HYDROCORTISONE- hydrocortisone lotion kit kit
Hydrocortisone by
Drug Labeling and Warnings
Hydrocortisone by is a Prescription medication manufactured, distributed, or labeled by Allegis Pharmaceuicals LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- WARNINGS AND PRECAUTIONS
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DESCRIPTION
Topical corticosteroids constitute a class of primarily synthetic steroids used a anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11Β)-. Its structural formula is:
Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg of hydrocortisone USP in a vehicle of isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride.
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CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
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 increase percutaneous absorption. Occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primaily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their matabolites are also excreted into the bile.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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PRECAUTIONS
General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment system absorption include the application of the more potent steroids, 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 or under an occlusive dressing 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 develps, topical corticosteroids should be discontinued and appropriate therapy instituted.
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, the corticosteroid should be discontinued until the infection has been adequately controlled.
Information for the Patient
Patients using topical corticosteroids should receive the following information and instructions:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under occlusive dressing.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as the garments may constitute occlusive dressings.
Laboratory Tests
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free corticol test
ACTH stimulation test
Carcinogensis, Mutagenesis, and 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 mutagencity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy Category C
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage lavels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on prenant 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 notlikely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use
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.
Hypothalamic-pituitary-adrenal (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 bilaterial papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.
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ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an aproximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermitis, allergic contact dermatis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
To report SUSPECTED ADVERSE REACTIONS, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or https://fda.gov/Safety/MedWatch/
- OVERDOSAGE
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DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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HOW SUPPLIED
Hydrocort Lotion Kit containing two 1oz (29.6 mL) bottles of hydrocortisone lotion UPS 2% and one 8oz (236.6 mL) bottle of shampoo and body wash (total kit volume: 296.8mL): NDC: 28595-840-90
- STORAGE
- SPL UNCLASSIFIED SECTION
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Shampoo & Body Wash
Shampoo & Body Wash Directions
Massage moderate amount into wet scalp and leave on scalp 2 to 3 minutes or apply to all areas of the body and lather then rinse thoroughly.
Sunburn Alert and Warnings
Suburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use sunscreen and limit sun exposure while using the product and for a week afterwards.
Warnings: For external use only, avoid contact with the eyes. If irritation occurs, wash product off, discontinue use and consult a physician.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone lotion kit kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 28595-840 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 28595-840-90 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 08/08/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BOTTLE 2 mL in 2 Part 2 0 BOTTLE 1 mL in 2 Part 1 of 2 SHAMPOO AND BODY WASH
shampoos (non-coloring) shampooProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCOLIC ACID (UNII: 0WT12SX38S) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR SODIUM CITRATE (UNII: 1Q73Q2JULR) INGR FRAGRANCE 13576 (UNII: 5EM498GW35) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) INGR MENTHOL, (+)- (UNII: C6B1OE8P3W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 236.6 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/10/2023 Part 2 of 2 HYDROCORTISONE
hydrocortisone lotion lotionProduct Information Item Code (Source) NDC: 28595-225 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 28595-225-31 29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA083231 06/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/08/2023 Labeler - Allegis Pharmaceuicals LLC (792272861)
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