hydrocortisone topical/pramoxine topical (Rx)

Brand and Other Names:Proctofoam HC, Analpram E, more...Analpram HC, Epifoam, ProCort, Pramosone, Pramosone E
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Dosing & Uses

AdultPediatricGeriatric

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

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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

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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

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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.

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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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Images

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.