Fluticasone (Topical)

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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

Absorption: 6% (animal studies; 5% systemic, 1% in skin)

(floo TIK a sone)

Corticosteroid-responsive dermatoses: Topical: Cream: Infants ≥3 months, Children, and Adolescents: Refer to adult dosing.

Atopic dermatitis: Topical: Cream, lotion: Infants ≥3 months, Children, and Adolescents: Refer to adult dosing.

Topical: Apply sparingly in a thin film. Rub in lightly. Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area. Unless otherwise directed by healthcare professional, do not use with occlusive dressing; do not use on children’s skin covered by diapers or plastic pants.

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue fluticasone if appropriate.

• Localized reactions: May cause local reactions, including skin atrophy; risk increased with use under occlusion.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Disease-related concerns:

• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue treatment if infection does not resolve promptly.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients. Safety and efficacy of lotion and cream (in children) beyond 4 weeks of use have not been established.

Dosage form specific issues:

• Lotion and cream: Contain imidurea, an excipient; imidurea releases trace amounts of formaldehyde which may cause irritation or allergic sensitization upon contact with skin. Discontinue lotion if irritation occurs and institute appropriate therapy.

Other warnings/precautions:

• Appropriate use: Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area (including diaper area). Avoid use with occlusive dressing unless directed by a health care provider. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); skin infections.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Fluticasone is for use only on the skin.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using fluticasone topical, unless you are using the medicine to treat the skin on your hands.

Do not cover the treated skin area unless your doctor tells you to. Covering the skin that is treated with fluticasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

When treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

If you need surgery, tell the surgeon ahead of time that you are using fluticasone topical. You may need to stop using the medicine for a short time.

Use fluticasone topical only until your skin condition clears up. Call your doctor if your symptoms do not improve after 2 weeks of treatment.

You should not use fluticasone topical for longer than 4 weeks, unless your doctor tells you to.

Keep the bottle tightly closed when not in use. Store at room temperature away from moisture and heat. Do not keep this medicine in a refrigerator.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Stop using fluticasone and call your doctor at once if you have:

• severe skin irritation after using the medicine; or

• possible signs of absorbing fluticasone through your skin--weight gain (especially in your face or your upper back and torso); slow wound healing, thinning skin, increased body hair; changes in sexual function; muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Common side effects may include:

• burning or stinging of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.