Hydrocortisone Acetate topical

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.b

Nonprescription preparations used for temporary relief of minor skin irritations, itching, and rash caused by eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, or jewelry.a

Nonprescription preparations used for temporary relief of itchy anal and/or genital areas.a

Nonprescription preparations used for temporary relief of itching and minor scalp irritation caused by scalp dermatitis.a

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).b

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.b

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.b

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)b

Response may vary from one topical corticosteroid preparation to another.b

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.b

Infected Dermatoses

Topical treatment of infected dermatoses in combination with topical anti-infectives (e.g., neomycin, polymyxin B) or antifungals.b

If a topical corticosteroid is used in combination with a topical anti-infective, weigh benefits against risks.b (See Skin Infection under Cautions.)b

Oral Lesions

Hydrocortisone acetate paste used as an adjunct for temporary symptomatic relief of oral inflammatory or ulcerative lesions resulting from trauma.a

Ulcerative Colitis and Anorectal Disorders

Used rectally as a retention enema for adjunctive treatment of mild or moderate acute ulcerative colitis limited to the rectosigmoid or left colon.b

Used rectally as a retention enema for mild acute ulcerative colitis of the transverse or descending colon.b

Retention enema usually is effective in mild or moderate acute rectosigmoid ulcerative colitis when response to sulfasalazine (generally considered the maintenance drug of choice) is inadequate or when sulfasalazine cannot be given.b

Systemic corticosteroids and/or corticosteroid enemas are more effective than sulfasalazine in acute ulcerative colitis attacks, but if surgery is required, it should not be delayed in favor of corticosteroid therapy.b

Hydrocortisone acetate rectal suppositories or suspension (foam), may be effective as adjunctive treatment of rectal ulcerative colitis.b

Hydrocortisone acetate rectal suppositories also are used in the treatment of other anorectal inflammatory conditions (e.g., inflamed hemorrhoids, postirradiation or factitial proctitis, cryptitis, pruritus ani).b

Fixed-combination preparations of a corticosteroid and local anesthetic may be useful for symptomatic relief of anorectal conditions (e.g., hemorrhoids), but combinations with antihistamines, astringents, keratolytics, and/or vasoconstrictors are of questionable efficacy.b

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.b

• Creams are suitable for most dermatoses,b but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.b

• Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).b Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.b

• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercial preparations with another vehicle may decrease effectiveness.b

• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).b (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.d e

Apply creams, lotions, ointments, solutions, and aerosol foams topically to the skin or scalp.a

Apply paste topically inside the oral cavity.a

Apply rectal creams and ointments externally to the anal area; some commercially available creams also may be applied externally to the anogenital areas.a

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.b

Apply cream, lotion, ointment, or solution sparingly in a thin film and rub gently into affected area.a

For scalp dermatoses, part the hair and apply small amount of lotion or solution directly to the affected area; rub gently into scalp.a Maintain usual hair care, but do not wash out lotion immediately after application.a Alternatively, for scalp dermatoses, apply aerosol to dry scalp after shampooing.a

To dispense foam, shake container well (for 5–10 seconds) immediately prior to use.f Hold container upright and press down on container cap until foam appears.f Apply a small amount to affected area.f

For use in the mouth, press a small amount of paste to the lesion without rubbing until a thin film develops.a

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.b

Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis).a (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film.b Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.b

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.b For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.b

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.b

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.b

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.b Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.b

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.b

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.b (See Occlusive Dressings under Cautions.)

Rectal Administration

Administer rectally as a retention enema, suppository, or aerosol foam.a

Administer retention enema, suppository, or foam carefully according to manufacturer’s instructions.a

Dosage

Available as hydrocortisone (dosage expressed in terms of the base) and as hydrocortisone acetate, buteprate, butyrate, and valerate (dosage expressed in terms of the salt).a

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.b (See Pediatric Use under Cautions.)

Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.b

Children ≥2 years of age: Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.a

Adults

Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.a

Apply aerosol foam to affected area 2–4 times daily.a f

Nonprescription preparations should not be used for self-medication for >7 days.a

If the condition worsens or symptoms persist, discontinue and consult a clinician.a

Apply a small amount of paste to the lesion 2 or 3 times daily after meals and at bedtime.a

If substantial regeneration or repair of oral tissues does not occur after 7 days, further investigate etiology of the lesions.a

Adjunctive treatment of ulcerative colitis: 100 mg nightly.a Some clinicians recommend 100 mg twice daily followed by 100 mg nightly when improvement occurs.a

Usually given for 21 days or until clinical and proctologic remissions are achieved.a

Lay on left side during and for 30 minutes after administration to distribute drug throughout the left colon.a Retain for ≥1 hour, preferably all night.a

Symptoms may improve in 3–5 days, followed by proctologic improvement.a Discontinue if clinical or proctologic improvement does not occur within 2–3 weeks.a

Protologic remission may require 2–3 months of therapy.a

Following treatment for >21 days, gradually withdraw use; give every other night for 2–3 weeks, then discontinue.a

Ulcerative proctitis of the distal rectum: 90 mg (1 applicatorful of a 10% aerosol foam suspension) 1 or 2 times daily for 2–3 weeks.a g Then, if necessary, every other day until clinical and proctologic improvement.a g

Symptoms may improve within 5–7 days.a g

Adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum: 25 mg in the morning and at night for 2 weeks.a

Severe proctitis: 25 mg 3 times daily or 50 mg twice daily.a

Adjunctive treatment of postirradiation or factitial proctitis: 25 mg in the morning and at night for 6–8 weeks (or less if an adequate response is attained).a

For internal hemorrhoid symptoms and adjunctive treatment of other anorectal inflammatory conditions: 10 mg in the morning and at night for 2–6 days.a

Prescribing Limits

Pediatric Patients

Maximum 7 days.a

Adults

Maximum 7 days.a

Specific Drugs and Laboratory Tests

Storage

Topical

Room temperature; consult product information for specific recommendations.

Rectal

Room temperature; consult product information for specific recommendations.

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed;b avoid contact with the eyes.d e (See Topical Administration under Dosage and Administration.)

• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.b

• Importance of informing parents of children receiving the drug that if hydrocortisone is applied in the diaper area, tight-fitting diapers or plastic pants should not be used since they may act as an occlusive dressing.b

• Importance of reporting any local adverse reactions, especially those occurring under occlusive dressings, to a clinician.b

• Potential for hydrocortisone acetate suppositories to stain fabric; take appropriate precautionary measures.b

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs; other corticosteroid-containing preparations should not be used without first consulting with clinician.c

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.b

• Importance of informing patients of other important precautionary information. (See Cautions.)

Before using this product, tell your doctor or pharmacist if you are allergic to hydrocortisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, eye problems, infections (especially rectal sores/infections), liver disease, stomach/intestinal problems.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Caution is advised when using this drug in children. Do not use this product over a large area or use tight-fitting diapers/plastic pants unless directed by your doctor.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. It should not be used for long periods of time or in large amounts. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.