Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

Warnings
Inadvertent intravascular injection may be associated with convulsions, followed by central nervous system or cardiorespiratory arrest. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use.

To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic 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.

It should be taken into consideration that during treatment with blood coagulation inhibitors (e.g.
heparin or acetylsalicylic acid), an inadvertent vasopuncture when administering the local anaesthetic can lead to serious bleeding, and the hemorrhagic tendency may be increased (see section 4.5).

Athletes should be warned that this medicinal product contains an active substance likely to yield a positive result in anti-doping tests.

The injection of this medicinal product must be avoided in infected area.

The patient must be warned of the possibility of injuries due to involuntary biting of the lips, tongue and buccal mucosa while these structures are anaesthetised. Consequently, food intake must be postponed until sensitivity returns.

The presence of sodium metabisulphite as an excipient may cause allergic reactions, including anaphylactic-type reactions and bronchospasm in susceptible patients, particularly those with an asthmatic or allergic history.

This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml, i.e., essentially sodium- free.

LIDOCADREN TEVA RH SY 03.2016

Precautions for use
The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine 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.

If sedatives are employed to reduce patient apprehension, reduced doses should be used since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent. Lidocaine should be used with caution in patients with severe shock or heart block.

The product should be administered with caution in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of atrioventricular conduction produced by these drugs (see section 4.3).

Local anesthetic solutions containing a vasoconstrictor should be used with caution in areas of the body supplied by end arteries or having otherwise compromised blood supply. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may result. Preparations containing a vasoconstrictor should be used with caution in patients during or following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur under such conditions.

LIDOCADREN TEVA should be used with precaution in patients with:
- angina pectoris
- arteriosclerosis
- impaired blood coagulation
- diabetes mellitus
- severe hepatic impairment. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations.
- lung diseases – particularly allergic asthma
- epilepsy
- phaeochromocytoma
- narrow-angle glaucoma
- thyrotoxicosis
- Acute porphyria LIDOCADREN TEVA is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients

Cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be monitored after each local anesthetic 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 anesthetic.


LIDOCADREN TEVA RH SY 03.2016
Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction, and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspected triggering agent (s) and prompt treatment, including oxygen therapy, dantrolene (consult dantrolene sodium intravenous package insert before using) and other supportive measures. Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

Use in the Head and Neck Area
Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression and/or respiratory arrest, and cardiovascular stimulation or depression have been reported.

These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded.

Effects on Driving

4.7   Effects on ability to drive and use machines

Depending on the dose and site of administration, local anaesthetics may affect mental functions and temporarily alter locomotion and coordination. When administering this medicine, the doctor or dentist must evaluate in each particular case whether the ability of the patient to react has been compromised and whether the patient can drive or use machines. The patient must remain in the consulting room for at least 30 minutes after the intervention.