Luxiq: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LUXIQ^® Foam is used for the relief of the inflammation and itching associated with moderate to severe psoriasis of the scalp for up to 4 weeks in adult patients 18 years of age and older.

What it does:

LUXIQ^® Foam contains betamethasone delivered in a foam formulation. 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.

When it should not be used:

Do not use if you:

• are allergic to betamethasone valerate, other

  corticosteroids, any component of the container or to any other ingredients in LUXIQ^® Foam (see What the important nonmedicinal ingredients are).

• have bacterial, fungal, parasitic, viral skin infection

  (e.g. herpes simplex, chickenpox), tuberculous or syphilis skin lesions, or a skin reaction following a recent vaccination.

• have acne.

• have rosacea (a facial skin condition where the nose,

  cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)).

• have rashes around the mouth.
• have itchy skin which is not inflamed.

Do not apply LUXIQ^® Foam in or near the eye.

What the medicinal ingredient is:

betamethasone valerate

What the important nonmedicinal ingredients are:

Other ingredients include cetyl alcohol, citric acid, ethanol, polysorbate 60, potassium citrate, propylene glycol, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized with a hydrocarbon (propane/butane) propellant.

What dosage forms it comes in:

LUXIQ^® (betamethasone valerate) Foam, 0.12% w/w. Each 1 g of LUXIQ^® Foam contains 1.2 mg of betamethasone valerate.

WARNINGS AND PRECAUTIONS

Topical corticosteroids, when used over large areas, on sensitive areas such as the scalp or broken skin, for prolonged periods, or under occlusive dressing are more likely to be absorbed into the bloodstream and cause side effects. Apply only enough to cover the affected areas. LUXIQ^® Foam should not be applied over large areas.

Inform your doctor if you have previously used corticosteroids.

Before using LUXIQ^® Foam, talk to your doctor or pharmacist if:

• you have other inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).

• you are pregnant or planning to become pregnant.

• you are breastfeeding.
• you have problems with your kidney or liver. You may need to use a smaller amount of LUXIQ^® or use it less often.

While using LUXIQ^® Foam, talk to your doctor or pharmacist if:

• you develop any skin infection
• you have an allergic reaction
• you develop significant skin irritation
• you experience skin thinning or softening
• your condition worsens or you develop raised bumps with pus under the skin

While using LUXIQ^® Foam:

• Do not use LUXIQ^® Foam on the face or in skin-fold areas.
• Avoid LUXIQ^® Foam from getting in the eye, or other mucous membrane. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).

• Do not use occlusive dressing such as a bandage, or

  cover the treated areas tightly.

• If you are over 65 years of age, use LUXIQ^® Foam with

  caution. You may need to use a smaller amount of LUXIQ^® or use it less often.

• LUXIQ^® Foam is not recommended for use in patients

  under 18 years of age. Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects.

• The propellant in LUXIQ^® Foam is extremely

  flammable. Avoid fire, open flame, spark or smoking during and immediately following application.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about all your other medications, including medicines that you bought without prescription, and natural health products.

Some medicines may affect how LUXIQ^® Foam works or make it more likely that you’ll have side effects. Examples of these medicines include:

• Ritonavir and itraconazole

PROPER USE OF THIS MEDICATION

For topical use only and not for use in the eyes.

Apply a thin layer of LUXIQ^® Foam to the affected area(s) twice daily, morning and evening.

Treatment should be limited to 4 weeks.

It is important to not stop using LUXIQ^® Foam suddenly or your skin condition could flare up again. If no improvement is seen within 2 weeks, contact your doctor.

How to apply LUXIQ^®:

Shake the can, hold it upside down and dispense a small amount of LUXIQ^® Foam (typically a dollop the size of a golf ball, approximately 3 g) 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.

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 for up to 4 weeks. 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.

Wash your hands immediately after applying LUXIQ^® Foam, and discard any unused dispensed medication.

Do not wash or rinse the treated areas immediately after applying LUXIQ^®

Foam.

LUXIQ^® Foam should be used for the minimum amount of time required to achieve the desired results, but always use LUXIQ^® Foam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

Missed Dose:

If you forget to apply LUXIQ^® Foam at the scheduled time, apply it as soon as you remember. If it is close to the time scheduled to apply your next dose, wait and apply your next scheduled dose and then continue as before. Do not apply extra LUXIQ^® to make up for missed doses. If you miss several doses, tell your doctor at your next appointment.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects with LUXIQ^® Foam include:

Very common:

• reactions at the application site, burning, stinging,

  itching

Common:

• tingling, pricking (paresthesia)
• itching
• local skin burning or pain
• psoriasis
• acne
• hair loss

• conjunctivitis (inflammation of the conjunctiva of the

  eye)

Less Common:

• application site infection, inflammation of hair follicles
• headache

Side effects with the use of topical corticosteroids, including LUXIQ^® Foam include:

• acne

• loss of skin color (hypopigmentation), pigmentation

  changes

• rash on the skin around the mouth or lips
• allergic contact dermatitis/dermatitis (a type of eczema)
• secondary infection
• application site irritation/pain

• local hypersensitivity

  • inflammation of the hair follicles, abnormal hair growth, hair loss
  • itching, local skin burning/skin pain, redness, rash or hives, heat rash (miliaria)
  • stretch marks
  • skin dryness, skin thinning/softening, skin wrinkling
  • swelling
  • flaking skin
  • superficial ulcers and blisters
  • raised bumps with pus under the skin (pustular psoriasis)
  • the appearance of blood vessels under the surface of your skin (telangiectasia)
  • worsening of condition
  • facial swelling

Serious side effects such as Cushing’s syndrome may be associated with absorption in the body of topical corticosteroids (for example, from long-term, improper or excessive use). Symptoms include: increased weight, moon face / rounding of the face and obesity.

Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after your medical examination to confirm whether you have osteoporosis.

Patients should report any signs of local or systemic adverse reactions to their doctor.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

This is not a complete list of side effects. For any unexpected effects while taking LUXIQ^® Foam, contact your doctor or pharmacist.

HOW TO STORE IT

Store upright at controlled room temperature (20–25°C). Avoid storage in an upside down position.

DANGER

EXTREMELY FLAMMABLE. AVOID FIRE, OPEN FLAME, SPARK OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Contents under pressure.

Do not place in hot water or near radiators, stoves or other sources of heat.

Do not puncture or incinerate container or store at temperatures above 49°C.

Avoid contact with eyes or other mucous membranes.

Keep out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

https://www.maynepharma.com/contact-us/ or by contacting the sponsor,

Mayne Pharma Inc.

1240 Sugg Parkway

Greenville, NC 27834

USA

Imported/Distributed by: C.R.I., Dundas, ON L9H 7P3

Last revised: March 2, 2018

^®LUXIQ is a registered trade-mark used under license by Mayne Pharma Inc.