Lidocaine Hydrochloride 2%

Sterile, Clear and Colorless Solution For Injection

Dosage Form

 50 ml multiple-dose with preservative (methylparaben)

Drug Classification and Categories

 Local anesthetic of amide type.

 Dosage and Administration

 In adult: The maximum individual dose should not exceed 4.5 mg/kg and in general it is recommended that the maximum total does not exceed 300 mg. In the elderly and children, the dose should be reduced. The concentration of 2% lidocaine vial is equal to 20 mg/ml. Only intradermal, subcutaneous, or submucosal injections are used.

Indications

Lidocaine injection solution is used as a local anesthetic.

Warnings

This product should not be used as an intravenous injection (IV), intramuscular injection (IM), intrathecal injection (spinal) and extracorporeal injection (epidural and caudal injection) due to its protective substance (methylparaben)

Side Effects

 Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by overdosage, rapid absorption, or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.

CNS manifestations are excitatory and/or depressant and may be characterized by the following signs and symptoms of escalating severity: circumoral paresthesia, light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, hyperacusis, tinnitus, blurred vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations (twitching, tremors and convulsions) may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, arrhythmia and cardiovascular collapse, which may lead to cardiac arrest. Allergic reactions are characterized by cutaneous lesions, urticaria, oedema in the most severe instances, anaphylactic shock.

Blood and the lymphatic system disorders: Methaemoglobinaemia.

Contraindications

•Known hypersensitivity to lidocaine or other anaesthetics of the amide type and hydroxybenzoates, complete heart block, hypovolemia, acute porphyria.

Pregnancy and Lactation

Pregnancy Category: B

Lactation: It is secreted in a small amount in milk, and the transfer to the baby through milk is very small.

Precautions

          •        Aspiration should be performed.

          •        Make sure the medicine is not injected into the arteries.

          •        Familial malignant hyperthermia has been reported in susceptible individuals following the use of certain amide anesthetic stimulants.

          •        Careful and constant monitoring of cardiovascular and monitoring (adequacy of ventilation) vital sign and the patient’s state consciousness should be accomplished after each local anesthetic injection.

Drug Interactions

Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs.

Storage Conditions

Store below 30°C and protect from light. The solution is clear, colorless and free of suspended particles, otherwise it should be avoided.

Packaging

Each box contains 50 vials with a volume of 50 ml and leaflets.