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HC Pram Cream

Generic Name: hydrocortisone acetate and pramoxine
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

HC Pram 2.5% Cream, HC Pram 1% Cream

HC Pram Cream Description

Topical corticosteroids are anti-inflammatory and anti-pruritic agents.

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INGREDIENTS

River’s Edge HC Pram 2.5% Cream – 2.5% Hydrocortisone Acetate, 1% Pramoxine HCl
Contains hydrocortisone acetate 25mg w/w and pramoxine hydrochloride 10mg
ACTIVE INGREDIENTS:
HYDROCORTISONE ACETATE 2.5%
PRAMOXINE HCl 1%
INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

River’s Edge HC Pram 1% Cream – 1% Hydrocortisone Acetate, 1% Pramoxine HCl
Contains hydrocortisone acetate 10mg w/w and pramoxine hydrochloride 10mg
ACTIVE INGREDIENTS:
HYDROCORTISONE ACETATE 1%
PRAMOXINE HCl 1%
INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

HC Pram Cream - Clinical Pharmacology

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

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

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

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, tipical 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 HC Pram Cream

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroids-responsive dermatoses.

Contraindications

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

Warnings and 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 and under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation test. 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 anti-bacterial 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. Aviod contact with the 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 dressings.
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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, 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 hydro-cortisone have revealed negative results.

Use in Pregnancy

Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systematically 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 amounts 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 lager skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intra-cranial 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:
Burining
Itching
Irritation
Dryness
Folliculitis
Hypertrichosis
Acneiform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis
Maceration of the skin
Secondary infection
Skin atrophy
Striae
Miliaria

To report suspected adverse reactions, contact River’s Edge Pharmaceuticals, LLC at 770-886-3417 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

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

HC Pram Cream Dosage and Administration

Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressing 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 HC Pram Cream Supplied

HC Pram 2.5% Cream is a topical cream and is supplied in the following:
1 oz. tube (NDC 68032-426-01)
4 gram tube (NDC 68032-426-04)
12 x 4 gram tubes (NDC 68032-426-12)
30 x 4 gram tubes (NDC 68032-426-30)

HC Pram 1% Cream is a topical cream and is supplied in the following:
1 oz. tube (NDC 68032-425-01)

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN

Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].

PACKAGING

HC PRAM 
hydrocortisone acetate, pramoxine hydrochloride cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-426
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SAFFLOWER OIL  
POLYOXYL 20 CETOSTEARYL ETHER  
CETOSTEARYL ALCOHOL  
DIMETHICONE  
GLYCERIN  
PHENOXYETHANOL  
PENTYLENE GLYCOL  
WATER  
STEARIC ACID  
STEARYL ALCOHOL  
EDETATE SODIUM  
Packaging
# Item Code Package Description
1 NDC:68032-426-01 30 g in 1 TUBE
2 NDC:68032-426-04 4 g in 1 TUBE
3 NDC:68032-426-12 4 g in 1 TUBE
4 NDC:68032-426-30 4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2009 04/30/2012
HC PRAM 
hydrocortisone acetate, pramoxine hydrochloride cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-425
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
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SAFFLOWER OIL  
POLYOXYL 20 CETOSTEARYL ETHER  
CETOSTEARYL ALCOHOL  
DIMETHICONE  
GLYCERIN  
PHENOXYETHANOL  
PENTYLENE GLYCOL  
WATER  
STEARIC ACID  
STEARYL ALCOHOL  
EDETATE SODIUM  
Packaging
# Item Code Package Description
1 NDC:68032-425-01 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2009 07/31/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC
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