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Pediaderm HC

Generic Name: hydrocortisone
Dosage Form: lotion

pediaderm® HC
Hydrocortisone Lotion USP 2%

Pediaderm HC Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as 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, (II β)-. Its structural formula is:

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Each mL of PEDIADERM-HC (Hydrocortisone Lotion USP 2%) contains 20 mg hydrocortisone USP in a lotion base consisting of water, isopropyl alcohol, polysorbate 20, propylene glycol, and benzalkonium chloride.

Pediaderm HC - 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 substantially increase the percutaneous absorption of topical corticosteroids. Thus, 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 primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Pediaderm HC

Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Hydrocortisone Lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic 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.

Children 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 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:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Patients should be advised not to use this medication for any other disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. 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 these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

  • Urinary free cortisol test
  • ACTH stimulation test

Carcinogenesis, 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 mutagenicity 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 levels. 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 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 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 children receiving topical corticosteroids. Manifestations of adrenal suppression in children 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.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

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 approximate decreasing order of occurrence:

Burning Perioral dermatitis
Itching Allergic contact dermatitis
Irritation Maceration of the skin
Dryness Secondary infection
Folliculitis Skin atrophy
Hypertrichosis Striae
Acneiform eruptions Miliaria
Hypopigmentation

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Pediaderm HC 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.

How is Pediaderm HC Supplied

PEDIADERM-HC (Hydrocortisone Lotion USP 2%) is supplied in 1 fluid ounce (29.6 mL) dispenser bottles (NDC: 24338-316-30) and 3 mL packets (NDC: 24338-316-03).

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

Manufactured for:
Arbor Pharmaceuticals, Inc.
Atlanta, GA 30328

Rev. 08/12
P1402.03

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 24338-420-01

pediaderm®HC
Hydrocortisone Lotion USP 2%

COMPLETE KIT

Pediaderm® HC
Complete Kit includes:

pediaderm®HC
Hydrocortisone Lotion USP 2%

pediaderm®
Protective Emollient

ONE UNIT
DO NOT DISPENSE SEPARATELY

For Topical Use Only
Rx ONLY

arbor®
PHARMACEUTICALS, INC.

Established Pharmacological Class
Substance Pharmacological Class
Pediaderm Protective Emollient Lotions, Oils, Powders, and Creams
Pediaderm HC 
hydrocortisone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24338-420
Packaging
# Item Code Package Description
1 NDC:24338-420-01 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 29.6 mL
Part 2 1 TUBE 85 g
Part 1 of 2
Pediaderm HC 
hydrocortisone lotion
Product Information
Item Code (Source) NDC:24338-316    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (Hydrocortisone) Hydrocortisone 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
isopropyl alcohol  
polysorbate 20  
propylene glycol  
benzalkonium chloride  
Packaging
# Item Code Package Description
1 NDC:24338-316-30 29.6 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083231 11/02/2009
Part 2 of 2
PEDIADERM   PROTECTIVE EMOLLIENT
inert cream
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
Water  
petrolatum  
glycerin  
mineral oil  
cetyl alcohol  
stearyl alcohol  
polyoxyl 20 cetostearyl ether  
ceramide 3  
isononyl isononanoate  
ethylhexyl isononanoate  
sodium laurate  
methylparaben  
propylparaben  
polyaminopropyl biguanide  
citric acid monohydrate  
cow milk fat  
Packaging
# Item Code Package Description
1 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 11/02/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083231 11/02/2009
Labeler - Arbor Pharmaceuticals, Inc. (781796417)
Revised: 10/2013
 
Arbor Pharmaceuticals, Inc.
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