2% Xylocaine DENTAL Solutions are indicated for the
production of local anesthesia for dental procedures by nerve block or
Only accepted procedures for these techniques as
described in standard textbooks are recommended.
DOSAGE AND ADMINISTRATION
The dosage of 2% Xylocaine DENTAL solutions (lidocaine
HCl and epinephrine) 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 used. The least volume of solution that results in
effective local anesthesia should be administered; time should be allowed
between injections to observe the patient for manifestations of an adverse
reaction. For specific techniques and procedures of a local anesthesia in the
oral cavity, refer to standard textbooks.
For most routine dental procedures, 2% Xylocaine DENTAL
with epinephrine 1:100,000 (lidocaine HCl 2% with a 1:100,000 epinephrine
concentration) is preferred. However, when greater depth and a more pronounced
hemostasis are required, 2% Xylocaine DENTAL with epinephrine 1:50,000 (lidocaine
HCl 2 % with 1:50,000 epinephrine concentration) should be used.
Dosage requirements should be determined on an individual
basis. In oral infiltration and / or mandibular block, initial dosages of 1.0 -
5.0 mL (½to 2½cartridges) of 2% Xylocaine DENTAL (lidocaine HCl 2%
solutions with a 1:50,000 or a 1:100,000 epinephrine concentration) are usually
In children under 10 years of age, it is rarely necessary
to administer more than one-half cartridge (0.9- 1.0 mL or 18-20 mg of
lidocaine) 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 of an entire quadrant. Aspiration is recommended since it reduces
the possibility of intravascular injection, thereby keeping the incidence of
side effects and anesthetic failures to a minimum. Moreover, injection should
always be made slowly.
Maximum recommended dosages for 2% Xylocaine DENTAL
(lidocaine HCl 2% solutions with a 1:50,000 or a 1:100,000 epinephrine
For normal healthy adults, the amount of lidocaine HCl
administered should be kept below 500 mg, and in any case, should not exceed 7
mg/kg (3.2 mg/lb) of body weight.
Pediatric patients: It is difficult to recommend a
maximum dose of any drug for pediatric patients since this varies as a function
of age and weight. For pediatric patients 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 pediatric patients of five years weighing 50
Ibs, the dose of lidocaine hydrochloride should not exceed 75- 100mg when
calculated according to Clark's rule. In any case, the maximum dose of
lidocaine hydrochloride should not exceed 7 mg/kg (3.2 mg/lb) of body weight.
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 and any unused portion of a
cartridge of 2% Xylocaine DENTAL should be discarded.
2% Xylocaine DENTAL with epinephrine 1:50,000 (Lidocaine
hydrochloride 2% and Epinephrine 1:50,000 injection) is available in cardboard
boxes containing 5 blisters of 10 — 1.7 mL cartridges (NDC 66312-181-16).
2% Xylocaine DENTAL with epinephrine 1:100,000 (Lidocaine
hydrochloride 2% and Epinephrine 1:100,000 injection) is available in cardboard
boxes containing 5 blisters of 10 — 1.7 mL cartridges (NDC 66312-176-16).
Store at controlled room temperature, below 25°C (77°F).
Protect from light. Do not permit to freeze.
BOXES : For protection from light, retain in box until
time of use. Once opened, the box should be reclosed by closing the end flap.
Do not use if color is pinkish or darker than slightly
yellow or if it contains a precipitate.
STERILIZATION : STORAGE AND TECHNICAL PROCEDURES
Cartridges should not be autoclaved, because the closures
employed cannot withstand autoclaving temperatures and pressures.
If chemical disinfection of anesthetic cartridges is
desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended.
Many commercially available brands of rubbing alcohol, as well as solutions of
ethyl alcohol not of U.S.P grade, contain denaturants that are injurious to
rubber and, therefore, are not to be used. It is recommended that chemical
disinfection be accomplished just prior to use by wiping the cartridge cap
thoroughly with a pledge of cotton that has been moistened with recommended
Certain metallic ions (mercury, zinc, copper, etc.) have
been related to swelling and edema after local anesthesia in dentistry.
Therefore, chemical disinfectants containing or releasing these ions are not
recommended. Antirust tablets usually contain sodium nitrite or some similar
agents that may be capable of releasing metal ions. Because of this, aluminium
sealed cartridges should not be kept in such solutions.
Quaternary ammonium salts, such as benzalkonium chloride,
are electrolytically incompatible with aluminium. Cartridges of 2% Xylocaine
DENTAL are sealed with aluminium caps and therefore should not be immersed in
any solution containing these salts.
To avoid leakage of solutions during injection, be sure
to penetrate the center of the rubber diaphragm when loading the syringe. An
off-center penetration produces an oval shaped puncture that allows leakage
around the needle.Other causes of leakage and breakage include badly worn syringes,
aspirating syringes with bent harpoons, the use of syringes not designed to
take 1.7 mL cartridges, and inadvertent freezing.
Cracking of glass cartridges is most often the result of
an attempt to use a cartridge with an extruded plunger. An extruded plunger
loses its lubrication and can be forced back into the cartridge only with
difficulty. Cartridges with extruded plungers should be discarded.
Store at controlled room temperature, below 25°C (77°F).
Manufactured for: DENTSPLY Pharmaceutical by Novocol
Pharmaceutical of Canada, Inc. Cambridge, Ontario, Canada N1R 6X3. Revised:. Dec 2011