CLODERM Cream (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

EPI Health, Inc

Λέξεις κλειδιά

71403-804

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1. Description

Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, ...

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

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

4. Contraindications

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

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 ...

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 body weight ...

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 Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. ...

11. How Supplied

Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes. 75 gram pump bottle NDC 71403-804-75 45 gram tube NDC 71403-804-45 90 gram tube NDC 71403-804-90 ...

12. Storage And Handling

Store Cloderm Cream between 15° and 30°C (59° and 86°F). Avoid freezing.