Clocortolone Pivalate
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.