Pramosone

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

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 dressing should be discontinued and appropriate antimicrobial therapy instituted.

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

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 Foliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

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.

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 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.

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

Pramosone ® Ointment is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in an emollient ointment base containing sorbitan sesquioleate, purified water, Aquaphor ®, and white petrolatum. 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 23 H 32 O 6; mol. wt: 404.50 pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17 H 27 NO 3 ,HCl: mol. wt: 329.87 Figure Figure

Pramosone® Ointment 1% 1 oz tube (NDC 54766-763-04) Pramosone® Ointment 2.5% 1 oz tube (NDC 54766-777-04) Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep tightly closed. 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 PI777040215 Rev. Feb. 2015 Aquaphor® is a registered trademark of Beiersdorf AG. Pramosone® is a registered trademark of Legacy Pharma Inc. ©2024 Reproduction prohibited

Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep tightly closed. 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 PI777040215 Rev. Feb. 2015 Aquaphor® is a registered trademark of Beiersdorf AG. Pramosone® is a registered trademark of Legacy Pharma Inc. ©2024 Reproduction prohibited