pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

Corticosteroid Hormone ReceptorGlucocorticoid ReceptorLipoxygenase

Indications

Sourced from openFDA
  • Flurandrenolide Lotion USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Sourced from openFDA
  • Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.contraindicated

Dosage & administration

Sourced from openFDA

Shake well before using. A small quantity of Flurandrenolide Lotion USP, 0.05% should be rubbed gently into the affected area 2 or 3 times daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Flurandrenolide Lotion USP, 0.05% should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

Adverse reactions

Sourced from openFDA

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 The following may occur more frequently with occlusive dressings: Maceration of the skin Secondary infection Skin atrophy Striae Miliaria Postmarketing Adverse Reactions The following adverse reactions have been identified during post approval use of flurandrenolide lotion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin : skin striae, hypersensitivity, skin atrophy, contact dermatitis, and skin discoloration.

Use in specific populations

Sourced from openFDA

Usage in Pregnancy - Pregnancy Category C - Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent cortico-steroids 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 for pregnant patients or 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 openFDA

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

Approval history

Sourced from openFDA
  • Oct 18, 1965NDANDA012806Ina Pharms
  • Jul 29, 1969NDANDA016455Almirall
  • Aug 30, 2016ANDAANDA207133Padagis Israel

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
311 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective278.7%
  2. 2Pruritus237.4%
  3. 3Nausea206.4%
  4. 4Fatigue185.8%
  5. 5Headache185.8%
  6. 6Pain185.8%
  7. 7Rash185.8%
  8. 8Diarrhoea165.1%
  9. 9Psoriasis165.1%
  10. 10Dyspnoea144.5%
  11. 11Pain In Extremity144.5%
  12. 12Off Label Use134.2%
  13. 13Dry Skin123.9%
  14. 14Depression113.5%
  15. 15Psoriatic Arthropathy113.5%

Literature

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Recent PubMed references pinned to Flurandrenolide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Flurandrenolide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Flurandrenolide work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Flurandrenolide used for?
According to FDA labeling, Flurandrenolide carries indications including: Flurandrenolide Lotion USP, 0.05% is 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 Flurandrenolide?
Flurandrenolide is classified as Corticosteroids, potent (group III), Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Antipruritic Activity, Decreased Glucocorticoid Secretion, Decreased Immunologically Active Molecule Activity, Vasoconstriction.
What are the brand names for Flurandrenolide?
Flurandrenolide is marketed under brand names including Cordran.
What are the contraindications for Flurandrenolide?
Flurandrenolide labeling lists contraindications including: Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.. Always consult the full prescribing information and a clinician.
Note. Data for flurandrenolide 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.

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