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Carmol HC

Generic Name: hydrocortisone acetate
Dosage Form: cream

CARMOL®HC
(Hydrocortisone Acetate Cream USP, 1%)

Rx Only

DESCRIPTION:

CARMOL®HC is intended for topical administration. The active component is the corticosteroid hydrocortisone acetate, which has the chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11β)-. It has the following chemical structure.

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Each gram of the cream contains 10 mg Hydrocortisone Acetate USP, in a water-washable vanishing cream base containing urea (10%), purified water, stearic acid, propylene glycol, isopropyl myristate, isopropyl palmitate, PPG-26 oleate, sodium laureth sulfate, triethanolamine, xanthan gum, sodium metabisulfite, cetyl alcohol, edentate disodium, carbomer with hypoallergenic perfume. It is nonocclusive, and contains no mineral oil, petrolatum, lanolin, or parabens.

CLINICAL PHARMACOLOGY:

Topical corticosteroids share anti-inflammatory, anti-pruritic 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.

The 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:

CARMOL®HC (Hydrocortisone Acetate Cream USP 1 %) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS:

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS:

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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 additions of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids 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 cortico-steroids. 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. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. 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 eyes.
  2. Patients should be advised not to use this medication for any 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 affect 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 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 a 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 use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1:

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

OVERDOSAGE:

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

DOSAGE AND ADMINISTRATION:

CARMOL®HC (Hydrocortisone Acetate Cream USP, 1%) is generally applied to the affected area as a thin film 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 SUPPLIED:

CARMOL®HC (Hydrocortisone Acetate Cream USP 1%) is supplied in:

1 oz. (28 g) tube NDC 10337-550-52
3 oz. (85 g) tube NDC 10337-550-19

Store at controlled room temperature 15°-30°C (59°-86° F). Protect from freezing.

Pharmacist: Dispense in tight containers as specified in USP.

Manufactured for:

Fairfield, New Jersey 07004-2402 USA
www.bradpharm.com

Manufactured by:
ENTREPRISES IMPORTFAB, INC.
Pointe-Claire, QC CANADA

IL135-R1

DOAK DERMATOLOGICS

A SUBSIDIARY OF BRADLEY PHARMACEUTICALS, INC.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3oz CONTAINER

NDC 10337-550-19

Rx Only

CARMOL® HC

(Hydrocortisone Acetate Cream USP, 1%)

NET WT 3 oz. (85g)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3oz CARTON

NDC 10337-550-19

Rx only

CARMOL® HC

(Hydrocortisone Acetate Cream USP, 1%)

For Topical Use Only

NET WT 3 oz. (85 g)

DOAK DERMATOLOGICS

Carmol HC 
hydrocortisone acetate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10337-550
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydrocortisone acetate (hydrocortisone) hydrocortisone acetate 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
urea 100 mg  in 1 g
water  
stearic acid  
propylene glycol  
isopropyl myristate  
isopropyl palmitate  
sodium laureth sulfate  
TROLAMINE  
xanthan gum  
sodium metabisulfite  
cetyl alcohol  
edetate disodium  
Packaging
# Item Code Package Description
1 NDC:10337-550-19 1 TUBE in 1 CARTON
1 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080505 01/12/1973
Labeler - PharmaDerm, A division of Fougera Pharmaceuticals Inc. (043838424)
Revised: 07/2012
 
PharmaDerm, A division of Fougera Pharmaceuticals Inc.



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