Aclovate

Name: Aclovate

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of alclometasone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Aclovate (alclometasone topical)?

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use alclometasone topical on broken or infected skin. Also avoid using this medicine in open wounds.

Avoid applying alclometasone topical to the skin of your face, underarms, or groin area without your doctor's instruction.

Do not use alclometasone topical to treat any condition that has not been checked by your doctor.

Uses for Aclovate

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.1 4 5 6 7 8 9 10 11 13 14 17 18 d

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).b

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.b

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.b

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)b

Response may vary from one topical corticosteroid preparation to another.b

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.b

Manufacturers state that alclometasone should not be used for the treatment of acne, rosacea, or perioral dermatitis.22 23

Alclometasone dipropionate 0.05% cream and ointment are considered to have low-to-medium range potency.b c d

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Alclometasone Dipropionate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.05%*

Alclometasone Dipropionate Cream (with propylene glycol)

Fougera, Taro

Aclovate (with propylene glycol)

GlaxoSmithKline

Ointment

0.05%*

Alclometasone Dipropionate Ointment

Fougera, Taro

Aclovate (with propylene glycol)

GlaxoSmithKline

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Change in color of skin.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Skin irritation.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Aclovate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aclovate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Dosage and administration

Apply a thin film of Aclovate® Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

Aclovate® Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of Aclovate® Cream or 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.

Aclovate® Cream or Ointment should not be used with occlusive dressings unless directed by a physician. Aclovate® Cream or 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 Aclovate® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Aclovate Drug Class

Aclovate is part of the drug classes:

  • Corticosteroids, moderately potent group II

  • Antiinflammatory Corticosteroids

Dosing & Uses

Dosage Forms & Strengths

cream

  • 0.05%

ointment

  • 0.05%

Inflammatory & Pruritic Skin Disorders

Apply thin film to affected area q8-12hr; discontinue treatment when control achieved

Reassess diagnosis if no improvement within 2 weeks

Dosage Forms & Strengths

cream

  • 0.05%

ointment

  • 0.05%

Inflammatory & Pruritic Skin Disorders

Apply thin film to affected area q8-12hr; discontinue treatment when control achieved

Reassess diagnosis if no improvement within 2 weeks

For the Consumer

Applies to alclometasone topical: external cream, external ointment

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