Source: FDA, National Drug Code (US) Revision Year: 2019
4% Citanest Plain Dental Injection is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
The dosage of 4% Citanest Plain Dental Injection varies and depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia. The least volume of injection that results in effective local anesthesia should be administered. For specific techniques and procedures of local anesthesia in the oral cavity, refer to standard textbooks.
There are no practical clinical differences between prilocaine with and without epinephrine when used for inferior alveolar blocks.
4% Citanest Plain Dental is recommended for use in maxillary infiltration anesthesia for procedures in which the painful aspects can be completed within 15 minutes after the injection. 4% Citanest Plain Dental is therefore especially suited to short procedures in the maxillary anterior teeth. For long procedures, or those involving maxillary posterior teeth where soft tissue numbness is not troublesome to the patient, Prilocaine HCl 4% with epinephrine 1:200,000 is recommended.
For most routine procedures, initial dosages of 1 to 2 mL of 4% Citanest Plain Dental Injection will usually provide adequate infiltration or major nerve block anesthesia.
The maximum recommended dose that should ever be administered within a two-hour period in normal healthy adults should be calculated based upon the patient’s weight as follows:
| Weight | Maximum recommended dose |
|---|---|
| <150 lb (<70 kg) | 4 mg/lb (8 mg/kg) |
| ≥150 lb (≥70 kg) | 600 mg (15 mL) or 8 cartridges |
In children under 10 years of age it is rarely necessary to administer more than one-half cartridge (40 mg) of 4% Citanest Plain Dental Injection per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug will allow treatment of the teeth in an entire quadrant.
ASPIRATION PRIOR TO INJECTION IS RECOMMENDED, since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failure to a minimum.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.
Any unused portion of a cartridge should be discarded.
In patients weighing <150 lb (70 kg), no more than 4 mg/lb (8 mg/kg) should be administered. In patients weighing ≥150 lb, no more than 600 mg (8 cartridges) of prilocaine HCl should be administered as a single injection.
It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, in a child of five years weighing 50 lb, the dose of prilocaine hydrochloride should not exceed 150 to 200 mg (6.6 to 8.8 mg/kg or 3 to 4 mg/lb of body weight) when calculated according to Clark’s rule.
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).
The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic 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 patient 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 anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (eg, ephedrine).
If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary 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 prilocaine.
Other causes of leakage and breakage include badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.8 mL cartridges, and inadvertent freezing.
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