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Lidocaine Hydrochloride 2% 40mg in 2ml (10 ampoules)

Lidocaine Hydrochloride 2% 40mg in 2ml (10 ampoules)

Generic

Prescription medicine
  • UK Licensed prescription Only medicine (POM) under MHRA regulation (specific licence details depend on the exact marketed brand and manufacturer)
  • Manufactured in accordance with Good Manufacturing Practice (GMP) for sterile injectable medicinal products
Local anaesthetic injection

Description

Lidocaine Hydrochloride 2% 40mg in 2ml is a prescription-only local anaesthetic injection containing lidocaine hydrochloride 20 mg/mL (40 mg in each 2 mL ampoule). It is supplied as 10 clear glass ampoules of sterile solution for intramuscular (IM), subcutaneous (SC), epidural, caudal, intravenous (IV) injection and IV infusion, for use by healthcare professionals. Lidocaine injection is indicated for local and regional anaesthesia, numbing a specific area to reduce pain and discomfort associated with invasive medical procedures such as needle punctures and minor surgical interventions, and is also used in some settings for the management of certain ventricular arrhythmias under specialist supervision.

Bnefits

  • Provides rapid-onset local anaesthesia to numb targeted areas of the body
  • Short-acting amide-type local anaesthetic suitable for a wide range of minor and intermediate procedures
  • 2% (20 mg/mL) concentration provides 40 mg per 2 mL ampoule, allowing flexible dosing by trained professionals
  • Can be used for local infiltration, nerve blocks, epidural and caudal anaesthesia, and in specific IV indications according to product guidance
  • Small 2 mL ampoules are convenient for procedures requiring modest volumes of anaesthetic
  • Well-established clinical profile with predictable onset and duration when used correctly
  • Generic formulation aligned with pharmacopoeial standards for lidocaine hydrochloride solution for injection

Indications

  • Local and regional anaesthesia by infiltration, peripheral nerve block, epidural and caudal routes for surgical, obstetric and diagnostic procedures, as described in the relevant Summary of Product Characteristics (SmPC)
  • Relief of pain associated with minor surgical or diagnostic procedures, including needle punctures and minor skin procedures, under appropriate medical supervision
  • Use in certain intravenous indications such as suppression of ventricular extrasystoles and ventricular tachycardia, particularly after acute myocardial infarction, where licensed and under specialist supervision
  • Use by trained healthcare professionals in hospitals, clinics, dental practices and approved aesthetic practice settings as part of local anaesthetic protocols

Composition

  • Active ingredient: Lidocaine hydrochloride 20 mg/mL (2% w/v); each 2 mL ampoule contains 40 mg lidocaine hydrochloride
  • Typical excipients: sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injections (exact excipients may vary slightly by manufacturer and are specified in the individual product SmPC)

Formulation

  • Sterile, clear, colourless aqueous solution for injection/infusion
  • Concentration: 20 mg/mL (2% w/v) lidocaine hydrochloride
  • Presentation: 2 mL clear glass ampoules
  • Pharmaceutical form: solution for injection and infusion for parenteral use by healthcare professionals only

Packaging

  • Carton containing 10 x 2 mL glass ampoules of lidocaine hydrochloride 2% solution for injection
  • Each ampoule labelled with drug name, strength, volume, batch number and expiry date
  • Outer carton printed with product name, concentration, batch and expiry details, route of administration, storage conditions and regulatory information

Usage

  • For use only by suitably trained and qualified healthcare professionals familiar with local anaesthetic agents, their dosing, indications, contraindications and management of potential complications.
  • Select dose, route and administration technique (e.g. local infiltration, peripheral nerve block, epidural, caudal, IV injection or infusion) according to the specific procedure, patient age, weight, clinical status and the detailed recommendations in the relevant SmPC for the chosen licensed product.
  • Before administration, visually inspect the solution; only clear, colourless solutions free from visible particles should be used, and ampoules must be intact.
  • Aspirate carefully before and during injection when performing regional blocks or infiltration to reduce the risk of inadvertent intravascular administration.
  • Use the lowest dose that achieves effective anaesthesia, adhering strictly to maximum recommended total doses for lidocaine, which depend on route, use with or without vasoconstrictor and patient factors.
  • Monitor cardiovascular and respiratory status during and after administration, ensuring that resuscitation equipment and emergency medicines are immediately available.
  • Discard any unused portion from an opened ampoule; the product is for single use only and must not be stored once opened.
  • Do not mix lidocaine with other medicinal products in the same syringe or infusion solution unless compatibility has been established in the specific product information.

Contraindications

  • Hypersensitivity to lidocaine, other amide-type local anaesthetics or any of the excipients
  • Severe hypovolaemia, shock or significant conduction disturbances (e.g. severe sinoatrial, atrioventricular or intraventricular block) when lidocaine is to be given systemically, unless resuscitation facilities and specialist supervision are available
  • Complete heart block in the absence of a pacemaker when used systemically for antiarrhythmic purposes
  • Intravenous regional anaesthesia (Bier’s block) using preparations containing preservatives or where specifically contraindicated in the product SmPC
  • Epidural or caudal anaesthesia in patients with uncorrected hypovolaemia, coagulation disorders, raised intracranial pressure or infection at the injection site, except under expert supervision after risk–benefit assessment
  • Any additional contraindications or restrictions listed in the SmPC for the specific licensed product supplied should be observed

Adverse Effects

  • Dose-related central nervous system effects such as dizziness, circumoral numbness, tingling, tinnitus, blurred vision, metallic taste and tremor, particularly if plasma levels rise due to inadvertent intravascular injection or overdose
  • Severe CNS toxicity at high plasma concentrations, including agitation, confusion, convulsions, respiratory depression and, in extreme cases, respiratory arrest
  • Cardiovascular effects such as hypotension, bradycardia, conduction disturbances, arrhythmias and cardiovascular collapse in cases of systemic toxicity or overdose
  • Local injection-site reactions including pain, bruising, oedema or, rarely, tissue necrosis if inadvertently injected intra-arterially or if excessive volumes are used in confined spaces
  • Allergic or hypersensitivity reactions, ranging from skin rash and urticaria to bronchospasm and, rarely, anaphylaxis
  • Neurological complications related to regional techniques (for example nerve injury, prolonged sensory or motor block, epidural or spinal complications), which may reflect both the product and the procedure

Storage Conditions

  • Store in accordance with the instructions on the outer carton and ampoule label, typically below 25°C and protected from light.
  • Do not refrigerate or freeze unless specifically stated otherwise in the product information.
  • Keep ampoules in the outer carton until use to protect from light and physical damage.
  • Do not use after the expiry date printed on the packaging.
  • Use only clear, particle-free solutions in intact ampoules; discard any ampoule that is cracked, damaged or contains discoloured or particulate solution.
  • Keep out of the sight and reach of children.

Duration

Administered as single or repeated doses during a procedure or short treatment episode, as determined by the clinical indication and professional judgement. Duration of anaesthetic effect typically ranges from around 1 to several hours depending on dose, route and vascularity of the tissue, with repeat dosing governed by maximum recommended dose limits and appropriate monitoring.

Onset

Lidocaine injection generally produces local anaesthesia within a few minutes of administration, with rapid onset particularly when used for local infiltration or nerve block; onset and duration vary with route, dose and injection site.

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