Articaine - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Accidental Intravascular Injection: May be associated with convulsions followed by coma and respiratory arrest.

Resuscitative equipment, oxygen and other resuscitative drugs should be available.

Systemic Toxicity: Systemic absorption of Articaine HCl and Epinephrine can produce effects on the central nervous and cardiovascular systems.

Vasoconstrictor Toxicity: Local anesthetic solutions like Articaine HCl and Epinephrine that contain a vasoconstrictor should be used cautiously, especially in patients with impaired cardiovascular function or vascular disease.

Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use.

5.1 Accidental Intravascular Injection Accidental intravascular injection of Articaine HCl and Epinephrine may be associated with convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest.

Dental practitioners who employ local anesthetic agents including Articaine HCl and Epinephrine should be well versed in diagnosis and management of emergencies that may arise from their use.

Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

To avoid intravascular injection, aspiration should be performed before Articaine HCl and Epinephrine is injected.

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 guarantee that intravascular injection has been avoided.

Small doses of local anesthetics injected in dental blocks may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.

Confusion, convulsions, respiratory depression 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 be observed constantly.

Resuscitative equipment and personnel for treating adverse reactions should be immediately available.

Dosage recommendations should not be exceeded [see Dosage and Administration ].

5.2 Systemic Toxicity This includes toxicity arising from accidental intravascular injection of Articaine HCl and Epinephrine discussed in Section 5.1, as well as that related to higher systemic concentrations of local anesthetics or epinephrine [see Warnings and Precautions ].

Systemic absorption of local anesthetics including Articaine HCl and Epinephrine can produce effects on the central nervous and cardiovascular systems.

At blood concentrations achieved with therapeutic doses of Articaine HCl and Epinephrine, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal.

However, toxic blood concentrations of Articaine HCl and Epinephrine can depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, possibly resulting in fatalities.

In addition, myocardial contractility is depressed and peripheral vasodilatation occurs, leading to decreased cardiac output and arterial blood pressure.

Articaine HCl and Epinephrine should also be used with caution in patients with heart block as well as those with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.

Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of central nervous system toxicity.

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after each local anesthetic injection of Articaine HCl and Epinephrine.