Fluocinolone

Fluocinolone is a prescription medication indicated for the treatment of atopic dermatitis, scalp psoriasis, seborrheic dermatitis of the scalp, and corticosteroid-responsive dermatoses.

• Fluocinolone is available under the following different brand names: Synalar, Capex, Fluoderm, DermaSmoothe FS

Common side effects of Fluocinolone include:

• stinging
• burning
• itching
• irritation
• dryness
• peeling
• redness at the application site when this medication is first applied to the skin
• thinning or softening of the skin
• swollen hair follicles
• blisters
• pimples
• crusting of treated skin
• changes in the color of treated skin
• skin rash or irritation around the mouth
• stretch marks

Serious side effects of Fluocinolone include:

• allergic reactions
• abnormal stress hormone levels
• weakened immune system (from long-term use)

Rare side effects of Fluocinolone include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Cream

• 0.025%
• 0.01%

Ointment

• 0.025%

Topical solution

• 0.01%

Topical oil

• 0.01%

Shampoo

• 0.01%

Atopic dermatitis

Adult dosage

• Body oil: Apply a thin film to the affected area every 8 hours

Pediatric dosage

• Topical oil (0.01%)
• Children aged 3 months and older and adolescents: Moisten skin with Derma-Smoothe/FS body oil; apply a thin film to the affected area two times a day; not for use more than 4 weeks
• Children older than 2 years and adolescents: Apply a thin film of Derma-Smoothe/FS scalp oil to the affected area twice daily; not for use more than 4 weeks

Corticosteroid responsive dermatoses

Adult dosage

• Cream, ointment, solution: Apply to the affected area as a thin film from two to four times daily depending on the severity of the condition
• In hairy sites, the hair should be parted to allow direct contact with the lesion
• Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions

Pediatric dosage

Children and adolescents

• Cream, ointment, solution: Apply to the affected area as a thin film from 2-3 times daily depending on the severity of the condition
• In hairy sites, the hair should be parted to allow direct contact with the lesion
• Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions

Scalp psoriasis

Adult dosage

• Scalp oil: Apply thin film onto scalp; massage thoroughly into wet or dampened hair/scalp; cover with shower cap; leave on overnight or for at least 4 hours; wash with shampoo and rinse thoroughly to remove

Seborrheic dermatitis of the scalp

Adult dosage

• Shampoo: Apply 1-ounce maximum to the scalp once daily; work into a lather and allow to remain on the scalp for 5 min; rinse thoroughly with water to remove from hair

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fluocinolone has no noted severe interactions with any other drugs
• Fluocinolone has no noted serious interactions with any other drugs
• Fluocinolone has no noted moderate interactions with any other drugs
• Fluocinolone has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluocinolone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluocinolone?”

Cautions

• Chronic topical corticosteroid therapy may interfere with growth and development in pediatric patients
• Use med to very high potency for less than 2 weeks to reduce local and systemic side effects
• Use low potency for chronic therapy
• Kaposi's sarcoma reported with prolonged corticosteroid therapy; if noted, consider discontinuing therapy
• Avoid medium to very high potency on the face, folds, and groin because can increase steroid absorption
• Use lower potency for children (ie, increase BSA/kg; therefore, increase systemic absorption)
• If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted
• Contact dermatitis may occur; may be diagnosed as failure to heal rather than clinical exacerbation
• As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues; when used on intertriginous or flexor areas, or on the face, this may occur even with short-term use
• In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted; if a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled
• Avoid contact with the eyes
• Patients should be advised not to use this medication for any disorder other than that for which it was prescribed
• Shampoo has only proven effective in corticosteroid-responsive dermatoses, other than seborrheic dermatitis of the scalp
• Hypothalamic-pituitary-adrenal (HPA) axis suppression
  • Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients
  • Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings
  • Patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and adrenocorticotropic hormone–stimulation tests
  • If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid
  • Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug
  • Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids
  • Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Excretion in milk unknown; use with caution