hydrocortisone topical/pramoxine topical (Proctofoam HC, Analpram E, Analpram HC, Epifoam, ProCort, Pramosone, Pramosone E)

Dosing and uses of Proctofoam HC, Analpram E (hydrocortisone topical/pramoxine topical)

• Adult
• Pediatric
• Geriatric

 

Adult dosage forms and strengths

hydrocortisone/pramoxine topicaL

rectal aerosol foam

• 1%HC/1% pramoxine

cream

• 0.5%HC/1% pramoxine
• 1%HC/1% pramoxine
• 2.3%HC/1.1% pramoxine (discontinued)
• 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

 

Pediatric dosage forms and strengths

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

 

Geriatric dosage forms and strengths

 

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

 

Proctofoam HC, Analpram E (hydrocortisone topical/pramoxine topical) adverse (side) 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

 

Pregnancy and 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 of Proctofoam HC, Analpram E (hydrocortisone topical/pramoxine topical)

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

 

Pharmacokinetics

Absorption: Extent determined by many factors including vehicle, integrity of epidermal barrier, use of occlusive dressings

Protein Bound: Variable

Metabolism: Primarily by liver

Excretion: Primarily by urine