Aclovate

Name: Aclovate

Aclovate Dosage and Administration

General

  • Consider location of the lesion and the condition being treated when choosing a dosage form.b

  • Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.b

  • Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.b

  • Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).c d (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.d

Apply creams and ointments topically to the skin or scalp.c

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.b

Apply cream or ointment sparingly in a thin film and rub gently into the affected area.1 d

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.b

Administration with Occlusive Dressing

Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis).1 17 (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream or ointment; rub gently into the lesion; and apply another thin film.b Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.b

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.b For added moisture in dry lesions, apply cream or ointment and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.b

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.b

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.b

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.b Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.b

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.b

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.b (See Occlusive Dressings under Cautions.)

Dosage

Pediatric Patients

Administer the least amount of topical preparations that provide effective therapy.b (See Pediatric Use under Cautions.)

Corticosteroid-responsive Dermatoses Topical

Children ≥1 year of age: Apply cream or ointment sparingly 2–3 times daily.1 d

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.c d

Adults

Corticosteroid-responsive Dermatoses Topical

Apply cream or ointment sparingly 2–3 times daily.1 d

May be used for 2–6 weeks5 6 7 8 9 10 11 13 14 18 ; however, more prolonged therapy23 with appropriate monitoring17 may be necessary in patients with resistant or chronic conditions.a

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.c d

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses Topical

Children ≥1 year of age: Maximum 3 weeks.c

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.c d

Renal Impairment

No specific dosage recommendations at this time.c d

Geriatric Patients

Careful dosage selection recommended.d

Aclovate Pharmacokinetics

Absorption

Bioavailability

Topically applied alclometasone can be absorbed through normal intact skin.4 22 b c d

Percutaneous penetration varies among individuals14 and can be altered by using occlusive dressings,1 4 16 17 d high corticosteroid concentrations, and certain vehicles.1 15 16 b d

Only minimal amounts of topical corticosteroid reach the dermis and subsequently the systemic circulation after application to most normal skin areas; more absorption occurs from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole.b

Absorption is markedly increased by loss of the skin’s keratin layer and by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema).1 16 17 b d

Distribution

Extent

Not known whether topical alclometasone is distributed into milk.c d

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.22 b

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.1 22

Stability

Storage

Topical

Cream and ointment: 2–30°C.1 Some manufacturers state 20–25°C.d Consult product information for specific recommendations.

Actions

  • Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.c d

  • Anti-inflammatory effects may occur through induction of phospholipase A2 inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids.d Decreased arachidonic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).d

  • Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.b

What are some things I need to know or do while I take Aclovate?

  • Tell all of your health care providers that you take Aclovate. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not use to treat diaper rash.
  • Do not use tight-fitting diapers or plastic pants if treated part is in the diaper area. This may cause more drug to get into the body.
  • Talk with your doctor before you use other drugs or products on your skin.
  • Do not put on cuts, scrapes, or damaged skin.
  • Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
  • Do not use longer than you have been told by the doctor.
  • Use with care in children. Talk with the doctor.
  • Do not give this medicine to a child younger than 1 year of age.
  • This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Aclovate while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Aclovate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and usage

Aclovate® Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Aclovate® Cream and 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). Since the safety and efficacy of Aclovate® Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL

NDC 0462-0263-60

PHARMADERM®

Aclovate® Cream, 0.05%

(alclometasone dipropionate cream)

For dermatologic use only – Not for ophthalmic use.

Rx only 60 g

Pharmacology

Mechanism of Action

Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation

Pharmacokinetics

Absorption: 3% absorbed systemically after 8 hr following skin application

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