药物信息为ORAVIG (miconazole) buccal tablets (Par Pharmaceuticals Companies, Inc.): 17 PATIENT COUNSELING INFORMATION

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  • See FDA-approved patient labeling.

  • 17.1 Instructions for Use

  • The tablet should be used immediately after removal from the bottle.

    • Instruct patients not to crush, chew, or swallow the tablet.
    • The rounded side of the tablet should be applied to the upper gum above the incisor tooth in the morning, after brushing the teeth.
    • The tablet should be held in place for 30 seconds with a slight pressure of the finger over the upper lip to make the tablet stick to the gum.
    • The tablet may be used if it sticks to the cheek, inside of the lip or the gum.
    • If the tablet does not adhere, it should be repositioned.
    • As the ORAVIG tablet absorbs moisture from the mouth, it will slowly dissolve over time and should be left in place—there is no need to remove the tablet.
    • Subsequent applications of ORAVIG should be made to alternate sides of the gum.
    • If ORAVIG does not stick or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet does not adhere, a new tablet should be placed.
    • If ORAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once.
    • If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next, regularly scheduled dose.

    Patients should avoid situations that could interfere with the sticking of the tablet including:

    • touching or pressing the tablet after placement
    • wearing upper denture
    • chewing gum
    • hitting tablet when brushing teeth
    • rinsing mouth too vigorously
  • 17.2 Hypersensitivity and Other Adverse Reactions

  • Patients who develop hives, skin rash, or other symptoms of an allergic reaction, and patients who develop swelling or pain, at the tablet application site should stop ORAVIG and contact a healthcare provider. Patients may experience other adverse reactions including diarrhea, headache, nausea, and change in taste.

  • Drug Information Provided by National Library of Medicine (NLM).
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