ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. oThe most common adverse reaction reported in 0.4% of adult patients is stinging. (6.1) oThe most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. (6.1, 8.4)To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. oThe most common adverse reaction reported in 0.4% of adult patients is stinging. (6.1) oThe most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. (6.1, 8.4). 6.1 Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.In controlled clinical trials, involving 242 adult subjects, the adverse reaction associated with the use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented)reported at frequency of 0.4% was stinging. It occurred in subject. In controlled clinical trial involving 67 pediatric subjects from months to 12 years of age, the adverse reactions associated with the use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) occurred in of 67 (10%) subjects. Reported reactions included signs of skin atrophy (telangiectasia, bruising, shininess).. 6.2 Postmarketing Experience. Because adverse reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.Postmarketing reports for local adverse reactions to topical corticosteroids may also include: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, skin atrophy, striae, and miliaria.Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in corticosteroid responsive dermatoses is unknown.. 12.2 Pharmacodynamics. Vasoconstrictor AssayTrials performed with Betamethasone Dipropionate Cream USP, 0.05% (Augmented) indicate that it is in the 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 Betamethasone Dipropionate Cream, 0.05% (Augmented). 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.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. The safety and efficacy of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque psoriasis. total of 81 subjects who received Betamethasone Dipropionate Cream USP, 0.05% (Augmented) were included in these trials. These trials evaluated Betamethasone Dipropionate Cream USP, 0.05% (Augmented) applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis.

CONTRAINDICATIONS SECTION.

4CONTRAINDICATIONS. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.. oHypersensitivity to any component of this medicine. (4). oHypersensitivity to any component of this medicine. (4).

DESCRIPTION SECTION.

11 DESCRIPTION. Betamethasone Dipropionate Cream USP 0.05%, (Augmented), contains betamethasone dipropionate USP, synthetic adrenocorticosteroid, for topical use in white to off-white cream base. Betamethasone, an analog of prednisolone, has high degree of corticosteroid activity and slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.Chemically, betamethasone dipropionate is 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, molecular weight of 504.6, and the following structural formula:Betamethasone dipropionate is white to creamy white, odorless crystalline powder, insoluble in water.Each gram of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in white to off-white cream base of purified water, chlorocresol, white petrolatum, white wax (beeswax), cyclomethicone, sorbitol solution, glyceryl monooleate, propylene glycol, ceteareth-30, carbomer 980, and sodium hydroxide.. chemstruct.

DOSAGE & ADMINISTRATION SECTION.

2DOSAGE AND ADMINISTRATION. Apply thin film of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) to the affected skin areas once or twice daily.Therapy should be discontinued when control is achieved. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is high-potency corticosteroid. Treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented) should not exceed 50 per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)].Betamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used with occlusive dressings unless directed by physician.Avoid contact with eyes. Wash hands after each application.Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.. oApply thin film to the affected skin areas once or twice daily. (2)oDiscontinue therapy when control is achieved. (2)oUse no more than 50 per week. (2)oDo not use with occlusive dressings unless directed by physician. (2)oAvoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2)oNot for oral, ophthalmic, or intravaginal use. (2). oApply thin film to the affected skin areas once or twice daily. (2). oDiscontinue therapy when control is achieved. (2). oUse no more than 50 per week. (2). oDo not use with occlusive dressings unless directed by physician. (2). oAvoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2). oNot for oral, ophthalmic, or intravaginal use. (2).

DOSAGE FORMS & STRENGTHS SECTION.

3DOSAGE FORMS AND STRENGTHS. Each gram of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in white to off-white cream base.. oCream, 0.05% (3). oCream, 0.05% (3).

GERIATRIC USE SECTION.

8.5 Geriatric Use. Clinical trials of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) included 104 subjects who were 65 years of age and over and 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.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. Betamethasone Dipropionate Cream USP,0.05% (Augmented) is supplied as follows: NDC 0168-0265-15, 15 gram tube NDC 0168-0265-50, 50 gram tube Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Protect from freezing.

INDICATIONS & USAGE SECTION.

