Warnings :

Dental practitioners who employ local anaesthetic agents should be well versed in diagnosis and management of emergencies which may arise from their use.  Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. LIGNOSAPN SPECIAL should not be used in bronchial asthmatics with hypersensitivity to sulfites. The reaction may be characterized by vomiting, diarrhea, dyspnea, acute asthma attacks, disorientation or shock.

Do not inject into a blood vessel. Inject slowly:

To minimize the likelihood of intravascular injection, aspiration should be performed before the local anaesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided and a double aspiration is always recommended.

Local anaesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection. This product does not contain any preservatives.

Precautions:

- General:

The safety and effectiveness of lignocaine depend on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. The lowest dosage that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lignocaine may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient, debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical condition, (see Dosage and Administration).

Patients with peripheral vascular disease may exhibit exaggerated vasoconstrictor response. Cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be monitored after each local anaesthetic injection. Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness should alert the practitioner to the possibility of central nervous system toxicity. Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position : placing the patient in the recumbent position is recommended when an adverse response is noted after injection of a local anaesthetic. (See Adverse Reactions, Cardiovascular system).

Lignocaine should be used with caution in patients with hepatic disease, since amide-type local anaesthetics are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anaesthetics normally, are at greater risk of developing toxic plasma concentrations.

- Use during Pregnancy and Lactation:

Pregnancy: on the basis of long usage, anaesthetics of the lignocaine type are considered reasonably safe for use on pregnant women. However, the safe use of lignocaine has not been established with respect to possible effects upon foetal development and careful consideration should be given to this fact before administering the anaesthetic solution during early pregnancy.
Nursing mothers: It is not known whether this drug is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised when lignocaine is administered to a nursing woman.

- Use of the cartridge:

Use on one patient during one session of treatment only, if only part is used, the remainder must be discarded.

- Storage:

Store in a dry place, below 25°C. Each time cartridges are taken from the can, remember to replace the cardboard disc and the polyethylene cap to omit light and aid stability.

Overdose:

Acute emergencies from local anaesthetics are generally related to high plasma levels encountered during therapeutic use of excessive dosage of local anaesthetics, or to unintended intravascular injection of local anaesthetic solution. (See Adverse Reactions, Warnings and Precautions).

Management of local anaesthetic emergencies :

- The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patients state of consciousness after each local anaesthetic injection. At the first sign of change, oxygen should be administered.

- The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.

- Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anaesthetics, with these anticonvulsant drugs. Supportive treatment of circulation depression may require  administration of intravenous fluids and, when appropriate vasopressor as directed by the clinical situation (e.g. ephedrine).

- If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrythmia and cardiac arrest. If cardiac arrest should occur, standard cardio-pulmonary resuscitative measures should be instituted.

- Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patient airway or if prolonged ventilatory support (assisted or controlled) is indicated. Dialysis is of negligible value in the treatment of acute overdosage with lignocaine.

Dosage and Administration:

- Adults: A single cartridge is generally sufficient. Two are used in case of large interventions. However, three may be used if deemed necessary for prolonged procedures.

- Adolescents between 14 and 17, and the elderly: Usual dose 1.8 ml (1 cartridge). Do not exceed 3.6 ml (2 cartridges) in usual cases.

- Children between 6 and 14: Usual dose 1.35 ml (3/4 of a cartridge). Do not exceed 2.7 ml (1 ½ cartridge) in usual cases.

- Children between 3 and 6: 0.9 to 1.8 ml (1/2 to 1 cartridge).

Do not use under 3 years of age.

Presentation: Can of 50 cartridges containing 1.8 ml of solution.

Israeli Drug Registration Number: 066.48.27684.00

Manufacturer: Specialite SEPTODONT, France

Importer: A. Levy Dental Company Ltd., 27 Kalisher street, Tel-Aviv 65165