Description
Halobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by certain skin conditions. It is also used to treat plaque psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Lotion
- Foam
- Cream
- Ointment
Before Using
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of halobetasol topical in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and use is not recommended.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of halobetasol topical in the elderly.
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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
- Hyperglycemia (high blood sugar) 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—The chance of side effects may be increased.
- Perioral dermatitis (skin problem) or
- Rosacea (skin problem)—Should not be used in patients with these conditions.
Proper Use
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine is for use only on the skin. Do not get it into your eyes, nose, mouth, or groin, or apply it on your face or under your arms. Do not use it on skin areas that have cuts, scrapes, or burns. Do not apply the lotion to your nipple or areola, if you are breastfeeding. If it does get on these areas, rinse it off right away with water.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Shake the aerosol foam can just before using.
- Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
- Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
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 or ointment):
- For redness, itching, and swelling of the skin:
- Adults and children 12 years of age and older—Apply to the affected area of the skin 1 or 2 times a day.
- Children younger than 12 years of age—Use is not recommended.
- For redness, itching, and swelling of the skin:
- For topical dosage form (foam or lotion):
- For plaque psoriasis:
- Adults and children 12 years of age and older—Apply to the affected area of the skin 2 times a day for up to 2 weeks.
- Children younger than 12 years of age—Use is not recommended.
- For plaque psoriasis:
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.
Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Precautions
It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.
If your or your child's symptoms do not improve within a few days or weeks, or if they become worse, check with your doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.
Halobetasol lotion may cause serious skin reactions, which may occur if you cover the treated skin area or use the medicine for a long time. Check with your doctor right away if you or your child have thinning of the skin with easy bruising, reddish purple lines on the arms, face, legs, trunk, or groin areas, acne or pimples, darkening or lightening of skin color, blistering, burning, crusting, dryness, flaking of the skin, or itching, scaling, severe redness, soreness, or swelling of the skin.
Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Do not use cosmetics or other skin care products on the treated areas.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Blisters under the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- dry skin
- flushing or redness of the skin
- headache
- hives or welts, itching, skin rash
- raised, dark red, wart-like spots on the skin, especially when used on the face
- stinging
- thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
- unusually warm skin
Incidence not known
- Blistering, burning, crusting, dryness, or flaking of the skin
- redness and scaling around the mouth
- scaling, severe redness, soreness, or swelling of the skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Acne or pimples
- burning and itching of the skin with pinhead-sized red blisters
Incidence not known
- Burning, itching, and pain in hairy areas, or pus at the root of the hair
- earache
- fever
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of treated areas of dark skin
- muscle aches
- painful blisters on the trunk of the body
- reddish purple lines on the arms, face, legs, trunk, or groin
- redness or swelling in the ear
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20073707
