Ultravate Ointment

DRUG DESCRIPTION

Ultravate® (halobetasol propionate ointment) Ointment,0.05% contains halobetasol propionate,a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent.

Chemically halobetasol propionate is 21-chloro-6?,9-difluoro-11?,17-dihydroxy-16?-methylpregna-1,4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:

Ultravate® (halobetasol propionate) Structural Formula Illustration

Halobetasol propionate has the molecular weight of 485.It is a white crystalline powder insoluble in water.

Each gram of Ultravate Ointment contains 0.5 mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pen-taerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate,and stearyl citrate.

What are the possible side effects of halobetasol topical (Ultravate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing halobetasol topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • ...

Read All Potential Side Effects and See Pictures of Ultravate Ointment »

What are the precautions when taking halobetasol propionate ointment (Ultravate Ointment)?

Before using halobetasol, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, immune system problems, certain skin conditions (rosacea, perioral dermatitis).

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore,...

Read All Potential Precautions of Ultravate Ointment »


Ultravate Ointment Consumer (continued)

SIDE EFFECTS: Burning, stinging, itching, dryness or redness may occur when first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, excessive hair growth, "hair bumps" (folliculitis).

Skin infections can become worse when using this medication. Notify your doctor promptly if redness, swelling or irritation does not improve.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using halobetasol, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, immune system problems, certain skin conditions (rosacea, perioral dermatitis).

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug, when applied to the skin, passes into breast milk. Other medications in this class, when taken by mouth, pass into breast milk. Consult your doctor before breast-feeding.


Ultravate Ointment Patient Information Including Side Effects

Brand Names: Ultravate

Generic Name: halobetasol topical (Pronunciation: HAL oh BAY ta sol)

  • What is halobetasol topical (Ultravate Ointment)?
  • What are the possible side effects of halobetasol topical (Ultravate Ointment)?
  • What is the most important information I should know about halobetasol topical (Ultravate Ointment)?
  • What should I discuss with my healthcare provider before using halobetasol topical (Ultravate Ointment)?
  • How should I use halobetasol topical (Ultravate Ointment)?
  • What happens if I miss a dose (Ultravate Ointment)?
  • What happens if I overdose (Ultravate Ointment)?
  • What should I avoid while using halobetasol topical (Ultravate Ointment)?
  • What other drugs will affect halobetasol topical (Ultravate Ointment)?
  • Where can I get more information?

What is halobetasol topical (Ultravate Ointment)?

Halobetasol is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Halobetasol topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Halobetasol topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of halobetasol topical (Ultravate Ointment)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing halobetasol topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling tired.

Less serious side effects may include:

  • mild skin rash, itching, burning, redness, or dryness;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • swollen hair follicles;
  • spider veins;
  • numbness or tingling;
  • changes in color of treated skin;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about halobetasol topical (Ultravate Ointment)?

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 halobetasol 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 within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

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