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
Capex topical
-
0.01 % shampoo
Yutiq intravitreal
-
0.18 mg implant
fluocinolone topical
-
0.01 % solution
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.025 % ointment
fluocinolone topical
-
0.01 % solution
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 % oil
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.01 % oil
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.01 % cream
fluocinolone topical
-
0.025 % cream
fluocinolone topical
-
0.01 % solution
Derma-Smoothe/FS Body Oil topical
-
0.01 % oil
Synalar topical
-
0.01 % solution
Synalar topical
-
0.01 % solution
Synalar topical
-
0.025 % ointment
Synalar topical
-
0.025 % cream

Copyright © 2010 First DataBank, Inc.

Previous
Next:

Patient Handout

Select a drug:
Patient Education
fluocinolone topical

FLUOCINOLONE ACETONIDE - SHAMPOO

(FLOO-oh-SIN-oh-lone uh-SEET-oh-nide)

COMMON BRAND NAME(S): Capex, FS Shampoo

USES: This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

HOW TO USE: This shampoo comes with a capsule of medication that the pharmacist must add to the shampoo before giving you this product. Once prepared, shake well before each use. Apply about one ounce of the shampoo to the scalp once daily by working into a lather. Allow it to remain on the scalp for 5 minutes. Then thoroughly rinse your scalp and hair two times. Also rinse any other body parts (e.g., hands, face, neck, shoulders) that may have come in contact with the shampoo.Do not bandage, wrap or cover the affected area (e.g., avoid using shower caps or bathing caps) unless directed by your doctor.This shampoo should be used only on the scalp. Do not apply this medication to your face, neck, groin, or underarms. After applying the medication, wash your hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.Do not use this medication more often or for a longer period than prescribed because the risk of side effects may be increased. Inform your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Burning, stinging, irritation, dryness, or redness may occur when this medication is first applied to the scalp. Acne, excessive hair growth, "hair bumps" (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects persist or worsen, 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.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, seek immediate medical attention 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 (e.g., prednisone, triamcinolone); 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: other skin/scalp conditions (e.g., rosacea, perioral dermatitis).Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when using this medication. Notify your doctor if redness, swelling or irritation does not improve.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 not known whether 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.Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.Inform all your doctors you use or have used this medication.

MISSED DOSE: If you miss a 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. Avoid freezing. Keep all medications away from children and pets. Discard after 2 months.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 August 2021. Copyright(c) 2021 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.