Amicla

Amicla^® (amcinonide) is a high potency topical corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses for a maximum duration of 5 days on the face, axillae, scrotum and scalp and a maximum of 3 weeks on the body.

Geriatrics (> 65 Years Of Age)

Safety and effectiveness of Amicla^® in geriatric patients over 65 years of age have not been established (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics (> 65 Years Of Age)).

Pediatrics (<18 Years Of Age)

Safety and effectiveness of Amicla^® in pediatric patients less than 18 years of age have not been established (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics (<18 Years Of Age)).

Dosing Considerations

• Patients/caregivers should be instructed to use the minimum quantity of Amicla^® for the shortest duration of time necessary to achieve the desired therapeutic benefit because of the potential for corticosteroids to suppress the hypothalamic-pituitary-adrenal (HPA) axis and cause skin atrophy (See WARNINGS AND PRECAUTIONS).
• If the condition worsens or does not improve within 2 weeks, treatment and diagnosis should be re-evaluated.
• Use in pediatric patients is not recommended. Pediatric patients are more likely to develop local and systemic toxicity from equivalent doses of topical corticosteroids because of their larger skin surface to body weight ratios.
• Geriatric patients may be more susceptible to percutaneous absorption and the potential effects of systemic absorption. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs.

Recommended Dose And Dosage Adjustment

Apply a thin layer to affected area once or twice daily and gently rub in. Allow adequate time for absorption after each application before applying an emollient.

Amicla^® should not be used for longer than 5 days on the face, axillae, scrotum and scalp (see WARNINGS AND PRECAUTIONS).

Amicla^® should not be used for longer than 2 to 3 weeks on the body (see WARNINGS AND PRECAUTIONS). If the condition worsens or does not improve within 2 weeks, treatment and diagnosis should be re-evaluated.

Avoid abrupt discontinuation of Amicla^® therapy once control is achieved as rebound of pre-existing dermatoses can occur. Continue an emollient as maintenance therapy.

Pediatrics (< 18 Years Of Age)

The safety and effectiveness of Amicla^® in pediatric patients less than 18 years of age have not been established (see WARNINGS AND PRECAUTIONS - Special Populations, Pediatrics (< 18 Years Of Age)).

Geriatrics (> 65 Years Of Age)

Amicla^® should be used with caution in geriatric patients due to increased risk of renal or hepatic impairment in this population. The minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS - Special Populations, Geriatrics (> 65 Years Of Age)).

Renal/Hepatic Impairment

In patients with renal or hepatic impairment, the minimum quantity should be used for the shortest duration to achieve the desired therapeutic benefit (see WARNINGS AND PRECAUTIONS - Special Populations, Patients With Renal / Hepatic Impairment).

Missed Dose

In the event of a missed dose, Amicla^® should be applied as soon as possible after the missed dose is remembered. If this is close to the scheduled application time or the next dose, the patient should wait and apply the next scheduled dose. The usual schedule should be resumed thereafter.

Administration

• Amicla ^® is for topical use only.
• Use with occlusive dressings is not recommended (see WARNINGS AND PRECAUTIONS).
• Amicla^® is not for use in or near the eye or on other mucous membranes.

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition And Packaging section of the Product Monograph.
• Patients who are hypersensitive to other corticosteroids.
• Patients with viral (e.g. herpes or varicella) lesions of the skin, bacterial or fungal skin infections, parasitic infections, skin manifestations relating to tuberculosis or syphilis, eruptions following vaccinations, pruritus without inflammation, perioral dermatitis, rosacea, acne vulgaris, perianal and genital pruritus.
• Topical application to the eye.

WARNINGS

Included as part of the "PRECAUTIONS" Section

PRECAUTIONS

General

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Amicla^® Cream, Ointment and Lotion should not be used under occlusion due to increased risk of systemic exposure and infection. When used under occlusive dressing, over extensive areas, or on the face, scalp, axillae, or scrotum, sufficient absorption may occur to result in adrenal suppression and other systemic effects (see Endocrine And Metabolism, Immune, And Ophthalmologic).

Cardiovascular

Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.

Use of corticosteroids around chronic leg ulcers may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

Endocrine And Metabolism

Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. Hyperglycemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids (see ADVERSE REACTIONS).

Conditions which augment systemic absorption include the formulation and potency of the topical corticosteroid, the application of topical corticosteroids over large body surface areas, application to intertriginous areas (such as the axillae), frequency of application, prolonged use, or the use of occlusive dressings. Other risk factors for increased systemic effects include increasing hydration of the stratum corneum, use on thin skin areas (such as the face), and use on broken skin or in conditions where the skin barrier may be impaired.

If patients must be treated over large body surface areas, they should be evaluated periodically for evidence of HPA axis suppression (see Monitoring And Laboratory Tests). If HPA axis suppression or Cushing’s syndrome is observed, an attempt should be made to withdraw the drug by reducing the frequency of application. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see ADVERSE REACTIONS).

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic corticosteroid supplementation, see the prescribing information for those products.

Under treatment with Amicla^®, systemic undesirable effects (see ADVERSE REACTIONS and OVERDOSE) may occur. This is dependent on the absorption of large quantities of the active ingredient through the skin. It must therefore be ensured that the specified duration of treatment (see DOSAGE AND ADMINISTRATION) is not exceeded and the size of the area treated is not more than 10-20% of the body surface area.

