Pronunciation:

bay-ta-METH-a-sone dye-PROE-pee-oh-nate

Brand Names:

• Alphatrex
• Del-Beta
• Diprosone
• Sernivo
• Dovobet
• Occlucort

Dosage Forms:

• Spray
• Cream
• Lotion
• Ointment

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Betamethasone

Uses of This Medicine:

Betamethasone topical cream, gel, lotion, and ointment are used to help relieve redness, itching, swelling, or other discomforts caused by certain skin conditions. Betamethasone topical spray is used to treat adults with mild to moderate plaque psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of betamethasone topical in children 13 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. Use in children 12 years of age and younger is not recommended.

Appropriate studies have not been performed on the relationship of age to the effects of betamethasone topical spray in the pediatric population. Safety and efficacy have not been established. Use is not recommended in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of betamethasone topical in the elderly.

Although appropriate studies on the relationship of age to the effects of betamethasone topical spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

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.

Other 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.

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:

• Cataracts or
• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Glaucoma 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 or
• Liver failure—May increase risk for more side effects.

• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—The gel should not be used in patients with these conditions.

Proper Use of This Medicine:

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 is for use on the skin only. Do not get it in your eyes, 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.

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

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 help clear up your skin problem completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses.

Do not use the topical cream, gel, lotion, ointment, and spray on the face, scalp, groin, or underarms unless directed to do so by your doctor. Do not use on skin areas that may rub or touch together.

To use:

• 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.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried.
• With the spray, shake well before each use.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with 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, gel, lotion, and ointment):
  • For redness, itching, and swelling of the skin:
    • Adults and children 13 years of age and older—Apply to the affected area of the skin 1 or 2 times a day.
    • Children younger than 13 years of age—Use is not recommended.
• For topical dosage form (spray):
  • For mild to moderate plaque psoriasis:
    • Adults—Apply to the affected area of the skin 2 times a day. Do not use this medicine longer than 4 weeks.
    • Children—Use is not recommended.

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—

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

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.

Throw away any unused betamethasone topical spray after 4 weeks.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

If your symptoms do not improve within 2 to 4 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 have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

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).

Check with your doctor right away if you have a skin rash, blistering, burning, crusting, dryness, flaking of the skin, itching, scaling, severe redness, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Tell your doctor if you are using other medications, including prescription or over-the-counter medications, especially if you take corticosteroid medications by mouth or use other corticosteroid-containing products on your skin. .

Side Effects of This Medicine:

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:

More common

Burning or stinging

itching at the application site

Less common

Blistering, burning, crusting, dryness, or flaking of the skin

cracking or tightening of the skin

dry skin

flushing or redness of the skin

irritation

itching, scaling, severe redness, soreness, or swelling of the skin

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

Rare

Blistering, peeling, or loosening of the skin

Incidence not known

Blindness

blurred vision

change in vision

decreased vision

eye pain

headache

loss of vision

nausea

redness and scaling around the mouth

tearing

vomiting

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

Raised, dark red, or wart-like spots on the skin, especially when used on the face

Rare

Burning, itching, and pain in hairy areas, or pus at the root of the hair

Incidence not known

Acne or pimples

burning and itching of the skin with pinhead-sized red blisters

increased hair growth on the forehead, back, arms, and legs

lightening of normal skin color

lightening of treated areas of dark skin

reddish purple lines on the arms, face, legs, trunk, or groin

softening of the skin

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.