PHENYLEPHRINE ACCORD phenylephrine hydrochloride 10 mg/1 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenylephrine hydrochloride, Quantity: 10 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous, Subcutaneous

Units in package:

10, 25

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anaesthesia, and as a vasoconstrictor in regional analgesia

Product summary:

Visual Identification: A clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-11-16

Patient Information leaflet

Version 1.0
Page 1 of 3
PHENYLEPHRINE ACCORD
_Phenylephrine Hydrochloride Injection 10 mg/1 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Phenylephrine Accord.
It does not contain all of 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
associated with giving you
Phenylephrine Accord against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, PHARMACIST OR NURSE.
Keep this leaflet while you are being
given Phenylephrine Accord. You may
need to read it again.
WHAT PHENYLEPHRINE
ACCORD IS USED FOR
Phenylephrine Accord is used to help
increase your blood pressure and slow
down your heart, for example, during
surgery or in states of shock. It does
this by causing constriction
(narrowing) of your blood vessels.
It belongs to a group of medicines
called vasoconstrictors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PHENYLEPHRINE
ACCORD HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is not addictive.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
PHENYLEPHRINE ACCORD
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
PHENYLEPHRINE ACCORD IF YOU ARE
ALLERGIC TO:
•
PHENYLEPHRINE
•
SODIUM METABISULFITE
•
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic reaction may
include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin.
You must not be given Phenylephrine
Accord if you have:
•
very high blood pressure.
•
a very fast heartbeat (palpitations)
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT. _
Tell your doctor if you have, or have
had, any medical conditions,

Summary of Product characteristics

Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
PHENYLEPHRINE ACCORD
(PHENYLEPHRINE HYDROCHLORIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Phenylephrine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of 1 mL contains 10 mg of phenylephrine hydrochloride.
EXCIPIENT WITH KNOWN EFFECT:
•
Sodium metabisulfite
For the full list of excipients,
SEE SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Solution for injection.
Phenylephrine Accord is a vasoconstrictor and pressor drug chemically
related to adrenaline and
ephedrine. Phenylephrine Accord is a clear, colourless, aqueous
solution, free from visible particulates,
in sterile form for parenteral injection.
Phenylephrine Accord contains no antimicrobial preservative.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Phenylephrine hydrochloride is intended for the maintenance of an
adequate level of blood pressure
during spinal and inhalation anaesthesia and for the treatment of
vascular failure in shock, shock-like
states, and drug-induced hypotension, or hypersensitivity. It is also
employed to overcome paroxysmal
supraventricular tachycardia, to prolong spinal anaesthesia, and as a
vasoconstrictor in regional
analgesia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
MILD OR MODERATE HYPOTENSION:
_Subcutaneously or Intramuscularly: _
Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose
should not exceed 5 mg.
_Intravenously: _
Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should
not exceed 0.5 mg.
Injections should not be repeated more often than every 10 to 15
minutes. A 5 mg intramuscular dose
should raise blood pressure for one to two hours. A 0.5 mg intravenous
dose should elevate the pressure
for about 15 minutes.
SEVERE HYPOTENSION AND SHOCK - INCLUDING MEDICINE-RELATED HYPOTENSION:
Blood volume depletion should always be corrected as fully as possible
before any vasopressor is
administered. When, as an emergency measure, intra-aortic pressures
must be maintained to prevent
cerebral or coronary arter