Dosing & Uses
Dosage Forms & Strengths
hydrocortisone/pramoxine topical
rectal aerosol foam
- 1%HC/1% pramoxine
cream
- 0.5%HC/1% pramoxine
- 1%HC/1% pramoxine
- 2.5%HC/1% pramoxine
lotion
- 1%HC/1% pramoxine
- 2.5%HC/1% pramoxine
Topical Inflammation
Relief of inflammation and pruritus associated with corticosteroid-responsive dermatoses
Apply to affected area q6-8hr depending on severity of condition
Hemorrhoids
Apply rectally q6-8hr
Administration: Using rectal applicator, insert tip into anus and expel measured cream/foam
Other Information
Topically applied corticosteroids can produce systemic effects
Occlusive dressings may be used for psoriasis or recalcitrant conditions if needed
Pramoxine’s unique chemical structure may minimize danger of cross-sensitivity reactions in patients allergic to other local anesthetics
Limit use in children to least amount compatible with an effective therapeutic regimen
Absorption in pediatrics may result in higher blood levels and thus more susceptibility to systemic toxicity
Topical Inflammation
Relief of inflammation and pruritus associated with corticosteroid-responsive dermatoses
Apply to affected area q6-8hr depending on severity of condition
Hemorrhoids
Apply rectally q6-8hr
Administration: Using rectal applicator, insert tip into anus and expel measured cream/foam
Adverse Effects
Frequency Not Defined
Burning
Itching
Irritation
Dryness
Folliculitis
Hypertrichosis
Acneiform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis
Maceration of the skin
Secondary infection
Skin atrophy
Striae
Miliaria
Warnings
Contraindications
Hypersensitivity to any components of preparation
Cautions
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria
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
Evaluate susceptible patients periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests; If HPA axis suppression is noted, withdraw the drug, reduce frequency of application, or substitute a less potent steroid
Contact dermatitis may occur; discontinue use if irritation occurs and treat appropriately
Prolonged use may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy
Topical corticosteroids may cause manifestations of Cushing’s syndrome, hyperglycemia, or glycosuria; absorption is increased by use of occlusive dressings, application to denuded skin, application to large surface, or prolonged use
Use caution in the elderly; use smallest possible effective dose for shortest duration
Do not insert any part of aerosol container directly into anus; discontinue if after 2-3 weeks there is no evidence of clinical or proctologic improvement or if condition worsens
Pregnancy & Lactation
Pregnancy Category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Hydrocortisone: anti-inflammatory, antipruritic and vasoconstrictive actions; may decrease inflammation by suppressing the migration of polymorphonuclear leukocytes (PMNs) and reversing increased capillary permeability
Pramoxine: surface or local anesthetic
Absorption
Extent determined by many factors including vehicle, integrity of epidermal barrier, use of occlusive dressings
Distribution
Protein bound: Variable
Metabolism
Primarily by liver
Excretion
Primarily by urine
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Formulary
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