Orabloc
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Uses
Orabloc® is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
History
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Other Information
Orabloc® injection is a sterile, aqueous solution that contains articaine HCl 4% (40mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula:
Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.
Epinephrine bitartrate, (-)-1-(3,4-dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor that is added to articaine HCl in a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula:
Orabloc® contains articaine HCl (40 mg/mL), epinephrine (1:200,000 or 1:100,000) (as epinephrine bitartrate) sodium chloride (1.0 mg/mL), sodium metabisulfite (0.5 mg/mL), and water for injection. The product is formulated with a 10% overage of epinephrine. The pH is adjusted to 3.6 with hydrochloric acid.
Sources
Orabloc Manufacturers
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Pierrel S.p.a.
![Orabloc (Articaine Hydrochloride And Epinephrine Bitartrate) Injection [Pierrel S.p.a.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Orabloc | Pierrel S.p.a.
2.1 General Dosing InformationTable 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 mgThe 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 PopulationsDose 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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