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Revisión médica por Kovalenko Svetlana Olegovna Última actualización de farmacia el 16.03.2022
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Indicación
CLOBEX® Spray, 0.05% es una formulación de corticosteroides tópica potente súper alta indicada para el tratamiento de la psoriasis en placas moderada a severa que afecta hasta un 20% del área de superficie corporal (BSA) en pacientes de 18 años de edad o mayores. La dosis total no debe exceder los 50 g (59 ml o 2 fl. oz.) por semana. No use más de 26 aerosoles por aplicación o 52 aerosoles por día. El tratamiento debe limitarse a 4 semanas consecutivas.
Se debe indicar a los pacientes que usen CLOBEX® Spray, 0.05% durante el tiempo mínimo necesario para lograr los resultados deseados. No se recomienda su uso en pacientes menores de 18 años porque no se ha establecido la seguridad y porque se observaron tasas numéricamente altas de supresión del eje HPA con otras formulaciones tópicas de propionato de clobetasol.
Limitaciones de uso
CLOBEX® Spray, 0.05% no debe usarse en la cara, las axilas o la ingle. CLOBEX® Spray, 0.05% no debe usarse si hay atrofia en el sitio de tratamiento. CLOBEX® Spray, 0.05% no debe usarse en el tratamiento de rosácea o dermatitis perioral.
Powercort Foam es un corticosteroide indicado para el tratamiento de la psoriasis en placas moderada a severa del cuero cabelludo y la psoriasis en placas leve a moderada de regiones no en escalope del cuerpo, excluyendo la cara y las áreas intertriginosas en pacientes de 12 años en adelante.
La pomada Powercort está indicada para el tratamiento a corto plazo de manifestaciones inflamatorias y pruriginosas de dermatosis sensibles a los corticosteroides moderadas a severas. No se recomienda el tratamiento más allá de dos semanas consecutivas, y la dosis total no debe exceder los 50 g por semana debido a la posibilidad de que el medicamento suprima el eje hipotalamipituitario-adrenal (HPA).
No se recomienda el uso de este producto en pacientes pediátricos menores de 12 años.
CLOBEX® Spray, 0.05% es solo para uso tópico, y no para uso oftálmico, oral o intravaginal.
CLOBEX® Spray, 0.05% debe rociarse directamente sobre las áreas afectadas de la piel dos veces al día y frotarse suave y completamente.
La dosis total no debe exceder los 50 g (59 ml o 2 onzas líquidas) por semana debido a la posibilidad de que el medicamento suprima el eje hipotalámico-pituitario-adrenal (HPA). No use más de 26 aerosoles por aplicación o 52 aerosoles por día.
CLOBEX® Spray, 0.05% contiene un corticosteroide tópico; por lo tanto, el tratamiento debe limitarse a 4 semanas. La terapia debe suspenderse cuando se haya logrado el control. El tratamiento más allá de 2 semanas debe limitarse a las lesiones localizadas de psoriasis en placas moderada a severa que no han mejorado lo suficiente después de las 2 semanas iniciales de tratamiento con CLOBEX® Spray, 0.05%. Si no se observa mejoría en 2 semanas, puede ser necesaria una reevaluación del diagnóstico. Antes de recetar durante más de 2 semanas, cualquier beneficio adicional de extender el tratamiento a 4 semanas debe sopesarse frente al riesgo de supresión del eje HPA.
No se recomienda su uso en pacientes pediátricos menores de 18 años debido a la posibilidad de supresión del eje HPA.
A menos que esté dirigido por un médico, CLOBEX® Spray, 0.05% no debe usarse con apósitos oclusivos.
Aplique una capa delgada de espuma Powercort en las áreas afectadas de la piel dos veces al día.
Powercort Foam es un corticosteroide tópico de muy alta potencia; por lo tanto, limite el tratamiento a 2 semanas consecutivas. Los pacientes no deben usar más de 50 gramos por semana o más de 21 cápsulas por semana debido a la posibilidad de que el medicamento suprima el eje hipotalámico-pituitario-adrenal (HPA).
La terapia debe suspenderse cuando se logra el control.
Powercort Foam no debe usarse con apósitos oclusivos a menos que lo indique un médico.
Powercort Foam es solo para uso tópico. No es para uso oral, oftálmico o intravaginal.
Evita el contacto con los ojos. Lávese las manos después de cada aplicación.
Evite su uso en la cara, la ingle o las axilas, o si hay atrofia de la piel en el sitio de tratamiento.
Se debe aplicar una capa delgada de ungüento Powercort con un suave roce en el área de la piel afectada dos veces al día, una por la mañana y otra por la noche.
