Calcipotriene and Betamethasone Dipropionate: Package Insert and Label Information (Page 3 of 3)
16 HOW SUPPLIED/STORAGE AND HANDLING
Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% is a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension. It is available as:
- 60 gram bottle (NDC 63629-8618-1)
Keep the bottle in the carton when not in use. Unused product should be discarded six months after the bottle has been opened. Shake before use. Keep out of reach of children.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information and Instructions for Use)
Administration Instructions
- •
- Instruct pediatric patients (12 to 17 years) not to use more than 60 grams per week.
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- Instruct adult patients (18 years and older) not to use more than 100 grams per week.
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- Instruct patients to discontinue therapy when control is achieved unless directed otherwise by the healthcare provider.
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- Advise patients not to apply Calcipotriene and Betamethasone Dipropionate Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to the hair since hair treatments may involve strong chemicals. Talk with healthcare provider first.
- •
- Inform patients that they should not take a bath or shower or wash their hair right after application of Calcipotriene and Betamethasone Dipropionate Topical Suspension.
- •
- Advise patients to avoid use of Calcipotriene and Betamethasone Dipropionate Topical Suspension on the face, underarms, groin or eyes. If this medicine gets on face or in eyes, wash area right away.
- •
- Advise patients not to occlude the treatment area with bandage or other covering unless directed by the healthcare provider.
- •
- Instruct patients to shake bottle prior to using Calcipotriene and Betamethasone Dipropionate Topical Suspension and to wash hands after application.
Local Reactions and Skin Atrophy
Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
Hypercalcemia and Hypercalciuria
Advise patients that hypercalcemia and hypercalciuria have been observed with the use of Calcipotriene and Betamethasone Dipropionate Topical Suspension [see Warnings and Precautions (5.1)].
HPA Axis Suppression, Cushing’s Syndrome, and Hyperglycemia
Advise patients that Calcipotriene and Betamethasone Dipropionate Topical Suspension can cause HPA access suppression, Cushing’s syndrome, and/or hyperglycemia [see Warnings and Precautions (5.2) ].
Ophthalmic Adverse Reactions
Advise patients to avoid contact of Calcipotriene and Betamethasone Dipropionate Topical Suspension with eyes and to report any visual symptoms [see Warnings and Precautions (5.5)].
Possible Avoidance of Other Products Containing Calcipotriene or a Corticosteroid
Instruct patients not to use other products containing calcipotriene or a corticosteroid with Calcipotriene and Betamethasone Dipropionate Topical Suspension without first talking to the healthcare provider.
Pregnancy and Lactation
- •
- Advise pregnant women that Calcipotriene and Betamethasone Dipropionate Topical Suspension may increase the potential risk of having a low birth weight infant and to use Calcipotriene and Betamethasone Dipropionate Topical Suspension on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].
- •
- Advise breastfeeding women not to apply Calcipotriene and Betamethasone Dipropionate Topical Suspension directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].
Made in Israel
Manufactured By Perrigo
Yeruham, Israel
Distributed By
Perrigo®
Allegan, MI 49010
www.perrigo.com
Rev 12-19
2B000 RC J2
PATIENT INFORMATION
Calcipotriene (kal-si-POE-try-een) and Betamethasone (bay-ta-METH-a-sone) Dipropionate Topical Suspension, 0.005%/0.064%
Important: Calcipotriene and Betamethasone Dipropionate Topical Suspension is for use on skin only (topical). Do not get Calcipotriene and Betamethasone Dipropionate Topical Suspension near or in your mouth, eyes, or vagina.
There are other medicines that contain the same medicine that is in Calcipotriene and Betamethasone Dipropionate Topical Suspension and are used to treat plaque psoriasis. Do not use other products containing calcipotriene or a corticosteroid medicine with Calcipotriene and Betamethasone Dipropionate Topical Suspension without talking to your healthcare provider first.
What is Calcipotriene and Betamethasone Dipropionate Topical Suspension?
Calcipotriene and Betamethasone Dipropionate Topical Suspension is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp in people 12 years and older and plaque psoriasis of the scalp and body in people 18 years and older.
It is not known if Calcipotriene and Betamethasone Dipropionate Topical Suspension is safe and effective in children under 12 years of age.
Before you use Calcipotriene and Betamethasone Dipropionate Topical Suspension, tell your healthcare provider about all of your medical conditions, including if you:
- •
- have a calcium metabolism disorder
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- have thinning skin (atrophy) at the treatment site.
