Topicort LP

Name: Topicort LP

What is the most important information I should know about Topicort LP (desoximetasone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with desoximetasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

How should I use Topicort LP (desoximetasone topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using desoximetasone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with desoximetasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use desoximetasone topical regularly to get the most benefit.

If you use this medication long-term, your blood will need to be tested often. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Keep from freezing.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of desoximetasone 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 other drugs will affect Topicort LP (desoximetasone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied desoximetasone. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Before Using Topicort LP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of desoximetasone topical spray in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of desoximetasone in children 10 years of age or older. However, because of this medicine's toxicity, it should be used with caution. Children and teenagers who must use this medicine should be checked often by their doctor since desoximetasone topical may be absorbed through the skin and can affect growth or cause other unwanted effects. Safety and efficacy have not been established in children younger than 10 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desoximetasone topical spray in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving desoximetasone topical spray.

No information is available on the relationship of age to the effects of desoximetasone topical in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cushing's syndrome (adrenal gland disorder) or
  • Diabetes or
  • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.
  • Infection of the skin at or near the place of application or
  • Large sores, broken skin, or severe skin injury at the place of application or
  • Liver failure—The chance of side effects may be increased.

Proper Use of desoximetasone

This section provides information on the proper use of a number of products that contain desoximetasone. It may not be specific to Topicort LP. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Do not use this medicine on your face, armpits, or groin area unless your doctor tells you to.

To use the cream, gel, ointment, or spray:

  • Wash your hands with soap and water before and after using this medicine.
  • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
  • Do not bandage, wrap, or use diapers on the skin being treated unless directed to do so by your doctor.
  • Do not use the spray for more than 4 weeks unless your doctor has told you to.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage forms (cream, gel, and ointment):
    • For redness, itching, and swelling of the skin:
      • Adults—Apply to the affected area of the skin two times a day.
      • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (spray):
    • For plaque psoriasis:
      • Adults—Apply to the affected area of the skin two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The spray bottle is flammable. Do not use it near heat, an open flame, or while smoking. Throw away any unused medicine after 30 days.

Uses of Topicort LP

  • It is used to treat skin rashes.
  • It is used to treat psoriasis.

If OVERDOSE is suspected

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.

For Healthcare Professionals

Applies to desoximetasone topical: compounding powder, topical cream, topical gel, topical ointment, topical spray

General

The most commonly reported side effects were application site dryness, application site irritation, and application site pruritus.[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Dermatologic

Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria[Ref]

Local

Common (1% to 10%): Application site dryness, application site irritation, application site pruritus
Frequency not reported: Burning, itching[Ref]

Metabolic

Frequency not reported: Hyperglycemia, latent diabetes mellitus[Ref]

Some side effects of Topicort LP may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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