DBL EPHEDRINE SULFATE 30mg/1mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ephedrine sulfate, Quantity: 30 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Subcutaneous, Intramuscular, Intravenous

Units in package:

5x30mg/1mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ephedrine is indicated in the treatment of shock unresponsive to fluid replacement. It is also indicated in the treatment of hypotension secondary to spinal anaesthesia. Ephedrine Sulfate Injection has also been used in the treatment of bronchial asthma and reversible bronchospasm although more selective agents (beta adrenergic agonists) are now available.

Product summary:

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

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™
Ephedrine Sulfate Injection CMI
Page 1
DBL™ EPHEDRINE SULFATE INJECTION
_ _
Ephedrine Sulfate_ (e-FED-rin SUL-fate)_
_ _
CONSUMER MEDICINE INFORMATION
_DATE OF DISPENSING_
_CONSUMER NAME _
_PHARMACIST NAME _
_CONSUMER ADDRESS _
_PHARMACIST ADDRESS _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Ephedrine Sulfate Injection. It
does not contain all the available
information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given DBL™
Ephedrine Sulfate
Injection against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE. You may need to read it
again.
WHAT DBL™
EPHEDRINE SULFATE
INJECTION IS USED FOR
DBL™
Ephedrine Sulfate
Injection is used to treat
bronchial asthma, reversible
spasm of the airways, and some
forms of shock. It is also used to
treat the low blood pressure
which may occur during spinal
anaesthesia.
It works by relaxing some of the
muscles in your airways,
stimulating your heart, and
contracting the blood vessels in
your limbs, so that more blood is
available for your brain, heart
and lungs.
_ _
Your doctor may have
prescribed this medicine for
another reason. Ask your doctor
if you have any questions about
why it has been prescribed for
you.
DBL™ Ephedrine Sulfate
Injection is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL™
EPHEDRINE
SULFATE INJECTION
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
DBL™
EPHEDRINE SULFATE
INJECTION IF:
•
YOU HAVE AN ALLERGY TO
EPHEDRINE OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET
Symptoms of an allergic
reaction to ephedrine may
include:
-
Shortness of breath,
wheezing or difficulty in
breathing
-
swelling of the face, lips,
tongue or other parts of
the body
-
rash, itching or hives on
the skin.
•
YOU HAVE, OR HAVE HAD ANY
OF

Summary of Product characteristics

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Supersedes: Version 6.0
Page 1 of 9
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
EPHEDRINE
SULFATE
INJECTION
(EPHEDRINE SULFATE)
1.
NAME OF THE MEDICINE
Ephedrine sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Ephedrine Sulfate Injection is a sterile solution of Ephedrine
Sulfate in Water for Injections.
Each mL contains 30 mg of Ephedrine Sulfate and 3 mg of Sodium
Chloride in Water for Injections
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL™ Ephedrine Sulfate is a clear colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™ Ephedrine Sulfate Injection is indicated in the treatment of
shock unresponsive to
fluid replacement. It is also indicated in the treatment of
hypotension secondary to spinal
anaesthesia. DBL™ Ephedrine Sulfate Injection has also been used in
the treatment of
bronchial
asthma
and
reversible
bronchospasm
although
more
selective
agents
(beta
adrenergic agonists) are now available.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
AS A PRESSOR:
_Adult dose:_
The usual adult dose is 25 to 50 mg (range 10 to 50 mg) administered
intramuscularly or subcutaneously. Additional doses should be based on
patient response.
The intravenous route may be used if an immediate response is
required. The dosage for the
intravenous route is 10 to 25 mg which may be repeated every 5 to 10
minute until the
desired response is obtained.
_Paediatric dose:_
The recommended paediatric dose is 3 mg/kg/day or 100 mg/m2/day via
the intravenous or subcutaneous route, given in 4 to 6 divided doses.
During therapy with a pressor agent, blood pressure should be elevated
to slightly less than
the patient’s normal blood pressure. In previously normotensive
patients, systolic blood
pressure should be maintained at 80 to 100 mmHg. In previously
hypertensive patients,
systolic blood pressure should be maintained at 30 to 40 mmHg below
their usual blood
Version: pfpephe10619
Supersedes: Version 6.0
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