Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 10631-122 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Ultravate |
||||||||
| Type | Brand | ||||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
||||||||
| Active Ingredients |
|
||||||||
| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| RxCUI drug identifier | 1789962, 1790329 |
||||||||
| Application Number | NDA208183 | ||||||||
| Labeler Name | Sun Pharmaceutical Industries, Inc. | ||||||||
| Packages |
|
||||||||
| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Ultravate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Topically applied ULTRAVATE lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] .
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with ULTRAVATE lotion twice daily for up to two weeks (up to approximately 50 grams/week). Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ULTRAVATE lotion twice daily for up to two weeks, and more frequently than in vehicle-treated subjects. Table 1. Adverse Reactions Occurring in ≥ 1% of Subjects Treated with ULTRAVATE Lotion for up to Two Weeks ULTRAVATE Lotion (N= 277) Vehicle Lotion (N= 259) Adverse Reaction % % Telangiectasia 1% 0% Application site atrophy 1% < 1% Headache 1% < 1% Less common adverse reactions (incidence less than 1% but greater than 0.1%) that occurred in subjects treated with ULTRAVATE lotion included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 in plaque psoriasis is unknown. 12.2 Pharmacodynamics Vasoconstriction: A vasoconstrictor assay in healthy subjects with ULTRAVATE lotion indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH). In the first study, ULTRAVATE lotion was applied to 20 adult subjects with moderate to severe plaque psoriasis. A mean dose of 3.5 grams ULTRAVATE lotion was applied twice daily for two weeks and produced HPA axis suppression in 5 of 20 (25%) subjects. The effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment. In the second study, ULTRAVATE lotion was applied to 16 adolescent subjects 12 years to less than 17 years of age with moderate to severe plaque psoriasis affecting a mean body surface area of 11.5% (range from 10% to 14%). The mean dose was 3.6 grams applied twice daily for two weeks. A subset of 14 of the 16 completed subjects had evaluable ACTH stimulation tests, and HPA axis suppression was observed in 1 of these 14 subjects (7%). In the second study also, the effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment. 12.3 Pharmacokinetics 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 from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. In the HPA clinical study [see Clinical Pharmacology ( 12.2 )] , pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects. Based on the geometric mean plasma concentrations at 12 hours post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) Cmax concentrations for ULTRAVATE lotion on Day 8 was 201.1 ± 157.5 pg/mL, with the corresponding median Tmax value of 3 hours (range 0 – 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCτ) was 1632 ± 1147 pg•h/mL. Specific Populations Pediatric Patients In the pediatric HPA study [see Clinical Pharmacology ( 12.2 )] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in a subset of 14 subjects. The HBP levels in the plasma were below the quantification limit (20 pg/mL) for all subjects at all time points with the exception of one subject at Day 15 (trough concentration of HBP of 28.2 pg/mL).
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Vasoconstriction: A vasoconstrictor assay in healthy subjects with ULTRAVATE lotion indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH). In the first study, ULTRAVATE lotion was applied to 20 adult subjects with moderate to severe plaque psoriasis. A mean dose of 3.5 grams ULTRAVATE lotion was applied twice daily for two weeks and produced HPA axis suppression in 5 of 20 (25%) subjects. The effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment. In the second study, ULTRAVATE lotion was applied to 16 adolescent subjects 12 years to less than 17 years of age with moderate to severe plaque psoriasis affecting a mean body surface area of 11.5% (range from 10% to 14%). The mean dose was 3.6 grams applied twice daily for two weeks. A subset of 14 of the 16 completed subjects had evaluable ACTH stimulation tests, and HPA axis suppression was observed in 1 of these 14 subjects (7%). In the second study also, the effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics 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 from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. In the HPA clinical study [see Clinical Pharmacology ( 12.2 )] , pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects. Based on the geometric mean plasma concentrations at 12 hours post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) Cmax concentrations for ULTRAVATE lotion on Day 8 was 201.1 ± 157.5 pg/mL, with the corresponding median Tmax value of 3 hours (range 0 – 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCτ) was 1632 ± 1147 pg•h/mL. Specific Populations Pediatric Patients In the pediatric HPA study [see Clinical Pharmacology ( 12.2 )] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in a subset of 14 subjects. The HBP levels in the plasma were below the quantification limit (20 pg/mL) for all subjects at all time points with the exception of one subject at Day 15 (trough concentration of HBP of 28.2 pg/mL).
