Luxiq

Name: Luxiq

Uses of Luxiq

Luxiq is a prescription medication used to reduce the inflammation, redness, swelling, itching, and tenderness associated with skin conditions of the scalp including scalp psoriasis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What is Luxiq (betamethasone topical)?

Betamethasone is a steroid. It prevents the release of substances in the body that cause inflammation.

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

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

What other drugs will affect Luxiq (betamethasone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied betamethasone. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Proper Use of betamethasone valerate

This section provides information on the proper use of a number of products that contain betamethasone valerate. It may not be specific to Luxiq. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, lotion, or ointment:

  • Wash your hands with soap and water before and after using this medicine.
  • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
  • With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
  • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
  • If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
  • If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use the foam:

  • This medicine comes with a patient information insert. Read and follow the instructions carefully.
  • Wash your hands with soap and water before and after using this medicine.
  • Turn the can upside down and place a small amount of medicine in a saucer or any cool, clean surface. Do not put the foam directly in your hands. This will melt the foam immediately upon contact with warm skin.
  • Move the hair away and put a small amount of the foam on the affected areas of the scalp. Massage it in gently until the medicine has dried.
  • Do not wash or rinse the treated areas immediately after applying the medicine.
  • Do not use this medicine near heat, open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For redness, itching, and swelling of the skin:
    • For topical dosage forms (cream and ointment):
      • Adults—Apply to the affected area of the skin one to three times per day.
      • Children—Use and dose must be determined by your doctor.
    • For topical dosage form (lotion):
      • Adults—Apply a few drops to the affected area of the skin two times per day (morning and evening).
      • Children—Use and dose must be determined by your doctor.
  • For scalp problems:
    • For topical dosage form (foam):
      • Adults—Apply to the affected area of the scalp two times per day (once in the morning and once at night).
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the can of the foam at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take Luxiq or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Luxiq. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Contraindications

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

Overdosage

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

How is Luxiq Supplied

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

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

Principal Display Panel

NDC 40076-021-50

Luxiq®

(betamethasone valerate)

Foam, 0.12%

50g

Luxiq 
betamethasone valerate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:40076-021
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE VALERATE 1.2 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
CITRIC ACID MONOHYDRATE  
ALCOHOL  
POLYSORBATE 60  
POTASSIUM CITRATE  
PROPYLENE GLYCOL  
WATER  
STEARYL ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:40076-021-50 50 g in 1 CAN
2 NDC:40076-021-00 100 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020934 10/16/2009
Labeler - Prestium Pharma, Inc. (078304674)
Registrant - Denco Asset, LLC (965099505)
Revised: 05/2014   Prestium Pharma, Inc.
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