LoKara

Desonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Desonide topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Desonide topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

This section provides information on the proper use of a number of products that contain desonide. It may not be specific to LoKara. 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, nose, 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 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 the topical gel on the groin or underarms unless directed to do so by your doctor, and do not use this form for more than 4 weeks.

To use cream, gel, lotion, or ointment:

• 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. Also, shake the lotion well before using it.
• 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.

To use the foam:

• Wash your hands with soap and water before and after using this medicine.
• Shake the foam well before using it.
• Do not put the foam directly on your face. Turn the can upside down and place a small amount of medicine in your hands. Massage it gently into the affected areas of the face until the medicine has dried. For areas other than the face, you may put it directly on the affected area.
• Do not wash or rinse the treated area right after applying the medicine.
• Do not use this medicine near heat, an open flame, or while smoking.

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 forms (foam or gel):
    • Adults and teenagers—Apply to the affected area of the skin two times per day.
    • 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 redness, itching, and swelling of the skin:
  • For topical dosage forms (cream, ointment, or lotion):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Use and dose must be determined by your doctor.

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

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.

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

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Use LoKara as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Shake well before use.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Skin irritation.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Change in color of skin.
• Swelling.

LoKara™ Lotion (desonide lotion 0.05%) contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α-) a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Chemically, desonide is C24H32O6. It has the following structural formula:

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water.

Each gram of LoKara™ Lotion (desonide lotion 0.05%) contains 0.5 mg of desonide in a base of sodium lauryl sulfate, light mineral oil, cetyl alcohol, stearyl alcohol, propylene glycol, methylparaben, propylparaben, sorbitan monostearate, glyceryl stearate SE, edetate sodium, citric acid anhydrous and purified water. May also contain additional citric acid and/or sodium hydroxide for pH adjustment.

Topically applied LoKara™ Lotion (desonide lotion 0.05%) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Applies to desonide topical: topical application cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment

Along with its needed effects, desonide topical (the active ingredient contained in LoKara) 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 desonide topical:

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• flushing or redness of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• peeling of the skin
• raised, dark red, wart-like spots on the skin, especially when used on the face
• stinging and burning
• unusually warm 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)

Some side effects of desonide 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:

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Cold flu-like symptoms
• congestion
• cough
• hoarseness
• irritability
• noisy breathing
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• voice changes
• wheezing

• 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
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin

Applies to desonide topical: compounding powder, topical cream, topical foam, topical gel, topical kit, topical lotion, topical ointment

General

The most commonly reported side effects were headache, insomnia, impetigo, skin infection, and rash.[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction including facial edema[Ref]

Dermatologic

Common (1% to 10%): Impetigo, skin infection, rash
Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria
Postmarketing reports: Pruritus, skin disorder[Ref]

Local

Frequency not reported: Burning, itching, irritation, dryness[Ref]

Other

Common (1% to 10%): Flu syndrome aggravated[Ref]

Nervous system

Common (1% to 10%): Headache, insomnia[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria, latent diabetes mellitus[Ref]

Some side effects of LoKara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.