EPHEDRINE INTERPHARMA ephedrine hydrochloride 30 mg/10 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ephedrine hydrochloride, Quantity: 30 mg

Available from:

Interpharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium citrate; citric acid; water for injections

Administration route:

Intravenous

Units in package:

10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EPHEDRINE INTERPHARMA injection is indicated in the treatment of hypotension secondary to spinal anaesthesia.

Product summary:

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

Authorization status:

Registered

Authorization date:

2018-01-17

Patient Information leaflet

Ephedrine Wockhardt injection
Page 1
EPHEDRINE WOCKHARDT
_ephedrine hydrochloride, 30 mg/10 mL, solution for injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ephedrine Wockhardt. It does not
contain all the available
information.
It does not take the place of
talking to your doctor.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Ephedrine Wockhardt against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EPHEDRINE
WOCKHARDT INJECTION
IS USED FOR
Ephedrine Wockhardt is used to
treat the low blood pressure
which may occur during spinal
anaesthesia.
It works by contracting the blood
vessels in your limbs, so that
more blood is available for your
heart.
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.
Ephedrine Wockhardt is
available only with a doctor’s
prescription.
Ephedrine Wockhardt is not
approved for use in children.
BEFORE YOU ARE GIVEN
EPHEDRINE
WOCKHARDT INJECTION
_WHEN YOU MUST NOT GIVEN _
_IT_
YOU SHOULD NOT BE GIVEN
EPHEDRINE WOCKHARDT 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
THE FOLLOWING MEDICAL
CONDITIONS:
-
heart problems
-
pheochromocytoma (a
rare tumour of the
adrenal gland near the
kidney)
-
closed angle glaucoma
(a condition in which
there is a build up of
pressure in the eye)
-
mood/thought disorders
and were given
monoamine oxidase
(MAO) inhibitors in last
two weeks or about to
commence on this
group of medicines.
•
USING AN ANTIBIOTIC MEDICIN

Summary of Product characteristics

Version 2.0 18 January 2018
Page 1
AUSTRALIAN PRODUCT INFORMATION – EPHEDRINE
WOCKHARDT (EPHEDRINE HYDROCHLORIDE) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Ephedrine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL contains 30 mg of ephedrine hydrochloride (equivalent to
24.6 mg ephedrine).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Solution for injection.
Ephedrine Wockhardt injection is a clear and colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ephedrine Wockhardt injection is indicated in the treatment of
hypotension secondary to spinal
anaesthesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Ephedrine Wockhardt injection should be given as a slow intravenous
injection of 3 to 7.5 mg
(maximum 10 mg), repeated as needed every 3-4 min to a maximum of 30
mg.
A lack of efficacy after 30 mg should lead to reconsideration of the
choice of the therapeutic
agent.
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
pressure. In some
patients with very severe hypotension, maintenance of even lower blood
pressure may be
desirable if blood or fluid volume replacement has not been completed.
Version 2.0 18 January 2018
Page 2
_PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT _
There are no specific dosage recommendations for patients with renal
or hepatic impairment.
_PAEDIATRIC USE _
Ephedrine Wockhardt injection is not approved for use in children.
METHOD OF ADMINISTRATION
Ephedrine Wockhardt injection
DOES NOT REQUIRE DILUTION
prior to administration.
Ephedrine Wockhardt injection is administered by the intravenous
route. The injection should
be given slowly. Care should be taken to avoid extravasation, since
this may result in ti