Clocortolone Pivalate

Clocortolone Pivalate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.[2]

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Overview

Clocortolone Pivalate is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.. Common adverse reactions include 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 decreasing order of occurrence:

Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Apply 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. If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area body weight ratio.

Off-Label Use and Dosage (Pediatric)

Contraindications

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

Warnings

There is limited information regarding Clocortolone Pivalate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clocortolone Pivalate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Clocortolone Pivalate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Clocortolone Pivalate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): 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 teratogenic after dermal application in laboratory animals. There are no adequate and wellcontrolled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of tim
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clocortolone Pivalate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Clocortolone Pivalate during labor and delivery.

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 are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area body weight ratio.

Geriatic Use

There is no FDA guidance on the use of Clocortolone Pivalate in geriatric settings.

Gender

There is no FDA guidance on the use of Clocortolone Pivalate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Clocortolone Pivalate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Clocortolone Pivalate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Clocortolone Pivalate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Clocortolone Pivalate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Clocortolone Pivalate in patients who are immunocompromised.

Administration and Monitoring

Administration

Apply 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. If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

Monitoring

There is limited information regarding Clocortolone Pivalate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Clocortolone Pivalate and IV administrations.

Overdosage

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

Pharmacology

There is limited information regarding Clocortolone Pivalate Pharmacology in the drug label.

Mechanism of Action

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Structure

There is limited information regarding Clocortolone Pivalate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Clocortolone Pivalate Pharmacodynamics in the drug label.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Nonclinical Toxicology

There is limited information regarding Clocortolone Pivalate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Clocortolone Pivalate Clinical Studies in the drug label.

How Supplied

Clocortolone Pivalate Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes.

Storage

Store Clocortolone Pivalate Cream 0.1% between 15° and 30° C (59° and 86° F). Avoid freezing.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Clocortolone Pivalate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Clocortolone Pivalate interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Clocortolone Pivalate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Clocortolone Pivalate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.