Lidocaine 4% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lidocaine

Available from:

Colorama Pharmaceuticals Ltd

INN (International Name):

Lidocaine

Dosage:

40mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100

Patient Information leaflet

LFxxxxxx_V11_F
1. What LMX4 is and what it is used for
2. What you need to know before you use LMX4
3. How to use LMX4
4. Possible side effects
5. How to store LMX4
6. Contents of the pack and other information
DOSAGE AND HOW TO APPLY LMX4 TO
PROVIDE PAIN RELIEF WHEN INSERTING A
NEEDLE INTO THE SKIN AND A VEIN:
1g of cream is approximately equal to a 5cm
length of cream squeezed from the 5g tube
or 3.5cm squeezed from the 30g tube.
ADULTS, INCLUDING THE ELDERLY, AND CHILDREN
OVER 1 YEAR OF AGE:
1g to 2.5g of cream, to cover an area of skin
2.5cm x 2.5cm (1”x1”) where the needle will
be inserted. Do not leave on the skin for
longer than 5 hours.
INFANTS OVER 3 MONTHS BUT BELOW
1 YEAR OF AGE:
No more than 1g of cream should be
applied. Do not leave on the skin for longer
than 4 hours.
INFANTS OVER 1 MONTH BUT BELOW
3 MONTHS OF AGE: No more than 1g of cream
should be applied. Do not leave on the skin
for longer than 1 hour.
DO NOT USE ON INFANTS BELOW ONE
MONTH OLD.
1. Apply LMX4 at least 30 minutes before
the procedure starts.
2. Using the quantity stated above, apply the
cream in a uniform layer to the skin.
3. If told to do so, cover the cream with a
dressing, to prevent it being accidentally
rubbed off the skin.
4. Shortly before the procedure is due to
begin, remove the dressing and remove
the cream thoroughly with a gauze swab.
DOSAGE AND HOW TO APPLY LMX4 TO
PROVIDE ANAESTHESIA PRIOR TO
ADMINISTRATION FOR PAINFUL TOPICAL
TREATMENTS ON LARGER SURFACE AREAS OF
INTACT SKIN:
1g of cream is approximately equal to a 5cm
length of cream squeezed from the 5g tube
or 3.5cm squeezed from the 30g tube.
ADULTS AND THE ELDERLY AGED 18 YEARS
AND OVER:
Use 1.5g to 2g on each 10cm
2
area of skin,
to cover a maximum total area of 900cm
2
(approximately equal to a back or thigh).
Do not exceed the recommended dose.
1. Apply LMX4 approximately 30 to 60
minutes before the procedure starts.
2. Using the quantities stated above, apply
the cream in a uniform layer to the skin.
3. Ensure the cream is not accidentally
rubbed off

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
LMX 4
Lidocaine 4%w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine 4%w/w
Excipient with known effect:
1 gram of cream contains 75mg of propylene glycol.
1 gram of cream contains 15mg of benzyl alcohol.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream
A white to off-white yellowish cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local anaesthetic for topical use to produce surface anaesthesia of
the skin
prior to:
-
venous cannulation or venipuncture
-
administration of painful topical treatments on larger surface areas
of
intact skin where use of a topical anaesthetic is appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
Venous cannulation or venipuncture:
Adults, including elderly, and children over one month of age:
Apply 1g to 2.5g of cream onto the skin to cover a 2.5cm x 2.5cm
(6.25cm2) area
where venous cannulation or venipuncture will occur. No more than 1g
of cream
should be applied to infants below the age of 1 year. 1g of cream
equates to
approximately 5cm of cream squeezed from the 5g tube, or 3.5cm from
the 30g tube.
The cream should remain undisturbed and the area can be covered with
an occlusive
dressing to prevent disturbance or interference by the patient or
other external factors.
Adequate anaesthesia should be obtained after 30 minutes, but the LMX4
Cream may
be applied for up to 5 hours under a dressing. Prior to starting the
procedure, the
LMX4 Cream should be removed using a clean gauze swab and the site for
venous
cannulation or venipuncture prepared in the usual manner. The
procedure should be
initiated shortly after the cream has been removed. Maximum
application time for 1
month up to 3 month infant should not exceed 60 minutes. Maximum
application time
for 3 month up to 12 month infant should not exceed 4 hours. Maximum
application
for 12 month infant – adult should not exceed 5 hours.
LMX4 is not recommended for use in infants under one mon