Cloderm

Cloderm

 [klo´derm]
trademark for a preparation of clocortolone pivalate, a synthetic glucocorticoid used in topical treatment of dermatoses.

clocortolone

(kloe-kore-toe-lone) ,

Cloderm

(trade name)

Classification

Therapeutic: anti inflammatories steroidal
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Management of inflammation and pruritis associated with various allergic/immunologic skin problems.

Action

Suppresses normal immune response and inflammation.

Therapeutic effects

Suppression of dermatologic inflammation and immune processes.

Pharmacokinetics

Absorption: Minimal. Prolonged use on large surface areas or large amounts applied or use of occlusive dressings may increase systemic absorption.
Distribution: Remains primarily at site of action.
Metabolism and Excretion: Usually metabolized in skin.
Half-life: Unknown.

Time/action profile (response depends on condition being treated)

ROUTEONSETPEAKDURATION
Topicalmin–hrshrs–dayshrs–days

Contraindications/Precautions

Contraindicated in: Hypersensitivity or known intolerance to corticosteroids or components of vehicles (ointment or cream base, preservative, alcohol); Untreated bacterial or viral infections.
Use Cautiously in: Hepatic dysfunction; Diabetes mellitus, cataracts, glaucoma, or tuberculosis (use of large amounts of high-potency agents may worsen condition); Patients with pre-existing skin atrophy; Pregnancy, lactation, or children (chronic high-dose usage may result in adrenal suppression in mother, growth suppression in children; children may be more susceptible to adrenal and growth suppression).

Adverse Reactions/Side Effects

Dermatologic

  • allergic contact dermatitis
  • atrophy
  • burning
  • dryness
  • edema
  • folliculitis
  • hypersensitivity reactions
  • hypertrichosis
  • hypopigmentation
  • irritation
  • maceration
  • miliaria
  • perioral dermatitis
  • secondary infection
  • striae

Miscellaneous

  • adrenal suppression (use of occlusive dressings, long-term therapy)

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

Topical (Adults and Children ≥12 yr) Apply to affected area(s) 3 times daily.

Availability

Cream: 0.1%

Nursing implications

Nursing assessment

  • Assess affected skin before and daily during therapy. Note degree of inflammation and pruritus. Notify physician or other health care professional if symptoms of infection (increased pain, erythema, purulent exudate) develop.
  • Lab Test Considerations: Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic topical therapy if suspected. Children and patients with dose applied to a large area, using an occlusive dressing, or using high-potency products are at highest risk for HPA suppression.
    • May cause increased serum and urine glucose concentrations if significant absorption occurs.

Potential Nursing Diagnoses

Risk for impaired skin integrity (Indications)
Risk for infection (Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Creams should be used on oozing or intertriginous areas, where the occlusive action of ointments might cause folliculitis or maceration. Creams may be preferred for esthetic reasons even though they may be more drying to skin than ointments.
  • Topical: Apply cream sparingly as a thin film to clean, slightly moist skin. Wear gloves. Apply occlusive dressing only if specified by physician or other health care professional.

Patient/Family Teaching

  • Instruct patient on correct technique of medication administration. Emphasize importance of avoiding the eyes. If a dose is missed, it should be applied as soon as remembered unless almost time for the next dose.
  • Caution patient to use only as directed. Avoid using cosmetics, bandages, dressings, or other skin products over the treated area unless directed by health care professional.
  • Advise parents of pediatric patients not to apply tight-fitting diapers or plastic pants on a child treated in the diaper area; these garments work like an occlusive dressing and may cause more of the drug to be absorbed.
  • Caution women that medication should not be used extensively, in large amounts, or for protracted periods if they are pregnant or planning to become pregnant.
  • Advise patient to consult health care professional before using medicine for condition other than indicated.
  • Instruct patient to inform health care professional if symptoms of underlying disease return or worsen or if symptoms of infection develop.

Evaluation/Desired Outcomes

  • Resolution of skin inflammation, pruritus, or other dermatologic conditions.
References in periodicals archive ?
0 million of alliance and royalty revenue related to the out-license of product rights for Cloderm, a mid-potency steroid with an annual revenue run rate of approximately $7 million, that was completed on March 31, 2011.
Excluding the purchase price adjustment on Cloderm as a result of the merger between Legacy Biovail and Legacy Valeant, adjusted income was $186.
2011 First Quarter Total Revenue $565 million, including $36 million related to out-license of Cloderm
Along with MENTAX, the sales force will detail Akne-Mycin, a topical antibiotic for acne, and Cloderm, a topical treatment for steroid-responsive dermatosis," continued Malchow.
Malchow added, "Akne-Mycin and Cloderm are Hermal brands and part of the Merck KGaA Group (Darmstadt, Germany).
The products, Akne-Mycin, a topical erythromycin acne treatment in a unique ointment carrier, and Cloderm, a unique topical steroid indicated for steroid-responsive dermatosis, are both approved for marketing in the US.
Akne-Mycin and Cloderm are brands of the Hermal dermatological group of Center Laboratories.
Penederm noted that events in the first quarter of 1997 included marketing approval from the FDA for Avita(TM), Penederm's retinoic acid cream prescription product for acne, United Kingdom marketing approval of the retinoic acid cream and gel formulations, expansion of the Company's product line through an agreement with Merck KGaA to co-promote Akne-mycin, a topical erythromycin acne treatment in a unique ointment carrier, and Cloderm, a topical steroid indicated for steroid responsive dermatosis, a second OTC product development arrangement with SmithKline Beecham, and a launch of Penederm's DuraScreen(R) to OTC skin care markets by Pierre Fabre, Inc.
Penederm's specialty dermatology sales force began detailing Mentax, Akne-mycin and Cloderm to the medical community earlier this year and expects to launch its Avita cream in the third quarter of 1997.
9 million for the twelve months ended December 31, 2012 and the divestiture of Cloderm resulting from the Legacy Valeant into Legacy Biovail merger, $18.
Cloderm Cream is available in a 45-gram and 90-gram tube, and in a 30-gram or 75-gram pump, by prescription only.
Non-GAAP benefit from the out-license of Cloderm (e)