For Infiltration Nerve Block, Local and Spinal Anesthesia: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action.

For Ventricular Arrhythmias: The effects of lidocaine on the electrophysiological properties of mammalian Purkinje fibers have shown that Lidocaine attenuates phase 4 diagnostic depolarization, and causes a decrease or no change in excitability and membrane responsiveness. Lidocaine raises the ventricular fibrillation threshold.

Lidocaine has little or no effect on autonomic tone.

Lidocaine is included in some intramuscular injections, such as depot corticosteroids and antibacterials to prevent pain, itching, and other local irritation.

 

Lidocaine is rapidly metabolized by the liver, and less than 10% of a dose is excreted unchanged in the urine.

The elimination half-life of lidocaine following an intravenous bolus injection is typically1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that alters liver function, including changes in liver blood flow, which could result from severe congestive heart failure or shock, may alter lidocaine kinetics. Renal dysfunction does not affect lidocaine kinetics, but may increase the accumulation of metabolites.

Therapeutics effects of lidocaine are generally associated with plasma levels of 1.5 to 6 mcg free base per mL. Objective adverse manifestations become increasingly apparent with increasing plasma levels above 6 mcg free base per mL.

The plasma protein binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg free base per mL, 60 to 80 percent of lidocaine is protein bound. Lidocaine readily crosses the placental and blood-brain barriers.

 

LIDOCAINE  ELSaad Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal.

 

- Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

- Lidocaine should not be used in patients with Stoke - Adams syndrome, Wolff - Parkinson - White syndrome, bradycardia, or with severe degrees of sinoatrial, atrioventrcular, or intraventricular block in the absence of an artificial pacemaker.

- Lidocaine should not be used in patients with severe hemorrhage, shock or heart block, local infection at the site of proposed puncture for spinal anesthesia and septicemia.

 

Local anesthetic solution containing antimicrobial preservatives (e.g. methylparaben) should not be used for epidermal or spinal anesthesia because the safety of these agents as not been established with regard to intrathecal injection, either intentional or accidental.

 

- In order to manage possible adverse reactions, resuscitative equipment, oxygen and other resuscitative drugs should be immediately available when lidocaine hydrochloride injection is used. If circulatory depression occur, vasopressors may be used.

- To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected.

- General consideration should be given before administering lidocaine hydrochloride injection to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

- Lidocaine hydrochloride Injection should be used with particular caution in labor and delivery.

- Caution should be exercised when Lidocaine hydrochloride injection is administered to a nursing woman.

- Dosages in children and elderly should be reduced, commensurate with age, body weight and physical condition.

- Caution should be employed in the use of Lidocaine hydrochloride injection in patients with severe liver or kidney disease.

- Lidocaine hydrochloride injection should be used with caution in the treatment of patients with hypovolemia, severe congestive heart failure, shock, and all forms of heart block; In patients with sinus bradycardia. The administration of Lidocaine hydrochloride injection intravenously for the elimination of ventricular ectopic bests, without prior acceleration in heart rate (by atropine, isoproterenol or electric pacing), may promote more frequent and serious ventricular arrhythmias or complete heart block.

- Lidocaine hydrochloride Injection should be used with caution in patients with malignant hypothermia, hypoxia and convulsions.

- The lowest dosage should be used to avoid high plasma levels and serious adverse effects. The following conditions may preclude the use of spinal anesthesia, depending upon the physician’s ability to deal with the complications:

   * Pre-existing diseases of the central nervous system.

   * Disturbance in blood morphology and/or anticoagulant therapy.

   * Extremes of age.

   * Chronic backache and preoperative headache.

   * Hypotension and hypertension.

   * Arthritis or spinal deformity.

   * Persistent paresthesias, persistent bloody tap.

   * Psychotic or uncooperative patients.

 

Lidocaine should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block.

Concomitant use of beta-blocking agents or cimetidine may reduce hepatic blood flow and thereby reduce Lidocaine clearance.

Lidocaine and tocainide are pharmacodynamically similar. The concomitant use of these two agents may cause an increased incidence of adverse reactions, including central nervous system adverse reactions such as seizure.

 

Central Nervous System: lightheadedness, nervousness, apprehension, euphoria, contusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.

Cardiovascular System: bradycardia, hypotension, and cardiovascular collapse.

Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.

 

The Table summarizes the recommended volumes and concentrations of LIDOCAINE ELSaad - Injection for various types of anesthetic procedures.

Recommended Dosages:

The dosages suggested in this table are for normal healthy adults (epinephrine-free solutions). When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated. These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the total dose of local anesthetic used.

The incidence of side effects with LIDOCAINE Injection is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected. For intravenous regional anesthesia, only the 50 mL of 0.5% single dose vial of LIDOCAINE Injection should be used.

For normal healthy adults, the individual maximum recommended dose of lidocaine hydrochloride without epinephrine should not exceed 300 mg per day.

For children over 3 years of age who have a normal body development, the maximum dose is determined by the weight. As a rule children receive up to 3 mg of LIDOCAINE Injection per body weight.

In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.

For Caesarean section and those deliveries requiring intrauterine manipulations, (75mg) is usually adequate.

Surgical Anesthesia: The dosage recommended for abdominal anesthesia is (75-100mg).

For continuous epidural or caudal anesthesia the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.

The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides. For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

LIDOCAINE Injection has been found to be chemically stable for 24 hours after dilution in 5% dextrose in water.

 

- LIDOCAINE ELSaad 0.5% - Injection: A pack of 1 multiple dose glass vial of 50 mL.  Each multiple dose glass vial (50 mL) contains Lidocaine HCl 250 mg.

- LIDOCAINE ELSaad 1% - Injection: A pack of 1 multiple dose glass vial of 50 mL.  Each multiple dose glass vial (50 mL) contains Lidocaine HCl 500 mg.

- LIDOCAINE ELSaad 2% - Injection: A pack of 1 multiple dose glass vial of 50 mL.  Each multiple dose glass vial (50 mL) contains Lidocaine HCl 1000 mg.

- LIDOCAINE ELSaad 0.5% - Injection: A pack of 1 single dose glass vial of 50 mL.  Each single dose glass vial (50 mL) contains Lidocaine HCl 250 mg.

- LIDOCAINE ELSaad 1% - Injection: A pack of 1 single dose glass vial of 50 mL.  Each single dose glass vial (50 mL) contains Lidocaine HCl 500 mg.

- LIDOCAINE ELSaad 1% - Injection: A pack of 5 or 25 glass ampoules of 2 mL. Each glass ampoule (2 mL) contains Lidocaine HCl 20 mg.

- LIDOCAINE ELSaad 2% - Injection: A pack of 5 or 25 glass ampoules of 2 mL. Each glass ampoule (2 mL) contains Lidocaine HCl 40 mg.

- LIDOCAINE ELSaad 1% - Injection: A pack of 5 or 105 plastic ampoules of 5 mL.  Each plastic ampoule (5 mL)  contains Lidocaine HCl 50mg.

 

Store LIDOCAINE ELSaad – Injection at temperature between (15-30)°C. Protect from light.