severe impairment of renal function, e.g. in chronic glomerular nephritis, lupus erythematosus and Kimmelstiel-Wilson syndrome. If diuresis is less than 2.5 L/day, dialysis has to be used.

Product summary:

Visual Identification: Clear, not more opalescent than ref. sol. 1 (Ph.Eur.), practically free of particles, not more intensely coloured than reference solution B7; Container Type: Ampoule; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-01

Patient Information leaflet

LASIX® AND LASIX® HIGH DOSE
1
LASIX
®
, LASIX
® M AND
LASIX
® HIGH DOSE
_Furosemide (Frusemide) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lasix oral medicines
(tablets, oral solution) and injections.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LASIX IS USED FOR
Lasix contains furosemide
(frusemide), which belongs to a
family of drugs called diuretics. A
diuretic helps reduce the amount of
excess fluid in the body by increasing
the amount of urine produced.
Lasix is used to treat swelling of the
ankles, feet, legs or even the brain or
lungs. This swelling is called oedema
and can occur in some heart, lung,
liver or kidney conditions.
Lasix may be used in some patients
with more serious kidney problems
who may have some fluid retention.
Lasix may also be used to lower high
blood pressure (which is also called
hypertension).
Everyone has blood pressure. This
pressure helps move your blood
around your body. Your blood
pressure may vary at different times
of the day, depending on how busy or
worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
If high blood pressure is not treated it
can lead to serious health problems,
including stroke, heart disease and
kidney failure.
Lasix may be taken alone or in
combination with other medicines to
treat your condition.
Your doctor may have prescribed
Lasix for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
This medi

Summary of Product characteristics

lasix-high-dose-ccdsv13-piv16-2jul20
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – LASIX
®
HIGH DOSE
(FUROSEMIDE (FRUSEMIDE))
1
NAME OF THE MEDICINE
Furosemide(frusemide)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lasix High Dose injection contains 250 mg/25 mL furosemide (frusemide)
in water for
injection (without solubiliser, pH about 9)
For the full list of excipients, see
Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Furosemide (frusemide) is a white to off-white odourless crystalline
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide (frusemide) high-dosage formulations are intended
exclusively for patients with
severely impaired renal function. Use under strict medical supervision
only within a hospital
setting (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION). High
doses of
furosemide (frusemide) may be used as an adjuvant treatment of
oliguria and in the
promotion of diuresis in the treatment of oedema; in selected patients
with acute renal failure
(e.g. in the post-operative phase and in association with septic
infections), in selected patients
with chronic renal failure with fluid retention, both in the
pre-dialysis phase and when
dialysis has become unavoidable, especially in the presence of acute
pulmonary oedema; and
in selected patients with the nephrotic syndrome with severe
impairment of renal function
(e.g. in chronic glomerular nephritis, lupus erythematous and
Kimmelstiel-Wilson
syndrome). If diuresis is less than 2.5 L/day, dialysis has to be
used.
4.2
DOSE AND METHOD OF ADMINISTRATION
The high dosage preparations are intended exclusively for
administration to patients with
greatly reduced glomerular filtration rate (GFR less than 20 mL/min
but greater than 5
mL/min). Normal doses of Lasix are usually adequate in patients with
greatly reduced GFR if
functional oliguria or anuria is observed. Thus, test a normal dose of
Lasix first, before
administering Lasix High Dose.
lasix-high-dose-ccdsv13-piv16-2jul20
Page 2 of 18
Furosemide (frusemide) is given intravenousl