DIPROLENE (Page 2 of 3)

8.4 Pediatric Use

Use of DIPROLENE Ointment in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see Warnings and Precautions (5.1)].

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, DIPROLENE AF Cream 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of DIPROLENE AF Cream, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of DIPROLENE Ointment in the treatment of diaper dermatitis.

8.5 Geriatric Use

Clinical trials of DIPROLENE Ointment included 225 subjects who were 65 years of age and over and 46 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

11 DESCRIPTION

DIPROLENE (augmented betamethasone dipropionate) Ointment, 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β, 17,21-trihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28 H37 FO7 , a molecular weight of 504.6 and the following structural formula:

Chemical Structure

It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Each gram of DIPROLENE Ointment, 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white ointment base of propylene glycol; propylene glycol stearate; white petrolatum; and white wax.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of DIPROLENE Ointment in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

Vasoconstrictor Assay

Trials performed with DIPROLENE Ointment, 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3 Pharmacokinetics

No pharmacokinetics trials have been conducted with DIPROLENE Ointment.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2)].

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) , and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

The safety and efficacy of DIPROLENE Ointment for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis. A total of 378 subjects, of whom 152 received DIPROLENE Ointment, were included in these trials. These trials evaluated DIPROLENE Ointment applied twice daily, for 14 days. DIPROLENE Ointment was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.

16 HOW SUPPLIED/STORAGE AND HANDLING

DIPROLENE Ointment 0.05% is a white ointment supplied in 15-g (NDC 78206-124-01) and 50-g (NDC 78206-124-02) tubes.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients of the following:

  • Discontinue therapy when control is achieved, unless directed otherwise by the physician.
  • Use no more than 50 grams per week of DIPROLENE Ointment and no longer than 2 consecutive weeks.
  • Avoid contact with the eyes.
  • Advise patients to report any visual symptoms to their healthcare providers.
  • Avoid use of DIPROLENE Ointment on the face, underarms, or groin areas unless directed by the physician.
  • Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
  • Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
  • Advise a woman to use DIPROLENE Ointment on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply DIPROLENE Ointment directly to the nipple and areola to avoid direct infant exposure.

Distributed by: Organon LLC, a subsidiary of
ORGANON & Co.,Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

© 2022 Organon group of companies. All rights reserved.

uspi-og1460-ot-2202r001

Patient InformationDIPROLENE® (DIH-pro-leen)(augmented betamethasone dipropionate) Ointment
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 2/2022
Important information: DIPROLENE Ointment is for use on skin only. Do not use DIPROLENE Ointment in your eyes, mouth, or vagina.
What is DIPROLENE Ointment? DIPROLENE Ointment 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.
  • DIPROLENE Ointment should not be used in children under 13 years of age.
Do not use DIPROLENE Ointment if you are allergic to betamethasone dipropionate or any of the ingredients in DIPROLENE Ointment. See the end of this leaflet for a complete list of ingredients in DIPROLENE Ointment.
Before using DIPROLENE Ointment, tell your healthcare provider about all of your medical conditions, including if you:
  • have had irritation or other skin reaction to a steroid medicine in the past.
  • have thinning of the skin (atrophy) at the treatment site.
  • have diabetes.
  • have adrenal gland problems.
  • have liver problems.
  • have cataracts or glaucoma.
  • are pregnant or plan to become pregnant. It is not known if DIPROLENE Ointment will harm your unborn baby. If you use DIPROLENE Ointment during pregnancy, use DIPROLENE Ointment on the smallest area of the skin and for the shortest time needed.
  • are breastfeeding or plan to breastfeed. It is not known if DIPROLENE Ointment passes into your breast milk. Breastfeeding women should use DIPROLENE Ointment on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply DIPROLENE Ointment 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.
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 DIPROLENE Ointment without talking to your healthcare provider first.
How should I use DIPROLENE Ointment?
  • Use DIPROLENE Ointment exactly as your healthcare provider tells you to use it.
  • Apply a thin layer (film) of DIPROLENE Ointment to the affected skin area 1 or 2 times each day. Do not use more than 50 grams of DIPROLENE Ointment in 1 week.
  • Do not use DIPROLENE Ointment for longer than 2 weeks in a row unless your healthcare provider tells you to.
  • Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with DIPROLENE Ointment.
  • Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.
  • DIPROLENE Ointment should not be used to treat diaper rash or redness.
  • Avoid using DIPROLENE Ointment on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.
  • Wash your hands after applying DIPROLENE Ointment unless you are using the medicine to treat your hands.
What are the possible side effects of DIPROLENE Ointment? DIPROLENE Ointment may cause serious side effects, including:
  • DIPROLENE Ointment can pass through your skin. Too much DIPROLENE Ointment passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
  • Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
  • High blood sugar (hyperglycemia).
  • Effects on growth and weight in children.
  • Vision problems. Topical corticosteroids including DIPROLENE Ointment may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with DIPROLENE Ointment.
  • Skin problems. Skin problems including, allergic reactions (contact dermatitis) may happen during treatment with DIPROLENE Ointment. Stop using DIPROLENE Ointment and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with DIPROLENE Ointment.
Your healthcare provider may do certain blood tests to check for side effects.
The most common side effects of DIPROLENE Ointment include redness of the skin, inflamed hair follicles, itching and blistering.
These are not all of the possible side effects of DIPROLENE Ointment.
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 DIPROLENE Ointment?
  • Store DIPROLENE Ointment at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep DIPROLENE Ointment and all medicines out of the reach of children.
General information about the safe and effective use of DIPROLENE Ointment. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DIPROLENE Ointment for a condition for which it was not prescribed. Do not give DIPROLENE Ointment 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 DIPROLENE Ointment that is written for health professionals.
What are the ingredients in DIPROLENE Ointment?
Active ingredient: augmented betamethasone dipropionateInactive ingredients: propylene glycol; propylene glycol stearate; white petrolatum; and white wax.
Distributed by: Organon LLC, a subsidiary of ORGANON & Co.,Jersey City, NJ 07302, USA
© 2022 Organon group of companies. All rights reserved.usppi-og1460-ot-2202r001For patent information: www.organon.com/our-solutions/patent/

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