Lidocaine 400mg/20ml (2%) solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lidocaine hydrochloride

Available from:

2%) solution for injection ampoules (Advanz Pharma

ATC code:

N01BB02

INN (International Name):

Lidocaine hydrochloride

Dosage:

20mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5099602320536

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 any of the side effects become serious, or if you notice any side
effects not listed
in this leaflet, please tell your doctor or pharmacist.
The product is referred as above but for ease it has been mentioned as
Lidocaine
hydrochloride throughout the leaflet.
In this leaflet:
1. What Lidocaine Hydrochloride is and what it is used for
2. Before you are given Lidocaine Hydrochloride
3. How Lidocaine Hydrochloride is given to you
4. Possible side effects
5. How to store Lidocaine Hydrochloride
6.Further information
1. WHAT LIDOCAINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Lidocaine Hydrochloride is a local anaesthetic and belongs to a class
of drugs called amide
type local anaesthetics. It produces loss of feeling or sensation
confined to one part of the body.
Lidocaine Hydrochloride Injection may be used to produce local
numbness (anaesthesia)
by injection of the solution into or around the area of operation. It
may also be used to
produce local anaesthesia by injection of the solution close to the
nerves whose conduction
is to be cut off, or into the epidural space near the spinal cord, or
by administering the
solution into a vein in a limb that has been isolated from the
circulation by means of a
tourniquet (bandage that stops the flow of blood from vessel by
applying pressure).
2. BEFORE YOU ARE GIVEN LIDOCAINE HYDROCHLORIDE
YOU SHOULD NOT BE GIVEN THIS MEDICINE:
• if you know you are allergic to lidocaine hydrochloride, to any of
the other ingredients
(see Section 6 of this leaflet) or to other similar amide type
anaesthetics
• if you suffer from state of decreased blood volume (hypovolaemia)
• if you suffer from abnormality of impulse propagation in the heart
causing decreased
bloo

Summary of Product characteristics

OBJECT 1
LIDOCAINE HYDROCHLORIDE 2% W/V SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 18-Sep-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Lidocaine Hydrochloride Injection BP 2% w/v.
2. Qualitative and quantitative composition
Each 1ml of solution contains 20mg of Lidocaine Hydrochloride.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Lidocaine is a local anaesthetic of the amide group. Lidocaine
Hydrochloride Injection BP is for use in
infiltration anaesthesia, intravenous regional anaesthesia and nerve
blocks.
4.2 Posology and method of administration
The method of administration of lidocaine varies according to the
procedure (infiltration anaesthesia,
intravenous regional anaesthesia or nerve block).
The dosage should be adjusted according to the response of the patient
and the site of administration. The
lowest concentration and smallest dose producing the required effect
should be given.
The maximum dose for healthy adults should not exceed 200 mg [or 500mg
if given in solutions
containing adrenaline (epinephrine)].
Children and elderly or debilitated patients require smaller doses,
commensurate with age & physical
status.
4.3 Contraindications
Known hypersensitivity to anaesthetics of the amide type; hypovolemia;
complete heart block.
Solutions containing adrenaline (epinephrine) should not be used in
areas of the body supplied by end
arteries or otherwise having a compromised blood supply such as
digits, nose, ear or penis. Solutions
containing adrenaline (epinephrine) should not be given intravenously.
4.4 Special warnings and precautions for use
Lidocaine should only be used by people with skills in resuscitation.
Facilities and equipment for resuscitation should be available when
administering local anaesthetics.
As with other local anaesthetics, lidocaine should be used with
caution in patients with epilepsy,
myasthenia gravis, congestive cardiac failure, bradycardia or
respiratory depression, inc