Fluocinolone acetonide

What is Fluocinolone acetonide?

• Fluocinolone acetonide (Capex Shampoo; Derma-Smoothe/FS; Fluocet; Fluonid; Fluotrex; Synalar) is a topical corticosteroid share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

Fluocinolone acetonide

Fluocinolone acetonide (Ball-n-Stick)

What are the uses of this medicine?

• Fluocinolone acetonide (Capex Shampoo; Derma-Smoothe/FS; Fluocet; Fluonid; Fluotrex; Synalar) for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
• Fluocinolone acetonide used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes).

How does this medicine work?

• Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.
• Fluocinolone is a glucocorticoid receptor agonist that binds to cytoplasmic glucocorticoid receptors and subsequently translocates to the nucleus where it initiates the transcription of glucocorticoid responsive genes such as lipocortins.
• Lipocortins inhibit phospholipase a2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandins and leukotrienes, both are potent mediators of inflammation.
• Fluocinolone exerts its vasoconstrictive effect through inhibition of nitric oxide synthase, thereby blocking nitric oxide production and effectively diminishing the effect of nitric oxide on vascular smooth muscles leading to reduced blood flow.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with a history of hypersensitivity to any of the components of the preparation.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• other corticosteroid medications and other topical medications

Is this medicine FDA approved?

• It was approved for medical use in 1961.

How should this medicine be used?

Recommended dosage:

• Topical corticosteroids are generally applied 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 dressings may be used for the management of psoriasis or recalcitrant conditions.

Administration:

• Fluocinolone topical comes in ointment, cream, solution, shampoo, and oil in various strengths for use on the skin or scalp.
• Fluocinolone ointment, cream, solution, and oil are usually applied two to four times a day.
• Fluocinolone shampoo is usually applied once a day.
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Your skin condition should improve during the first 2 weeks of your treatment.
• To use fluocinolone topical, apply a small amount of the ointment, cream, solution, or oil to cover the affected area of skin with in a thin even film and rub it in gently.
• To use the shampoo, shake the bottle well, apply a small amount of the medicine to the scalp, and use your fingers to form a lather.
• Leave the shampoo on your skin for 5 minutes and then rinse the shampoo out of your hair and off your body with plenty of water.
• Do not cover your head with a shower cap, bathing cap, or towel while the shampoo is on your scalp unless directed to do so by your doctor.
• To use the ointment, cream, or solution on your scalp, part your hair, apply a small amount of the medicine on the affected area, and rub it in gently.
• To use the oil on your scalp to treat psoriasis, wet your hair and scalp and apply a small amount of the oil to the scalp and rub it in gently.
• Cover your head with the shower cap supplied for at least 4 hours or overnight and then wash your hair as usual, making sure to rinse your hair thoroughly.
• This medication is only for use on the skin or scalp.
• Do not let fluocinolone topical get into your eyes or mouth and do not swallow fluocinolone.
• Avoid use on the face, in the genital and rectal areas, and in skin creases and armpits unless directed by your doctor to use in these areas.
• Do not wrap or bandage the treated area unless your doctor tells you that you should.
• If you are using fluocinolone topical on a child's diaper area, do not use tight-fitting diapers or plastic pants.
• Do not apply cosmetics or other skin preparations or products on the treated area without talking with your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As ointment, cream, solution, shampoo, and oil

This medicine is available in fallowing brand namesː

• Capex Shampoo; Derma-Smoothe/FS; Fluocet; Fluonid; Fluotrex; Synalar

What side effects can this medication cause?

The most common side effects of this medicine include:

• Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae and Miliaria

Children who use fluocinolone topical may have an increased risk of side effects including slowed growth and delayed weight gain.

Fluocinolone topical may cause serious side effects which may include:

• severe skin rash
• difficulty breathing or swallowing
• wheezing
• redness, swelling, or other signs of skin infection
• hives

What special precautions should I follow?

• 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.
• 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 the drug, to reduce the frequency of application, or to substitute a less potent steroid.
• Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
• If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
• In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.
• It is for external use only. Avoid contact with the eyes.
• 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.
• It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when topical corticosteroids are administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
• 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.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Can this medicine be used in children?

• Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
• Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.
• Chronic corticosteroid therapy may interfere with the growth and development of children.

What are the active and inactive ingredients in this medicine?

Fluocinolone Acetonide Cream and Ointment Active ingredient:

• FLUOCINOLONE ACETONIDE

Inactive ingredients:

• MINERAL OIL
• LANOLIN ALCOHOLS
• ISOPROPYL PALMITATE
• PROPYLENE GLYCOL STEARATE
• CETYL ALCOHOL
• SORBITAN MONOSTEARATE
• POLYSORBATE 60
• SORBIC ACID
• POLYOXYL 40 STEARATE
• WATER
• PROPYLENE GLYCOL
• PROPYLPARABEN
• METHYLPARABEN

Who manufactures and distributes this medicine?

Fluocinolone Acetonide Cream and Ointment

Distributed by:

• Cosette Pharmaceuticals, Inc.
• South Plainfield, NJ

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 15°-30° C (59°-86° F).

• Dailymed label info on Fluocinolone acetonide
• FDA Fluocinolone acetonide

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