药物信息为ORAVIG (miconazole) buccal tablets (Par Pharmaceuticals Companies, Inc.): 17 PATIENT COUNSELING INFORMATION
- 1 INDICATIONS AND USAGE
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 6 ADVERSE REACTIONS
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 14 CLINICAL STUDIES
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FDA-Approved Patient Labeling
- Principal Display Panel - Bottle Label
- Principal Display Panel - Carton Label
- Principal Display Panel - Bottle Label - 2 Tablet Professional SAMPLE
- Principal Display Panel - Carton Label - 2 Tablet Professional SAMPLE
- 外部链接相关的ORAVIG (miconazole) buccal tablets (Par Pharmaceuticals Companies, Inc.)
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).
