Usual Adult Dose for Oral Thrush

Apply 50 mg buccally to the upper gum region (canine fossa) once a day for 14 consecutive days.

Use: For the local treatment of oropharyngeal candidiasis

Usual Pediatric Dose for Oral Thrush

16 years or older: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.

Use: For the local treatment of oropharyngeal candidiasis

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Liver dysfunction: Caution recommended.

Precautions

CONTRAINDICATIONS:
Known hypersensitivity (e.g., anaphylaxis) to the active component, milk protein concentrate, or any of the other ingredients

Safety and efficacy have not been established in patients younger than 16 years; this drug is not recommended for use in younger children (due to potential risk of choking).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Apply with dry hands each morning after brushing teeth.
• Place tablet against the upper gum, above the incisor tooth (canine fossa), and hold in place with slight pressure over the upper lip for 30 seconds to ensure adhesion; once in place, the buccal tablet stays in position and gradually dissolves.
• Apply subsequent tablets to alternate sides of the mouth; clear away any remaining tablet material before the next tablet is applied.
• Do not crush, chew, or swallow the tablet.
• Can take food and drink normally when the buccal tablet is in place but avoid chewing gum
• If the buccal tablet does not adhere or falls off within the first 6 hours, reposition the same tablet immediately; if the tablet still does not adhere, use a new tablet.
• If the buccal tablet is swallowed within the first 6 hours, drink a glass of water and apply a new tablet only once.
• If the buccal tablet falls off or is swallowed after it was in place for at least 6 hours, do not apply a new tablet until the next scheduled dose.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Protect from moisture.

• Read the US FDA-approved patient labeling.
• Use the tablet immediately after removing from the bottle.
• Stop this drug and contact healthcare provider if hives, skin rash, or other symptoms of allergic reaction develop or if swelling or pain at the tablet application site occurs.

Frequently asked questions

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