Esmolol hydrochloride 2.5g powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esmolol hydrochloride

Available from:

AOP Orphan Ltd

ATC code:

C07AB09

INN (International Name):

Esmolol hydrochloride

Dosage:

2.5gram

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 9120015450452

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESMOLOL HYDROCHLORIDE 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
Esmolol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ESMOLOL HYDROCHLORIDE is and what it is used for
2.
What you need to know before you use ESMOLOL HYDROCHLORIDE
3.
How to use ESMOLOL HYDROCHLORIDE
4.
Possible side effects
5.
How to store ESMOLOL HYDROCHLORIDE
6.
Contents of the pack and further information
1. WHAT ESMOLOL HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Esmolol belongs to the group of beta blockers these medicines slow
down the heart beat and reduce
blood pressure.
Esmolol is used for short term treatment if your heart beats too fast.
Esmolol is also used during or straight after surgery if your blood
pressure gets too high and/or your
heart beats too fast.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ESMOLOL HYDROCHLORIDE
DO NOT USE ESMOLOL HYDROCHLORIDE IF YOU
-
are allergic to esmolol hydrochloride or any of the other ingredients
of this medicine (listed in
section 6)
-
have a very slow heart beat
-
have a problem with the electrical messages that control your
heartbeat (a problem called “heart
block”).
-
have a serious heart failure
-
have a fast or alternating fast and slow heartbeat (a problem called
the “Sick Sinus” syndrome)
-
have a phaeochromocytoma not yet treated. (A phaeochromocytoma is a
condition of the adrenal
gland that may be accompanied by a sudden increase of blood pressure,
severe headache,
sweating and increased heartbeat)
-
have a problem with

Summary of Product characteristics

OBJECT 1
ESMOLOL HYDROCHLORIDE 2500 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 12-Feb-2018 | AOP Orphan
Pharmaceuticals AG
1. Name of the medicinal product
ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for
infusion
2. Qualitative and quantitative composition
A vial of 50 ml contains 2500 mg esmolol hydrochloride.
Each ml of reconstituted concentrate for solution for infusion
contains 50 mg esmolol hydrochloride (50
mg/ml).
Each ml of the diluted solution for infusion contains 10 mg esmolol
hydrochloride (10 mg/ml).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion
The powder is white to almost white.
4. Clinical particulars
4.1 Therapeutic indications
Esmolol hydrochloride is indicated for supraventricular tachycardia
(except for pre- excitation
syndromes), and for the rapid control of ventricular rate in patients
with atrial fibrillation or atrial flutter
in perioperative, postoperative, or other circumstances where
short-term control of the ventricular rate
with a short acting agent is desirable.
Esmolol hydrochloride is also indicated for tachycardia and
hypertension occurring in the perioperative
phase and non-compensatory sinus tachycardia where, in the physician's
judgement the rapid heart rate
requires specific intervention.
Esmolol hydrochloride is not intended for use in chronic settings.
4.2 Posology and method of administration
ESMOLOL HYDROCHLORIDE 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION MUST
NOT BE ADMINISTERED WITHOUT RECONSTITUTION/DILUTION.
The reconstituted/diluted solution for infusion must be used
immediately after opening (see sections 4.4
and 6).
The administration of incorrect reconstituted/diluted ESMOLOL
HYDROCHLORIDE may result in
death (see section 4.4).
POSOLOGY
SUPRAVENTRICULAR TACHYARRHYTHMIA
The dosage of esmolol should be titrated individually. A starting dose
is required, followed by a
maintenance dosage.
The effective dose