Pramosone Cream
(hydrocortisone acetate)Pramosone Cream Prescribing Information
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of theinflammatory and pruritic manifestations of corticosteroid-responsivedermatoses.
DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to theaffected area as a thin film three to four times daily depending on theseverity of the condition. Occlusive dressings may be used for the managementof psoriasis or recalcitrant conditions. If an infection develops, the use ofocclusive dressings should be discontinued and appropriate antimicrobialtherapy instituted.
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in thosepatients with a history of hypersensitivity to any of the components of thepreparation.
ADVERSE REACTIONS: The following local adverse reactions are reportedinfrequently with topical corticosteroids, but may occur more frequently withthe use of occlusive dressings. These reactions are listed in an approximate decreasingorder 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 |
DESCRIPTION: Pramosone ® Cream 1% is a topical preparationcontaining hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w ina 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 andanti-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)morpholinehydrochloride
C 17H 27NO 3.HCl; mol. wt.: 329.87
CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruriticand vasoconstrictive actions.
The mechanism of anti-inflammatory activity of topicalcorticosteroids is unclear. Various laboratory methods, includingvasoconstrictor assays, are used to compare and predict potencies and/orclinical efficacies of the topical corticosteroids. There is some evidence tosuggest that a recognizable correlation exists between vasoconstrictor potencyand therapeutic efficacy in man.
Pramoxine hydrochloride is a topical anesthetic agent whichprovides temporary relief from itching and pain. It acts by stabilizing theneuronal membrane of nerve endings with which it comes into contact.
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
Pramosone Cream Prior Authorization Resources
Most recent state uniform prior authorization forms
Pramosone Cream Financial Assistance Options
Copay savings program
Overview
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form