Alclometasone

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

• Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ).

• Alclometasone Dipropionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.contraindicated

Apply a thin film of Alclometasone Dipropionate Ointment USP, 0.05% to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Alclometasone dipropionate ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing. Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Alclometasone dipropionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Metabolism

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration.

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

• Jul 29, 2004ANDAANDA076730Sun Pharma Canada
• Jul 12, 2005ANDAANDA076973Fougera Pharms
• Sep 15, 2005ANDAANDA076587Sun Pharma Canada
• Jul 30, 2009ANDAANDA079227Glenmark Pharms Ltd

1. 1Rash299.5%
2. 2Pruritus289.2%
3. 3Drug Ineffective247.9%
4. 4Product Use In Unapproved Indication227.2%
5. 5Diarrhoea175.6%
6. 6Nausea165.3%
7. 7Fatigue134.3%
8. 8Product Dose Omission Issue134.3%
9. 9Erythema123.9%
10. 10Dermatitis Atopic113.6%
11. 11Dry Skin113.6%
12. 12Dizziness103.3%
13. 13Off Label Use103.3%
14. 14Pain103.3%
15. 15Eczema93.0%

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

• Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
  Completed · Phase 2 · Interventional · 236 enrolled · Pfizer
  NCT01465802updated 2019-01-09
• Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream
  Completed · Phase 2 · Interventional · 310 enrolled · GlaxoSmithKline
  NCT02075632updated 2014-09-05

Frequently asked questions

How does Alclometasone work?

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

What is Alclometasone used for?

According to FDA labeling, Alclometasone carries indications including: Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Alclometasone?

Alclometasone is classified as Corticosteroids, moderately potent (group II), Corticosteroids, plain, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Antipruritic Activity, Decreased Immunologically Active Molecule Activity, Decreased Protein Synthesis, Vasoconstriction.

What are the contraindications for Alclometasone?

Alclometasone labeling lists contraindications including: Alclometasone Dipropionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.. Always consult the full prescribing information and a clinician.