Esracain 1%, 2%

/ Rafa

Single Intravenous Injection (Bolus Injection): The usual dose is 50-100mg administered INTRAVENOUSLY, under ECG monitoring, at a rate of approximately 20-50mg/min. Sufficient time should be allowed to enable a slow circulation to carry the drug to its site of action. If the above initial injection of 50-100mg does not produce a desired response, a second dose may be repeated after 5 minutes. NOTE: No more than 200-300mg of lidocaine hydrochloride should be administered during a onehour period.
Continuous Intravenus Infusion: The I.V. bolus is only used to establish rapid therapeutic levels. A I.V. continuous infusion is used to maintain therapeutic levels. An infusion solution should be prepared using 5% dextrose in water. This solution is stable for a minimum of 24 hours at room temperature. For full details see prescribing information.

Local or regional anesthesia.

Known history of hypersensitivity to local anesthetics of the amide type. Patients with myasthenia gravis, severe shock or impaired cardiac conduction. By any route when the area or site of injection is infected or inflamed. Patients with skin infections anywhere on the body. Contraindications to epidural (including caudal) anesthesia include serious diseases of the CNS or of the spinal cord such as meningitis, spinal fluid block, cranial or spinal hemorrhage, tumors, poliomyelitis, syphilis and tuberculosis. Spinal deformities, arteriosclerosis, occlusive arterial disease, pernicious anemia with spinal cord involvement, severe anemia, cachexia or moribund condition, septicemia, bowel obstruction, chronic backache, preoperative headaches of long duration or history of migraine, high or low blood pressure and emotional instability, hysteria or nervous tension.

Pregnancy: Should not be used during early pregnancy unless the potential benefits outweigh the unknown hazards, including the use of this drug at term for obstetrical analgesia. Labor and delivery: Local anesthetics rapidly cross the placenta and can cause maternal, fetal and neonatal toxicity. Potential for toxicity depends upon procedure performed, type and amount of drug used, and technique of drug administration. Material hypotension has resulted from regional anesthesia. Continuous fetal heart rate and electronic fetal monitoring are highly advisable. The physician should weigh the possible advantages against risks when considering a paracervical block in prematurity, toxemia of pregnancy and fetal distress. Careful adherence to recommended dosage is of utmost importance. Lactation: Caution should be exercised when administered to a nursing woman. To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. Pediatrics: Dosage in children should be reduced according to age, body weight and physical conditions. In caudal or lumbar epidural blocks, occasional unintentional penetration of the subarchnoid space by the catheter may occur. The lowest effective dosage should be used. Careful and constant monitoring of CVS and respiratory (adequacy of ventilation) vital signs and the patient? state of consciousness should be accomplished after each local anesthetic injection. Patients with digitalis toxicity accompanied by atrioventricular block. Debilitated, elderly patients. Epidural anesthesia and caudal anesthesia should be used with extreme caution in conditions such as those existing in neurological disease, spinal deformities, septicemia, severe hypertension and in the extremely young. Patients with malignant hyperthermia. Use in the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.
See prescribing information for full details.

Most commonly reported: CNS: Lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, repiratory depression and arrest. Drowsiness, merging into unconsciousness and repiratory arrest. Cardiovascular system: Bradycardia, hypotension and cardiovascular collapse, which may lead to cardiac arrest. Allergic: Allergic reactions are extremely rare and characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Neurologic: Three percent for positional headaches, hypotension and backache, shivering; and less than one percent for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision.

Lidocaine/Anticonvulsants/or benzodiazepines/or barbiturates: May lower plasma levels of lidocaine when used concomitantly.
Lidocaine/Beta-adrenoreceptor blocking agents: Co-administration of beta-blockers may reduce the plasma clearance of lidocaine; possibly enhancing its toxicity.
Lidocaine/Cimetidine: Combined use results in increased plasma concentrations of lidocaine and, thus, enhanced toxicity.
Lidocaine/Disopyramide: Very high doses of lidocaine and disopyramide were reported, in one case to prolong the Q-T interval and to produce atrioventricular block and ventricular fibrillation.
Lidocaine/Muscle relaxants: The neuro-blocking effect of succinylcholine is increased by high I.V. doses of lidocaine.
Lidocaine/Phenytoin: Concurrent use yields a high incidence of CNS toxicity. Sino-atrial arrest occurred in one case with heart block when both drugs were given intravenously.
Lidocaine/Procainamide/Quinidine: Concurrent use is synergistic.
Lidocaine/Sympathomimetic Agents
Isoprenaline increases total body clearance of lidocaine. Noradrenaline has the opposite effect.
Diagnostic Interference
Because IM injection of lidocaine may increase serum creatinine phosphokinase (CPK) concentrations, isoenzyme separation is necessary when CPK determinations are used in the diagnosis of acute myocardial infarction in patients receiving the drug IM.

Pregnancy: Safe use has not been established. Lidocaine hydrochloride should not be used in women of childbearing potential, particularly during early pregnancy, unless, in the opinion of the clinician, the potential benefits outweigh the unknown hazards.
Use in Labor and Delivery: The effects on the mother and the fetus in the management of cardiac arrhythmias during labor and delivery are not known. Lidocaine hydrochloride readily crosses the placental barrier.
Lactation: It is not known whether this drug is excreted in human milk. However, because many drugs are
excreted in human milk, it is recommended that nursing be discontinued when lidocaine is indicated.
Use in Pediatrics: Safety of use of this drug in children has not been established.

Manifestations: Reactions due to overdose are systemic and involve the central nervous and cardiovascular
systems. Nervousness, dizziness, blurred vision or tremors may occur followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.Reactions involving the cardiovascular system include depression of the myocardium, hypotension, bradycardia and even cardiac arrest.
Treatment: In the treatment of CNS and cardiovascular reactions, general physiological supportive measures, such as maintenance of an adequate airway, oxygen uptake and carbon dioxide removal should be instituted immediately. Administration of oxygen and assisted respiration may be sufficient to control anoxia in patients with convulsions, and avoids the hazards associated with the administration of CNS depressant drugs. For control of severe convulsions, slow I.V. infusion of diazepam or an ultra-short or shortacting barbiturate has been recommended. If these are not available, a short-acting muscle relaxant (succinylcholine) together with oxygen may be used. If circulatory depression occurs, administer vasopressors and, if necessary, institute CPR.