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Pramoxine and Hydrocortisone

Pronunciation

(pra MOKS een & hye droe KOR ti sone)

Index Terms

  • Hydrocortisone and Pramoxine
  • Pramoxine Hydrochloride and Hydrocortisone Acetate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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: Pramoxine hydrochloride 1% and hydrocortisone acetate 1% (30 g); pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (30 g)

Analpram Advanced Kit: Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% [kit includes Analpram HC cream, diosmiplex (Vasculera) tablets, AloeClean wipes, and applicators]

Analpram E Kit: Pramoxine hydrochloride 1% and hydrocortisone acetate 2.5% (4 g, 30 g) [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, 60 g)

ProCort: Pramoxine hydrochloride 1.15% and hydrocortisone acetate 1.85% (60 g)

Gel, topical:

Novacort: Pramoxine hydrochloride 1% and hydrocortisone acetate 2% (29 g) [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)

Brand Names: U.S.

  • Analpram E
  • Analpram HC
  • Epifoam
  • Novacort
  • PramCort
  • Pramosone
  • Pramosone E
  • ProCort
  • ProctoFoam HC

Pharmacologic Category

  • Anesthetic/Corticosteroid

Pharmacology

See individual agents.

Use: Labeled Indications

Dermatoses: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Contraindications

Hypersensitivity to pramoxine, hydrocortisone, or any component of the formulation

Dosing: Adult

Dermatoses: Topical, rectal: Apply to affected areas 3 to 4 times daily.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Dermatoses: Infants, Children, and Adolescents: Topical, rectal: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

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 in pediatric patients being treated in the diaper area.

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.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

EpiFoam and Proctofoam HC: Store upright at 20°C to 25°C (68°F to 77°F). Do not refrigerate. Contents are under pressure; do not burn or puncture the container; do not store at temperatures above 49°C (120°F).

Pramcort: Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Adverse Reactions

See individual agents.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism 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:

• Elderly: 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.

Monitoring Parameters

May consider the use of urinary free cortisol test and ACTH stimulation test in patients with suspected hypothalamic-pituitary-adrenal (HPA) axis suppression.

Pregnancy Risk Factor

C

Pregnancy Considerations

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.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin, burning, or itching. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), weight gain, vision changes, severe headache, severe skin irritation, severe rectal bleeding, or severe rectal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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