BETAMETHASONE DIPROPIONATE- betamethasone dipropionate cream
Glenmark Pharmaceuticals Inc., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE CREAM.
BETAMETHASONE DIPROPIONATE cream (augmented), for topical use Initial U.S. Approval: 1983 INDICATIONS AND USAGEBetamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 8/2020 |
Risk Summary
There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding.
It is possible that topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for betamethasone dipropionate cream (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream (augmented) or from the underlying maternal condition.
Clinical Considerations
To minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate cream (augmented) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (Error! Hyperlink reference not valid.)].
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.
Manufactured by:
Glenmark Pharmaceuticals Limited
Baddi, Himachal Pradesh 173205, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
August 2020
Betamethasone Dipropionate
(bay’’ ta meth’ a sone dye proe’ pee oh nate)
Cream (Augmented)
Important information: Betamethasone dipropionate cream (augmented) is for use on skin only. Do not use betamethasone dipropionate cream (augmented) in your eyes, mouth, or vagina.
What is betamethasone dipropionate cream (augmented)?
Betamethasone dipropionate cream (augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older.
Do not use betamethasone dipropionate cream (augmented) if you are allergic to betamethasone dipropionate or any of the ingredients in betamethasone dipropionate cream (augmented). See the end of this leaflet for a complete list of ingredients in betamethasone dipropionate cream (augmented).
Before using betamethasone dipropionate cream (augmented), tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or injection or use other products on your skin or scalp that contain corticosteroids.
Do not use other products containing a steroid medicine with betamethasone dipropionate cream (augmented) without talking to your healthcare provider first.
How should I use betamethasone dipropionate cream (augmented)?
What are the possible side effects of betamethasone dipropionate cream (augmented)?
Betamethasone dipropionate cream (augmented) may cause serious side effects, including:
Your healthcare provider may do certain blood tests to check for side effects.
The most common side effect of betamethasone dipropionate cream (augmented) in adults includes stinging.
The most common side effects of betamethasone dipropionate cream (augmented) in children include thinning of the skin (atrophy), tiny red lines or blood vessels showing under the skin (telangiectasia), bruising and shininess.
These are not all of the possible side effects of betamethasone dipropionate cream (augmented).
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 betamethasone dipropionate cream (augmented)?
General information about the safe and effective use of betamethasone dipropionate cream (augmented).
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use betamethasone dipropionate cream (augmented) for a condition for which it was not prescribed. Do not give betamethasone dipropionate cream (augmented) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about betamethasone dipropionate cream (augmented) that is written for health professionals.
What are the ingredients in betamethasone dipropionate cream (augmented)?
Active ingredient: betamethasone dipropionate
Inactive ingredients: carbomer homopolymer, ceteareth-30, chlorocresol, cyclomethicone, glyceryl oleate/propylene glycol, purified water, propylene glycol, sodium hydroxide, sorbitol solution, white petrolatum and white wax.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Glenmark Pharmaceuticals Limited
Baddi, Himachal Pradesh 173205, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
August 2020
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate cream |
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Labeler - Glenmark Pharmaceuticals Inc., USA (130597813) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Glenmark Pharmaceuticals Limited | 676115028 | ANALYSIS(68462-290) , MANUFACTURE(68462-290) |