Patient information: uses, side effects, how to take - Sernivo
What is SERNIVO Spray?
- SERNIVO Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.
It is not known if SERNIVO Spray is safe and effective in children under 18 years of age. SERNIVO Spray is not recommended for use in patients under 18 years of age.
Before you use SERNIVO Spray, tell your doctor about all of your medical conditions, including if you:
- are allergic to any of the ingredients in SERNIVO Spray. See the end of this leaflet for a list of the ingredients in SERNIVO Spray.
- have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if SERNIVO Spray will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if SERNIVO Spray passes into breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.
How should I use SERNIVO Spray?
See the “Instructions for Use” for detailed information about the right way to apply SERNIVO Spray.
- Use SERNIVO Spray exactly as your doctor tells you to use it.
- Your doctor should tell you how much SERNIVO Spray to use and where to apply it.
- Apply SERNIVO Spray 2 times a day.
- Use SERNIVO Spray for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 4 weeks of using SERNIVO Spray. Do not use SERNIVO Spray for longer than 4 weeks.
- Wash your hands after applying SERNIVO Spray.
- Do not use SERNIVO Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
- Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.
What are the possible side effects of SERNIVO Spray?
- SERNIVO Spray can pass through your skin. Too much SERNIVO Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.
The most common side effects of SERNIVO Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.
These are not all the possible side effects of SERNIVO Spray.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SERNIVO Spray?
- Store SERNIVO Spray at room temperature between 68°F to 77°F (20°C to 25°C).
- Throw away (discard) any unused SERNIVO Spray after 4 weeks
Keep SERNIVO Spray and all medicines out of the reach of children.
General information about the safe and effective use of SERNIVO Spray.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SERNIVO Spray for a condition for which it was not prescribed. Do not give SERNIVO Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about SERNIVO Spray that is written for health professionals.
What are the ingredients in SERNIVO Spray?
Active ingredient: betamethasone dipropionate
Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Encore Dermatology, Inc. Scottsdale, AZ 85254
SER 1288
4/19
Instructions for Use
SERNIVO™ (ser-ne-vo)
(betamethasone dipropionate)
Spray, 0.05%
Important: SERNIVO Spray is for use on the skin only. Do not get SERNIVO Spray near or in your eyes, mouth, or vagina.
Read this “Instructions for Use” before you start using SERNIVO Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
Parts of the SERNIVO Spray bottle. (See Figure A)
Figure A
How to apply SERNIVO Spray:
Step 1: Shake the SERNIVO Spray bottle well. Remove the cap from the pump top.
Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply SERNIVO Spray to the affected area as instructed by your doctor. (See Figure B)
Figure B
Step 3: Spray only enough SERNIVO Spray to cover the affected area, for example, the elbow (See Figure C). Rub in SERNIVO Spray gently.
Figure C
Repeat Steps 2 and 3 to apply SERNIVO Spray to other affected areas as instructed by your doctor.
Step 4: After applying SERNIVO Spray, place the cap back onto the pump top. (See Figure D)
Figure D
How should I store SERNIVO Spray?
- Store SERNIVO Spray at room temperature between 68°F to 77°FF (20°FC to 25°C).
- Throw away (discard) any unused SERNIVO Spray after 28 days.
Keep SERNIVO Spray and all medicines out of the reach of children.
This "Instructions for Use" has been approved by the U.S. Food and Drug Administration.
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Encore Dermatology, Inc., Scottsdale AZ 85254
SERNIVO is a registered trademark of Encore Dermatology, Inc
Issued: 02/2016
Revised: 04/2019
SER1289
4/19