ANALPRAM HC  - hydrocortisone acetate and pramoxine hydrochloride cream 
Ferndale Laboratories, Inc.

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Analpram HC Cream 2.5% (hydrocortisone acetate 2.5%/pramoxine HCl 1%)

DESCRIPTION:  Analpram® HC Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water.

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

hydrocortisone acetate

hydrocortisone acetate
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
C23H32O6; mol. wt.: 404.50

pramoxinehcl

pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
C17H27NO3.HCl; mol. wt.: 329.87

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:




INIDCATIONS AND USAGE:

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

PRECAUTIONS: General:








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: 



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:  Teratogenic Effects:  Pregnancy Category C:

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.





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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE: 

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 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.

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

HOW SUPPLIED:

Analpram HC® Cream 2.5%

1 oz tube (NDC 0496-0799-04)

12 x 4 gram tubes (NDC 0496-0799-65)

30 x 4 gram tubes (NDC 0496-0799-64)

Rx Only.






Aquaphor® is a registered trademark of Beiersdorf AG.

Analpram HC® is a registered trademark of Ferndale IP, Inc.


analpramhc1ozcarton

analpramhc12x4gcarton

analpramhc30x4gcarton


ANALPRAM HC 
hydrocortisone acetate and pramoxine hydrochloride   cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0496-0799
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
STEARIC ACID  
CETYL ALCOHOL  
ISOPROPYL PALMITATE  
POLYOXYL 40 STEARATE  
PROPYLENE GLYCOL  
POTASSIUM SORBATE  
SORBIC ACID  
TROLAMINE LAURYL SULFATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0799-65 12 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR (0496-0799-36)
1 0496-0799-36 4 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (0496-0799-65)
2 0496-0799-64 30 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR (0496-0799-36)
2 0496-0799-36 4 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (0496-0799-64)
3 0496-0799-04 28.4 g In 1 TUBE, WITH APPLICATOR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 10/15/2009

Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
Name Address ID/FEI Operations
Ferndale Laboratories, Inc. 005320536 manufacture
Revised: 10/2009 Ferndale Laboratories, Inc.