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Oraverse

Oraverse Recall

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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Uses

OraVerse is indicated for reversal of the soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).

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History

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Other Information

Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H-imidazol-2-yl)methyl](4-methyl-phenyl)amino]-, methanesulfonate (salt), a non-specific alpha adrenergic blocker.

Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a molecular weight of 377.46. It is sparingly soluble in water, soluble in alcohol, and slightly soluble in chloroform. The empirical formulation is C 17H19N3O•CH4O3S, and the chemical structure is:

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OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate. Either acetic acid or sodium hydroxide is used as necessary to adjust the pH.

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Oraverse Manufacturers

  • Novalar Pharmaceuticals
    Oraverse | Novalar Pharmaceuticals
    No Recall

    Oraverse | Novalar Pharmaceuticals

    Oraverse | Novalar Pharmaceuticals
    2.1 General Dosing Information

    The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered:

    Amount of Local
    Anesthetic Administered Dose of OraVerse
    [mg] Dose of OraVerse
    [Cartridge] ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2

    OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.

    Note: Do not administer OraVerse if the product is discolored or contains particulate matter.

    2.2 Dosing in Special Populations

    In pediatric patients weighing 15-30 kg, the maximum dose of OraVerse recommended is 1/2 cartridge (0.2 mg).

    (Note: Use in pediatric patients under 6 years of age or weighing less than 15 kg (33 lbs) is not recommended. A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 12 years of age.)

  • Septodont, Inc.
    Oraverse | Septodont, Inc.
    No Recall

    Oraverse | Septodont, Inc.

    Oraverse | Septodont, Inc.
    2.1 General Dosing information

    The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered:

    Amount of Local Anesthetic Administered Dose of OraVerse [mg] Dose of OraVerse [Cartridge(s)] ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2

    OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.

    Note: Do not administer OraVerse if the product is discolored or contains particulate matter.

    2.2 Dosing in Special Populations

    In pediatric patients weighing 15-30 kg, the maximum dose of OraVerse recommended is 1/2 cartridge (0.2 mg).

    (Note: Use in pediatric patients under 6 years of age or weighing less than15 kg (33 lbs) is not recommended. A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 12 years of age.)

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