Lidocaine 20mg/2ml (1%) solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lidocaine hydrochloride

Available from:

1%) solution for injection ampoules (hameln pharma Ltd

ATC code:

N01BB02

INN (International Name):

Lidocaine hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Epidural; Intravenous; Intramuscular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5016386001024

Patient Information leaflet

PATIENT INFORMATION LEAFLET
LIDOCAINE HYDROCHLORIDE INJECTION 1%
LIDOCAINE HYDROCHLORIDE
1.
What Lidocaine Hydrochloride Injection
1% is and what it is used for
Lidocaine Hydrochloride Injection 1% is a local
anaesthetic. It is used to:
•
produce local anaesthesia (numb a specific
area) and
STOP PAIN BEING FELT
in the area of
the body where it is administered.
•
control fast or abnormal heart beats that you
might experience after a
HEART ATTACK.
2.
What you need to know before you use
Lidocaine Hydrochloride Injection 1%
DO
NOT
USE
LIDOCAINE
HYDROCHLORIDE
INJECTION 1%:
•
if you are
SENSITIVE OR ALLERGIC
to Lidocaine
Hydrochloride or any of the other ingredients in
this injection (listed in section 6). Tell your doctor
if you ever had an
ALLERGIC
or
BAD REACTION
,
for example, skin rash or breathlessness, to
ANY LOCAL ANAESTHETIC
medicines.
•
if
you
have
certain
HEART
disorders.
Tell
your doctor if you have any heart problems
particularly where your heart may pump blood
less efficiently, may beat irregularly, or may
beat more slowly.
•
if you suffer from a state of decreased blood
volume (hypovolaemia)
•
if you suffer from
PORPHYRIA
– a disorder of
the blood. Tell your doctor if you have any
blood disorders.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE
BEFORE
USING
LIDOCAINE
HYDROCHLORIDE
INJECTION 1%:
•
if you suffer from a
HEART
or a
BREATHING
disorder.
•
if you have
KIDNEY
or
LIVER
disease.
•
if you are feeling
UNWELL
or
RUN DOWN
for any
reason.
•
if you suffer from
EPILEPSY
or have
FITS
.
•
if you have
MYASTHENIA GRAVIS
(a condition
causing weakness of your muscles).
•
if you are in
SHOCK
.
•
if
you
have
a
BLOOD
DISORDER
or
an
IMBALANCE
in
the
CONSTITUENTS
of
your
BLOOD
.
•
if you have
INFLAMMATION
or
INFECTION
in the
AREA
to be injected.
OTHER
MEDICINES
AND
LIDOCAINE
HYDROCHLORIDE INJECTION 1%:
Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any
other medicines, including medicines obtained
without a prescription. Th

Summary of Product characteristics

OBJECT 1
LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V
Summary of Product Characteristics Updated 26-May-2015 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Lidocaine Hydrochloride Injection BP 1% w/v.
2. Qualitative and quantitative composition
Each 1 ml contains 10.0 mg of lidocaine hydrochloride, corresponding
to 8.1 mg lidocaine
Each 2 ml solution contains 20 mg Lidocaine Hydrochloride E.P.
Each 5 ml solution contains 50 mg Lidocaine Hydrochloride E.P.
Each 10 ml solution contains 100 mg Lidocaine Hydrochloride E.P.
Each 20 ml solution contains 200 mg Lidocaine Hydrochloride E.P.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Suppression of ventricular extrasystoles and ventricular tachycardia,
especially after an acute myocardial
infarction.
Local anaesthesia by surface infiltration, regional, epidural and
caudal routes, dental anaesthesia, either
alone or in combination with adrenaline.
Lidocaine may also be administered by subcutaneous, intramuscular or
intravenous injection.
Not intended for use in the eye.
4.2 Posology and method of administration
IN VENTRICULAR ARRHYTHMIAS
The usual adult IV bolus dose is 50-100 mg administered at a rate of
approximately 25-50 mg per minute.
If the desired response is not achieved, a second dose may be
administered 5 minutes after completion of
the first injection. Not more than 200-300 mg should be administered
during a one hour period. Elderly
patients and those with congestive heart failure or cardiogenic shock
may require smaller bolus doses.
Maintenance infusion of a 0.2 or 0.4% solution in 5% glucose.
Adults: 20-50 micrograms/kg/minute (1-4 mg/minute in an average 70 kg
adult).
Slower infusion rates should be used in patients with congestive heart
failure or liver disease; no dosing
modification appears necessary in patients with renal failure. When
arrhythmias reappear during a
constant infusion of Lidocaine, a small bol