Hydrocortisone Butyrate - Hydrocortisone Butyrate lotion

Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

• Apply Hydrocortisone Butyrate Lotion for up to 2 weeks as a thin layer to the affected skin two times daily and rub in gently.
• Discontinue Hydrocortisone Butyrate Lotion when control is achieved.
• If no improvement is seen within 2 weeks, consider reassessment of the diagnosis. Before prescribing for more than 2 weeks, the additional benefits of extending treatment up to 4 weeks should be weighed against the risk of endocrine system adverse reactions and local adverse reactions
  
  
  [see
  
  

  5.1 Endocrine System Adverse Reactions

  Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. 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. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH_1-24) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue Hydrocortisone Butyrate Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids

  [see Adverse Reactions (6)].

  Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion due to their larger skin-surface-to-body-mass ratios

  [see Use in Specific Populations (8.4)].

  Cushing’s Syndrome, Hyperglycemia, and Glucosuria

  Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

  Additional Considerations for Endocrine Adverse Reactions

  Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

  Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [

  see Dosage and Administration (2)

  ].
  ,
  
  
  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.

  The safety data described below reflect exposure to Hydrocortisone Butyrate Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age and 301 adult subjects with mild to moderate atopic dermatitis

  [see Clinical Studies (14)]

  .

  The incidence of selected adverse reactions reported by ≥1% of subjects during the studies is presented in Table 1 and Table 2.

  Table 1. Adverse Reactions in ≥1% of Hydrocortisone Butyrate Lotion-treated Pediatric Subjects 3 Months to 18 Years of Age with Mild to Moderate Atopic Dermatitis

  	Hydrocortisone Butyrate Lotion (n=139) n (%)	Vehicle (n=145) n (%)
  Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation	2 (1)	20 (14)
  Infantile acne	1 (1)	0 (0)
  Skin depigmentation	1 (1)	0 (0)

  Table 2. Adverse Reactions in ≥1% of Hydrocortisone Butyrate Lotion-treated Adult Subjects with Mild to Moderate Atopic Dermatitis

  	Hydrocortisone Butyrate Lotion (n=151) n (%)	Vehicle (n=150) n (%)
  Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus	5 (3)	7 (5)

  ,
  
  

  6.2 Postmarketing Experience

  The following adverse reactions have been identified during postapproval use of topical corticosteroids, including Hydrocortisone Butyrate Lotion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  Local Adverse Reactions

  : folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, and telangiectasia.

  Ophthalmic Adverse Reactions:

  blurred vision, cataracts, glaucoma, and increased intraocular pressure.

  ].
  
  
• Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or intravaginal use.
• Do not use Hydrocortisone Butyrate Lotion
  
  
  [see
  
  

  5.1 Endocrine System Adverse Reactions

  Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. 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. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH_1-24) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue Hydrocortisone Butyrate Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids

  [see Adverse Reactions (6)].

  Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion due to their larger skin-surface-to-body-mass ratios

  [see Use in Specific Populations (8.4)].

  Cushing’s Syndrome, Hyperglycemia, and Glucosuria

  Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

  Additional Considerations for Endocrine Adverse Reactions

  Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

  Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [

  see Dosage and Administration (2)

  ].

  ]
  
  
  .
  
• With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
• On the face, underarms, or groin areas unless directed by a healthcare provider.

Lotion: Each gram contains 1 mg of hydrocortisone butyrate (0.1%) in a white to off-white lotion base.

There are no controlled or large-scale epidemiologic studies with Hydrocortisone Butyrate Lotion in pregnant women, and available data on hydrocortisone butyrate use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes.

In animal reproduction studies, when administered subcutaneously or topically to pregnant rats, rabbits, and mice, hydrocortisone butyrate induced adverse reproductive and developmental outcomes, including abortion, fetal death, malformation, delayed ossification, decrease in fetal weight, and delay in sexual maturation (

The 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 2-4% and 15-20%, respectively.

Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 0.6, 1.8, and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 – 17. In the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day included increased ossification variations and unossified sternebra. No treatment-related embryofetal toxicity or malformation were noted at 5.4 and 1.8 mg/kg/day, respectively.

Subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 – 20. Increased abortion was noted at 0.3 mg/kg/day. In the absence of maternal toxicity, a dose-dependent decrease in fetal body weight was noted at doses ≥0.1 mg/kg/day. Embryofetal toxicities (reduction in litter size, decreased number of viable fetuses, and increased post-implantation loss) were noted at doses ≥0.2 mg/kg/day. Additional fetal effects included delayed ossification noted at doses ≥0.1 mg/kg/day and increased fetal malformations (primarily skeletal malformations) noted at doses ≥0.2 mg/kg/day. A dose at which no embryofetal toxicity or malformation was observed was not established in this study.

Additional systemic embryofetal development studies were conducted in rats and mice. Subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 – 15. In the presence of maternal toxicity, an increase in fetal death and fetal resorption and an increase in ossification of caudal vertebrae were noted at 9 mg/kg/day. No treatment-related embryofetal toxicity or malformation was noted at 0.1 mg/kg/day.

Subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 – 13. In the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at 1 mg/kg/day. No treatment-related embryofetal toxicity or malformation was noted at 1 and 0.2 mg/kg/day.

No topical embryofetal development studies were conducted with hydrocortisone butyrate lotion. However, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation. Topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 – 15 or pregnant female rabbits during gestation days 6 – 18. A dose-dependent increase in fetal resorption was noted in rabbits and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose. No treatment-related embryofetal toxicity was noted at the 1% hydrocortisone butyrate ointment dose in rats. A dose at which no embryofetal toxicity was observed in rabbits after topical administration of hydrocortisone butyrate ointment was not established. No treatment-related malformation was noted at a dose of 10% hydrocortisone butyrate ointment in rats or rabbits.

A peri- and post-natal development study was conducted in rats. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats from gestation day 6 to lactation day 20. In the presence of maternal toxicity, a dose-dependent decrease in fetal weight was noted at doses ≥1.8 mg/kg/day. No treatment-related fetal toxicity was noted at 0.6 mg/kg/day. A delay in sexual maturation was noted at 5.4 mg/kg/day. No treatment-related effects on sexual maturation were noted at 1.8 mg/kg/day. No treatment-related effects on behavioral development or subsequent reproductive performance were noted at 5.4 mg/kg/day.

• Endocrine System Adverse Reactions:
• Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if Hydrocortisone Butyrate Lotion is applied to large surface areas or used under occlusion. If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid. (
  
  
  5.1 Endocrine System Adverse Reactions

  Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. 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. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH_1-24) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue Hydrocortisone Butyrate Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids

  [see Adverse Reactions (6)].

  Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion due to their larger skin-surface-to-body-mass ratios

  [see Use in Specific Populations (8.4)].

  Cushing’s Syndrome, Hyperglycemia, and Glucosuria

  Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

  Additional Considerations for Endocrine Adverse Reactions

  Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

  Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [

  see Dosage and Administration (2)

  ].
  ,
  
  
  8.4 Pediatric Use

  The safety and effectiveness of Hydrocortisone Butyrate Lotion for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 3 months of age and older. Use of Hydrocortisone Butyrate Lotion for this indication is supported by evidence from an adequate and well-controlled trial in 284 pediatric patients 3 months to 18 years of age with mild to moderate atopic dermatitis.

  The safety and effectiveness of Hydrocortisone Butyrate Lotion have not been established in pediatric patients younger than 3 months of age.

  Endocrine Adverse Reactions

  Eighty-four (84) pediatric subjects (3 months to less than 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Hydrocortisone Butyrate Lotion three times daily for up to 4 weeks were assessed for HPA axis suppression. The disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in this HPA axis trial were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (twice daily) for which Hydrocortisone Butyrate Lotion is indicated. Seven of the 82 evaluable subjects (8.5%) demonstrated laboratory evidence of HPA axis suppression, where the criterion for defining HPA axis suppression was a serum cortisol level of less than or equal to 18 mcg/dL after cosyntropin stimulation. Subjects with HPA axis suppression ranged from 1 to 12 years of age and, at the time of enrollment, had 35% to 90% BSA involvement. These subjects did not develop any other signs or symptoms of HPA axis suppression. At the first follow-up visit, approximately 1 month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by the second post-treatment visit, 55 days post-treatment

  [see Clinical Pharmacology (12.2)]

  .

  Because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids

  [see Warnings and Precautions (5.1)]

  . They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment.

  Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
  )
  
• Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. (
  
  
  5.1 Endocrine System Adverse Reactions

  Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. 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. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH_1-24) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue Hydrocortisone Butyrate Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids

  [see Adverse Reactions (6)].

  Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion due to their larger skin-surface-to-body-mass ratios

  [see Use in Specific Populations (8.4)].

  Cushing’s Syndrome, Hyperglycemia, and Glucosuria

  Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

  Additional Considerations for Endocrine Adverse Reactions

  Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

  Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [

  see Dosage and Administration (2)

  ].
  ,
  
  
  8.4 Pediatric Use

  The safety and effectiveness of Hydrocortisone Butyrate Lotion for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 3 months of age and older. Use of Hydrocortisone Butyrate Lotion for this indication is supported by evidence from an adequate and well-controlled trial in 284 pediatric patients 3 months to 18 years of age with mild to moderate atopic dermatitis.

  The safety and effectiveness of Hydrocortisone Butyrate Lotion have not been established in pediatric patients younger than 3 months of age.

  Endocrine Adverse Reactions

  Eighty-four (84) pediatric subjects (3 months to less than 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Hydrocortisone Butyrate Lotion three times daily for up to 4 weeks were assessed for HPA axis suppression. The disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in this HPA axis trial were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (twice daily) for which Hydrocortisone Butyrate Lotion is indicated. Seven of the 82 evaluable subjects (8.5%) demonstrated laboratory evidence of HPA axis suppression, where the criterion for defining HPA axis suppression was a serum cortisol level of less than or equal to 18 mcg/dL after cosyntropin stimulation. Subjects with HPA axis suppression ranged from 1 to 12 years of age and, at the time of enrollment, had 35% to 90% BSA involvement. These subjects did not develop any other signs or symptoms of HPA axis suppression. At the first follow-up visit, approximately 1 month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by the second post-treatment visit, 55 days post-treatment

  [see Clinical Pharmacology (12.2)]

  .

  Because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids

  [see Warnings and Precautions (5.1)]

  . They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment.

  Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
  )
  
• Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios. (
  
  
  5.1 Endocrine System Adverse Reactions

  Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. 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. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH_1-24) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue Hydrocortisone Butyrate Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids

  [see Adverse Reactions (6)].

  Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion due to their larger skin-surface-to-body-mass ratios

  [see Use in Specific Populations (8.4)].

  Cushing’s Syndrome, Hyperglycemia, and Glucosuria

  Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

  Additional Considerations for Endocrine Adverse Reactions

  Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

  Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [

  see Dosage and Administration (2)

  ].
  ,
  
  
  8.4 Pediatric Use

  The safety and effectiveness of Hydrocortisone Butyrate Lotion for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 3 months of age and older. Use of Hydrocortisone Butyrate Lotion for this indication is supported by evidence from an adequate and well-controlled trial in 284 pediatric patients 3 months to 18 years of age with mild to moderate atopic dermatitis.

  The safety and effectiveness of Hydrocortisone Butyrate Lotion have not been established in pediatric patients younger than 3 months of age.

  Endocrine Adverse Reactions

  Eighty-four (84) pediatric subjects (3 months to less than 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Hydrocortisone Butyrate Lotion three times daily for up to 4 weeks were assessed for HPA axis suppression. The disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in this HPA axis trial were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (twice daily) for which Hydrocortisone Butyrate Lotion is indicated. Seven of the 82 evaluable subjects (8.5%) demonstrated laboratory evidence of HPA axis suppression, where the criterion for defining HPA axis suppression was a serum cortisol level of less than or equal to 18 mcg/dL after cosyntropin stimulation. Subjects with HPA axis suppression ranged from 1 to 12 years of age and, at the time of enrollment, had 35% to 90% BSA involvement. These subjects did not develop any other signs or symptoms of HPA axis suppression. At the first follow-up visit, approximately 1 month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by the second post-treatment visit, 55 days post-treatment

  [see Clinical Pharmacology (12.2)]

  .

  Because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids

  [see Warnings and Precautions (5.1)]

  . They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment.

  Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
  )
  
• Ophthalmic Adverse Reactions:
  Topical corticosteroids, including Hydrocortisone Butyrate Lotion, may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (
  
  
  5.2 Ophthalmic Adverse Reactions

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in post-marketing experience with the use of topical corticosteroid products

  [see Adverse Reactions (6.2)]

  .

  Avoid contact of Hydrocortisone Butyrate Lotion with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
  )
  
• Skin Infections:
  Initiate appropriate therapy if concomitant skin infections develop. (
  
  
  5.3 Skin Infections

  Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, an appropriate antimicrobial agent should be used. If a favorable response does not occur promptly, use of Hydrocortisone Butyrate Lotion should be discontinued until the infection has been adequately controlled

  [see Adverse Reactions (6)].
  )