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.
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References in periodicals archive ?
Reddy's Laboratories divests Cloderm (clocortolone pivalate) Cream, 0.1% franchise
Reddy's Laboratories Ltd (BSE: 500124)(NSE:DRREDDY) (NYSE:RDY) disclosed on Tuesday the sale its rights of Cloderm (clocortolone pivalate) Cream, 0.1% and its authorised generic version for an undisclosed amount.
Under the terms of the agreement, the company's wholly owned subsidiary Promius Pharma LLC has sold the rights of Cloderm (clocortolone pivalate) Cream, 0.1% and its authorised generic version to EPI Health LLC, an affiliate of EPI Group LLC.
Effective immediately, Promius Pharma is eligible to receive an upfront payment plus future royalties as the consideration for Cloderm Cream and its authorised generic in the US.
In addition to Atralin, Coria's roster of prescription products includes Cloderm 0.1% clocortolone pivalate cream for the treatment of steroid responsive conditions and Salex 6% salicylic acid cream and lotion kits for the treatment of hyperkerototic conditions.
Healthpoint has introduced a number of innovative products over the past three years, including Salex cream and lotion; Ovace wash and foam for seborrheic dermatitis; Cloderm, Akne-Mycin for acne treatment; and TheraSeal, a hand protectant.
M2 EQUITYBITES-April 4, 2011-Promius Pharma LLC and Valeant Pharmaceuticals International Inc partnership to unveil Cloderm Cream in the US market(C)2011 M2 COMMUNICATIONS http://www.m2.com
Promius Pharma LLC and Valeant Pharmaceuticals International Inc (NYSE:VRX) (TSX:VRX.to) jointly reported on Friday the execution of a collaboration agreement for Cloderm (clocortolone pivalate 0.1%) Cream with immediate effect for an undisclosed value.
Pursuant to the agreement, Promius Pharma will make an upfront payment as well as future royalties for the right to manufacture, distribute and market Cloderm Cream in the US.
According to the companies, Cloderm (clocortolone pivalate) Cream (0.1%) is a topical mid potent steroid product indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
To further strengthen its position the supplier purchased Cloderm, a midpotency topical steroid, and Aknemycin, an erythromycin ointment, from Hermal Laboratories.