FUROSEMIDE-BAXTER furosemide (frusemide) 20 mg/2 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

furosemide, Quantity: 20 mg

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

furosemide (frusemide)

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; sodium chloride; hydrochloric acid

Administration route:

Intramuscular, Intravenous

Units in package:

25 x 2 mL ampoules, 5 x 2mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oedema: FUROSEMIDE-BAXTER Injection is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. Frusemide is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. FUROSEMIDE-BAXTER Injection is also indicated as adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset is desired. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, frusemide is indicated by the intravenous route. Parenteral use should be replaced with oral frusemide as soon as practical.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-04-03

Summary of Product characteristics

Furosemide- Baxter Furosemide (frusemide)
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AUSTRALIAN PRODUCT INFORMATION
FUROSEMIDE-BAXTER (FUROSEMIDE (FRUSEMIDE))
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Furosemide (Frusemide).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide (Frusemide) 20 mg/2 mL and 50 mg/5 mL solution for
injection.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection, for Intramuscular (I.M.) or Intravenous (I.V.)
use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oedema
Furosemide-Baxter Injection is indicated in adults, infants and
children for the treatment of
oedema associated with congestive heart failure, cirrhosis of the
liver and renal disease
including the nephrotic syndrome.
Furosemide (frusemide) is particularly useful when an agent with
greater diuretic potential
than that of those commonly employed is desired. Parenteral therapy
should be reserved for
patients unable to take oral medication or for patients in emergency
clinical situations.
Furosemide-Baxter Injection is also indicated as adjunctive therapy in
acute pulmonary
oedema
and cerebral oedema
where intense
and rapid
onset
of
diuresis
is desired. If
gastrointestinal absorption is impaired or oral medication is not
practical for any reason,
furosemide (frusemide) is indicated by the intravenous route.
Parenteral use should be replaced
with oral furosemide (frusemide) as soon as practical.
Furosemide- Baxter Furosemide (frusemide)
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4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS:
Parenteral therapy with Furosemide-Baxter injection should be used
only in patients unable to
take oral medication or in emergency situations and should be replaced
with oral therapy as
soon as practical.
Oedema:
The usual initial dose of Furosemide-Baxter is 20 to 40 mg given as a
single dose, injected
intramuscularly or intravenously. The intravenous dose should be given
slowly (see Section
4.4 Special warnings and precautions for use). Ordinarily
a
prompt
diuresis
ensues.
If
neede