Derma-Smoothe/FS

For adults, this medication should be applied 2 to 3 times daily. For children over the age of 3 months, this medication should be applied 2 times daily.

After wetting or dampening the affected area, apply a thin film of oil to the skin as prescribed by your doctor. Massage the oil into the skin gently.

Do not cover the affected area with dressings that do not allow the skin to breathe, including diapers when applied to small children. Do not apply this medication to the face, groin, or underarm areas. Applying the oil to these areas may cause enough medication to be absorbed into the body to cause side effects.

If this medication is being used to treat a scalp condition, wet hair and scalp, then apply thin film of oil to entire scalp. Massage scalp and cover with supplied shower cap overnight (for at least 4 hours).

Use the oil for the minimum length of time necessary to heal the skin condition. It should not be used for longer than 4 weeks in children. If no improvement is seen within 2 weeks, contact your doctor.

Avoid getting this medication into your eyes. If contact does occur, flush your eyes immediately with plenty of water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store all forms of this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Topical oil
Each mL of topical oil contains fluocinolone acetonide 0.01%. Nonmedicinal ingredients: refined peanut oil NF, light mineral oil, oleth-2, isopropyl myristate, isopropyl alcohol, cream fragrance, and balsam pine fragrance.

Do not use fluocinolone acetonide if you:

• are allergic to fluocinolone acetonide or any ingredients of this medication

• are allergic to peanuts

• have skin infections caused by viruses, including herpes simplex, vaccinia, and varicella (chickenpox)

• have tuberculous skin lesions

• have untreated infected skin lesions caused by an infection with fungi or bacteria

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burning, dryness, irritation, itching, or redness of the skin (usually mild and temporary)

• ear discomfort (if using ear drops)

• increased redness or scaling of skin sores (usually mild and temporary)

• skin rash (usually mild and temporary)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blood-containing blisters on the skin

• burning and itching of the skin

• change of skin colour (loss of colour or darkening)

• lack of healing or worsening of the skin condition

• numbness in the fingers

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

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

• skin infection

• thinning of the skin with easy bruising

Stop taking the medication and seek immediate medical attention if any of the following occur:

• bulging of the soft parts of the head (fontanelles) in infants

• severe headache or change in vision in children

• symptoms of a serious allergic reaction (e.g., difficulty breathing, dizziness, itching, rash, swelling)

• symptoms of high levels of corticosteroids in the blood stream (e.g., fatigue, increased thirst and urination, irritability, muscle weakness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Absorption: When fluocinolone is used over extensive areas for prolonged periods and under dressings that don't breathe, it is possible that enough medication will absorb into the bloodstream to give rise to unwanted side effects. Therefore, it is advisable to use fluocinolone for brief periods only and to stop using it as soon as the problem clears.

Eyes: Use this medication with caution on lesions close to the eye. Take care to ensure that it does not enter the eye, as glaucoma may result. Cataracts have been reported following internal use of corticosteroids.

Infection: Topical corticosteroids may increase the risk of developing a skin infection. Contact your doctor if you notice any increased redness, swelling, heat or pain around the area where the medication is applied as these are possible signs of infection.

Peanut allergy: Some formulations of this medication contain refined peanut oil. People with peanut allergy should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Thinning of skin: Using topical corticosteroid medications for a long period of time can cause skin to thin or soften or cause stretch marks. Your doctor may recommend you stop using this medication once in a while or to apply to one area of the body at a time. Suddenly stopping corticosteroid medication may cause your skin condition to return.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking fluocinolone acetonide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using certain formulations of fluocinolone acetonide have not been established for children. Check with your doctor or pharmacist before using this medication on a child.

The active ingredient in these medications, fluocinolone, belongs to the family of medications known as corticosteroids. Children may be more likely to experience the side effects encountered by using large amounts of this class of medication for long periods of time (e.g., slowing down of growth, delayed weight gain). The use of this medication by children should be limited to the smallest amount that will be effective. Discuss with your doctor the risks and benefits of the use of this medication by children. The use of this medication on children should be limited to a 4 week duration.

There may be an interaction between fluocinolone acetonide and any of the following:

• aldesleukin

• deferasirox

• hyaluronidase

• other topical medications that contain corticosteroids

• other topical medications that have irritating effects

If you are using any medications that fit this description, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription) and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Derma-SmootheFS