El ungüento Powercort es potente; por lo tanto, el tratamiento debe limitarse a dos semanas consecutivas, y no se deben usar cantidades superiores a 50 g por semana. Powercort Ointment no debe usarse con apósitos oclusivos.
Ninguna.
Powercort (propionato de clobetasol) La espuma está contraindicada en pacientes hipersensibles al propionato de clobetasol, a otros corticosteroides o a cualquier ingrediente de esta preparación.
Powercort Ointment está contraindicado en pacientes hipersensibles al propionato de clobetasol, a otros corticosteroides o a cualquier ingrediente de esta preparación.
WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
Effects on the Endocrine System
Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, using the Cosyntropin Stimulation Test, CLOBEX® Spray, 0.05% demonstrated rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15-20%, respectively), in adult patients with moderate to severe plaque psoriasis ( ≥ 20%BSA). In these studies, HPA axis suppression was defined as serum cortisol level ≤ 18 μg/dL 30-min post cosyntropin stimulation.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.
Local Adverse Reactions with Topical Corticosteroids
The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.
Allergic Contact Dermatitis
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Concomitant Skin Infections
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX® Spray, 0.05% should be discontinued until the infection has been adequately controlled.
Flammable Contents
CLOBEX® Spray, 0.05% is flammable; keep away from heat or flame.
Patient Counseling Information
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
- This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
- This medication should not be used for any disorder other than that for which it was prescribed.
- Do not use other corticosteroid-containing products while using CLOBEX® Spray, 0.05% unless directed by your physician.
- The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
- Patients should wash their hands after applying the medication.
- Patients should report any signs of local or systemic adverse reactions to the physician.
- Patients should inform their physicians that they are using CLOBEX® Spray, 0.05% if surgery is contemplated.
- If you go to another doctor for illness, injury or surgery, tell that doctor you are using CLOBEX® Spray, 0.05%.
- This medication is for external use only. It should not be used on the face, underarms, or groin area. Also avoid contact with the eyes and lips.
- As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
- Patients should not use more than 50 g (59 mL or 2 fl.oz.) per week of CLOBEX® Spray, 0.05%.
- Do not use more than 26 sprays per application or 52 sprays per day.
- This medication is flammable; avoid heat, flame or smoking when applying this product.
Instructions to the Pharmacist:
- Remove the spray pump from the wrapper
- Remove and discard the cap from the bottle
- Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened
- Dispense the bottle with the spray pump inserted
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m²/day basis). Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.
Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test
The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 μg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 μg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m²/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.
Use In Specific Populations
Pregnancy
Teratogenic Effects: Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Therefore, CLOBEX® Spray, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.
Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent.
The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 μg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal NOEL for clobetasol propionate was less than 12.5 μg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 μg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m²/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m²/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.
Nursing Mothers
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 breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX® Spray, 0.05% is administered to a nursing woman.
Pediatric Use
Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with CLOBEX® Spray, 0.05% have not been established.
Because of higher ratio of skin surface area to body mass, 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 glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Geriatric Use
Clinical studies of CLOBEX® Spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In two randomized, vehicle controlled clinical trials, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
WARNINGS
Included as part of the "PRECAUTIONS" Section
PRECAUTIONS
Effects On Endocrine System
Powercort Foam can cause 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 a patient 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.
In a trial evaluating the effects of Powercort Foam on the HPA axis, 13 subjects applied Powercort Foam to at least 20% of involved body surface area for 14 days. HPA axis suppression was identified in 5 out of 13 subjects (38%).
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.
Cushing’s syndrome and hyperglycemia may also occur due to the systemic effects of the topical corticosteroid. These complications 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.
Ophthalmic Adverse Reactions
Use of topical corticosteroids, including Powercort Foam, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products.
Avoid contact of Powercort Foam with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
Allergic Contact Dermatitis
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.
Flammable Contents
Powercort Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.
Patient Counseling Information
See FDA-approved patient labeling (PATIENT INFORMATION and Instructions For Use)
Effects On Endocrine System
Powercort Foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including Powercort Foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using Powercort Foam if surgery is contemplated.
Ophthalmic Adverse Reactions
Advise patients to report any visual symptoms to their healthcare providers.
Local Adverse Reactions
Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
Pregnancy
Advise pregnant women of the potential risk to a fetus and to use Powercort Foam on the smallest area of skin and for the shortest duration possible.
Lactation
Advise a woman to use Powercort Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Powercort Foam directly to the nipple and areola to avoid direct infant exposure.
Important Administration Instructions
Inform patients of the following:
- Avoid use of Powercort Foam 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.
- Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
- For proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin.
- Limit treatment to 2 consecutive weeks. Use no more than 50 grams of Powercort Foam per week, or more than 21 capfuls per week.
- Avoid use of Powercort Foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
- The product is flammable; avoid heat, flame, and smoking when applying this product.
- Do not use other corticosteroid-containing products without first consulting with the physician.
Powercort is a registered trademark of Stiefel Laboratories, Inc., a GSK Company, exclusively licensed to the Mylan Companies.
For additional information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or visit www.Powercort.com.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Powercort Foam or clobetasol propionate.
In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from 0.001% to 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol 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 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 for carcinogenesis.
Clobetasol propionate was nonmutagenic in the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. In the in vivo mouse micronucleus test, a positive finding was observed at 24 hours, but not at 48 hours, following oral administration at a dose of 2,000 mg/kg.
Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
Use In Specific Populations
Pregnancy
Risk Summary
There are no available data on Powercort Foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes.
Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use Powercort Foam on the smallest area of skin and for the shortest duration possible (see Data). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 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 [adjusted RR, 7.74 (95% CI, 1.49–40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month (range, 12–170g) over long periods of time.
Animal Data
Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities.
Lactation
Risk Summary
There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate 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 Powercort Foam and any potential adverse effects on the breastfed infant from Powercort Foam or from the underlying maternal condition.
Clinical Considerations
To minimize potential exposure to the breastfed infant via breast milk, use Powercort Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Powercort Foam directly to the nipple and areola to avoid direct infant exposure.
Pediatric Use
Safety and effectiveness of Powercort Foam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.
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 they are treated with topical drugs. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids.
Rare systemic toxicities 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 striae have also been reported with use of topical corticosteroids in pediatric patients.
Avoid use of Powercort Foam in the treatment of diaper dermatitis.
Geriatric Use
Clinical studies of Powercort Foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
WARNINGS
No information provided.
PRECAUTIONS
General
Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions that augment systemic absorption include the application of more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS: Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.
As with other potent topical corticosteroids, Powercort Ointment should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis.
Laboratory Tests
The following tests may be helpful in evaluating HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone have revealed negative results.
Pregnancy
Teratogenic Effects: Pregnancy Category C: The more potent corticosteroids have been shown to be teratogenic in animals after dermal application. Clobetasol propionate has not been tested for teratogenicity by this route; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.
There are no adequate and well-controlled studies of the teratogenic effects of topically applied corticosteroids, including clobetasol, in pregnant women. Therefore, clobetasol and other topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and they should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are prescribed for a nursing woman.
Pediatric Use
Use of Powercort Ointment in pediatric patients under 12 years of age is not recommended.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Geriatric Use
Clinical studies of clobetasol propionate scalp application, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
Experiencia en ensayos clínicos
Debido a que los ensayos clínicos se llevan a cabo en condiciones muy variables, las tasas de reacciones adversas observadas en los ensayos clínicos de un medicamento no se pueden comparar directamente con las tasas en los ensayos clínicos de otro medicamento y pueden no reflejar las tasas observadas en la práctica.
En ensayos clínicos controlados con CLOBEX® Spray, 0.05%, la reacción adversa más común fue arder en el sitio de aplicación [40% de los sujetos tratados con CLOBEX® Spray, 0.05% y 47% de los sujetos tratados con Spray Vehicle]. En la Tabla 1 se observan otras reacciones adversas comúnmente reportadas para CLOBEX® Spray, 0.05% y Spray Vehicle, respectivamente.
Tabla 1: Reacciones adversas de ocurrencia común (incidencia ≥ 1%)
Reacción adversa | Propionato de clobetasol 0.05% Spray (N = 120) | Spray de vehículos (N = 120) |
Sistema de clasificación de órganos | ||
Trastornos generales y condiciones del sitio de administración | 50 (42%) | 56 (47%) |
Sitio de aplicación quemando | 48 (40%) | 56 (47%) |
Secado del sitio de aplicación | 2 (2%) | 0 (0%) |
Irritación en el sitio de aplicación | 1 (1%) | 0 (0%) |
Dolor en el sitio de aplicación | 1 (1%) | 2 (2%) |
Cambios en la pigmentación del sitio de aplicación | 1 (1%) | 0 (0%) |
Prurito del sitio de aplicación | 4 (3%) | 3 (3%) |
Infecciones e infestaciones | 17 (14%) | 12 (10%) |
Nasofaringitis | 6 (5%) | 3 (3%) |
Faringitis estreptocócica | 1 (1%) | 0 (0%) |
Infección del tracto respiratorio superior | 10 (8%) | 2 (2%) |
Trastornos de la piel y del tejido subcutáneo | 4 (3%) | 2 (2%) |
Eczema asteatótico | 2 (2%) | 0 (0%) |
La mayoría de las reacciones adversas locales se calificaron como leves a moderadas y no se ven afectadas por la edad, la raza o el género.
La absorción sistémica de corticosteroides tópicos ha producido supresión del eje hipotalámico-pituitario-adrenal (HPA), manifestaciones del síndrome de Cushing, hiperglucemia y glucosuria en algunos pacientes.
Experiencia de postmarketing
Debido a que estas reacciones se informan voluntariamente de una población de tamaño incierto, no siempre es posible estimar de manera confiable su frecuencia o establecer una relación causal con la exposición a drogas.
Se han identificado las siguientes reacciones adversas durante el uso posterior a la aprobación de CLOBEX® Spray, 0.05%.
Piel:Quemaduras, prurito, eritema, dolor, irritación, erupción cutánea, descamación, urticaria y dermatitis de contacto.
Las siguientes reacciones adversas se analizan con mayor detalle en otras secciones del etiquetado:
- Efectos sobre el sistema endocrino
- Reacciones adversas oftálmicas
Experiencia en ensayos clínicos
Debido a que los ensayos clínicos se llevan a cabo en condiciones muy variables, las tasas de reacciones adversas observadas en los ensayos clínicos de un medicamento no se pueden comparar directamente con las tasas en los ensayos clínicos de otro medicamento y pueden no reflejar las tasas observadas en la práctica clínica.
En un ensayo clínico controlado que involucró a 188 sujetos con psoriasis del cuero cabelludo, no se informaron reacciones adversas localizadas en el cuero cabelludo en los sujetos tratados con Powercort Foam. En 2 ensayos clínicos controlados con Powercort Foam en 360 sujetos con psoriasis de regiones sin cuero cabelludo, los eventos adversos localizados que ocurrieron en los sujetos tratados con Powercort Foam incluyeron la quema del sitio de aplicación (10%), la sequedad del sitio de aplicación (<1%) y otros reacciones en el sitio de aplicación (4%).
En ensayos controlados más grandes con otras formulaciones de propionato de clobetasol, las reacciones adversas locales más frecuentes han incluido ardor, picazón, irritación, prurito, eritema, foliculitis, grietas y fisuras de la piel, entumecimiento de los dedos, atrofia de la piel y telangiectasia (todos menos del 2%).
Experiencia de postmarketing
Debido a que las reacciones adversas se informan voluntariamente de una población de tamaño incierto, no siempre es posible estimar de manera confiable su frecuencia o establecer una relación causal con la exposición a medicamentos.
Las reacciones adversas locales a los corticosteroides tópicos pueden incluir: estrías, picazón, erupciones acneiformes, hipopigmentación, dermatitis perioral, dermatitis alérgica de contacto, infección secundaria, hipertricosis y miliaria.
Las reacciones adversas oftálmicas pueden incluir: cataratas, glaucoma, aumento de la presión intraocular y coriorretinopatía serosa central.
La pomada Powercort generalmente se tolera bien cuando se usa durante períodos de tratamiento de dos semanas. Las reacciones adversas más frecuentes informadas para la pomada de propionato de clobetasol han sido locales y han incluido sensación de ardor, irritación y picazón. Estos ocurrieron en aproximadamente el 0.5% de los pacientes. Las reacciones adversas menos frecuentes fueron picaduras, grietas, eritema, foliculitis, entumecimiento de los dedos, atrofia de la piel y telangiectasia, que ocurrieron en aproximadamente el 0.3% de los pacientes.
Las siguientes reacciones adversas locales se informan con poca frecuencia cuando se usan corticosteroides tópicos como se recomienda. Estas reacciones se enumeran en un orden de ocurrencia aproximadamente decreciente: ardor, picazón, irritación, sequedad, foliculitis, hipertricosis, erupciones acneiformes, hipopigmentación, dermatitis perioral, dermatitis alérgica de contacto, maceración de la piel, infección secundaria, atrofia de la piel, estrías y miliaria. La absorción sistémica de corticosteroides tópicos ha producido una supresión reversible del eje HPA, manifestaciones del síndrome de Cushing, hiperglucemia y glucosuria en algunos pacientes. En casos raros, se cree que el tratamiento (o la retirada del tratamiento) de la psoriasis con corticosteroides exacerbó la enfermedad o provocó la forma pustular de la enfermedad, por lo que se recomienda una cuidadosa supervisión del paciente.
El aerosol CLOBEX® aplicado tópicamente, 0.05% puede ser absorbido en cantidad suficiente para producir efectos sistémicos.
