Beta-Val

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.

Common side effects include mild burning, stinging, or itching at the site of application.

This is not a complete list of Luxiq side effects. Ask your doctor or pharmacist for more information.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of betamethasone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the foam form, safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of betamethasone topical in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

• Tell all of your health care providers that you take Beta-Val. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told by the doctor.
• Use care when using on a large part of the skin. Talk with the doctor.
• Do not use to treat diaper rash or redness. Avoid putting this medicine in the diaper area.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Beta-Val while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take Beta-Val by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Some of these drugs need to be shaken before use. Be sure you know if this product needs to be shaken before using it.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Skin irritation.
• Thinning of the skin.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Dry skin.
• Burning.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to betamethasone topical: topical application cream, topical application lotion, topical application ointment, topical application spray

Other dosage forms:

• topical application cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment

Along with its needed effects, betamethasone topical (the active ingredient contained in Beta-Val) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking betamethasone topical:

• Burning or stinging
• itching at the application site

• Blistering, burning, crusting, dryness, or flaking of the skin
• cracking or tightening of the skin
• dry skin
• flushing or redness of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• unusually warm skin

• Blistering, peeling, or loosening of the skin

• Redness and scaling around the mouth

Some side effects of betamethasone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Raised, dark red, or wart-like spots on the skin, especially when used on the face

• Burning, itching, and pain in hairy areas, or pus at the root of the hair

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Applies to betamethasone topical: topical cream, topical foam, topical gel, topical lotion, topical ointment, topical spray

General

The most commonly reported side effects were pruritus, burning, itching, irritation.

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity

Endocrine

Frequency not reported: Cushing's syndrome[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Folliculitis, skin infections (including bacterial, fungal and viral skin infections)
Frequency not reported: Dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, miliaria[Ref]

Local

Uncommon (0.1% to 1%): Application site pain
Frequency not reported: Burning, itching, irritation[Ref]

Ocular

Rare (less than 0.1%): Eye disorder[Ref]

Metabolic

Frequency not reported: Hyperglycemia

Renal

Frequency not reported: Glucosuria

Other

Rare (less than 0.1%): Rebound effect

Some side effects of Beta-Val may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.