Dosing & Uses
Dosage Forms & Strengths
cream
- 0.025%
- 0.01%
ointment
- 0.025%
topical solution
- 0.01%
topical oil
- 0.01%
Shampoo
- 0.01%
Atopic Dermatitis
Body oil: Apply thin film to affected area q8hr
Corticosteroid responsive dermatoses
Cream, ointment, solution: Apply to affected area as a thin film from two to four times daily depending on severity of condition
In hairy sites, the hair should be parted to allow direct contact with lesion
Occlusive dressing may be used for management of psoriasis or recalcitrant conditions
Dosing considerations
- Some plastic films may be flammable; exercise due care in their use; employ caution when such films are used on children or left in their proximity, to avoid possibility of accidental suffocation
- If an infection develops, the use of occlusive dressings should be discontinued, and appropriate antimicrobial therapy instituted
Scalp psoriasis
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 hr; wash with shampoo and rinsing thoroughly to remove
Seborrheic dermatitis of the scalp
Shampoo: Apply 1-ounce maximum to scalp once daily; work into a lather and allow to remain on scalp for 5 min; rinse thoroughly with water to remove from hair
Dosing considerations
Patients using topical corticosteroids should receive the following information and instructions
This medication is to be used as directed by physician; it is for external use only; avoid contact with eyes
Patients should be advised not to use medication for any disorder other than that for which it was prescribed
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician
Patients should report any signs of local adverse reactions, especially under occlusive dressing
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings
Dosage Forms & Strengths
cream
- 0.025%
- 0.1%
ointment
- 0.025%
topical solution
- 0.01%
topical oil
- 0.01%
Corticosteroid responsive dermatoses
Children and adolescents
- Cream, ointment, solution: Apply to affected area as a thin film from 2-3 times daily depending on severity of condition
- In hairy sites, the hair should be parted to allow direct contact with lesion
- Occlusive dressing may be used for management of psoriasis or recalcitrant conditions
Dosing considerations
- Some plastic films may be flammable; exercise due care in their use; employ caution when such films are used on children or left in their proximity, to avoid possibility of accidental suffocation
- If an infection develops, the use of occlusive dressings should be discontinued, and appropriate antimicrobial therapy instituted
Atopic Dermatitis
Topical oil (0.01%)
≥3 Months and adolescents: Moisten skin with Derma-Smoothe/FS Body oil; apply thin film to affected area BID; not for use >4 weeks
>2 Years and adolescents: Apply thin film of Derma-Smoothe/FS scalp oil to affected area twice daily; not for use >4 weeks
Dosing considerations
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio
HPA axis suppression, Cushing’s syndrome, and intracranial hypertension reported in children receiving topical corticosteroids
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema
Adverse Effects
Frequency Not Defined
Skin atrophy
Striae
Intracranial hypertension
Telangiectasia
Acneiform eruptions
Ketatosis pilaris
Papules
Pustules
Burning
Dryness
Erythema
Pigmentation changes
HPA suppression (with higher potency used >2 wk)
Warnings
Contraindications
Hypersensitivity
Cautions
Chronic topical corticosteroid therapy may interfere with growth & development in pediatric patients
Use med to very high potency for <2 wk 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 face, folds, 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 skin and subcutaneous tissues; when used on intertriginous or flexor areas, or on face, this may occur even with short-term use
In 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 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 only proven effective in corticosteroid-responsive dermatoses, other than seborrheic dermatitis of the scalp
HPA axis suppression
- Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (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 ACTH stimulation tests
- If HPA axis suppression is noted, an attempt should be made to withdraw drug, reduce 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 & Lactation
Pregnancy Category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation
Pharmacokinetics
Excretion: Urine (primarily); feces (minimal)
Distribution: Throughout local skin
Absorption: Minimal (~1%); nature of skin at application; occlusion and inflammation may increase absorption
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| fluocinolone topical - | 0.025 % ointment |  | |
| fluocinolone topical - | 0.01 % oil |  | |
| fluocinolone topical - | 0.025 % ointment |  | |
| fluocinolone topical - | 0.01 % solution |  | |
| fluocinolone topical - | 0.01 % oil |  | |
| fluocinolone topical - | 0.01 % solution |  | |
| fluocinolone topical - | 0.025 % cream |  | |
| fluocinolone topical - | 0.025 % cream |  | |
| fluocinolone topical - | 0.025 % ointment |  | |
| fluocinolone topical - | 0.025 % ointment |  | |
| fluocinolone topical - | 0.01 % solution |  | |
| fluocinolone topical - | 0.025 % ointment |  | |
| fluocinolone topical - | 0.01 % cream |  | |
| fluocinolone topical - | 0.01 % cream |  | |
| fluocinolone topical - | 0.01 % cream |  | |
| fluocinolone topical - | 0.025 % cream |  | |
| fluocinolone topical - | 0.01 % solution |  | |
| fluocinolone topical - | 0.01 % oil |  | |
| fluocinolone topical - | 0.01 % oil |  | |
| fluocinolone topical - | 0.01 % cream |  | |
| fluocinolone topical - | 0.01 % solution |  | |
| fluocinolone topical - | 0.01 % oil |  | |
| fluocinolone topical - | 0.01 % solution |  | |
| fluocinolone topical - | 0.025 % cream |  | |
| fluocinolone topical - | 0.025 % cream |  | |
| fluocinolone topical - | 0.025 % ointment |  | |
| Yutiq intravitreal - | 0.18 mg implant |  | |
| Capex topical - | 0.01 % shampoo |  | |
| Synalar topical - | 0.01 % solution |  | |
| Synalar topical - | 0.01 % solution |  | |
| Synalar topical - | 0.025 % cream |  | |
| Synalar topical - | 0.025 % ointment |  | |
| Derma-Smoothe/FS Body Oil topical - | 0.01 % oil |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fluocinolone topical
FLUOCINOLONE ACETONIDE - TOPICAL
(FLOO-oh-SIN-oh-lone uh-SEET-oh-nide)
COMMON BRAND NAME(S): Synalar
USES: This medication is used to treat a variety of skin conditions (such as eczema, dermatitis, allergies, rash). Fluocinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.
HOW TO USE: Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in as directed by your doctor, usually 3 to 4 times daily. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water.Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.Inform your doctor if your condition lasts or gets worse after 2 weeks.
SIDE EFFECTS: Stinging, burning, itching, irritation, dryness, or redness at the application site may occur when this medication is first applied to the skin. These effects should disappear in a few days as your body adjusts to the medication. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, small red bumps on the skin (folliculitis).Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve.Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems.Do not use if there is an infection or sore in the area to be treated.Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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