Halog

These medicines are like cortisone. They belong to the general family of medicines called steroids .

These corticosteroids are available only with your doctor`s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although this use is not included in product labeling, topical corticosteroids may be used in certain patients with the following medical condition:

• Phimosis

This product is available in the following dosage forms:

• Ointment


• Cream


• Foam


• Lotion


• Solution


• Emollient Cream


• Gel/Jelly


• Spray


• Kit


• Tape

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Children and teenagers who must use this medicine should be checked often by their doctor since this medicine may be absorbed through the skin and can affect growth or cause other unwanted effects.

Geriatric

Certain side effects may be more likely to occur in elderly patients since the skin of older adults may be naturally thin. These unwanted effects may include tearing of the skin or blood-containing blisters on the skin .

Pregnancy

When used properly, these medicines have not been shown to cause problems in humans. Studies on birth defects have not been done in humans. However, studies in animals have shown that topical corticosteroids, when applied to the skin in large amounts or used for a long time, could cause birth defects.

Breastfeeding

Topical corticosteroids have not been reported to cause problems in nursing babies when used properly. However, corticosteroids should not be applied to the breasts before nursing.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or


• Glaucomaa€”Corticosteroids may make these medical problems worse, especially when stronger corticosteroids are used in the eye area.

• Infection or sores at the place of treatment (unless your doctor also prescribed medicine for the infection) or


• Tuberculosisa€”Corticosteroids may make existing infections worse or cause new infections.

• Skin conditions that cause thinning of skin with easy bruisinga€”Corticosteroids may make thinning of the skin worse.

Proper Use

Be very careful not to get this medicine in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get this medicine in your eyes, flush them with water .

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor .

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed . If you have any questions about this, check with your doctor .

Do not use on face, groin, or armpits unless directed to do so by your doctor .

For patients using the foam form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Do not use near heat, near an open flame, or while smoking.

For patients using the topical aerosol form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• It is important to avoid breathing in the vapors from the spray or getting them in your eyes. If you accidentally get this medicine in your eyes, flush them with water .


• Do not use near heat, near an open flame, or while smoking.

For patients using flurandrenolide tape:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.

Do not use this medicine more often or for a longer time than your doctor ordered. To do so may increase the chance of absorption through the skin and the chance of side effects. In addition, too much use, especially on areas with thinner skin (for example, face, armpits, groin), may result in thinning of the skin and stretch marks or other unwanted effects.

Do not use this medicine for other skin problems without first checking with your doctor . Topical corticosteroids should not be used on many kinds of bacterial, viral, or fungal skin infections.

The dose of topical corticosteroid will be different for different patients and products . Follow your doctor`s orders or the directions on the label.

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Do not puncture, break, or burn aerosol containers, even after they are empty .

Precautions

Check with your doctor if your symptoms do not improve within 1 week or if your condition gets worse.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child`s diaper area. Plastic pants or tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

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 as soon as possible if any of the following side effects occur:

Less common or rare

• Blood-containing blisters on skin


• Burning and itching of skin


• Increased skin sensitivity (for some brands of betamethasone lotion)


• Lack of healing of skin condition


• Loss of top skin layer (for tape dosage forms)


• Numbness in fingers


• Painful, red or itchy, pus-containing blisters in hair follicles


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


• Skin infection


• Thinning of skin with easy bruising

Additional side effects may occur if you use this medicine improperly or for a long time. Check with your doctor if any of the following side effects occur:

Rare

• Acne or oily skin


• Backache


• Blurring or loss of vision (occurs gradually if certain products have been used near the eye)


• Burning and itching of skin with pinhead-sized red blisters


• Eye pain (if certain products have been used near the eye)


• Filling or rounding out of the face


• Increased blood pressure


• Irregular heartbeat


• Irregular menstrual periods


• Irritability


• Irritation of skin around mouth


• Loss of appetite


• Mental depression


• Muscle cramps, pain, or weakness


• Nausea


• Rapid weight gain or loss


• Reddish purple lines (stretch marks) on arms, face, legs, trunk, or groin


• Skin color changes


• Softening of skin


• Stomach bloating, burning, cramping, or pain


• Swelling of feet or lower legs


• Tearing of the skin


• Unusual bruising


• Unusual decrease in sexual desire or ability (in men)


• Unusual increase in hair growth, especially on the face


• Unusual loss of hair, especially on the scalp


• Unusual tiredness or weakness


• Vomiting


• Weakness of the arms, legs, or trunk (severe)


• Worsening of infections

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 or rare

• Burning, dryness, irritation, itching, or redness of skin


• Increased redness or scaling of skin sores


• Skin rash

When the foam, gel, lotion, solution, or aerosol form of this medicine is applied, a mild, temporary stinging may be expected .

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.