Enstilar topical

You should not use this medicine if you are allergic to betamethasone or calcipotriene.

To make sure this medicine is safe for you, tell your doctor if you have:

• high levels of calcium in your blood (hypercalcemia);

• a history of kidney stones;

• liver or kidney disease;

• severe forms of psoriasis (with pus, skin peeling, severe redness);

• a skin infection; or

• if you are receiving UV light treatments (phototherapy).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether betamethasone and calcipotriene topical passes into breast milk or if it could harm a nursing baby. Do not apply this medicine to your breasts if you are breast-feeding a baby.

Do not use this medicine on a child without a doctor's advice. Children can absorb larger amounts of steroid medicine through the skin and may be more likely to have side effects. Steroid medicine can also affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Betamethasone and calcipotriene topical is not approved for use by anyone younger than 12 years old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not use betamethasone and calcipotriene topical to treat any condition that has not been checked by your doctor.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use in the vagina.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying this medicine, unless you are using the medicine to treat the skin on your hands.

Shake the suspension (liquid) or foam just before using it.

Apply this medicine once daily to the affected skin and rub it in gently. Do not spread the medicine over a large skin area. Do not apply to areas of thinner skin (face, underarms, groin) unless your doctor tells you to.

Do not cover the treated skin area. Covering skin treated with a topical steroid can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

If you use betamethasone and calcipotriene foam: Do not use more than 60 grams (1 full can) in 4 days.

If you use betamethasone and calcipotriene liquid:

• Adults should not use more than 100 grams (1 full bottle) of the liquid in 1 week.

• Children age 12 and older should not use more than 60 grams of the liquid in 1 week.

If you use betamethasone and calcipotriene ointment: Do not use more than 100 grams (1 large tube) of the ointment in 1 week. Avoid treating an area that is larger than 30% or one-third of your entire body.

Ask your pharmacist if you have questions about how much to apply each time you use the medicine.

Betamethasone and calcipotriene ointment or foam can be applied daily for up to 4 weeks. The liquid can be used daily for up to 8 weeks. Follow your doctor's instructions about your individual treatment schedule.

Call your doctor if your skin condition does not improve after several days of treatment, or if it gets worse while using this medicine.

If you use betamethasone and calcipotriene long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle or tube tightly closed when not in use.

Stop using the medicine when your skin clears up, unless your doctor tells you otherwise.

Betamethasone and calcipotriene foam is flammable. Do not use near high heat or open flame. Do not smoke until the medicine has completely dried on your skin.

This medication is used to treat psoriasis. It helps to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Healthy skin lowers your risk for infection and protects you against the environment. This product contains 2 drugs. Betamethasone is a very strong corticosteroid drug that works by decreasing swelling, redness, and itching. Calcipotriene is a form of vitamin D. It is also known as calcipotriol in other countries. It works by slowing down the growth of skin cells so that they don't build up into thickened, scaly skin patches.

This product should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis over most of your body with intense redness/shedding/oozing). Consult your doctor for more information.

How to use Enstilar Foam

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. Apply a thin layer to the affected area(s), usually once daily or as directed by your doctor. Rub it in gently and completely. Wash your hands after using, unless you are using this medication to treat the hands. Avoid getting any medication in the eyes or mouth. If this occurs, rinse right away with water. Do not apply this product to the face, underarms, or groin area. Do not use this medication for more than 4 weeks unless directed by your doctor.

If you are using the ointment, because of the increased risk of side effects, adults should not use more than 100 grams of the ointment per week unless directed and closely monitored by the doctor. Also, children and teenagers should not use more than 60 grams of the ointment per week.

If you are using the foam, shake the can before using. Do not use more than 60 grams of the foam every 4 days.

Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not apply this medication to large areas of damaged skin or use it in skin folds. Do not apply more of this medication than prescribed or use it more often or for longer than directed. Doing so may increase the amount of medication that is absorbed into your bloodstream, an effect that may increase your risk of side effects.

Inform your doctor if your condition does not improve or if it worsens. It may take a week to see any improvement and 4 weeks to see the full benefit of this medication.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as adrenal gland function tests) may be done while you are using this medication, especially if you use it for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Try to identify and reduce the triggers that may worsen your psoriasis (such as stress, skin injury). Discuss with your doctor additional ways to control symptoms, such as using a moisturizer to treat dry, itching skin.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store the US ointment in its tightly capped tube at room temperature.

Store the Canadian ointment in the refrigerator or at room temperature between 41-77 degrees F (5-25 degrees C). However, refrigerating the product may make it more difficult to apply. If you are using this product on delicate skin, it is best to store this medication at room temperature so it is easier to rub it in. Check the product instructions about how long you may store the tube once it is opened.

Store the foam at room temperature. Do not freeze. The foam is flammable. Avoid smoking during and right after applying the foam. Do not puncture the foam can or expose to high heat or open flame. Use the foam within 6 months after first opening the can.

Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.