Alclometasone

Name: Alclometasone

Forms of Medication

Alclometasone is available in the following forms:

  • Topical Cream
  • Topical Ointment

How is this medicine (Alclometasone) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Use as you have been told, even if your signs get better.
  • Do not take alclometasone by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
  • Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
  • Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
  • Clean affected part before use. Make sure to dry well.
  • Put a thin layer on the affected skin and rub in gently.
  • Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.

What do I do if I miss a dose?

  • Put on a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not put on 2 doses or extra doses.

What are some other side effects of Alclometasone?

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.

Alclometasone Description

Alclometasone dipropionate cream USP, 0.05% and Alclometasone dipropionate ointment USP, 0.05% contain Alclometasone dipropionate USP (7α-chloro-11ß,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Chemically, Alclometasone dipropionate USP is C28H37ClO7. It has the following structural formula:

Alclometasone dipropionate USP has the molecular weight of 521. It is a white powder insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol.

Each gram of Alclometasone dipropionate cream USP contains 0.5 mg of Alclometasone dipropionate USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, Ceteth-20, monobasic sodium phosphate monohydrate, chlorocresol, phosphoric acid, and purified water.

Each gram of Alclometasone dipropionate ointment USP contains 0.5 mg of Alclometasone dipropionate USP in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.

Alclometasone Dosage and Administration

Apply a thin film of Alclometasone dipropionate cream USP or Alclometasone dipropionate ointment USP to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of Alclometasone dipropionate 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.

Alclometasone dipropionate cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate 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 Alclometasone dipropionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Pronunciation

(al kloe MET a sone)

Onset of Action

Initial response (Ruthven 1988): Eczema: 5.3 days; Psoriasis: 6.7 days

Time to Peak

Peak response (Ruthven 1988): Eczema: 13.9 days; Psoriasis: 14.8 days

Dosing Renal Impairment

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

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

What are some other side effects of this drug?

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.

Usual Adult Dose for Dermatitis

Apply a thin film to the affected area two or three times a day

Comments: Massage gently until the drug disappears

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

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