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. None. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula: Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water. structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently. Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 ml) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1 )] . Do not use with occlusive dressings unless directed by a physician. ULTRAVATE lotion is for external use only. Avoid use on the face, scalp, groin, or axillae. ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use. • Apply a thin layer to the affected areas twice daily. (2) • Limit use to 50 g/week. (2) • Discontinue treatment when control is achieved. (2) • If no improvement is seen within 2 weeks, reassess diagnosis. (2) • Treatment beyond 2 consecutive weeks is not recommended. (2) • Do not use with occlusive dressings unless directed by a physician. (2) • Avoid use on the face, scalp, groin, or axillae. (2) • Not for ophthalmic, oral, or intravaginal use.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS ULTRAVATE (halobetasol propionate) lotion, 0.05% is a white to off-white lotion. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate. Lotion: 0.05% (0.5 mg/g).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
Spl product data elements
Usually a list of ingredients in a drug product.Ultravate halobetasol propionate HALOBETASOL PROPIONATE HALOBETASOL DIISOPROPYL ADIPATE OCTYLDODECANOL CETETH-20 POLOXAMER 407 CETYL ALCOHOL STEARYL ALCOHOL GLYCERIN CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL SODIUM HYDROXIDE PROPYLPARABEN BUTYLPARABEN WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of halobetasol propionate lotion at dose concentrations from 0.05% to 0.1% or from 0.25 to 0.5 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. Studies in the rat following oral administration at dose levels up to 50 µg/kg/day indicated no impairment of fertility or general reproductive performance.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of halobetasol propionate lotion at dose concentrations from 0.05% to 0.1% or from 0.25 to 0.5 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. Studies in the rat following oral administration at dose levels up to 50 µg/kg/day indicated no impairment of fertility or general reproductive performance.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Ultravate Lotion 60mL (59 g) Carton PDP-60ml
Ultravate Lotion 120 mL (2 bottles of 60 mL/ 59 g) R:\Regulatory\spl\Jennifer\Ultravate Lotion\March 2018\Pictures\ultravate-03.jpg
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage ( 1 ) 08/2020 Warnings and Precautions ( 5.1 ) 08/2020
Ultravate: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients using ULTRAVATE lotion of the following information and instructions: Important Administration Instructions Instruct patients to discontinue ULTRAVATE lotion when psoriasis is controlled. ULTRAVATE lotion should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks. Inform patients that total dosage should not exceed 50 grams per week [see Dosage and Administration ( 2 )] . Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae [see Dosage and Administration ( 2 )] . Effects on Endocrine System ULTRAVATE lotion may cause HPA axis suppression. Advise patients that use of ULTRAVATE lotion, may require periodic evaluation for HPA axis suppression. Advise patients to avoid use of multiple corticosteroid-containing products [see Warnings and Precautions ( 5.1 )] . Local Adverse Reactions Inform patients that topical corticosteroids may cause local adverse reactions, some of which may be irreversible. These reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids, including ULTRAVATE lotion [see Warnings and Precautions ( 5.2 )]. Breastfeeding women should not apply ULTRAVATE lotion directly to the nipple and areola to avoid directly exposing the infant [see Lactation ( 8.2 )] . ULTRAVATE is a trademark of Sun Pharmaceutical Industries, Inc. Manufactured by: Ferndale Laboratories, Inc., Ferndale, MI 48220 Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 U.S. Patent 8,962,028 Revised: 08/2020
