Luxiq

Luxíq (betamethasone valerate) Foam, 0.12% is supplied as follows:

50g aluminum can NDC 40076-021-50
100g aluminum can NDC 40076-021-00

Store at controlled room temperature 68–77°F (20–25°C).

WARNING

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATE-LY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Manufactured for Prestium Pharma, Inc. Newtown, PA 18940. By DPT Laboratories, Ltd. San Antonio, TX 78215. Revised: June 2013

Luxíq is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive derma-toses of the scalp.

Note: For proper dispensing of foam, can must be inverted.

For application to the scalp invert can and dispense a small amount of Luxíq onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Luxíq should not be used with occlusive dressings unless directed by a physician.

Luxíq is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

WARNINGS

No information provided.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticos-teroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients applying a topical steroid to a large surface area or to ar-eas under occlusion should be evaluated periodically for evidence of HPA axis suppression. 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 upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticoster-oid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS - Pediatric Use.)

If irritation develops, Luxiq should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observa-tion should be corroborated with appropriate diagnostic patch testing.

In the presence of dermatological infections, the use of an appropriate antifun-gal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Luxiq should be discontinued until the infection has been adequately controlled.

Information for Patients

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 exter-nal use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.
5. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Long-term animal studies have not been performed to evaluate the carcino-genic potential or the effect on fertility of betamethasone valerate.

Betamethasone was genotoxic in the in vitro human peripheral blood lympho-cyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticoster-oids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Therefore, Luxiq should be used during pregnancy only if the poten-tial 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.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detect-able quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Luxiq is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syn-drome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappro-priate use of topical corticosteroids in infants and children.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifesta-tions of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corti-costeroid therapy may interfere with the growth and development of children.

SIDE EFFECTS

The most frequent adverse event was burning/itching/stinging at the applica-tion site; the incidence and severity of this event were as follows:

Other adverse events which were considered to be possibly, probably, or definitely related to Luxíq occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreas-ing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria.

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.

DRUG INTERACTIONS

No information provided.

The most frequent adverse event was burning/itching/stinging at the applica-tion site; the incidence and severity of this event were as follows:

Other adverse events which were considered to be possibly, probably, or definitely related to Luxíq occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreas-ing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria.

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.

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

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many fac-tors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to sys-temically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.