Clocortolone
/api/v1/drug/clocortoloneMechanism of action
Sourced from openFDAMechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
Indications
Sourced from openFDA- Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
Sourced from openFDA- Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.contraindicated
Dosage & administration
Sourced from openFDAApply clocortolone pivalate cream USP, 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.
Adverse reactions
Sourced from openFDAThe 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 Acneform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria
Use in specific populations
Sourced from openFDAPregnancy 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 well-controlled 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 time.
Pharmacokinetics
Sourced from openFDA- Metabolism
- 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.
Overdosage
Sourced from openFDATopically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
Approval history
Sourced from openFDA- Apr 21, 2020ANDAANDA206370Taro
FAERS reports
- 1Pruritus520%
- 2Rash520%
- 3Cardiac Disorder312%
- 4Condition Aggravated312%
- 5Skin Exfoliation312%
- 6Conjunctivitis28.0%
- 7Dermatitis Atopic28.0%
- 8Eczema28.0%
- 9Erythema28.0%
- 10Palpitations28.0%
- 11Skin Erosion28.0%
- 12Sleep Apnoea Syndrome28.0%
- 13Therapeutic Response Decreased28.0%
- 14Weight Decreased28.0%
- 15Acne14.0%
Clinical trials
The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Clocortolone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% CreamCompleted · Phase 1 · Interventional · 124 enrolled · Sun Pharmaceutical Industries, Inc.NCT04358770updated 2020-04-24
- Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque PsoriasisCompleted · Phase 4 · Interventional · 60 enrolled · Promius Pharma, LLCNCT01714544updated 2014-07-23
Frequently asked questions
- How does Clocortolone work?
- Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
- What is Clocortolone used for?
- According to FDA labeling, Clocortolone carries indications including: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Clocortolone?
- Clocortolone is classified as Corticosteroids, moderately potent (group II), Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Antipruritic Activity, Decreased Immunologically Active Molecule Activity, Decreased Protein Synthesis, Vasoconstriction.
- What are the brand names for Clocortolone?
- Clocortolone is marketed under brand names including Cloderm.
- What are the contraindications for Clocortolone?
- Clocortolone labeling lists contraindications including: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.. Always consult the full prescribing information and a clinician.
clocortolone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.