Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream Kit

HYDROCORTISONE ACETATE PRAMOXINE HCL  - hydrocortisone acetate, pramoxine hydrochloride   
River's Edge Pharmaceuticals, LLC

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.

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DESCRIPTION:

Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The chemical name, molecular formula and molecular weight for active ingredients are presented below.

Hydrocortisone acetate
Pregn-4-ene-3,20-dione,21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
Molecular Formula: C23H32O6
Molecular weight: 404.50

Pramoxine hydrochloride
4-(3-(p-n-butoxyphenoxy)propyl)morpholine hydrochloride
Formula: C17H28ClNO3
Molecular weight: 329.86

INGREDIENTS:

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream
Contains hydrocortisone acetate 25mg w/w and pramoxine hydrochloride 10mg w/w

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.

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 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.

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, 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:

Topical corticosteroids are 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 AND PRECAUTIONS:

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-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. Avoid 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 hydrocortisone have revealed negative results.

USE IN PREGNANCY:

Teratogenic Effects: 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 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 larger 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:

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

To report SUSPECTED ADVERSE REACTIONS, contact 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.)

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 SUPPLIED:

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream is a topical cream and is supplied in the following:

1 oz. Tube KIT (NDC 68032-470-91)
Each KIT Contains: 1- 1oz. (30 g) tube (NDC 68032-470-01), 1 Applicator, and 6 Pramoxine HCl 1% Premoistened Anorectal Wipes (NDC 68032-471-06)

4 gram Tube KIT (NDC 68032-472-91)
Each KIT Contains: 30 Single-Use 4 g tubes (NDC 68032-472-04), 30 Single-Use Applicators, and 18 Pramoxine HCl 1% Premoistened Anorectal Wipes (NDC 68032-471-06)

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN

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

See back of carton for complete directions for use.

Rx Only

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Rev. 1/10
472-10

PACKAGING:

carton

HYDROCORTISONE ACETATE PRAMOXINE HCL 
hydrocortisone acetate, pramoxine hydrochloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68032-470
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68032-470-911 KIT ( KIT) in 1 CARTONNone
QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 TUBE, WITH APPLICATOR   30 g
Part 21 PACKET   1 mL
Part 1 of 2
HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE 
hydrocortisone acetate, pramoxine hydrochloride cream
Product Information
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE25 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SAFFLOWER OIL 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
GLYCERIN 
PHENOXYETHANOL 
WATER 
STEARIC ACID 
STEARYL ALCOHOL 
EDETATE SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
130 g in 1 TUBE, WITH APPLICATORNone
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201001/13/2011

Part 2 of 2
PRAMOXINE HYDROCHLORIDE 
pramoxine hydrochloride cloth
Product Information
Item Code (Source)NDC:68032-471
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PHENOXYETHANOL 
POTASSIUM SORBATE 
WATER 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
16 PACKET ( PACKET) in 1 CARTONcontains a PACKET (68032-471-06)
168032-471-061 mL in 1 PACKETThis package is contained within the CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201001/13/2011


Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201001/13/2011

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 05/2011 River's Edge Pharmaceuticals, LLC