Derma Smoothe FS (Fluocinolone Acetonide)
Derma Smoothe FS (flucinolone acetonide) Dosage and Side Effects
DERMA SMOOTHE FS is used to relieve inflammation and itching associated with skin conditions such as moderate-to-severe allergic dermatitis, eczema of the outer ear in children, eczema in adults, and seborrheic dermatitis.
Warnings and Precautions
Do not use fluocinolone acetonide if you:
- are allergic 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
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.
Adverse effects: Although adverse effects associated with the use of this medication are uncommon and not to be expected from ordinary use, sensitization, irritation, and failure of therapeutic response have been noticed in rare instances. If you don't notice an improvement in your skin condition after using this medication for one week, contact your doctor.
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: This medication contains 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 psoriasis 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 fluocinolone acetonide topical oil have not been established for children under 1 year old. The safety and effectiveness of fluocinolone acetonide ear drops has not been established in children under 12 years old.
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.
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 disconfort
- 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
- lack of healing 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:
- flare-up or worsening of existing skin condition
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.
Interactions with this medication
There may be an interaction between fluocinolone acetonide and any of the following:
- 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.
Proper Use of this medication
Shampoo: Approximately one ounce (about 30 mL) or less of shampoo should be applied to wet hair and scalp once daily. Work into a lather and leave on the scalp for 5 minutes before rinsing twice with clear water.
Otic (ear) solution: Tilt the head so the affected ear is facing up. Gently pull the earlobe backward and upward to open the ear canal. Apply 5 drops of solution into the ear and keep head tilted for one minute to let the drops run into the ear canal. This should be repeated twice daily. Improvement should occur within 7 days. Contact your physician if your condition does not begin to improve within 7 days.
Do not use the ear solution if the eardrum is perforated.
Oil: After wetting or dampening the affected area, apply a thin film of oil 2 to 3 times daily as prescribed by your doctor. Massage the oil into the skin gently.
The affected area should not be covered with dressings that do not allow the skin to breathe, including diapers when applied to small children. This medication should not be applied 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.
Use the oil for the minimum length of time necessary to heal the skin condition.
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, 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.
Safely discard any remaining shampoo 3 months after it is prepared by the pharmacist.
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.
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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.