Version May 2024
Anorectal inflammation (rectal suppository): Rectal: Insert 1 suppository 2 times daily; in severe cases, may increase to 1 suppository 3 times daily or 2 suppositories 2 times daily. Treat nonspecific proctitis for 2 weeks and factitial proctitis for 6 to 8 weeks or less according to clinical response.
Dermatoses: Topical, rectal: Apply to affected areas 3 to 4 times daily.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Dermatoses: Infants, Children, and Adolescents: Topical, rectal: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
See individual agents.
Hypersensitivity to pramoxine, hydrocortisone, or any component of the formulation
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of the hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: May occur; discontinue use if irritation occurs and treat appropriately.
• Immunosuppression: Prolonged use of corticosteroids may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, prolonged use, or application to large surface areas.
Special populations:
• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Appropriate use: Avoid use of topical preparations with occlusive dressings or on weeping or exudative lesions.
• Rectal foam: Do not insert any part of the aerosol container directly into the anus. Discontinue use if there is no evidence of clinical or proctologic improvement within 2 or 3 weeks after initiation of therapy or if the condition worsens.
• Rectal suppositories: Perform a proper proctologic exam prior to beginning therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol, foam, rectal:
ProctoFoam HC: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (10 g)
Aerosol, foam, topical:
Epifoam: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (10 g)
Cream, topical:
Analpram Advanced Kit: Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% [kit includes Analpram HC cream, diosmiplex (Vasculera) tablets, AloeClean wipes, and applicators] [DSC]
Analpram E Kit: Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (4 g [DSC], 30 g [DSC]) [kit includes Prax wipes]
Analpram HC: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (4 g, 30 g); pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (4 g, 30 g)
PramCort: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (30 g) [contains propylene glycol]
Pramosone: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (30 g, 60 g); pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (30 g, 60 g)
Pramosone E: Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (30 g [DSC], 60 g [DSC])
ProCort: Pramoxine hydrochloride 1.15% and hydrocortisone acetate 1.85% (60 g)
Generic: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (30 g); Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (30 g)
Gel, topical:
Novacort: Pramoxine hydrochloride 1% and hydrocortisone acetate 2% (29 g [DSC]) [contains aloe, benzyl alcohol, propylene glycol]
Lotion, topical:
Analpram-HC: Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (60 mL)
Pramosone: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (60 mL, 120 mL, 240 mL); pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (60 mL, 120 mL)
Ointment, topical:
Pramosone: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (30 g); pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (30 g)
Suppository, Rectal:
Generic: Pramoxine hydrochloride 18 mg and hydrocortisone acetate 25 mg
Yes: Cream
Cream (Analpram HC External)
2.5-1% (per gram): $10.26
Cream (Analpram HC Singles External)
2.5-1% (per gram): $5.06
Cream (Analpram-HC External)
1-1% (per gram): $10.88
Cream (Hydrocort-Pramoxine (Perianal) External)
2.5-1% (per gram): $2.26 - $4.57
Cream (Hydrocortisone Ace-Pramoxine External)
1-1% (per gram): $4.85
Cream (Pramosone External)
1-1% (per gram): $10.29
1-2.5% (per gram): $11.21
Cream (ProCort External)
1.85-1.15% (per gram): $7.60
Foam (Epifoam External)
1-1% (per gram): $10.90
Foam (Proctofoam HC External)
1-1% (per gram): $21.16
Lotion (Analpram-HC External)
2.5-1% (per mL): $6.54
Lotion (Pramosone External)
1-1% (per mL): $5.01
1-2.5% (per mL): $6.29
Ointment (Pramosone External)
1-1% (per gram): $9.79
1-2.5% (per gram): $10.20
Suppository (Hydrocortisone Ace-Pramoxine Rectal)
25-18 mg (per each): $41.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: Apply a thin film to the affected area. The treated area should not be bandaged or otherwise covered or wrapped as to be occlusive; however, occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. Discontinue the use of occlusive dressings if infection develops. The use of tight-fitting diapers or plastic pants should be avoided.
Foam: Epifoam: Shake vigorously for 5 to 10 seconds before each use. May apply directly to the affected are or alternatively, may dispense a small amount to a pad and apply to affected areas. Do not insert container into vagina or anus. Disassemble container and cap after each use and rinse with warm water.
Lotion: Shake well before use.
Rectal:
Proctofoam HC: Shake vigorously for 5 to 10 seconds prior to use. Do not remove cap during use. Hold container upright to fill applicator. Gently insert applicator tip into anus. Only use applicator provided by manufacturer; do not insert any part of the aerosol container in the anus. Clean applicator after each use with warm water. For perianal application, transfer a small amount on to a tissue and gently rub into affected area.
Suppository: Holding suppository upright, carefully remove from wrapper, exposing pointed end first. Insert pointed end of suppository into the rectum in the morning and at night. Avoid handling unwrapped suppository for too long.
Topical: For external use only; avoid contact with eyes. Do not bandage or use occlusive dressing unless treating psoriasis or recalcitrant conditions. Discontinue the use of occlusive dressings if infection develops. The use of tight-fitting diapers or plastic pants should be avoided in pediatric patients being treated in the diaper area.
Cream, Ointment: Apply a thin film to the affected area.
Foam: Epifoam: Shake vigorously for 5 to 10 seconds before each use. Prime prior to use by holding upright and pressing down on applicator several times until foam appears. May apply directly to the affected area or alternatively, may dispense a small amount to a pad and apply to affected areas. Do not insert container into vagina or anus. Disassemble container and cap after each use and rinse with warm water.
Lotion: Shake well before use. Apply thin film to affected area.
Rectal: Proctofoam HC: Place cap on top of container; shake vigorously for 5 to 10 seconds prior to each use. Do not remove cap during use. Hold container upright to fill applicator. Place tip of applicator on top of container cap, pull plunger past fill line on applicator barrel. Prime container by pressing down and releasing; with initial prime a burst of air comes out; usually takes 1 to 2 pumps for foam to appear. Fill applicator barrel by pressing down for 1 to 2 seconds, release, and wait to allow foam to appear in applicator barrel (5 to 10 seconds); repeat until foam reaches fill line; usually takes 3 to 4 pumps to reach fill line. Foam should not go beyond fill line or it will create back up. Gently insert applicator tip into anus, do not insert past the anus. Only use applicator provided by manufacturer; do not insert any part of the aerosol container in the anus. Clean applicator after each use with warm water. For perianal application, transfer a small amount to a tissue and gently rub into affected area.
Anorectal inflammation (rectal suppository): Temporary relief of inflammation associated with hemorrhoids, post irradiation (factitial) proctitis, and other inflammatory conditions of the anorectum and pruritus ani; adjunct in the treatment of chronic ulcerative colitis; cryptitis.
Dermatoses: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Pramosone may be confused with predniSONE
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Adverse events have been observed with corticosteroids in animal reproduction studies. Rectal use of pramoxine and hydrocortisone for the treatment of hemorrhoids in the third trimester of pregnancy was not shown to affect birth weight (Ebrahimi 2011). Also refer to Hydrocortisone (Topical) monograph.
Refer to Hydrocortisone (Topical) monograph.
May consider the use of urinary free cortisol test and ACTH stimulation test in patients with suspected hypothalamic-pituitary-adrenal (HPA) axis suppression.
See individual agents.
See individual agents.
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