- •
- are pregnant or plan to become pregnant. It is not known if Calcipotriene and Betamethasone Dipropionate Topical Suspension will harm your unborn baby. Calcipotriene and Betamethasone Dipropionate Topical Suspension may increase your chance of having a low birth weight baby. If you use Calcipotriene and Betamethasone Dipropionate Topical Suspension during pregnancy, use Calcipotriene and Betamethasone Dipropionate Topical Suspension on the smallest area of the skin and for the shortest time needed.
- •
- are breastfeeding or plan to breastfeed. It is not known if Calcipotriene and Betamethasone Dipropionate Topical Suspension passes into your breast milk. Breastfeeding women should use Calcipotriene and Betamethasone Dipropionate Topical Suspension on the smallest area of the skin and for the shortest time needed. Do not apply Calcipotriene and Betamethasone Dipropionate Topical Suspension directly to the nipple and areola to avoid contact with your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.
How should I use Calcipotriene and Betamethasone Dipropionate Topical Suspension?
See the “Instructions for Use” for detailed information about the right way to use Calcipotriene and Betamethasone Dipropionate Topical Suspension.
- •
- Use Calcipotriene and Betamethasone Dipropionate Topical Suspension exactly as your healthcare provider tells you to use it.
- •
- Your healthcare provider should tell you how much Calcipotriene and Betamethasone Dipropionate Topical Suspension to use and where to use it.
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- Apply Calcipotriene and Betamethasone Dipropionate Topical Suspension to affected areas on the scalp and body 1 time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your healthcare provider gives you other instructions.
- •
- If you are 12 to 17 years of age, you should not use more than 60 grams of Calcipotriene and Betamethasone Dipropionate Topical Suspension in 1 week.
- •
- If you are 18 years of age or older, you should not use more than 100 grams of Calcipotriene and Betamethasone Dipropionate Topical Suspension in 1 week.
- •
- Do not use Calcipotriene and Betamethasone Dipropionate Topical Suspension longer than prescribed. Using too much Calcipotriene and Betamethasone Dipropionate Topical Suspension, or using it too often, or for too long can increase your risk for having serious side effects.
- •
- Do not apply Calcipotriene and Betamethasone Dipropionate Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your healthcare provider first.
- •
- Do not use Calcipotriene and Betamethasone Dipropionate Topical Suspension in the mouth, eyes, or vagina.
- •
- Do not use Calcipotriene and Betamethasone Dipropionate Topical Suspension on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.
- •
- If you accidentally get Calcipotriene and Betamethasone Dipropionate Topical Suspension on your face or in your eyes, wash the area with water right away.
- •
- Wash your hands after applying Calcipotriene and Betamethasone Dipropionate Topical Suspension.
- •
- Do not take a bath or shower or wash your hair right after applying Calcipotriene and Betamethasone Dipropionate Topical Suspension as the medicine will not work as well to treat your psoriasis.
- •
- Do not bandage or cover the treated skin area, unless instructed by your healthcare provider.
What are the possible side effects of Calcipotriene and Betamethasone Dipropionate Topical Suspension?
Calcipotriene and Betamethasone Dipropionate Topical Suspension may cause serious side effects, including:
- •
- Too much calcium in your blood or urine. Your healthcare provider may tell you to stop or temporarily stop treatment with Calcipotriene and Betamethasone Dipropionate Topical Suspension if you have too much calcium in your blood or urine.
- •
- Calcipotriene and Betamethasone Dipropionate Topical Suspension can pass through your skin. Too much Calcipotriene and Betamethasone Dipropionate Topical Suspension passing through you skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
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- Cushing’s syndrome , a condition that happens when your body is exposed to large amounts of the hormone cortisol.
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- High Blood sugar (hyperglycemia).
- •
- Skin problems. Tell your healthcare provider if you have any skin problems, including:
- o
- thinning of your skin
- o
- dryness
- o
- burning
- o
- changes in skin color
- o
- inflammation
- o
- redness
- o
- itching
- o
- infection
- o
- irritation
- o
- raised bumps on your skin
- •
- Eye Problems. Using Calcipotriene and Betamethasone Dipropionate Topical Suspension may increase your chance of getting cataracts and glaucoma. Do not get Calcipotriene and Betamethasone Dipropionate Topical Suspension in your eyes because it may cause eye irritation. Tell your healthcare provider if you have blurred vision or other vision problems during treatment with Calcipotriene and Betamethasone Dipropionate Topical Suspension.
The most common side effects of Calcipotriene and Betamethasone Dipropionate Topical Suspension include inflamed hair pores (folliculitis) and skin burning.
