Locoid Lipocream

• Humira
• Locoid Lotion

• Trianex

Read the Locoid Lipocream User Reviews »

© Locoid Lipocream Patient Information is supplied by Cerner Multum, Inc. and Locoid Lipocream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

In the U.S.

• Ala-Cort
• Ala-Scalp HP
• Anusol HC
• Aquanil HC
• Beta HC
• Caldecort
• Cetacort
• Cortaid
• Corticaine
• Corticool Maximum Strength
• Cortizone-10
• Cortizone-5
• Cotacort
• Delacort
• Dermarest
• Dermasorb HC Complete Kit
• Dermtex-HC
• Gly-Cort
• Hydrozone Plus
• Hytone
• Instacort-10
• Ivy Soothe
• IvyStat
• Keratol HC
• Kericort 10
• Lacticare-HC
• Locoid
• Locoid Lipocream
• Medi-Cortisone Maximum Strength
• Microcort
• Mycin Scalp
• Neutrogena T/Scalp
• NuCort
• Nupercainal HC
• Nutracort
• Pandel
• Pediaderm HC Kit
• Preparation H Hydrocortisone
• Proctocream-HC
• Recort Plus
• Sarnol-HC Maximum Strength
• Scalacort
• Scalpcort
• Summer's Eve Specialcare
• Texacort
• Therasoft Anti-Itch & Dermatitis
• U-Cort
• Westcort

In Canada

• Barriere-Hc
• Cortate
• Cort-Eze
• Cortoderm Mild Ointment
• Cortoderm Regular Ointment
• Emo-Cort
• Emo-Cort Scalp Solution
• Hydrocortisone Cream
• Novo-Hydrocort
• Novo-Hydrocort Cream
• Prevex Hc
• Sarna Hc

Available Dosage Forms:

• Solution
• Cream
• Spray
• Lotion
• Ointment
• Pad
• Liquid
• Gel/Jelly
• Kit
• Foam
• Stick
• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Locoid Lipocream. Please read with care.

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.

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, shake it well before using.
• 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.
• 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 redness, itching, and swelling of the skin:
  • For topical dosage form (cream):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Apply to the affected area of the skin two or three times per day.
  • For topical dosage form (lotion):
    • Adults—Apply to the affected area of the skin two to four times per day.
    • Children—Apply to the affected area of the skin two to four times per day.
  • For topical dosage form (ointment):
    • Adults—Apply to the affected area of the skin three or four times per day.
    • Children—Apply to the affected area of the skin three or four times per day.
  • For topical dosage form (solution):
    • Adults—Apply to the affected area of the skin three or four times per day.
    • Children—Apply to the affected area of the skin three or four times per day.

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.

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 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.

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:

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away 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:

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• 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.

None.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Locoid Lipocream®. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid Lipocream® due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4)].

Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST).

Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Locoid Lipocream® as recommended [see Dosage and Administration (2)].

If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids [see Adverse Reactions (6)].

Concomitant Skin Infections

If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of Locoid Lipocream® should be discontinued until the infection has been adequately controlled [see Adverse Reactions (6)].

Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue Locoid Lipocream® if the diagnosis is established [see Adverse Reactions (6)].

Locoid Lipocream® (hydrocortisone butyrate) Cream, 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is 11ß,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula:

Hydrocortisone butyrate is a white to off white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform.

Each gram of Locoid Lipocream® contains 1 mg hydrocortisone butyrate in a white to off white hydrophilic cream base consisting of anhydrous citric acid, ceteth-20, cetostearyl alcohol, butylparaben, mineral oil, propylparaben, purified water, sodium citrate, and white petrolatum.

Locoid Lipocream® Cream, 0.1% is white to off white in color, and supplied in tubes of 45 g (NDC 16781-384-45) and 60 g (NDC 16781-384-60).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Applies to hydrocortisone topical: topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

Other dosage forms:

• topical application cream, topical application lotion, topical application ointment, topical application solution
• topical application cream
• topical application cream, topical application ointment

Along with its needed effects, hydrocortisone topical (the active ingredient contained in Locoid Lipocream) 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 while taking hydrocortisone topical:

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects of hydrocortisone topical 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:

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• 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