بتامتازون
Betamethasone Valerate Foam (Luxiq)
بتامتازون

نام ژنریک

Betamethasone Valerate (T

شکل دارویی

اشكال دارويي:


Cream , Lotion, Ointment: 0.1% (as valerate)

موارد مصرف

موارد و مقدار مصرف


توجه: N-Betamethasone حاوي نئومايسين است و در درمان التهابهاي پوستي همراه با عفونت ثانويه مصرف مي‌شود.


درماتوزهاي پاسخ‌دهنده به كورتيكواستروئيدها.


بزرگسالان و كودكان: اشكال كرم، لوسيون يا پماد، 4-1 بار در روز بر روي پوست ماليده مي‌شوند.


روش تجويز (بتامتازون موضعي) : ‌فرم موضعي براي مصرف در نواحي صدمه ديده يا دچار عفونت مناسب نيست. بدون تجويز پزشك بر روي زخمهاي ترشح‌دار استفاده نشود. به هيچ‌وجه محل زخم پانسمان نشود. فرآورده‌هاي با قدرت بالا روي صورت، كشاله ران و زير بغل استفاده نشوند.


مكانيسم اثر


اثر ضد التهاب: بتامتازون ساخت آنزيم هاي مورد نياز براي كاهش پاسخهاي التهابي را تحريك مي‌كند. بتامتازون، به دليل داشتن فلوئور در ساختمان خود، اين مزيت را دارد كه مي‌تواند در پايه‌هاي متفاوتي در دسترس قرار گيرد و بنابراين، براي افراد مختلف در قدرت اثرهاي متفاوت وجود دارد.

موارد منع مصرف

عوارض جانبي


موضعي: سوزش ، خارش، تحريك، خشكي، فوليكوليت، پر مويي، ضايعات آكنه مانند، كمي تشكيل رنگدانه‌هاي پوست، درماتيت اطراف دهان، درماتيت تماسي آلرژيك، نرم شدن پوست، عفونت ثانويه، آتروفي پوست، ايجاد رگه‌هاي پوستي، عرق سوز شدن پوست.


ادراري ـ تناسلي: گلوکوزوري (با بتامتازون دي پروپيونات).


متابوليك: هايپرگليسمي.


توجه: در صورت بروز تحريك موضعي، عفونت، جذب سيستميك يا حساسيت مفرط، بايد مصرف دارو قطع شود.

موارد قابل توجه

-

مکانیزم اثر

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد احتياط : به هيچ وجه از پانسمان بسته روي ضايعات اگزوداتيو استفاده نشود چون ريسك عوارض جانبي افزايش مي‌يابد.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: گلوكوكورتيكوئيد موضعي.


طبقه‌بندي درماني: ضد التهاب.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


در مصارف طولاني مدت يا مصرف روي سطح وسيعي از بدن، بيمار را از نظر عوارض سيستميك مانيتور كنيد.


نكات قابل توصيه به بيمار


1- در مورد نحوه مصرف فرآورده به بيمار توضيح دهيد.


2- قبل از مصرف به آرامي پوست را شستشو دهيد. براي جلوگيري از آسيب، به آهستگي لايه نازكي از فرآورده را روي وضع بماليد.


3- در صورت بروز علائم سيستميك، تحريك يا زخم پوستي، حساسيت يا عفونت، مصرف دارو قطع شده و به پزشك مراجعه شود.

Betamethasone Valerate Foam (Luxiq)

Luxiq®
(betamethasone valerate) Foam, 0.12%

For Dermatologic Use Only

Not for Ophthalmic Use

DRUG DESCRIPTION

Luxiq Foam 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:

Luxiq® (betamethasone valerate)  Structural Formula Illustration

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

What are the possible side effects of betamethasone topical?

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

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • feeling tired.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Luxiq »

What are the precautions when taking betamethasone valerate foam (Luxiq)?

Before using betamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a lowered immune system.

Do not use this medication if you have a scalp infection. Corticosteroids can make skin infections worse and more difficult to treat. Tell your doctor if you have a skin infection so it can be treated. Tell your doctor promptly if your condition does not improve or if you have worsening skin symptoms.

Rarely,...

Read All Potential Precautions of Luxiq »

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Luxiq (betamethasone valerate foam) is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

DOSAGE AND ADMINISTRATION

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

For application to the scalp invert can and dispense a small amount of Luxiq (betamethasone valerate foam) 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.