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES ULTRAVATE lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled trials. These trials were conducted in 443 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level global evaluation scale, on which a subject scored either moderate or severe. Overall, 57% of subjects were male and 86% were Caucasian. Subjects applied ULTRAVATE lotion or vehicle to all affected areas twice daily for up to 14 consecutive days. The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two grade improvement from baseline at Week 2 (end of treatment). Table 2 presents these results. Table 2. Overall Treatment Success in Subjects with Plaque Psoriasis at Week 2 Study 1 Study 2 ULTRAVATE Lotion N= 110 Vehicle Lotion N =111 ULTRAVATE Lotion N=110 Vehicle Lotion N=112 Overall Treatment Success* 49 (44.5%) 7 (6.3%) 49 (44.5%) 8 (7.1%) * Subjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two grade improvement from baseline. The secondary measures of efficacy were Treatment Success for individual signs of psoriasis (scaling, erythema, and plaque elevation) at the end of treatment (see Table 3). Table 3. Individual Signs Treatment Success in Subjects with Plaque Psoriasis at Week 2 Study 1 Study 2 Treatment Success* ULTRAVATE Lotion N= 110 Vehicle Lotion N= 111 ULTRAVATE Lotion N= 110 Vehicle Lotion N= 112 Scaling 61 (55.5%) 12 (10.8%) 65 (59.1%) 11 (9.8%) Erythema 40 (36.4%) 8 (7.2%) 48 (43.6%) 12 (10.7%) Plaque Elevation 50 (45.5%) 9 (8.1%) 48 (43.6%) 9 (8.0%) * Subjects who were cleared or almost cleared of the designated clinical sign with at least a two grade improvement from baseline.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies with ULTRAVATE lotion included 89 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years. Clinical studies of ULTRAVATE lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness of ULTRAVATE lotion for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older. It is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled safety trial in 16 adolescents (12 to less than 17 years of age). Adolescent patients with moderate to severe plaque psoriasis covering a minimum of 10% of the total body surface area were treated twice daily for 2 weeks with ULTRAVATE lotion. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 14 patients. After 2 weeks of treatment, 1 of 14 patients (7%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 μg/dL) that recovered upon retest. No other adverse reactions were reported in the study. Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary There are no available data on Ultravate lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data]. The clinical relevance of the animal findings is not clear. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to be teratogenic in rats and rabbits when given systemically during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. These doses are approximately 13, 33, and 3 times, respectively, the human topical dose of halobetasol propionate, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on Ultravate lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data]. The clinical relevance of the animal findings is not clear. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to be teratogenic in rats and rabbits when given systemically during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. These doses are approximately 13, 33, and 3 times, respectively, the human topical dose of halobetasol propionate, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits. 8.2 Lactation Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids 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 ULTRAVATE lotion and any potential adverse effects on the breastfed infant from ULTRAVATE lotion or from the underlying maternal condition. Clinical Considerations Advise breastfeeding women not to apply ULTRAVATE lotion directly to the nipple and areola to avoid direct infant exposure. 8.4 Pediatric Use Safety and effectiveness of ULTRAVATE lotion for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older. It is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled safety trial in 16 adolescents (12 to less than 17 years of age). Adolescent patients with moderate to severe plaque psoriasis covering a minimum of 10% of the total body surface area were treated twice daily for 2 weeks with ULTRAVATE lotion. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 14 patients. After 2 weeks of treatment, 1 of 14 patients (7%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 μg/dL) that recovered upon retest. No other adverse reactions were reported in the study. Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. 8.5 Geriatric Use Clinical studies with ULTRAVATE lotion included 89 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years. Clinical studies of ULTRAVATE lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING ULTRAVATE lotion, 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 mL (59 g) of ULTRAVATE lotion. NDC 10631-122-04 60 mL (59 g) bottle NDC 10631-122-51 120 mL (2-60 mL/59 g bottles) Store at 25°C (77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API