1INDICATIONS AND USAGE. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.. Betamethasone Dipropionate Cream, 0.05% (Augmented) is corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following:oDiscontinue therapy when control is achieved, unless directed otherwise by the physician. oUse no more than 50 grams per week.oAvoid contact with the eyes.oAdvise patients to report any visual symptoms to their healthcare providers.oAvoid use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the face, underarms, or groin areas unless directed by the physician.oDo not occlude the treatment area with bandage or other covering, unless directed by the physician.oNote that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.oAdvise woman to use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) directly to the nipple and areola to avoid direct infant exposure. E. FOUGERA CO. division of Fougera Pharmaceuticals Inc. Melville, New York 11747 46274295A R09/2020 59. oDiscontinue therapy when control is achieved, unless directed otherwise by the physician. oUse no more than 50 grams per week.. oAvoid contact with the eyes.. oAdvise patients to report any visual symptoms to their healthcare providers.. oAvoid use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the face, underarms, or groin areas unless directed by the physician.. oDo not occlude the treatment area with bandage or other covering, unless directed by the physician.. oNote that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.. oAdvise woman to use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) directly to the nipple and areola to avoid direct infant exposure.. E. FOUGERA CO.. division of Fougera Pharmaceuticals Inc.. Melville, New York 11747. 46274295A R09/2020. 59.

LACTATION SECTION.

8.2 Lactation Risk SummaryThere 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 USP, 0.05% (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 mothers clinical need for Betamethasone Dipropionate Cream USP, 0.05% (Augmented)and any potential adverse effects on the breastfed infant from Betamethasone Dipropionate Cream USP, 0.05% (Augmented)or from the underlying maternal condition.Clinical ConsiderationsTo minimize potential exposure to the breastfed infant via breast milk, use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in corticosteroid responsive dermatoses is unknown.

NONCLINICAL TOXICOLOGY SECTION.

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 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 15 Tube. NDC 0168-0265-15Fougera(R) BETAMETHASONEDIPROPIONATE CREAMUSP, 0.05%(AUGMENTED)Strength expressed as betamethasone Rx only For topical use only.Not for oral, ophthalmic, orintravaginal use. See crimp of tube forLot Number and Exp. Date. NET WT 15 grams. BETAMETHASONEDIPROPIONATE CREAMUSP, 0.05%(AUGMENTED)Strength expressed as betamethasone For topical use only.Not for oral, ophthalmic, orintravaginal use. See crimp of tube forLot Number and Exp. Date. 15gTubeLabel.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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 months to 12 years of age with atopic dermatitis, Betamethasone Dipropionate Cream USP, 0.05% (Augmented)was applied twice daily for to weeks over mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either <=5 mcg/dL pre-stimulation cortisol, or 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, subjects were tested weeks after discontinuation of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and of the (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 higher ratio of skin surface area to body mass, pediatric patients are at 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 Cushings 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 Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in the treatment of diaper dermatitis.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. Vasoconstrictor AssayTrials performed with Betamethasone Dipropionate Cream USP, 0.05% (Augmented) indicate that it is in the 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.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. No pharmacokinetics trials have been conducted with Betamethasone Dipropionate Cream, 0.05% (Augmented). 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.

PREGNANCY SECTION.

8.1 Pregnancy. Risk SummaryThere are no available data on Betamethasone Dipropionate Cream USP, 0.05% (Augmented) use in pregnant women to identify drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women that Betamethasone Dipropionate Cream USP, 0.05% (Augmented)may increase the risk of having low birthweight infant and to use Betamethasone Dipropionate Cream USP, 0.05% (Augmented)on the smallest area of skin and for the shortest duration possible.In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented)(see Data).The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.DataAnimal DataBetamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

RECENT MAJOR CHANGES SECTION.

Warnings and Precautions Ophthalmic Adverse Reactions (5.2) 05/2019. Warnings and Precautions Ophthalmic Adverse Reactions (5.2) 05/2019.

SPL PATIENT PACKAGE INSERT SECTION.

