fluocinolone (Rx)

Brand and Other Names:Synalar, Capex, more...Fluoderm, DermaSmoothe FS
  • Print

Dosing & Uses

AdultPediatric

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

Next:

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)

Previous
Next:

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
Previous
Next:

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.

Previous
Next:

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

Previous
Next:

Images

BRAND FORM. UNIT PRICE PILL IMAGE
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.01 % solution
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.01 % oil
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
-
0.01 % solution
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.01 % solution
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.025 % ointment
Yutiq intravitreal
-
0.18 mg implant
Derma-Smoothe/FS Body Oil topical
-
0.01 % oil
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

Copyright © 2010 First DataBank, Inc.

Previous
Next:

Patient Handout

Select a drug:
Patient Education
fluocinolone intravitreal

NO MONOGRAPH AVAILABLE AT THIS TIME

USES: Consult your pharmacist.

HOW TO USE: Consult your pharmacist.

SIDE EFFECTS: Consult your 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: Consult your pharmacist.

DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: 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: No monograph available at this time.

MISSED DOSE: Consult your pharmacist.

STORAGE: Consult your pharmacist.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 for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2022 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.

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.