CORDRAN Lotion (2019)

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Almirall, LLC

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1. Description

Cordran (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically ...

2. Clinical Pharmacology

Cordran is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions. The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. ...

3. Indications and Usage

Cordran Lotion is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses.

4. Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

6.1. General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings syndrome, hyperglycemia, and glucosuria in some ...

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 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. Studies to determine mutagenicity with prednisolone and hydrocortisone ...

6.7. Pregnancy

Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be ...

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 do 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 <em>(see PRECAUTIONS)</em>.

10. Dosage and Administration

Shake well before using. A small quantity of Cordran Lotion should be rubbed gently into the affected area 2 or 3 times daily. Therapy should be discontinued when control is achieved. If no improvement ...

11. How Supplied

Cordran Lotion, 0.05% is supplied in plastic squeeze bottles as follows: 15 mL (NDC 16110-052-15) 60 mL (NDC 16110-052-60) 120 mL (NDC 16110-052-12) Manufactured by DPT Laboratories, San Antonio, TX 78215 ...

12. Storage and Handling

<b>Keep out of reach of children.</b> Storage: Avoid freezing. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP ...