Taclonex Scalp (Topical application)

Betamethasone and calcipotriene combination is used on the skin and scalp to treat plaque psoriasis.

Betamethasone is a corticosteroid (cortisone-like medicine or steroid). It helps relieve redness, pain, itching, swelling, or other discomfort caused by certain skin problems.

Calcipotriene is a form of Vitamin D. It works by changing how the skin cells are produced in the areas affected by psoriasis.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress during regular visits to ensure that this medicine is working properly. Blood, urine, and other tests may be necessary to check for unwanted effects.

If your psoriasis does not improve within a few weeks or gets worse, contact your doctor.

Using too much of this medicine or using it for a long time may increase your risk of adrenal gland problems. The risk is higher for children and patients who use large amounts for an extended period. Talk to your doctor if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause too much calcium to build up in your body. Excess calcium may increase your risk for adrenal gland problems. Talk to your doctor if you have stomach pain, confusion, constipation, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, a metallic taste, muscle weakness, nausea, thirst, unusual tiredness, vomiting, or weight loss.

Contact your doctor right away if you have blistering, burning, crusting, dryness, flaking, itching, scaling, severe redness, soreness, or swelling of the skin.

Make sure your doctor knows if you are also receiving ultraviolet (UV) light treatments (phototherapy) for your psoriasis before using this medicine.

This medicine may make your skin more sensitive to sunlight. Use sunscreen and wear protective clothing when you are outdoors. Avoid sunlamps and tanning beds.

Do not use cosmetics or other skin care products on the treated areas.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Studies have not been done to check how betamethasone and calcipotriene cream affects children. Safety and effectiveness have not been established.

Also, studies have not been done on the effects of betamethasone and calcipotriene topical foam, ointment, and suspension in children younger than 12 years. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of betamethasone and calcipotriene combination. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may change the dose or take other precautions. It's especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or adjust some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Cobicistat
• Darunavir
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dipyrone
• Drospirenone
• Droxicam
• Enoxacin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mestranol
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Alcuronium
• Atracurium
• Auranofin
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rifapentine
• Saiboku-To

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical problems may affect how you use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Atrophy (thin skin) at the treatment site or
• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head) or
• Posterior subcapsular cataract—Use with caution. May worsen these conditions.

• Erythrodermic (redness), exfoliative (peeling), or pustular (with pus) psoriasis or
• Hypercalcemia (high calcium in the blood) or
• Hypercalciuria (high calcium in the urine) or
• Severe kidney disease or
• Severe liver disease—Use has not been studied in patients with these conditions.

• Skin or scalp infection at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site or
• Liver failure—The risk of side effects may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Burning, itching, and pain in hairy areas
• burning sensation of the skin
• flushing or redness of the skin
• itching skin
• pus at the root of the hair
• red, scaling, or crusted skin
• scaly rash
• skin irritation
• thinning of the skin with easy bruising
• unusually warm skin

Rare

• Body aches or pain
• chills
• cough
• darkening of the skin
• diarrhea
• difficulty with breathing
• ear congestion
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• lightening of normal skin color
• lightening of the treated areas of dark skin
• loss of appetite
• loss of voice
• muscle aches and pains
• nausea
• raised, dark red, or wart-like spots on the skin
• red, sore eyes
• shivering
• sneezing
• sore throat
• spots on your skin that look like a blister or pimple
• stuffy or runny nose
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• worsening of psoriasis

Incidence not known

• Blindness
• blurred vision
• burning and itching of the skin with pinhead-sized red blisters
• decreased vision
• eye pain
• tearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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:

Less common

• Bruising
• large, flat, blue, or purplish patches in the skin
• pain

Rare

• Blemishes on the skin
• pimples

Incidence not known

• Dryness of the skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness and scaling around the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Enstilar
• Taclonex
• Taclonex Scalp
• Wynzora

Available Dosage Forms:

• Ointment
• Suspension
• Foam
• Cream

Therapeutic Class: Antipsoriatic

Pharmacologic Class: Betamethasone

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 should only be used on the skin or scalp. Do not get it into your eyes, nose, mouth, vagina, or apply it on your face, under your arms, or on your groin area. Do not use it on skin or scalp areas that have cuts or scrapes. If it does get on these areas, rinse it off right away with water.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.

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

The treated areas should not be bandaged or covered after the medicine is applied, unless your doctor tells you to.

To use the topical cream:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected areas of the skin and rub it in gently.
• Do not use the cream for more than 8 weeks unless your doctor has told you to.
• Do not cover the treated skin area unless your doctor told you to do so.

To use the foam:

• Wash your hands before and after using this medicine.
• Shake the foam can before using the medicine.
• Apply the medicine to the affected areas of the skin and rub it in gently.
• Use this medicine within 6 months after opening.
• This medicine can catch on fire. Do not use it near heat, an open flame, or while smoking.

To use the ointment:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected areas of the skin and rub it in gently.
• Do not use the ointment for more than 4 weeks unless your doctor has told you to.

To use the topical suspension:

• Wash your hands with soap and water before and after using this medicine.
• Shake the bottle before using the medicine.
• Part your hair so you can see the patches on your scalp.
• Apply enough medicine to the affected areas on your scalp and rub it in gently.
• Do not wash your hair or take a bath or shower right after applying this medicine.
• Do not apply this medicine in the 12 hours before or after using any hair chemical treatments. Talk with your doctor first about it.
• Do not use the topical suspension for more than 8 weeks unless your doctor has told you to.

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 topical dosage form (cream):For plaque psoriasis: Adults—Apply to the affected area of the skin once a day for up to 8 weeks or until the area is cleared or as determined by your doctor. Do not use more than 100 grams (g) per week. Children—Use and dose must be determined by your doctor.
• For topical dosage form (foam):For plaque psoriasis: Adults and children 12 years of age and older—Apply to the affected area of the skin once a day for up to 4 weeks or until the area is cleared or as determined by your doctor. Do not use more than 60 grams every 4 days. Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For topical dosage form (ointment):For plaque psoriasis: Adults—Apply to the affected area of the skin once a day for up to 4 weeks or until the area is cleared or as determined by your doctor. Do not use more than 100 grams per week. Children 12 to 17 years of age—Apply to the affected area of the skin once a day for up to 4 weeks or until the area is cleared or as determined by your doctor. Do not use more than 60 grams per week. Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For topical dosage form (suspension): For plaque psoriasis of the body: Adults—Apply to the affected area of the skin once a day for up to 8 weeks or until the area is cleared or as determined by your doctor. Do not use more than 100 grams per week. Children—Use and dose must be determined by your doctor. For plaque psoriasis of the scalp: Adults—Apply to the affected area on the scalp once a day for up to 8 weeks or until the area is cleared or as determined by your doctor. Do not use more than 100 grams per week. Children 12 to 17 years of age—Apply to the affected area on the scalp once a day for up to 8 weeks or until the area is cleared or as determined by your doctor. Do not use more than 60 grams per week. Children younger than 12 years of age—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

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

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.

Keep the bottle of topical suspension in the carton when not in use. Use it within 6 months after it has been opened.

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

Store the cream can at room temperature, away from heat and direct light. Do not freeze. Use it within 6 months after it has been opened.

• Can Enstilar be used on the scalp?