Ultacan

ULTACAN- articaine hydrochloride and epinephrine bitartrate injection, solution
ULTACAN FORTE- articaine hydrochloride and epinephrine bitartrate injection, solution
HANSAmed, Inc.

1 INDICATIONS AND USAGE

Ultacan® and Ultacan® forte, an amide local anesthetic containing a vasoconstrictor, are indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Table 1 (below) summarizes the recommended volumes and concentrations of Ultacan® and Ultacan® forte for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.

Table 1: Recommended Dosages for Both Strengths
Procedure Ultacan® and Ultacan® forte Injection
Volume (mL) Total dose of articaine HCl (mg)
Infiltration 0.5–2.5 20–100
Nerve block 0.5–3.4 20–136
Oral surgery 1.0–5.1 40–204

The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.

The onset of anesthesia and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.

For most routine dental procedures, Ultacan® containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Ultacan® forte containing epinephrine 1:100,000 may be used.

2.2 Maximum Recommended Dosages

  • Adults: For normal healthy adults, the maximum dose of Articaine HCl 4% with epinephrine administered by submucosal infiltration or nerve block should not exceed 7 mg/kg (0.175 mL/kg).
  • Pediatric Patients Ages 4 to 16 Years: The quantity of Articaine HCl 4% with epinephrine in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of Articaine HCl 4% with epinephrine should not exceed 7 mg/kg (0.175 mL/kg) [see Use in Specific Populations (8.4)].
  • Safety and effectiveness of Articaine HCl 4% with epinephrine in pediatric patients below the age of 4 years have not been established.

2.3 Dosing in Special Populations

Dose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease. [see Warnings and Precautions (5.2), Use in Specific Populations (8.4, 8.5, and 8.6)]

3 DOSAGE FORMS AND STRENGTHS

Injection (clear colorless solution), containing:

  • Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL)
  • Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL)

4 CONTRAINDICATIONS

Ultacan® and Ultacan® forte are contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people [see Warnings and Precautions ( 5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Accidental Intravascular Injection

Accidental intravascular injection of Ultacan® or Ultacan® forte 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 Ultacan® or Ultacan® forte 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 Ultacan® or Ultacan® forte 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 (2.1)].

5.2 Systemic Toxicity

This includes toxicity arising from accidental intravascular injection of Ultacan® or Ultacan® forte discussed in Section 5.1, as well as that related to higher systemic concentrations of local anesthetics or epinephrine [see Warnings and Precautions (5.3)]. Systemic absorption of local anesthetics including Ultacan® or Ultacan® forte can produce effects on the central nervous and cardiovascular systems.

At blood concentrations achieved with therapeutic doses of Ultacan® or Ultacan® forte , changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations of Ultacan® or Ultacan® forte 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. Ultacan® or Ultacan® forte 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 Ultacan® or Ultacan® forte . Repeated doses of Ultacan® or Ultacan® forte may cause significant increases in blood levels because of possible accumulation of the drug or its metabolites. The lowest dosage that results in effective anesthesia should be used to decrease the risk of high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. Precautions for epinephrine administration, discussed in Section 5.3, should be observed.

Debilitated patients, elderly patients, acutely ill patients, and pediatric patients should be given reduced doses commensurate with their age and physical condition [see Dosage and Administration (2.1, 2.3)]. No studies have been performed in patients with liver dysfunction, and caution should be used in patients with severe hepatic disease.

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