Luxiq (betamethasone valerate foam) should not be used with occlusive dressings unless directed by a physician.

HOW SUPPLIED

Luxiq (betamethasone valerate foam) is supplied in 150 gram (NDC 63032-021-01), 100 gram (NDC 63032-021-00) and 50 gram (NDC 63032-021-50) aluminum cans.

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

WARNING

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY 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 Stiefel Laboratories, Inc., Coral Gables, FL 33134, USA. For additional information: 1-888-500-DERM or visit www.luxiq (betamethasone valerate foam) .com. FDA Rev date: 7/11/2006

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

Incidence and severity of burning/itching/stinging
Product Total incidence Maximum severity
Mild Moderate Severe
Luxiq Foam
n=63
34 (54%) 28 (44%) 5 (8%) 1 (2%)
Betamethasone valerate lotion
n=63
33 (52%) 26(41%) 6 (10%) 1 (2%)
Placebo Foam
n=32
24 (75%) 13(41%) 7 (22%) 41 (2%)
Placebo Lotion
n=30
20 ( 6 7%) 12(40%) 5 (17%) 31 (0%)

Other adverse events which were considered to be possibly, probably, or definitely related to Luxiq (betamethasone valerate foam) 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 decreasing 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.

Read the Luxiq (betamethasone valerate foam) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

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, Luxiq (betamethasone valerate foam) 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 Luxiq (betamethasone valerate foam) 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, Luxiq (betamethasone valerate foam) 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 Luxiq (betamethasone valerate foam) 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.

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Topically applied Luxiq (betamethasone valerate foam) can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS)

CONTRAINDICATIONS

Luxiq (betamethasone valerate foam) is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, betamethasone valerate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, 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 systemically 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.

Clinical Studies

The safety and efficacy of Luxiq (betamethasone valerate foam) 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 Luxiq (betamethasone valerate foam) Foam, 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 Luxiq (betamethasone valerate foam) Foam 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 Luxiq Foam
n (%)
BMV lotion
n (%)
Placebo foam
n (%)
Scaling 30 (47%) 22 (35%) 26 (%)
Erythema 26 (41%) 16 (25%) 26 (%)
Plaque Thickness 42 (66%) 25 (40%) 51 (6%)
Investigator's Global: Subjects Completely Clear or Almost Clear at Endpoint 43 (67%) 29 (46%) 61 (9%)

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Luxiq®
(betamethasone valerate) Foam, 0.12%

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 corticosteroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions.

Other ingredients in Luxiq (betamethasone valerate foam) include cetyl alcohol, citric acid, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hydrocarbon 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 Luxiq (betamethasone valerate foam) ?
  • Are you pregnant? Planning on becoming pregnant while using Luxiq (betamethasone valerate foam) ? Or are you breastfeeding?
  • Do you think you have an infection on your scalp?

How to apply Luxiq (betamethasone valerate foam)

How to apply Luxiq - Illustration 1

Turn the can upside down and dispense a small amount of Luxiq (betamethasone valerate foam) 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. How to apply Luxiq (betamethasone valerate foam)

How to apply Luxiq - Illustration 2

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.

Gently massage the foam in until it is absorbed 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.

How to apply Luxiq - Illustration 3

Wash your hands immediately after applying Luxiq (betamethasone valerate foam) , and discard any unused dispensed medication.

How to apply Luxiq - Illustration 4

Do not wash or rinse the treated areas immediately after applying Luxiq (betamethasone valerate foam) .

  • Do not use this medication for any condition other than the one for which it was prescribed.
  • Luxiq (betamethasone valerate foam) 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 KNOWABOUT LUXIQ (betamethasone valerate foam) :

What to do if you miss an application If you forget to apply Luxiq (betamethasone valerate foam) 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 (betamethasone valerate foam) include mild burning, stinging, or 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 all 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 (betamethasone valerate foam) to anyone else. Your doctor has prescribed this medicine for your use only.

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Luxiq®
(betamethasone valerate) Foam, 0.12%

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 corticosteroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions.

Other ingredients in Luxiq (betamethasone valerate foam) include cetyl alcohol, citric acid, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hydrocarbon 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 Luxiq (betamethasone valerate foam) ?
  • Are you pregnant? Planning on becoming pregnant while using Luxiq (betamethasone valerate foam) ? Or are you breastfeeding?
  • Do you think you have an infection on your scalp?

