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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Amcinonide: Drug information

Amcinonide: Drug information
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For additional information see "Amcinonide: Patient drug information" and "Amcinonide: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • RATIO-Amcinonide [DSC];
  • TARO-Amcinonide
Pharmacologic Category
  • Corticosteroid, Topical
Dosing: Adult

Dosage guidance:

Dosage form information: Amcinonide lotion has been discontinued in the United States for >1 year.

Dermatosis, corticosteroid responsive

Dermatosis, corticosteroid responsive:

Cream/ointment: Topical: Apply to the affected area 2 to 3 times daily.

Lotion: Topical: Apply to the affected area, particularly hairy areas, 2 times daily.

Duration of therapy: Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Amcinonide: Pediatric drug information")

Dosage guidance:

Dosage form information: Amcinonide lotion has been discontinued in the United States for >1 year.

Dermatoses

Dermatoses (corticosteroid-responsive, including contact/atopic dermatitis): Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time to avoid hypothalamic-pituitary-adrenal (HPA) axis suppression. Therapy should be discontinued when control is achieved.

Infants ≥3 months, Children, and Adolescents (Ref):

Cream, ointment: 0.1%: Topical: Apply thin film to affected areas 2 to 3 times daily.

Lotion 0.1%: Topical: Apply to the affected area, particularly hairy areas, 2 times per day.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Localized burning

Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, folliculitis, hypertrichosis, hypopigmentation, local dryness, maceration of the skin, miliaria, pruritus, skin atrophy, telangiectasia

Endocrine & metabolic: Cushing's syndrome, growth suppression (long-term use), HPA-axis suppression, hyperglycemia; these reactions occur more frequently with occlusive dressings

Infection: Secondary infection

Local: Local irritation

Contraindications

Hypersensitivity to amcinonide or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Disease-related concerns:

• Infected/weeping lesions: Occlusive dressings should not be used in presence of infection or weeping lesions.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form-specific issues:

• Benzyl alcohol: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).

Warnings: Additional Pediatric Considerations

The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Product Availability

Amcinonide lotion has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Generic: 0.1% (15 g [DSC], 30 g [DSC], 60 g)

Lotion, External:

Generic: 0.1% (60 mL [DSC])

Ointment, External:

Generic: 0.1% (60 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Amcinonide External)

0.1% (per gram): $38.16

Ointment (Amcinonide External)

0.1% (per gram): $38.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Generic: 0.1% (15 g, 30 g, 60 g)

Lotion, External:

Generic: 0.1% ([DSC])

Ointment, External:

Generic: 0.1% ([DSC])

Administration: Adult

Topical: For external use only. Apply a thin film to clean, dry skin and rub in gently. Avoid contact with eyes. Use of occlusive dressings is not recommended unless treating psoriasis or recalcitrant conditions, or directed by health care provider; discontinue use if an infection develops. Wash hands thoroughly before and after use. Shake lotion well before use; protect the area from washing, clothing, or rubbing until the lotion has dried.

Administration: Pediatric

Topical: For topical use only; avoid contact with eyes. Do not use on open skin or wounds; wash hands after application. Do not use tight fitting diapers, plastic pants, or other occlusive dressing unless directed by health care provider.

Cream, ointment: Apply a thin film sparingly.

Lotion: Shake well before use. Apply a thin film sparingly. Rub into affected area completely.

Use: Labeled Indications

Steroid-responsive dermatoses: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (high potency corticosteroid).

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).

Pregnancy Considerations

Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).

When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).

Breastfeeding Considerations

It is not known if topical application will result in detectable quantities in breast milk. However, systemic corticosteroids are excreted in human milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).

Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019)

Mechanism of Action

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Amcinonide has high potency.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Adequate through intact skin; increases with skin inflammation or occlusion

Metabolism: Hepatic

Excretion: Urine and feces

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Visderm;
  • (BE) Belgium: Amicla;
  • (DE) Germany: Amciderm;
  • (EC) Ecuador: Visderm;
  • (FR) France: Penticort;
  • (JP) Japan: Coupe am;
  • (KR) Korea, Republic of: Visderm;
  • (LU) Luxembourg: Amicla;
  • (MX) Mexico: Visderm h;
  • (PK) Pakistan: Cyclocort;
  • (PR) Puerto Rico: Cyclocort;
  • (TH) Thailand: Amciderm | Visderm;
  • (TW) Taiwan: Saugea | Visderm
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