LMX4 Lidocaine 4% w/w Cream 30g

LMX4

Topical Anaesthetic

Local Anaesthetic Cream

UK Marketing Authorisation PL 20685/0034 (LMX4 Lidocaine 4% w/w Cream).
Licensed medicine regulated by the UK MHRA.
Manufactured and controlled in accordance with EU/UK Good Manufacturing Practice (GMP) for medicinal products.

UK Marketing Authorisation PL 20685/0034 (LMX4 Lidocaine 4% w/w Cream).
Licensed medicine regulated by the UK MHRA.
Manufactured and controlled in accordance with EU/UK Good Manufacturing Practice (GMP) for medicinal products.

Local Anaesthetic Cream

Description

LMX4 is a prescription-strength topical anaesthetic cream containing 4% w/w lidocaine in a liposomal cream base. It is used to provide surface anaesthesia of intact skin prior to procedures such as venous cannulation, venipuncture and other painful topical treatments on larger areas of intact skin where the use of a local anaesthetic is appropriate.

Bnefits

Provides effective surface anaesthesia of intact skin prior to needle and other superficial procedures.
Contains 4% w/w lidocaine in a liposomal cream for reliable dermal analgesia.
Non-invasive alternative to injectable local anaesthetics for many minor procedures.
Fast onset of action, with adequate anaesthesia typically achieved after about 30 minutes of application.
Can be used on larger areas of intact skin in adults for painful topical treatments when used according to dosing guidance.
Available as a 30 g tube, allowing multiple applications in clinical and aesthetic practice.

Indications

Topical local anaesthesia of intact skin prior to venous cannulation.
Topical local anaesthesia prior to venipuncture or blood sampling.
Topical local anaesthesia prior to administration of painful topical treatments on larger areas of intact skin where a topical anaesthetic is appropriate.
Commonly used prior to aesthetic procedures involving needle insertion (e.g. dermal filler or toxin injections) in accordance with local protocols.

Composition

Lidocaine 4% w/w (40 mg/g) as the active local anaesthetic.
Propylene glycol 75 mg/g (excipient with known effect).
Benzyl alcohol 15 mg/g (excipient with known effect).
Carbomers.
Cholesterol.
Phospholipon 80H (hydrogenated soy lecithin).
Polysorbate 80 (Tween 80).
Trolamine.
Vitamin E acetate.
Purified water.

Formulation

Topical cream formulation.
White to off-white, yellowish liposomal cream.
Amide-type local anaesthetic (lidocaine) providing dermal analgesia by stabilising neuronal membranes.
Designed for use on intact skin only.

Packaging

30 g aluminium tube with internal lacquer, fitted with plastic cap, supplied in a carton.
Also authorised in 5 g tube presentations (not relevant to this specific 30 g product variant).

Usage

For cutaneous use on intact skin only.
For venous cannulation or venipuncture in adults, elderly and children over 1 month: apply approximately 1 g to 2.5 g of cream to cover an area of about 2.5 cm x 2.5 cm.
Apply in a uniform layer over the procedure site and, if required, cover with an occlusive dressing to prevent disturbance.
Allow approximately 30 minutes for adequate anaesthesia before starting the procedure; cream may remain under occlusion for up to 5 hours in adults if clinically indicated.
For painful topical treatments on larger areas of intact skin in adults: apply about 1.5–2 g LMX4 per 10 cm² of skin, up to a maximum treated area of about 900 cm², typically for 30–60 minutes.
Remove the cream with a clean gauze swab before the procedure and prepare the skin as usual.
Do not reapply more frequently than every 12 hours and do not exceed 2 applications in any 24-hour period.
Not recommended for use in infants under 1 month of age.
Avoid contact with eyes, mucous membranes, open wounds, blistered, raw or irritated skin.
Use with caution in patients with severe hepatic disease, acutely ill, debilitated or elderly patients, and when used with other lidocaine-containing products.

Contraindications

Hypersensitivity to lidocaine or other amide-type local anaesthetics.
Hypersensitivity to any of the excipients (including propylene glycol or benzyl alcohol).
Use on irritated, inflamed, blistered, raw or damaged skin.
Use on mucous membranes, open wounds or areas of atopic dermatitis (due to lack of clinical data).
Use in infants under 1 month of age.
Caution or avoidance in patients with severe hepatic disease or conditions that may increase systemic exposure to lidocaine.

Adverse Effects

Transient local skin reactions at the application site such as irritation, erythema, itching or rash.
Transient blanching followed by erythema at the application site.
Possible allergic reactions to lidocaine or excipients, including rare systemic hypersensitivity and anaphylactic reactions.
Corneal irritation in the event of accidental eye exposure.
Systemic toxicity with excessive dosing or absorption, with symptoms such as dizziness, drowsiness, blurred vision, difficulty breathing, tremor, chest pain or arrhythmia (overdose or misuse).

Storage Conditions

No special storage conditions required for the unopened product.
Shelf life unopened: 36 months.
Use within 6 months after first opening the tube.
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the packaging.

Duration

Single-application topical anaesthetic per procedure; cream may remain on intact skin for up to 5 hours under occlusion in adults, with a maximum of 2 applications in any 24-hour period.