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Ndc, Inc. Drugs
2.1 General Dosing Information
Table 1 (below) summarizes the recommended volumes and concentrations of Articaine HCl and Epinephrine 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 Articaine HCl and Epinephrine Injection Procedure 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, Articaine HCl and Epinephrine containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articaine HCl and Epinephrine containing epinephrine 1:100,000 may be used.
2.2 Maximum Recommended DosagesAdults: For normal healthy adults, the maximum dose of articaine HCl 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 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% should not exceed 7 mg/kg (0.175 mL/kg) [see Use in Specific Populations (8.4)]. Safety and effectiveness of Articaine HCl and 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)]
The dosage of Lidocaine and Epinephrine Injections, USP 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, Lidocaine and Epinephrine 1:100,000 Injection is preferred. However, when greater depth and a more pronounced hemostasis are required, a 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 (1/2 to 2.5 cartridges) of Lidocaine and Epinephrine Injections 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 Lidocaine and Epinephrine Injections.
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 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 Lidocaine and Epinephrine Injections should be discarded.
As with all local anesthetics, the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose needed to provide effective anesthesia should be administered. For specific techniques and procedures refer to standard dental manuals and textbooks.
For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.
Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%).
5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated according to the patient's weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.
The maximum pediatric dose should be carefully calculated.
Maximum dose for pediatric population =Child's Weight (lbs.) 150 × Maximum Recommended Dosefor Adults (400 mg)
The following table, approximating these calculations, may also be used as a guide. This table is based upon a recommended maximum for larger pediatric population of 5.3 cartridges (the maximum recommended adult dose) during any single dental sitting, regardless of the pediatric patient's weight or (for 2% mepivacaine) calulated maximum amount of drug:
Maximum Allowable Dosage*3% Mepivacaine 2% Mepivacaine 1:20,000 Levonordefrin 3 mg/lb 3mg/lb (270 mg max.) (180 mg max.) Weight (lb.) mg Number of Cartridges mg Number of Cartridges 20 60 1.2 60 1.8 30 90 1.8 90 2.6 40 120 2.3 120 3.5 50 150 2.9 150 4.4 60 180 3.5 180 5.3 80 240 4.7 180 5.3 100 270 5.3 180 5.3 120 270 5.3 180 5.3
*Adapted from Malamed, Stanley F. Handbook of medical emergencies in the dental office, ed. 2, St. Louis, 1982. The C.V. Mosby Co.
When using Mepivacine HCl Injection USP for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.
Any unused portion of a cartridge should be discarded.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Hydrogen Peroxide Solution
First Aid Antiseptic clean the affected area apply a small amount of product on the area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first
Oral Debriding Agent (oral rinse):
Adults and children 2 years of age & over:mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor
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