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KOURZEQ

RxNorm 1085728· TRIAMCINOLONE ACETONIDE· TOPICAL

Corticosteroid [EPC] · MidAmerica Pharmaceuticals

Indications and usage

INDICATIONS AND USAGE KOURZEQ is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

Dosage and administration

DOSAGE AND ADMINISTRATION Press a small dab (about ¼ inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops. The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.

Contraindications

CONTRAINDICATIONS Triamcinolone Acetonide Dental Paste USP, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

Nursing mothers

Nursing Mothers It is not known whether oral application of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when corticosteroid-containing dental pastes are prescribed for a nursing woman.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • drug ineffective5,174
  • off label use2,787
  • pruritus2,388
  • rash2,347
  • pain2,123
  • fatigue2,036
  • nausea1,950
  • headache1,835
  • condition aggravated1,680
  • product use in unapproved indication1,656
  • diarrhoea1,651
  • vomiting1,622
  • arthralgia1,559
  • dizziness1,528
  • malaise1,378
  • pyrexia1,319

Adverse reactions (label)

ADVERSE REACTIONS The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption.