PRAMOSONE CREAM- hydrocortisone acetate and pramoxine hydrochloride cream

Pramosone Cream by

Drug Labeling and Warnings

Pramosone Cream by is a Prescription medication manufactured, distributed, or labeled by Sebela Pharmaceuticals Inc., Ferndale Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

DESCRIPTION: Pramosone ® Cream 1% is a topical preparation containing hydrocortisone acetate 1% 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, 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)-
C 23H 32O 6; mol.wt.: 404.50

pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
C 17H 27NO 3.HCl; mol. wt.: 329.87

CLINICAL PHARMACOLOGY

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

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 & USAGE

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

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

PRECAUTIONS

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 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 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 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 PATIENTS

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

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test
ACTH stimulation test

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

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

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

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 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 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 fontanels, 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

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

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

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.

HOW SUPPLIED

HOW SUPPLIED:    Pramosone® Cream 1%       1 oz tube (NDC: 54766-716-04)
                                                                                   2 oz tube (NDC: 54766-716-03)

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

Rx Only.

Manufactured for Sebela Ireland Ltd.

By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.

Distributed by Sebela Pharmaceuticals Inc.
645 Hembree Parkway, Suite I
Roswell, GA 30076

www.sebelapharma.com
Toll Free 1-844-732-3521

Aquaphor® is a registered trademark of Beiersdorf AG.
Pramosone® is a registered trademark of Sebela International Limited.

#6988I
PI716041014

©2014 Reproduction prohibited

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - NDC: 54766-716-04 - 1 oz Cream

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - NDC: 54766-716-03 - 2 oz Cream

INGREDIENTS AND APPEARANCE

PRAMOSONE CREAM 
hydrocortisone acetate and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54766-716
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBIC ACID (UNII: X045WJ989B)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54766-716-04	28.4 g in 1 TUBE; Type 0: Not a Combination Product	08/04/2015
2	NDC: 54766-716-03	57 g in 1 TUBE; Type 0: Not a Combination Product	08/04/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA085368	08/04/2015

Labeler - Sebela Pharmaceuticals Inc. (079104574)

Establishment
Name	Address	ID/FEI	Business Operations
Ferndale Laboratories, Inc.		005320536	analysis(54766-716) , label(54766-716) , manufacture(54766-716)