Betamethasone Valerate Foam

Name: Betamethasone Valerate Foam

Description

Luxiq Foam contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primar-ily synthetic steroids used topically as anti-inflammatory agents.

Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58.The following is the chemical structure:

Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether.

Luxiq® (betamethasone valerate) Foam, 0.12%, contains 1.2 mg betametha-sone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60.4%), polysorbate 60, potas-sium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Patient information

About Luxiq

Your doctor has prescribed Luxiq (betamethasone valerate) Foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Luxiq works because its active ingredient is betamethasone valerate, 0.12%. Betamethasone belongs to a group of medicines known as topical corticos-teroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions.

Other ingredients in Luxiq include cetyl alcohol, citric acid, ethanol, polysor-bate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hyrdrocarbon propellant (propane and butane).

If you answer YES to one or more of the following questions, tell your doctor (or pharmacist) before using this medicine, so you can get advice about what to do.

  • Are you allergic to any of the ingredients contained in Luxfq?
  • Are you pregnant? Planning on becoming pregnant while using Luxfq? Or are you breastfeeding?
  • Do you think you have an infection on your scalp?

How to apply Luxiq

Turn the can upside down and dispense a small amount of Luxiq onto a clean saucer or other cool, clean surface. Do not dispense directly onto hands, as foam will begin to melt immediately upon contact with warm skin.

Figure A

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. Use sparingly – only enough to cover the affected areas.

Figure B

Gently massage the foam in until it is ab-sorbed and allow the areas to dry naturally.

When applying to the scalp, move the hair away so that the foam can be applied directly to each affected area.

Wash your hands immediately after applying Luxiq, and discard any unused dispensed medication.

Figure C

Do not wash or rinse the treated areas immediately after applying Luxiq.

Figure D

  • Do not use this medication for any condition other than the one for which it was prescribed.
  • Luxfq is for external use only.
  • Keep the foam away from your eyes, as it will sting. If the foam gets into your eyes, rinse well with cold water. If the stinging continues, contact your doctor immediately.

WHAT YOU SHOULD KNOW ABOUT LUXIQ:

What to do if you miss an application

If you forget to apply Luxrq at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at or about the time of your next daily application, apply that dose and continue with your normal application schedule. If you miss several doses, tell your doctor at your next appointment.

About Side Effects

As with all medications, there may be some side effects. The most frequent side effects associated with the use of Luxiq include mild burning, stinging, of itching at the site of application. These side effects typically disappear shortly after application.

Let your doctor know if you notice any of the following:

  • Any unusual effects that you do not understand
  • Affected areas that do not seem to be healing after several weeks of using the foam.

Important Safety Notes

  • The treated areas should not be bandaged or covered unless directed by your doctor.
  • Keep this and aII medicines out of the reach of children.
  • Store the can at controlled room temperature 68-77°F (20-25°C) and protect it from direct sunlight, as this is a pressurized container.
  • Keep away from and do not spray near fire, open flame, or direct heat--this product is flammable. Do not smoke while using or holding the can. Keep) the can away from all sources of ignition. Do not pierce or burn the can, and never throw the can in a fire, even if empty.
  • When you have finished your treatment, dispose of the can safely. A completely empty can is recyclable.
  • Do not use the foam after the expiration date shown on the bottom of the can.
  • Do not give Luxiq to anyone else. Your doctor has prescribed medicine for your use only.

Betamethasone Valerate Foam Description

Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents.

Betamethasone valerate is 9-fluoro11β,17, 21-trihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58. The following is the chemical structure:

Betamethasone valerate

Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether.

Betamethasone Valerate Foam, 0.12%, contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of alcohol (60.4%), cetyl alcohol, citric acid anhydrous, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Clinical Studies

The safety and efficacy of Betamethasone Valerate Foam, 0.12% has been demonstrated in a four-week trial. An adequate and well-controlled clinical trial was conducted in 190 patients with moderate to severe scalp psoriasis. Patients were treated twice daily for four weeks with Betamethasone Valerate Foam, 0.12%, Placebo foam, a commercially available betamethasone valerate lotion 0.12% (formerly expressed as 0.1% betamethasone), or Placebo lotion. At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of Betamethasone Valerate Foam, 0.12% in treating scalp psoriasis is superior to that of Placebo foam, and is comparable to that of a currently marketed BMV lotion (see Table below).

Subjects with Target Lesion Parameter Clear at Endpoint Betamethasone Valerate Foam, 0.12%
n
(%)
BMV lotion
n
(%)
Placebo foam
n
(%)
Scaling 30 (47%) 22 (35%) 2 (6%)
Erythema 26 (41%) 16 (25%) 2 (6%)
Plaque Thickness 42 (66%) 25 (40%) 5 (16%)
Investigator's Global: Subjects Completely Clear or Almost Clear at Endpoint 43 (67%) 29 (46%) 6 (19%)

Precautions

General

Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid 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 areas 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 glucocorticosteroid 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, Betamethasone Valerate Foam, 0.12% 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 observation should be corroborated with appropriate diagnostic patch testing.

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, use of Betamethasone Valerate Foam, 0.12% 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 external 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 carcinogenic potential or the effect on fertility of betamethasone valerate.

Betamethasone was genotoxic in the in vitro human peripheral blood lymphocyte 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 corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Therefore, Betamethasone Valerate Foam, 0.12% 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.

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 detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Betamethasone Valerate Foam, 0.12% 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 syndrome 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 inappropriate 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. Manifestations 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 corticosteroid therapy may interfere with the growth and development of children.

Overdosage

Topically applied Betamethasone Valerate Foam, 0.12% can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS)

How is Betamethasone Valerate Foam Supplied

Betamethasone Valerate Foam, 0.12% is supplied in 50 gram (NDC 51672-4188-3) and 100 gram (NDC 51672-4188-7) aluminum cans.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

What should i discuss with my healthcare provider before using betamethasone topical?

Do not use this medication if you are allergic to betamethasone.

Before using betamethasone topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether betamethasone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of betamethasone topical.

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