Pediatric patients may absorb larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface to body mass ratios as compared with adult patients (see Special Populations, Pediatrics).

Immune

Topical corticosteroids may increase the risk of infections including aggravation of cutaneous infection, masked infection and secondary infections. In particular, bacterial infection is encouraged by the warm, moist conditions within skin-fold areas, or caused by occlusive dressings. If concomitant skin infections develop, Amicla^® should be discontinued and antimicrobial therapy should be administered.

Ophthalmologic

Topical corticosteroids should be used with caution on lesions close to the eye because systemic absorption may cause increased intraocular pressure, glaucoma or cataracts.

Sensitivity

Local hypersensitivity reactions (see ADVERSE REACTIONS) may resemble symptoms of the condition under treatment. If hypersensitivity reactions occur, Amicla^® should be discontinued and appropriate therapy initiated.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

Sexual Function/Reproduction

There are no data in humans to evaluate the effect of topical corticosteroids on fertility. Corticosteroids have been shown to impair fertility in animal studies.

Skin

Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.

If significant irritation develops, Amicla^® should be discontinued and appropriate therapy should be instituted.

Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. Topical corticosteroids should be used with caution on lesions of the face, groin, and axillae as these areas are more prone to atrophic changes than other areas of the body. Frequent observation is important if these areas are to be treated. If skin atrophy is observed, treatment should be discontinued.

Special Populations

Pregnant Women

Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to humans has not been established.

There are no adequate and well-controlled studies of Amicla^® in pregnant women. Administration of Amicla^® during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus. The minimum quantity should be used for the minimum duration.

Due to the expected systemic re-sorption of the active ingredient, intrauterine growth disorders and atrophy of the adrenal cortex of the fetus as observed following long-term oral therapy with glucocorticoids cannot be excluded with long-term use of Amicla^® and its use on large areas.

Nursing Women

The safe use of topical corticosteroids during lactation has not been established.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human breast milk.

Because many drugs are excreted in human milk, caution should be exercised when Amicla^® is administered to a nursing woman. Administration of Amicla^® during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant. Nursing mothers must not apply Amicla^® to the breast area in order to prevent direct contact of the nursing infant with the active ingredient.

It is not known whether Amicla^® is excreted into breast milk. If its use is required on large areas during lactation, nursing mothers should cease nursing.

Pediatrics (<18 Years Of Age)

The safety of Amicla^® has not been studied in pediatric patients.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.

Adverse effects including striae have been reported with use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatrics (> 65 Years Of Age)

The safety of Amicla^® has not been studied in geriatric patients.

In general, topical corticosteroids should be used cautiously in elderly patients, reflecting their increased skin fragility and greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant disease or other drug therapy. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs.

There are no adequate and well-controlled studies of Amicla^® in geriatric patients. For geriatric patients over 65 years of age, the minimum quantity should be used for the minimum duration (see DOSAGE AND ADMINISTRATION).

Patients With Renal / Hepatic Impairment

The safety of Amicla^® has not been studied in patients with renal or hepatic impairment.

In case of systemic absorption, metabolism and elimination may be delayed leading to increased risk of systemic toxicity.

There are no adequate and well controlled studies of Amicla^® in patients with renal or hepatic impairment. For patients with renal or hepatic impairment, the minimum quantity should be used for the minimum duration (see DOSAGE AND ADMINISTRATION).

Monitoring And Laboratory Tests

The cosyntropin (ACTH_1-24) stimulation test may be helpful in evaluating patients for HPA axis suppression.

Post-Market Adverse Drug Reactions

The following adverse reactions are reported when topical corticosteroids are used as recommended. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.

Endocrine Disorders

Hypothalamic-pituitary adrenal (HPA) axis suppression, cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, steroid withdrawal syndrome

Eye Disorders

glaucoma, cataract subcapsular

Gastrointestinal Disorders

upper abdominal pain

General Disorders And Administration Site Conditions

Application site irritation/pain.

Immune System Disorders

local hypersensitivity (see Skin And Subcutaneous Tissue Disorders)

Infections And Infestations

secondary infection

Investigations

Decreased glucose tolerance has also been reported

Skin And Subcutaneous Tissue Disorders

skin striae, skin atrophy, telangiectasia, purpura-like bleeding, acne, dermatitis, hypertrichosis, skin depigmentation, erythema, burning sensation, pruritus, eczema, dryness, itching, local irritation, atrophy of the subcutaneous tissues, pustules, miliaria, folliculitis, pyoderma, allergic contact dermatitis, acneiform eruptions, perioral dermatitis, rash, urticaria, pustular psoriasis, skin wrinkling, alopecia, trichorrhexis, skin infection.

Vascular Disorders

thrombosis

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS AND PRECAUTIONS). In the event of overdose or misuse, the features of hypercortisolism may occur (see ADVERSE REACTIONS).

Excessive prolonged use or misuse may suppress hypothalamic-pituitary-adrenal (HPA) axis function, resulting in secondary adrenal insufficiency. If symptoms of HPA axis suppression occur, amcinonide should be withdrawn gradually by reducing the frequency of application, or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency. Further management should be as clinically indicated. If toxic effects occur, Amicla^® should be discontinued and symptomatic therapy should be administered.