Lidocaine Hydrochloride 2% w/v Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LIDOCAINE HYDROCHLORIDE

Available from:

Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC code:

N01BB02

INN (International Name):

LIDOCAINE HYDROCHLORIDE 2 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

LIDOCAINE HYDROCHLORIDE 2 mg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Withdrawn

Authorization date:

2006-12-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIDOCAINE HYDROCHLORIDE 0.5% W/V SOLUTION FOR INJECTION
LIDOCAINE HYDROCHLORIDE 1% W/V SOLUTION FOR INJECTION
LIDOCAINE HYDROCHLORIDE 2% W/V SOLUTION FOR INJECTION
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, pharmacist 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, pharmacist or
nurse. This includes any possible
side effects not listed in this leafleat. See section 4.
The product is referred as above but for ease it has been mentioned as
Lidocaine hydrochloride
throughout the leaflet.
WHAT IS IN THIS LEAFLET
1. What Lidocaine Hydrochloride is and what it is used for
2. What you need to know 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. Contents of the pack and other information. WHAT LIDOCAINE
HYDROCHLORIDE IS AND
WHAT IT IS USED FOR
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 L

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lidocaine Hydrochloride 2% w/v Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 2.0% w/v of Lidocaine Hydrochloride B.P.
Excipient(s) with known effect
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for Injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lidocaine is a local anaesthetic of the amide group. The injectable
form has a
wide range of applications for nerve blockade. It can be used by
percutaneous
infiltration; to block a major nerve plexus such as the brachial; for
epidural
anaesthesia; for intravenous regional analgesia.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
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 200mg.
Children
and
elderly
or
debilitated
patients
require
smaller
doses,
commensurate with age and physical status.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to anaesthetics of the amide
type or to
any of the excipients listed in section 6.1.
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Lidocaine is contraindicated in patients with:
-
Complete heart block
-
Hypovolaemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lidocaine should be administered by persons with resuscitative skills
and
equipment. Facilities for resuscitation should be available when
administering
local anaesthetics.
It should be used with caution in patients with myasthenia gravis,
epilepsy,
congestive
heart
failure,
bradycardia
or
respiratory
depression,
including
where agents are known to interact with Lidocaine either to increase
its
availability or additive effects e.g. phenytoin or prolong its
elimination e.g.
hepatic or end renal insufficiency where the metabolites of Lidocaine
may
accumulate.
Intramuscular
Lidocaine
may
increase
creatinine
phosphokinase
concentration