Amcinonide

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# Overview
Amcinonide is a corticosteroid that is FDA approved for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.   Common adverse reactions include burning sensation, itching, skin irritation, soreness, stinging of skin.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
- Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition.
- Occlusive dressings may be a valuable therapeutic adjunct for the management of psoriasis or recalcitrant conditions.
- If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amcinonide in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Amcinonide in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
- Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amcinonide in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Amcinonide in pediatric patients.

# Contraindications
- Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

# Warnings
- Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia and glucosuria in some patients.
- Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent steroid.
- Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
- Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
- Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
- If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
- In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
- These products are not for ophthalmic use.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Amcinonide in the drug label.

## Postmarketing Experience
- Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.
- Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent steroid.
- Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
- Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
- Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
- If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
- In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
- These products are not for ophthalmic use.

# Drug Interactions
There is limited information regarding Amcinonide Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- 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 ]. 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.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amcinonide in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Amcinonide during labor and delivery.

### Nursing Mothers
- It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

### Pediatric Use
- Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
- Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Amcinonide with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Amcinonide with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Amcinonide with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Amcinonide in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Amcinonide in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Amcinonide in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Amcinonide in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral
- Intravenous

### Monitoring
There is limited information regarding Monitoring of Amcinonide in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Amcinonide in the drug label.

# Overdosage
- Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

# Pharmacology

## Mechanism of Action
- Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
- The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

## Structure
- The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
- TOPICAL CREAM USP, 0.1%
- Each gram of Amcinonide Cream contains 1 mg of the active steroid amcinonide in a white, smooth, homogeneous, opaque emulsion composed of benzyl alcohol (as preservative), emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water and sorbitol solution 70%.
- TOPICAL OINTMENT USP, 0.1%
- Each gram of Amcinonide Ointment contains 1 mg of the active steroid amcinonide in a specially formulated base composed of benzyl alcohol 2.2% (wt/wt) as preservative, butylated hydroxyanisole, citric acid anhydrous, emulsifying wax, propyl gallate, propylene glycol, and white petrolatum.
- Chemically, amcinonide is:

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Amcinonide in the drug label.

## Pharmacokinetics
- 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. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
- Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
- Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Amcinonide in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Amcinonide in the drug label.

# How Supplied
- Amcinonide Topical Cream USP, 0.1% (1 mg/g) is supplied in 4 gm, 15 gm, 30 gm and 60 gm tubes.
- Amcinonide Topical Ointment USP, 0.1% (1 mg/g) is supplied in 15 gm, 30 gm and 60 gm tubes.

## Storage
- Store at 20 -25C (68-77F)
- DO NOT FREEZE.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Patients using topical corticosteroids should receive the following information and instructions:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under occlusive dressing.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area since these garments may constitute occlusive dressings.

# Precautions with Alcohol
- Alcohol-Amcinonide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- AMCINONIDE

# Look-Alike Drug Names
There is limited information regarding Amcinonide Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price