Dermasorb hc complete kit kit

Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatoryand antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone ispregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11). Its structural formula is:

hydrocortisone structure

Each mL of DERMASORB™HC (Hydrocortisone USP, 2%) Lotion contains 20 mg hydrocortisone USPin a lotion base consisting of water, isopropyl alcohol, polysorbate 20, propylene glycol, andbenzalkonium chloride.

Clinical pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratorymethods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinicalefficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlationexists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factorsincluding 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 diseaseprocesses in the skin increase percutaneous absorption. Occlusive dressings substantially increase thepercutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuabletherapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokineticpathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasmaproteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excretedby the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and usage

DERMASORB™HC lotion is indicated for the relief of the inflammatory and pruritic manifestations ofcorticosteroid-responsive dermatoses.

Contraindications

DERMASORB™HC lotion is contraindicated in those patients with a history of hypersensitivity to any ofthe components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA)axis suppression, manifestations of Cushings syndrome, hyperglycemia, and glucosuria in some patients.Conditions that augment systemic absorption include the application of the more potent steroids, useover 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 orunder an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression byusing the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attemptshould be made to withdraw the drug, to reduce the frequency of application, or to substitute a lesspotent 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 systemiccorticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be moresusceptible 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 agentshould be instituted. If a favorable response does not occur promptly, the corticosteroid should bediscontinued 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 contactwith the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which itwas prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusiveunless 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 achild 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 effecton 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 atrelatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic afterdermal application in laboratory animals. There are no adequate and well-controlled studies in pregnantwomen on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroidsshould 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 forprolonged periods of time.

Nursing mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemicabsorption to produce detectable quantities in breast milk. Systemically administered corticosteroids aresecreted 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 axissuppression and Cushings syndrome than mature patients because of a larger skin surface area to bodyweight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome, and intracranialhypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenalsuppression in children include linear growth retardation, delayed weight gain, low plasma cortisollevels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension includebulging fontanelles, headaches, and bilateral papilledema.

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

Adverse reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but mayoccur more frequently with the use of occlusive dressings. These reactions are listed in an approximatedecreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiformeruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin,Secondary infection, Skin Atrophy, Striae, and Miliaria.

Overdosage

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

Dosage and administration

Topical corticosteroids are generally applied to the affected area as a thin film from two to four timesdaily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If aninfection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobialtherapy instituted.

Packaging and storage:

Store at room temperature 15C- 30C (59F - 86F) in original container.

Protect from freezing.

How supplied:

DERMASORB™ HC (Hydrocortisone USP, 2%) Lotion is supplied in:

1 fluid ounce (29.6 ml) bottle NDC 0316-0201-01

Rx Only

PRINTED IN USA

P6171.01

Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN, 37604

Ingredients and appearance - Product information

Dermasorb hc complete kit kit- Hydrocortisone lotion with shampoo and body wash

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0316-1005
Route of Administration Topical

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA083231 USA 2013/11/14

Labeler - Crown Laboratories( 079035945)

Establishment

Name ID/FEI Business Operations
Crown Laboratories 079035945 manufacture( 0316-1005)

Dermasorb hc complete kit

p617201