Patient Package Insert Patient Information Betamethasone Dipropionate Cream USP, 0.05% (Augmented) (BAY-ta-METH-a-sone)Important information: Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is for use on skin only. Do not use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in your eyes, mouth, or vagina. What is Betamethasone Dipropionate Cream USP, 0.05% (Augmented)Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is 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.oBetamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used in children under 13 years of age.Do not use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) if you are allergic to betamethasone dipropionate or any of the ingredients in Betamethasone Dipropionate Cream USP, 0.05% (Augmented). See the end of this leaflet for complete list of ingredients in Betamethasone Dipropionate Cream USP, 0.05% (Augmented).Before using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) tell your healthcare provider about all of your medical conditions, including if you:ohave had irritation or other skin reaction to steroid medicine in the past.ohave thinning of the skin (atrophy) at the treatment site.ohave diabetes.ohave adrenal gland problems.ohave liver problems.ohave cataracts or glaucoma.oare pregnant or plan to become pregnant. It is not known if Betamethasone Dipropionate Cream USP, 0.05% (Augmented) will harm your unborn baby. If you use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) during pregnancy, use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of the skin and for the shortest time needed.oare breastfeeding or plan to breastfeed. It is not known if Betamethasone Dipropionate Cream USP, 0.05% (Augmented) passes into your breast milk. Breastfeeding women should use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of the skin and for the shortest time needed. Do not apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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 steroid medicine with Betamethasone Dipropionate Cream USP, 0.05% (Augmented) without talking to your healthcare provider first.How should use Betamethasone Dipropionate Cream USP, 0.05% (Augmented)oUse Betamethasone Dipropionate Cream USP, 0.05% (Augmented) exactly as your healthcare provider tells you to use it.oApply thin layer (film) of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) to the affected skin area or times each day. Do not use more than 50 grams of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in week. oDo not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.oBetamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used to treat diaper rash or redness.oAvoid using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.oWash your hands after applying Betamethasone Dipropionate Cream USP, 0.05% (Augmented) unless you are using the medicine to treat your hands.What are the possible side effects of Betamethasone Dipropionate Cream USP, 0.05% (Augmented)Betamethasone Dipropionate Cream USP, 0.05% (Augmented) may cause serious side effects, including:oBetamethasone Dipropionate Cream USP, 0.05% (Augmented) can pass through your skin. Too much Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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.oCushings syndrome, condition that happens when your body is exposed to too much of the hormone cortisol.oHigh blood sugar (hyperglycemia).oEffects on growth and weight in children.oVision problems. Topical corticosteroids including Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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 Betamethasone Dipropionate Cream USP, 0.05% (Augmented).oSkin problems.Skin problems including, allergic reactions (contact dermatitis) may happen during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented). Stop using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented).Your healthcare provider may do certain blood tests to check for side effects.The most common side effect of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in adults includes stinging. The most common side effects of Betamethasone Dipropionate Cream USP, 0.05% (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 USP, 0.05% (Augmented).Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should store Betamethasone Dipropionate Cream USP, 0.05% (Augmented)oStore Betamethasone Dipropionate Cream USP, 0.05% (Augmented) at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Protect from freezing.oKeep Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and all medicines out of the reach of children.General information about the safe and effective use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented).Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) for condition for which it was not prescribed. Do not give Betamethasone Dipropionate Cream USP, 0.05% (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 USP, 0.05% (Augmented) that is written for health professionals.What are the ingredients in Betamethasone Dipropionate Cream USP, 0.05% (Augmented)Active ingredient: betamethasone dipropionate, USPInactive ingredients: purified water; chorocresol; white petrolatum; white wax (beeswax); cyclomethicone; sorbitol solution; glyceryl monooleate; propylene glycol; ceteareth-30; carbomer 980; and sodium hydroxide.. Patient Information. Betamethasone Dipropionate Cream USP, 0.05% (Augmented). (BAY-ta-METH-a-sone). oBetamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used in children under 13 years of age.. ohave had irritation or other skin reaction to steroid medicine in the past.. ohave thinning of the skin (atrophy) at the treatment site.. ohave diabetes.. ohave adrenal gland problems.. ohave liver problems.. ohave cataracts or glaucoma.. oare pregnant or plan to become pregnant. It is not known if Betamethasone Dipropionate Cream USP, 0.05% (Augmented) will harm your unborn baby. If you use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) during pregnancy, use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of the skin and for the shortest time needed.. oare breastfeeding or plan to breastfeed. It is not known if Betamethasone Dipropionate Cream USP, 0.05% (Augmented) passes into your breast milk. Breastfeeding women should use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of the skin and for the shortest time needed. Do not apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) directly to the nipple and areola to avoid contact with your baby.. oUse Betamethasone Dipropionate Cream USP, 0.05% (Augmented) exactly as your healthcare provider tells you to use it.. oApply thin layer (film) of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) to the affected skin area or times each day. Do not use more than 50 grams of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in week. oDo not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.. oBetamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used to treat diaper rash or redness.. oAvoid using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.. oWash your hands after applying Betamethasone Dipropionate Cream USP, 0.05% (Augmented) unless you are using the medicine to treat your hands.. oBetamethasone Dipropionate Cream USP, 0.05% (Augmented) can pass through your skin. Too much Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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.. oCushings syndrome, condition that happens when your body is exposed to too much of the hormone cortisol.. oHigh blood sugar (hyperglycemia).. oEffects on growth and weight in children.. oVision problems. Topical corticosteroids including Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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 Betamethasone Dipropionate Cream USP, 0.05% (Augmented).. oSkin problems.Skin problems including, allergic reactions (contact dermatitis) may happen during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented). Stop using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented).. oStore Betamethasone Dipropionate Cream USP, 0.05% (Augmented) at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Protect from freezing.. oKeep Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and all medicines out of the reach of children.

