Flurandrenolide Lotion

Flurandrenolide is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Flurandrenolide topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Flurandrenolide topical may also be used for purposes not listed in this medication guide.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Do not use flurandrenolide topical in larger amounts, or for longer than recommended by your doctor. Do not apply to your face, underarms, or groin area unless your doctor tells you to.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with flurandrenolide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use.

Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

• It is used to treat skin irritation.
• It is used to treat skin rashes.

Use flurandrenolide lotion as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Put a thin layer on the affected skin and rub in gently.
• Shake well before use.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One g dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52.

The chemical name of flurandrenolide is Pregn-4-ene-3, 20-dione, 6-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C 24H 33FO 6. The structure is as follows:

Each mL of Flurandrenolide Lotion, USP 0.05% contains 0.5 mg (1.145 μmol) (0.05%) flurandrenolide in an oil-in-water emulsion base composed of glycerin, cetyl alcohol, stearic acid, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, menthol, benzyl alcohol, and purified water.

General –
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 application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, 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 using 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.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See Pediatric Use under PRECAUTIONS).

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. If a favorable response does not occur promptly, Flurandrenolide Lotion should be discontinued until the infection has been adequately controlled.

Information for the Patient –
Patients using topical corticosteroids should receive the following information and
instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. Do not use Flurandrenolide Lotion on the face, underarms, or groin areas unless directed by your physician.
3. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
4. The treated skin area should not be bandaged or otherwise covered or wrapped in order to be occlusive unless the patient is directed to do so by the physician.
5. Patients should report any signs of local adverse reactions, especially under occlusive dressing.
6. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a patient being treated in the diaper area, because these garments may constitute occlusive dressings.
7. If no improvement is seen within 2 weeks, contact your physician.
8. Do not use other corticosteroid-containing products while using Flurandrenolide Lotion without first consulting your physician.

Laboratory Tests –
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility –
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Usage in Pregnancy –
Pregnancy Category C. – Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, 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 for pregnant patients or in large amounts or for prolonged periods of time.

Nursing Mothers –
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use –
Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushing’s syndrome than do mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).