TOPICORT Cream / Gel (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Taro Pharmaceuticals U.S.A., Inc.

Λέξεις κλειδιά

51672-5205 51672-5204 51672-5202

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1. Description

Topicort (desoximetasone cream USP) 0.05%, Topicort (desoximetasone cream USP) 0.25%, and Topicort (desoximetasone gel USP) 0.05% contain the active synthetic corticosteroid desoximetasone. The topical ...

2. Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, ...

3. Indications and Usage

Topicort (desoximetasone cream USP) 0.05%, Topicort (desoximetasone cream USP) 0.25%, and Topicort (desoximetasone gel USP) 0.05% are indicated for the relief of the inflammatory and pruritic manifestations ...

4. Contraindications

Topicort (desoximetasone cream USP) 0.05%, Topicort (desoximetasone cream USP) 0.25%, and Topicort (desoximetasone gel USP) 0.05% are contraindicated in those patients with a history of hypersensitivity ...

5. Warnings

Keep out of reach of children.

6. Precautions

Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include ...

6.1. General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur ...

6.2. Information for Patients

Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact ...

6.3. Laboratory Tests

The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression: Urinary free cortisol test ACTH stimulation test

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Desoximetasone was nonmutagenic in the Ames test.

6.7. Pregnancy

Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have ...

6.9. Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids ...

6.10. Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushings syndrome than mature patients because of a larger skin surface area to body ...

7. Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate ...

9. Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

10. Dosage and Administration

Apply a thin film of Topicort (desoximetasone cream USP) 0.05%, Topicort (desoximetasone cream USP) 0.25%, or Topicort (desoximetasone gel USP) 0.05% to the affected skin areas twice daily. Rub in gently. ...

11. How Supplied

Topicort (desoximetasone cream USP) 0.05% is supplied in: 5 gram tubes for physician samples, 15 gram (NDC 51672-5205-1), 30 gram (NDC 51672-5205-2), 60 gram (NDC 51672-5205-3) and 100 gram (NDC 51672-5205-7) ...

12. Storage and Handling

Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]