Pronunciation:

floo-TIK-a-sone PROE-pee-oh-nate

Brand Names:

• Cutivate

Dosage Forms:

• Lotion
• Ointment
• Cream

Classifications:

Therapeutic—

Corticosteroid, Intermediate

Pharmacologic—

Fluticasone

Uses of This Medicine:

Fluticasone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis). 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 fluticasone lotion in children 1 year of age and older, and the fluticasone cream in children 3 months 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. For the ointment form, use in children is not recommended.

Older adults—

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

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:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Glucosuria (sugar in the urine) or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Diaper dermatitis in infants or
• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Should not be used in patients with these conditions.

• Eczema (skin problem) or
• Psoriasis (skin problem)—Cutivate® cream may decrease cortisol (hormone released by the adrenal gland) levels in the blood.

• Formaldehyde (formalin) allergy, history of—Cutivate® cream or lotion should not be used in patients with this condition as it may prevent healing or worsen skin conditions.

• 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.

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. 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 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.

Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

Do not use the this medicine for more than four weeks.

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.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor. Cutivate® cream or lotion should not be used in the diaper areas.
• 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 atopic dermatitis:
  • For topical dosage form (cream):
    • Adults and children 3 months of age and older—Apply to the affected area of the skin one or two times per day.
    • Infants younger than 3 months of age—Use and dose must be determined by your doctor.
  • For topical dosage form (lotion):
    • Adults and children 1 year of age and older—Apply to the affected area of the skin once per day.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
• For redness, itching, and swelling of the skin:
  • For topical dosage form (cream):
    • Adults and children 3 months of age and older—Apply to the affected area of the skin two times per day.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
  • For topical dosage form (ointment):
    • Adults—Apply to the affected area of the skin two times per day.
    • 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.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child 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 two 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 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.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

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

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

Dry skin

Less common

Breakdown of the skin

burning or stinging skin

hives or welts

irritation and redness of the skin

itching

numbness of the fingers

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

skin rash

Rare

Pain

red rash with watery, yellow-colored, or pus filled blisters

skin rash, encrusted, scaly, and oozing

swelling

tenderness

thick yellow to honey-colored crusts

warmth on the skin

Incidence not known

Abdominal or stomach pain

backache

black, tarry stools

bleeding gums

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

blood in the urine or stools

blurred vision

chest pain

cough or hoarseness

dry mouth

facial hair growth in females

fever or chills

flushed, dry skin

fractures

fruit-like breath odor

full or round face, neck, or trunk

increased hunger

increased thirst or urination

irritability

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

loss of sexual desire or ability

lower back or side pain

menstrual irregularities

muscle wasting

nausea

painful or difficult urination

pinpoint red spots on the skin

redness and scaling around the mouth

shortness of breath

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sugar in the urine

sweating

swelling of the throat

swollen glands

thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

tightness in the chest

troubled breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

wheezing

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

Body aches or pain

change in hearing

common cold

diarrhea

difficulty with breathing

ear congestion

ear drainage

earache or pain in the ear

headache

loss of voice

nasal congestion

runny nose

Rare

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

stuffy nose

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

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.