EPHEDRINE HYDROCHLORIDE AGUETTANT 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:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: citric acid monohydrate; water for injections; sodium chloride; dilute hydrochloric acid; sodium hydroxide; sodium citrate

Administration route:

Intravenous

Units in package:

10 pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypotension secondary to spinal anaesthesia

Product summary:

Visual Identification: A clear and colourless, isotonic, sterile and pyrogen free solution in packs of 10; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-03-23

Patient Information leaflet

Page 1
EPHEDRINE HYDROCHLORIDE AGUETTANT
_Ephedrine Hydrochloride solution for injection, 30 mg/10 mL_
_ _
_ _
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
Ephedrine Hydrochloride
Aguettant. 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 Hydrochloride
Aguettant 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
HYDROCHLORIDE
AGUETTANT INJECTION IS
USED FOR
Ephedrine Hydrochloride
Aguettant 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 Hydrochloride
Aguettant is available only with a
doctor’s prescription.
Ephedrine Hydrochloride
Aguettant is not approved for use
in children.
BEFORE YOU ARE GIVEN
EPHEDRINE
HYDROCHLORIDE
AGUETTANT INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT_
_ _
YOU SHOULD NOT BE GIVEN
EPHEDRINE HYDROCHLORIDE
AGUETTANT 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
conditio

Summary of Product characteristics

Australian Product Information
Page | 1
EPHEDRINE HYDROCHLORIDE AGUETTANT
SOLUTION FOR INJECTION
_ _
_ (EPHEDRINE HYDROCHLORIDE) _
_ _
PRODUCT INFORMATION
1 NAME OF THE MEDICINE
Ephedrine Hydrochloride Aguettant contains ephedrine hydrochloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine Hydrochloride Aguettant is a sterile solution of ephedrine
hydrochloride in water for
injections. Each 10 mL contains 30 mg of ephedrine hydrochloride
(equivalent to 24.6 mg
ephedrine), sodium chloride, citric acid monohydrate, and sodium
citrate in Water for Injections.
The pH is 4.0 – 5.5.
Ephedrine Hydrochloride Aguettant contains no preservative and is for
single use in one patient
on one occasion only. Discard any remaining residue.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Ephedrine hydrochloride 30mg/10mL solution for injection polypropylene
ampoule
Ephedrine hydrochloride 30mg/10mL solution for injection polypropylene
syringe
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ephedrine Hydrochloride Aguettant is indicated in the treatment of
hypotension secondary to
spinal anaesthesia
4.2 DOSE AND METHOD OF ADMINISTRATION
Ephedrine Hydrochloride Aguettant is not approved for use in children
(see SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
The injection should be given slowly. Care should be taken to avoid
extravasation, since this
may result in tissue necrosis and sloughing. Ephedrine hydrochloride
should be administered
in the lowest effective dose.
The 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
hypertensiv