SPL UNCLASSIFIED SECTION.

5.1 Effects on Endocrine System. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) was applied once daily at grams per day for week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the HPA axis. The results suggested that the drug lowered adrenal corticosteroid secretion, although plasma cortisol levels did not go below the lower limit of the normal range.In an open-label pediatric trial of 60 evaluable subjects (3 months to 12 years of age), 19 subjects showed evidence of HPA axis suppression. Four (4) subjects were tested weeks after discontinuation of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), and of the (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.If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Cushings syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

STORAGE AND HANDLING SECTION.

Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Protect from freezing.

TERATOGENIC EFFECTS SECTION.

Risk SummaryThere are no available data on Betamethasone Dipropionate Cream USP, 0.05% (Augmented) use in pregnant women to identify drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women that Betamethasone Dipropionate Cream USP, 0.05% (Augmented)may increase the risk of having low birthweight infant and to use Betamethasone Dipropionate Cream USP, 0.05% (Augmented)on the smallest area of skin and for the shortest duration possible.In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented)(see Data).The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.DataAnimal DataBetamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryThere are no available data on Betamethasone Dipropionate Cream USP, 0.05% (Augmented) use in pregnant women to identify drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women that Betamethasone Dipropionate Cream USP, 0.05% (Augmented)may increase the risk of having low birthweight infant and to use Betamethasone Dipropionate Cream USP, 0.05% (Augmented)on the smallest area of skin and for the shortest duration possible.In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented)(see Data).The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.DataAnimal DataBetamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. 8.2 Lactation Risk SummaryThere 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 USP, 0.05% (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 mothers clinical need for Betamethasone Dipropionate Cream USP, 0.05% (Augmented)and any potential adverse effects on the breastfed infant from Betamethasone Dipropionate Cream USP, 0.05% (Augmented)or from the underlying maternal condition.Clinical ConsiderationsTo minimize potential exposure to the breastfed infant via breast milk, use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)]. 8.4 Pediatric Use. Use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) 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 months to 12 years of age with atopic dermatitis, Betamethasone Dipropionate Cream USP, 0.05% (Augmented)was applied twice daily for to weeks over mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either <=5 mcg/dL pre-stimulation cortisol, or 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, subjects were tested weeks after discontinuation of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and of the (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 higher ratio of skin surface area to body mass, pediatric patients are at 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 Cushings 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 Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in the treatment of diaper dermatitis.. 8.5 Geriatric Use. Clinical trials of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) included 104 subjects who were 65 years of age and over and 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.

WARNINGS AND PRECAUTIONS SECTION.

5WARNINGS AND PRECAUTIONS. oEffects on endocrine system: Betamethasone Dipropionate Cream, 0.05% (Augmented) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.1, 8.4)oOphthalmic Adverse Reactions: Betamethasone Dipropionate Cream, 0.05% (Augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. (5.2). oEffects on endocrine system: Betamethasone Dipropionate Cream, 0.05% (Augmented) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.1, 8.4). oOphthalmic Adverse Reactions: Betamethasone Dipropionate Cream, 0.05% (Augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. (5.2). 5.1 Effects on Endocrine System. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. Betamethasone Dipropionate Cream USP, 0.05% (Augmented) was applied once daily at grams per day for week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the HPA axis. The results suggested that the drug lowered adrenal corticosteroid secretion, although plasma cortisol levels did not go below the lower limit of the normal range.In an open-label pediatric trial of 60 evaluable subjects (3 months to 12 years of age), 19 subjects showed evidence of HPA axis suppression. Four (4) subjects were tested weeks after discontinuation of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), and of the (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.If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Cushings syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].. 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Betamethasone Dipropionate Cream USP, 0.05% (Augmented), may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including Betamethasone Dipropionate Cream USP, 0.05% (Augmented) [see Adverse Reactions (6.2)].Avoid contact of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.. 5.3 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.