Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED - 2% Xylocaine DENTAL with Epinephrine 1:50,000 (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges (NDC 66312-181-16). - 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose 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 pledget of cotton that has been moistened with recommended alcohol. 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).; 1:50,000 CARTRIDGE CARTON Dentsply Sirona NDC 66312-181-16 Reorder #: 22216 2% Xylocaine® DENTAL with Epinephrine 1:50,000 (Lidocaine HCI and Epinephrine Injection, USP) Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 Injection Store below 25°C (77°F) DO NOT PERMIT TO FREEZE For dental block and infiltration injections only. 50 Single-Dose Cartridges, 1.7 mL each Sterile aqueous Solution for Injection Rx only 1:50,000 CARTRIDGE CARTON 1:100,000 CARTRIDGE CARTON Dentsply Sirona NDC 66312-176-16 Reorder #: 20016 2% Xylocaine® DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection, USP) Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 Injection Store below 25°C (77°F) DO NOT PERMIT TO FREEZE For dental block and infiltration injections only. 50 Single-Dose Cartridges, 1.7 mL each Sterile aqueous Solution for Injection Rx only 1:100,000 CARTRIDGE CARTON
- HOW SUPPLIED - 2% Xylocaine DENTAL with Epinephrine 1:50,000 (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges (NDC 66312-181-16). - 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose 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 pledget of cotton that has been moistened with recommended alcohol. 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).
- 1:50,000 CARTRIDGE CARTON Dentsply Sirona NDC 66312-181-16 Reorder #: 22216 2% Xylocaine® DENTAL with Epinephrine 1:50,000 (Lidocaine HCI and Epinephrine Injection, USP) Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 Injection Store below 25°C (77°F) DO NOT PERMIT TO FREEZE For dental block and infiltration injections only. 50 Single-Dose Cartridges, 1.7 mL each Sterile aqueous Solution for Injection Rx only 1:50,000 CARTRIDGE CARTON 1:100,000 CARTRIDGE CARTON Dentsply Sirona NDC 66312-176-16 Reorder #: 20016 2% Xylocaine® DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection, USP) Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 Injection Store below 25°C (77°F) DO NOT PERMIT TO FREEZE For dental block and infiltration injections only. 50 Single-Dose Cartridges, 1.7 mL each Sterile aqueous Solution for Injection Rx only 1:100,000 CARTRIDGE CARTON
Overview
2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula: C 14 H 22 N 2 O • HCI • H 2 O M.W. 288.8 Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula: C 9 H 13 NO 3 M.W. 183.21 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. COMPOSITION OF THE 2% Xylocaine DENTAL INJECTIONS BRAND NAME PRODUCT IDENTIFICATION FORMULA SINGLE DOSE CARTRIDGE Lidocaine hydrochloride Epinephrine (as the bitartrate) Sodium Chloride Potassium metabisulfite Edetate Disodium Concentration % Dilution (mg/mL) (mg/mL) (mg/mL) 2% Xylocaine Dental with Epinephrine 1:50,000 2 1:50,000 6.5 1.2 0.25 2% Xylocaine Dental with Epinephrine 1:100,000 2 1:100,000 6.5 1.2 0.25 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. Lidocaine Hydrochloride Epinephrine
Indications & Usage
2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
Dosage & Administration
The dosage of 2% Xylocaine DENTAL solutions (lidocaine HCI 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 HCI 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 HCI 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 (½ to 2 ½ cartridges) of 2% Xylocaine DENTAL (lidocaine HCI 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration) are usually effective. 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 HCI 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration). Adult For normal healthy adults, the amount of lidocaine HCI 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 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 - 100 mg 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.
Warnings & Precautions
WARNINGS DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES WHICH MAY ARISE FROM THEIR USE. 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. Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection. 2% Xylocaine DENTAL solutions contain potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non asthmatic people. The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: “Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used.” (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association.) Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue 2% Xylocaine DENTAL and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Contraindications
2% Xylocaine DENTAL is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.
Adverse Reactions
Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide-type local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels (which may be caused by excessive dosage, rapid absorption, unintended intravascular injection or slow metabolic degradation), injection technique, volume of injection, hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular system Cardiovascular manifestations in response to lidocaine are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. In addition, the beta-adrenergic receptor-stimulating action of epinephrine may lead to excitatory cardiovascular responses, such as tachycardia, palpitations, and hypertension. Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position. Less commonly, they may result from a direct effect of the drug. Failure to recognize the premonitory signs such as sweating, a feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and ventilation with oxygen. Supportive treatment of circulatory depression may require the administration of intravenous fluids and, when appropriate, a vasopressor (e.g, ephedrine) as directed by the clinical situation. Allergic reactions Allergic reactions are characterized by cutaneous lesions, urticaria, edema, anaphylactoid reactions, or dyspnea due to bronchoconstriction. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Neurologic reactions The incidences of adverse reactions (e.g., persistent neurologic deficit) associated with the use of local anesthetics may be related to the technique employed, the total dose of local anesthetic administered, the particular drug used, the route of administration, and the physical condition of the patient. Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of lidocaine, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.
Drug Interactions
Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. As the 2% Xylocaine DENTAL solutions both contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible heart block. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: EXAMPLES OF DRUGS ASSOCIATED WITH METHEMOGLOBINEMIA: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic Agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine
Storage & Handling
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.
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