Powercort (propionato de clobetasol) aplicado tópicamente La espuma se puede absorber en cantidades suficientes para producir efectos sistémicos. Ver PRECAUCIONES .
El ungüento Powercort aplicado tópicamente puede absorberse en cantidades suficientes para producir efectos sistémicos (ver PRECAUCIONES).
Ensayo Vasoconstrictor
CLOBEX® Spray, 0.05% está en el rango de potencia súper alto como se demuestra en un estudio vasoconstrictor en sujetos sanos en comparación con otros corticosteroides tópicos. Sin embargo, puntajes de blanqueamiento similares no implican necesariamente equivalencia terapéutica.
Supresión del eje hipotalámico-pituitario-adrenal (HPA)
El efecto de CLOBEX® Spray, 0.05% sobre la función del eje hipotalámico-pituitario-adrenal (HPA) se investigó en adultos en dos estudios. En el primer estudio, los pacientes con psoriasis en placas que cubren al menos el 20% de su cuerpo aplicaron CLOBEX® Spray, 0.05% dos veces al día durante hasta 4 semanas. El 15% (2 de 13) de los pacientes mostraron supresión suprarrenal después de 4 semanas de uso según la prueba de estimulación de cosintropina. La supresión de laboratorio fue transitoria; Todos los sujetos volvieron a la normalidad después del cese del consumo de drogas. En el segundo estudio, los pacientes con psoriasis en placas que cubren al menos el 20% de su cuerpo aplicaron CLOBEX® Spray, 0.05% dos veces al día durante 2 o 4 semanas. El 19% (4 de 21) de los pacientes tratados durante 2 semanas y el 20% (3 de 15) de los pacientes tratados durante 4 semanas mostraron supresión suprarrenal al final del tratamiento según la prueba de estimulación con cosyntropin. La supresión de laboratorio fue transitoria; Todos los sujetos volvieron a la normalidad después del cese del consumo de drogas. En estos estudios, la supresión del eje HPA se definió como la estimulación del nivel sérico de cortisol ≤ 18 μg / dL 30 minutos después de la cosintropina (ACTH 1-24).
En un ensayo farmacocinético controlado, 5 de 13 sujetos experimentaron una supresión reversible de las glándulas suprarrenales en cualquier momento durante los 14 días de tratamiento con Powercort Foam aplicada al menos al 20% de la superficie corporal involucrada. De los 13 sujetos estudiados, 1 de 9 con psoriasis fue suprimido después de 14 días y los 4 de los sujetos con dermatitis atópica tenían niveles anormales de cortisol indicativos de supresión suprarrenal en algún momento después de comenzar la terapia con espuma Powercort (ver Tabla 1 a continuación).
Tabla 1: Sujetos con supresión reversible del eje HPA en cualquier momento durante el tratamiento
Dermatosis | Espuma de la fuente de alimentación |
Psoriasis | 1 de 9 |
Dermatitis atópicaa | 4 de 4 |
a Powercort Foam no está indicado para dermatitis atópica sin cuero cabelludo, ya que no se ha establecido la seguridad y eficacia de Powercort Foam en dermatitis atópica sin cuero cabelludo. No se recomienda su uso en niños menores de 12 años. |
El grado de absorción percutánea de corticosteroides tópicos está determinado por muchos factores, incluido el vehículo, la integridad de la barrera epidérmica y la oclusión.
Los corticosteroides tópicos pueden absorberse de la piel intacta normal. La inflamación y otros procesos de enfermedad en la piel pueden aumentar la absorción percutánea.
No hay datos en humanos sobre la distribución de corticosteroides a los órganos del cuerpo después de la aplicación tópica. Sin embargo, una vez absorbidos a través de la piel, los corticosteroides tópicos se manejan a través de vías metabólicas similares a los corticosteroides administrados sistémicamente. Se metabolizan, principalmente en el hígado, y luego se excretan por los riñones. Además, algunos corticosteroides y sus metabolitos también se excretan en la bilis.
Los corticosteroides tópicos pueden absorberse de la piel sana intacta. El grado de absorción percutánea de corticosteroides tópicos está determinado por muchos factores, incluida la formulación del producto y la integridad de la barrera epidérmica. La oclusión, la inflamación y / u otros procesos de enfermedad en la piel también pueden aumentar la absorción percutánea. Una vez absorbidos a través de la piel, los corticosteroides tópicos se metabolizan, principalmente en el hígado, y luego son excretados por los riñones. Algunos corticosteroides y sus metabolitos también se excretan en la bilis.
However, we will provide data for each active ingredient