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Enstilar (calcipotriene, betamethasone dipropionate): Side Effects & Warnings

What is Enstilar, and how does it work?

Enstilar Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 12 years of age and older. It is not known if Enstilar Foam is safe and effective in children under 12 years of age.

What are the side effects of Enstilar?

Enstilar Foam may cause
serious side effects, including:

  • Too much calcium in your
    blood or urine.
    Your healthcare provider
    may tell you to stop or temporarily stop treatment with Enstilar Foam if you
    have too much calium in your blood or urine.
  • Enstilar Foam can pass
    through your skin.
    Too much Enstilar Foam
    passing through your skin can cause your adrenal glands to stop working
    properly. Your healthcare provider may do blood tests to check for adrenal
    gland problems.
  • Cushing’s syndrome, a condition that happens
    when your body is exposed to too much of the hormone cortisol.
  • High blood sugar
    (hyperglycemia) and sugar in your urine.

Your healthcare provider may do
blood and urine tests to check your calcium levels and adrenal gland function while you are using Enstilar Foam.

  • Skin problems, including reactions where Enstilar Foam is applied, and
    allergic reactions (allergic contact dermatitis).
  • Eye problems. Using Enstilar Foam may increase your chance of getting
    cataracts and glaucoma. Do not get Enstilar
    Foam in your eyes because it may cause eye irritation. Tell your healthcare
    provider if you have blurred vision or other vision problems during treatment
    with Enstilar Foam.

The most common side effects
of Enstilar Foam include:

These are not all the possible
side effects of Enstilar Foam.

Call your doctor for medical
advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

What is the dosage for Enstilar?

Instruct patients to shake can prior to using Enstilar
Foam and to wash their hands after applying the product. Apply Enstilar Foam to
affected areas once daily for up to 4 weeks. Rub in Enstilar Foam gently.
Discontinue Enstilar Foam when control is achieved. Patients should not to use
more than 60 grams every 4 days.

Enstilar Foam should not be:

  • Used with occlusive dressings unless directed by a
    healthcare provider.
  • Used on the face, groin, or axillae, or if skin atrophy
    is present at the treatment site.

Enstilar Foam is not for oral, ophthalmic, or
intravaginal use.

What drugs interact with Enstilar?

No Information provided

Is Enstilar safe to use while pregnant or breastfeeding?

  • Available data with Enstilar Foam are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes.
  • Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of Enstilar Foam is likely to be low.
  • There is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Concentrations of calcipotriene in plasma are low after topical administration, and therefore, concentrations in human milk are likely to be low.

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