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 Calcipotriene and Betamethasone Dipropionate Topical Suspension?
- •
- Store Calcipotriene and Betamethasone Dipropionate Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C).
- •
- Do not refrigerate Calcipotriene and Betamethasone Dipropionate Topical Suspension.
- •
- Keep the bottle in the outer carton when not in use.
- •
- Throw away (discard) unused Calcipotriene and Betamethasone Dipropionate Topical Suspension 6 months after it has been opened.
Keep Calcipotriene and Betamethasone Dipropionate Topical Suspension and all medicines out of the reach of children.
General information about Calcipotriene and Betamethasone Dipropionate Topical Suspension.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Calcipotriene and Betamethasone Dipropionate Topical Suspension for a condition for which it was not prescribed. Do not give Calcipotriene and Betamethasone Dipropionate Topical Suspension to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Calcipotriene and Betamethasone Dipropionate Topical Suspension that is written for health professionals.
What are the ingredients in Calcipotriene and Betamethasone Dipropionate Topical Suspension?
Active ingredients: calcipotriene and betamethasone dipropionate.
Inactive ingredients: hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac -alpha-tocopherol, butylhydroxytoluene and mineral oil.
Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.
Made in Israel
Manufactured by Perrigo, Yeruham, Israel
Distributed by Perrigo, Allegan, MI 49010
For more information, go to www.perrigo.com or call 1-866-634-9120.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised 12/2019
INSTRUCTIONS FOR USE
Calcipotriene (kal-si-POE-try-een) and Betamethasone (bay-ta-METH-a-sone) Dipropionate Topical Suspension, 0.005%/0.064%
Important: Calcipotriene and Betamethasone Dipropionate Topical Suspension is for use on skin only (topical). Do not get Calcipotriene and Betamethasone Dipropionate Topical Suspension near or in your mouth, eyes or vagina.
Read this Instructions for Use before you start using Calcipotriene and Betamethasone Dipropionate Topical Suspension and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
How to apply Calcipotriene and Betamethasone Dipropionate Topical Suspension to your body:
Follow your healthcare provider’s instructions of how much Calcipotriene and Betamethasone Dipropionate Topical Suspension to use and where to use it. Apply Calcipotriene and Betamethasone Dipropionate Topical Suspension directly to areas affected by plaque psoriasis and gently rub in. Wash your hands after applying Calcipotriene and Betamethasone Dipropionate Topical Suspension, unless you are treating areas on your hands.
How to apply Calcipotriene and Betamethasone Dipropionate Topical Suspension to your scalp:
You do not need to wash your hair before you apply Calcipotriene and Betamethasone Dipropionate Topical Suspension
Step 1: Shake the bottle before use. Remove the cap from the bottle.
(See Figure A).
Step 2: Locate the area to treat using your fingers and part your hair.
(See Figure B).
Step 3: Squeeze a drop of Calcipotriene and Betamethasone Dipropionate Topical Suspension to your fingertip. (See Figure C).
Step 4: Use your fingers to apply the drop of Calcipotriene and Betamethasone Dipropionate Topical Suspension directly to scalp affected by plaque psoriasis. Gently rub in. (See Figure D).
Step 5: After applying Calcipotriene and Betamethasone Dipropionate Topical Suspension, put the cap back on the bottle.
Step 6: Wash your hands after applying Calcipotriene and Betamethasone Dipropionate Topical Suspension. Do not wash your hair right after you apply Calcipotriene and Betamethasone Dipropionate Topical Suspension to your scalp.
How should I store Calcipotriene and Betamethasone Dipropionate Topical Suspension?
- •
- Store the Calcipotriene and Betamethasone Dipropionate Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C).
- •
- Do not refrigerate Calcipotriene and Betamethasone Dipropionate Topical Suspension.
- •
- Keep bottle in the carton when not in use.
- •
- Discard unused Calcipotriene and Betamethasone Dipropionate Topical Suspension 6 months after it has been opened.
Keep Calcipotriene and Betamethasone Dipropionate Topical Suspension and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Made in Israel
Manufactured by Perrigo, Yeruham, Israel
Distributed by Perrigo, Allegan, MI 49010
Rev 12-2019
Calcipotriene Betamethasone Dipro Oint #60
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| Labeler — Bryant Ranch Prepack (171714327) |
| Registrant — Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bryant Ranch Prepack | 171714327 | REPACK (63629-8618), RELABEL (63629-8618) | |
Revised: 04/2022 Bryant Ranch Prepack
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