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Luxiq (Betamethasone Valerate Topical) - Warnings and Precautions

 
 



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, Luxíq 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 Luxíq 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, Luxíq 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 Luxíq 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.

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:
Prestium Pharma, Inc.
Newtown, PA 18940

By DPT Laboratories, Ltd.
San Antonio, TX 78215 

For additional information:
1-866-897-5002

Or visit
www.luxiq.com

LUXIQ  is a registered trademark of Stiefel Laboratories, Inc.
2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

June 2013

PATIENT INFORMATION

Luxíq®

(betamethasone valerate) Foam, 0.12%

About Luxíq

Your doctor has prescribed Luxíq (betamethasone valerate) Foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Luxíq 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 Luxíq 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 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 Luxíq?
  • Are you pregnant? Planning on becoming pregnant while using Luxíq? Or are you breastfeeding?
  • Do you think you have an infection on your scalp?
  • Do not use this medication for any condition other than the one for which it was prescribed.
  • Luxíq 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 LUXÍQ:

What to do if you miss an application

If you forget to apply Luxíq 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 Luxíq 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 68-77oF (20-25oC) 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 Luxíq to anyone else. Your doctor has prescribed this medicine for your use only.

Manufactured for:
Prestium Pharma, Inc.
Newtown, PA 18940

By DPT Laboratories, Ltd.
San Antonio, TX 78215 

For additional information:
1-866-897-5002

Or visit
www.luxiq.com

LUXIQ  is a registered trademark of Stiefel Laboratories, Inc.
2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

June 2013

Page last updated: 2014-05-29

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