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
  • Halcinonide cream, USP, 0.1% is 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 preparations.contraindicated

Dosage & administration

Sourced from openFDA

Apply the 0.1% halcinonide cream, USP, to the affected area two to three times daily. Rub in gently. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply halcinonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

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 (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, and miliaria.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects 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.

Overdosage

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Nov 27, 1974NDANDA017556Sun Pharm Inds Inc
  • May 4, 1977NDANDA017823Sun Pharm Inds Inc
  • Aug 12, 2019ANDAANDA211027Mylan
  • May 29, 2024ANDAANDA217671Encube

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.
192 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 Ineffective2312%
  2. 2Psoriasis199.9%
  3. 3Rash168.3%
  4. 4Pain136.8%
  5. 5Pruritus136.8%
  6. 6Arthralgia126.3%
  7. 7Diarrhoea105.2%
  8. 8Headache105.2%
  9. 9Nausea105.2%
  10. 10Fatigue94.7%
  11. 11Off Label Use94.7%
  12. 12Condition Aggravated73.6%
  13. 13Depression73.6%
  14. 14Weight Decreased73.6%
  15. 15Dyspnoea63.1%

Literature

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

Clinical trials

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The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Halcinonide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Halcinonide work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Halcinonide used for?
According to FDA labeling, Halcinonide carries indications including: Halcinonide cream, USP, 0.1% 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 Halcinonide?
Halcinonide is classified as Corticosteroids, very potent (group IV), 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 Halcinonide?
Halcinonide is marketed under brand names including Halog.
What are the contraindications for Halcinonide?
Halcinonide labeling lists contraindications including: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.. Always consult the full prescribing information and a clinician.
Note. Data for halcinonide 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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