Del-Beta (Topical application)

Betamethasone topical cream, gel, lotion, and ointment are used to reduce redness, itching, swelling, or other discomforts caused by some 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.

It is very important that your doctor checks 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 get worse, contact 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 using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Contact 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.

Inform 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.

In deciding to use a medicine, the risks of taking it must be balanced against the benefits. This is a choice you and your doctor will make. For this medicine, consider the following:

Allergies

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

Pediatric

Studies have not shown any specific problems that would limit the use of betamethasone topical in children 13 years of age and older. However, due to this medicine's potential for toxicity, it should be used carefully. Children may absorb significant amounts through their skin, which can lead to serious side effects. If your child is using this medicine, closely follow your doctor's instructions. Use in children 12 years of age and younger is not recommended.

Studies have not been conducted on the effects of betamethasone topical spray in the pediatric population. Safety and effectiveness have not been established. Use is not recommended in children.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the usefulness of betamethasone topical.

Although studies on the effects of betamethasone topical spray in older adults have not been done, no specific problems have been documented to date.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, 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 worsen these conditions.

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site or
• Liver failure—May increase the risk of more side effects.

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

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 in skin folds (e.g., 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.

In the U.S.

• Alphatrex
• Del-Beta
• Diprosone
• Sernivo

In Canada

• Dovobet
• Occlucort

Available Dosage Forms:

• Spray
• Cream
• Lotion
• Ointment

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Betamethasone

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.