Pierrel S.p.a.

Pierrel S.p.a. Drugs

• Orabloc
  

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  Orabloc

  

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  2.1 General Dosing Information

  Table 1 (below) summarizes the recommended volumes and concentrations of Orabloc® 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 Orabloc® Injection Volume (mL) Total dose of articaine HCl (mg) Infiltration 0.5 mL to 2.5 mL 20 mg to 100 mg Nerve block 0.5 mL to 3.4 mL 20 mg to 136 mg Oral surgery 1 mL to 5.1 mL 40 mg to 204 mg

  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, Orabloc® containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Orabloc® containing epinephrine 1:100,000 may be used.

  2.2 Maximum Recommended Dosages

  Adults: For normal healthy adults, the maximum dose of Orabloc® administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg) of articaine HCl. Pediatric Patients Ages 4 to 16 Years: The quantity of Orabloc® 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 Orabloc® should not exceed 7 mg/kg (0.175 mL/kg) of articaine HCl. [see Use in Specific Populations (8.4)]. Safety and effectiveness of Orabloc® 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)]

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