ESMOLOL HYDROCHLORIDE MEDSURGE esmolol hydrochloride 100 mg/10 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esmolol hydrochloride, Quantity: 100 mg

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

20 x 10mL vials, 25 x 10mL vials, 5 x 10mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Esmolol Hydrochloride Medsurge is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol Hydrochloride Medsurge is also indicated in non-compensatory sinus tachycardia where, in the physician?s judgement, the rapid heart rate requires specific intervention. Esmolol Hydrochloride Medsurge is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

Product summary:

Visual Identification: A clear, colourless to light yellow, sterile, nonpyrogenic solution. Practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-05-04

Patient Information leaflet

Esmolol Hydrochloride Medsurge
1
ESMOLOL HYDROCHLORIDE MEDSURGE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ESMOLOL HYDROCHLORIDE MEDSURGE?
Esmolol Hydrochloride Medsurge contains the active ingredient esmolol
hydrochloride. Esmolol Hydrochloride Injection is
used as a short-term treatment for irregular heartbeat before, during
or after surgery. It is also used in emergency situations. For
more information, see Section 1. Why am I using Esmolol Hydrochloride
Medsurge? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ESMOLOL HYDROCHLORIDE MEDSURGE?
Do not use if you have ever had an allergic reaction to esmolol
hydrochloride or any of the ingredients listed at the end of this
leaflet.
TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OTHER MEDICAL CONDITIONS,
ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Esmolol Hydrochloride Medsurge? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Esmolol Hydrochloride Medsurge and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ESMOLOL HYDROCHLORIDE MEDSURGE?
Esmolol Hydrochloride Medsurge is given as a slow injection into a
vein by a doctor or nurse. Your doctor will decide what
dose and how long you will receive Esmolol Hydrochloride Medsurge
Injection. This depends on your condition and other
factors, such as your weight.
More instructions can be found in Section 4. How do I use Esmolol
Hydrochloride Medsurge? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ESMOLOL HYDROCHLORIDE MEDSURGE?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicines, remind your
doctor or pharmacist that you have
recently been given Esmolol Hydrochloride Injection.
•
If you are being treated for diabetes, make sure you

Summary of Product characteristics

ESMOLOL HYDROCHLORIDE
MEDSURGE
Esmolol Hydrochloride Medsurge PI v1.0
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
ESMOLOL HYDROCHLORIDE MEDSURGE (ESMOLOL HYDROCHLORIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Esmolol Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esmolol Hydrochloride Medsurge Injection is supplied as 100 mg/10 mL
vial containing 100 mg
esmolol hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
100 MG/ 10 ML VIAL:
Esmolol Hydrochloride Medsurge Injection is a clear, colourless to
light yellow, sterile,
nonpyrogenic solution of esmolol hydrochloride for intravenous
infusion. The single dose
vial has a pH range of 4.5 to 5.5.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SUPRAVENTRICULAR TACHYCARDIA
Esmolol Hydrochloride Medsurge is indicated for the rapid control of
ventricular rate in
patients with atrial fibrillation or atrial flutter in perioperative,
postoperative, or other
emergent circumstances where short term control of ventricular rate
with a short-acting agent
is desirable. Esmolol Hydrochloride Medsurge is also indicated in
non-compensatory sinus
tachycardia
where,
in
the
physician’s judgement, the rapid heart rate requires specific
intervention. Esmolol Hydrochloride Medsurge is not intended for use
in chronic settings where
transfer to another agent is anticipated or for treatment periods
greater than 24 hours duration.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Note: _
Parenteral drug products should be inspected visually prior to
administration. Any
solutions which contain visible particulate matter or are hazy or
discoloured should not be
used. Product is for single use in one patient only. Discard any
residue.
ESMOLOL HYDROCHLORIDE MEDSURGE IS AVAILABLE AS A 100 MG/10 ML SOLUTION
FOR INJECTION
VIAL. ESMOLOL HYDROCHLORIDE POWDER FOR INJECTION IS AVAILABLE IN
ANOTHER BRAND (FOR
MAINTENANCE
INFUSION
DOSING
ONLY).
IF
USING
THE
ESMOLOL
HYDROCHLORIDE
POWDER
OF
INJECTION,
REFER
TO
THE
SPECIFIC
PRODUCT
INFORMATION
F