How to apply Luxiq (betamethasone valerate foam)

How to apply Luxiq - Illustration 1

Turn the can upside down and dispense a small amount of Luxiq (betamethasone valerate foam) 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. How to apply Luxiq (betamethasone valerate foam)

How to apply Luxiq - Illustration 2

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.

Gently massage the foam in until it is absorbed 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.

How to apply Luxiq - Illustration 3

Wash your hands immediately after applying Luxiq (betamethasone valerate foam) , and discard any unused dispensed medication.

How to apply Luxiq - Illustration 4

Do not wash or rinse the treated areas immediately after applying Luxiq (betamethasone valerate foam) .

  • Do not use this medication for any condition other than the one for which it was prescribed.
  • Luxiq (betamethasone valerate foam) 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 KNOWABOUT LUXIQ (betamethasone valerate foam) :

What to do if you miss an application If you forget to apply Luxiq (betamethasone valerate foam) 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 (betamethasone valerate foam) include mild burning, stinging, or 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 all 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 (betamethasone valerate foam) to anyone else. Your doctor has prescribed this medicine for your use only.

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Luxiq Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BETAMETHASONE FOAM - TOPICAL

(bay-ta-METH-a-sone)

COMMON BRAND NAME(S): Luxiq

USES: This medication is used to treat skin conditions of the scalp (such as psoriasis, seborrhea). Betamethasone works by decreasing the swelling (inflammation), itching, and redness. It belongs to a class of drugs known as corticosteroids. This medication is a medium-strength corticosteroid.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use only on the skin. Apply to the scalp as directed by your doctor, usually twice daily (in the morning and evening).

To apply this medication, turn the container upside down, and spray out a small amount on a clean, cool surface (such as a small plate or saucer). Dispense only enough foam to cover the affected areas on the scalp. Do not spray the foam directly on your hands since warm skin will cause the foam to melt too quickly. Using your fingers, scoop up some of the foam and gently massage it into the affected area until the foam is absorbed. Repeat until the entire affected area is treated. Discard any leftover drug from the saucer. Do not cover the treated area with bandages or other dressings unless instructed to do so by your doctor. Do not wash or rinse the medication off immediately after applying it. Wash your hands with soap and water after each use.

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, rinse thoroughly with water and call your doctor if irritation persists.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

Tell your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.

Disclaimer

Luxiq Consumer (continued)

SIDE EFFECTS: Burning, itching, or stinging may occur when you apply this medication, but usually only last a short time. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Luxiq (betamethasone valerate foam) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using betamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a lowered immune system.

Do not use this medication if you have a scalp infection. Corticosteroids can make skin infections worse and more difficult to treat. Tell your doctor if you have a skin infection so it can be treated. Tell your doctor promptly if your condition does not improve or if you have worsening skin symptoms.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Luxiq Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: other corticosteroids (including skin products such as hydrocortisone or clobetasol, oral products such as prednisone).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from direct sunlight. This product is flammable so keep away from heat, fire, and open flame. Do not smoke during and immediately after applying this medication. The contents of the container are under pressure. Therefore, do not puncture or burn it. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.

Luxiq Patient Information Including Side Effects

Brand Names: Alphatrex, Beta-Val, Diprolene, Diprolene AF, Diprosone, Luxiq

Generic Name: betamethasone topical (Pronunciation: bay ta METH a sone)

What is betamethasone topical (Luxiq)?

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

Betamethasone topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of betamethasone is used to treat mouth ulcers.

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

What are the possible side effects of betamethasone topical?

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

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • feeling tired.

Less serious side effects may include:

  • skin redness, burning, itching, or peeling;
  • thinning of your skin; or
  • blistering skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Luxiq (betamethasone valerate foam) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about betamethasone topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. 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 betamethasone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

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

Betamethasone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Luxiq Patient Information including How Should I Take

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.

How should I use betamethasone topical?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Betamethasone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using betamethasone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

If you are using the dental paste, apply the medication in a thin layer, just enough to cover the mouth ulcer. The paste may stick better if you dry the mouth ulcer before applying the medication.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. 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 betamethasone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use betamethasone topical regularly to get the most benefit.

Store betamethasone topical at room temperature away from moisture and heat.

Luxiq Patient Information including If I Miss a Dose

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of betamethasone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using betamethasone topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use betamethasone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

What other drugs will affect betamethasone topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied betamethasone topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about betamethasone topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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