Adult Dosing

Pruritic steroid-responsive dermatoses

• Apply a small amount to the affected area tid-qid depending on severity of the condition

Note:

• Do not insert the aerosol container into the anus or vagina

Pediatric Dosing

Pruritic steroid-responsive dermatoses

• Apply a small amount to the affected area tid-qid depending on severity of the condition

Note:

• Do not insert the aerosol container into the anus or vagina

[Outline]

• Adult Dosing
• Pediatric Dosing

• Indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Indicated for external use only; avoid contact with the eyes
• Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. Suspend the use of occlusive dressings if an infection develops and institute appropriate antimicrobial therapy
• Do not use therapy for long duration
• Discontinue use and consult a physician if redness, pain, irritation or swelling persists
• Systemic absorption of topical corticosteroids may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria
• Application over large surface areas, prolonged use, and the addition of occlusive dressings may augment systemic absorption. Periodically evaluate such patients for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. Recovery of HPA axis function is prompt and complete upon therapy discontinuation
• Signs and symptoms of steroid withdrawal may occur occasionally, requiring supplemental systemic corticosteroids
• Pediatric patients may demonstrate greater susceptibility to systemic toxicity because of a larger skin surface area to body weight ratio; chronic corticosteroid therapy may interfere with the growth and development of pediatric patients
• If irritation develops during therapy, discontinue corticosteroids and institute appropriate therapy
• Use of an appropriate antifungal or antibacterial agent should be instituted in the presence of dermatological infections. If a favorable response does not occur promptly, discontinue therapy until the infection has been adequately controlled

Cautions: Use cautiously in

• Skin infections
• Pediatric patients

Supplemental Patient Information

• Instruct patients to promptly report any signs of local adverse reactions especially under occlusive dressings
• Advise parents of pediatric patients not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area

Pregnancy Category:C

Breastfeeding: No studies have been conducted during breastfeeding for topical hydrocortisone; short-term application of topical corticosteroids is not expected to pose a risk to the breastfed infant by passage into breastmilk. Use of least potent drug on the smallest area of the mother's skin is recommended. Ensure that the infant's skin does not come into direct contact with the areas treated with this drug. Only lower potency corticosteroids or water-miscible cream products should be applied to the breast. Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the nipple area. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 May 2011). However, manufacturer advises caution while using in nursing women.

• CNS: Intracranial hypertension (pediatric patients)
• ENDO: HPA axis suppression, Cushing syndrome
• METABOLIC: Hyperglycemia
• DERM: Burning, stinging, pruritus, irritation, dryness, folliculitis, hypertrichosis, acneiform eruption, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration, secondary infection, skin atrophy, striae, miliaria

Hydrocortisone

• Corticosteroid; exact mechanism of anti-inflammatory action unknown; induces phospholipase A2 inhibitory proteins (lipocortins). These proteins inhibit the release of their common precursor arachidonic acid, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes
• Minimal systemic availability after topical application. Presence of inflammation and occlusive dressings substantially increase systemic absorption
• Primarily metabolized by liver; CYP450: Unknown
• Renally excreted
• Half-life: 8-12 hrs

Pramoxine

• Local anesthetic; exact mechanism of action unknown; possibly blocks both initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions. This inhibits depolarization, resulting in subsequent conduction blockade
• Minimal systemic absorption
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Analpram HC
• Epifoam
• Pramosone
• Pramosone E
• Proctofoam HC

US Availability

Epifoam, Proctofoam HC (hydrocortisone/pramoxine)

• Aerosol: 1%/1%

Pramosone (hydrocortisone/pramoxine)

• CRE:
• 0.5%/1%
• 1%/1%

• LOTN:
• 2.5%/1%
• 1%/1%

Pramosone E (hydrocortisone/pramoxine)

• CRE:
• 2.5%/1%

Analpram HC (hydrocortisone/pramoxine)

• CRE:
• 2.5%/1%
• 1%/1%

• LOTN:
• 2.5%/1%

Canadian Trade Name(s)

• Pramox HC

Canadian Availability

Pramox HC (hydrocortisone/pramoxine)

• CRE: 1%/1%
• LOTN: 1%/1%

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Corticosteroid/Anesthetic Combination (Topical)

Pricing data from www.DrugStore.com in U.S.A.

• Proctofoam HC 1-1 % FOAM [Can] (MEDA PHARMACEUTICALS)
  10 % = $79.99
  30 % = $219.96
• Pramosone 1-1 % OINT [Tube] (FERNDALE LAB)
  28.4 % = $92.05
  85.2 % = $248.37
• Pramosone 1-2.5 % LOTN [Bottle] (FERNDALE LAB)
  118 % = $170.46
  354 % = $496.34
• Hydrocortisone Ace-Pramoxine 1-1 % CREA [Tube] (PERRIGO PHARMACEUTICALS)
  30 % = $79.99
  90 % = $219.98
• Pramosone 1-1 % LOTN [Bottle] (FERNDALE LAB)
  59 % = $98.9
  118 % = $183.98
• Pramosone 1-2.5 % CREA [Tube] (FERNDALE LAB)
  57 % = $117.27
  171 % = $346.2
• Hydrocortisone Ace-Pramoxine 2.5-1 % CREA [Tube] (PERRIGO PHARMACEUTICALS)
  30 % = $51.99
  90 % = $145.97
• Pramosone 1-1 % CREA [Tube] (FERNDALE LAB)
  28.4 % = $95.33
  85.2 % = $245.45
• Pramosone 1-2.5 % CREA [Tube] (FERNDALE LAB)
  28.4 % = $89.82
  56.8 % = $172.74

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.