Ala-Scalp HP

In the U.S.

• Ala-Cort
• Ala-Scalp HP
• Anusol HC
• Aquanil HC
• Beta HC
• Caldecort
• Cetacort
• Cortaid
• Corticaine
• Corticool Maximum Strength
• Cortizone-10
• Cortizone-5
• Cotacort
• Delacort
• Dermarest
• Dermasorb HC Complete Kit
• Dermtex-HC
• Gly-Cort
• Hydrozone Plus
• Hytone
• Instacort-10
• Ivy Soothe
• IvyStat
• Keratol HC
• Kericort 10
• Lacticare-HC
• Locoid
• Locoid Lipocream
• Medi-Cortisone Maximum Strength
• Microcort
• Mycin Scalp
• Neutrogena T/Scalp
• NuCort
• Nupercainal HC
• Nutracort
• Pandel
• Pediaderm HC Kit
• Preparation H Hydrocortisone
• Proctocream-HC
• Recort Plus
• Sarnol-HC Maximum Strength
• Scalacort
• Scalpcort
• Summer's Eve Specialcare
• Texacort
• Therasoft Anti-Itch & Dermatitis
• U-Cort
• Westcort

In Canada

• Barriere-Hc
• Cortate
• Cort-Eze
• Cortoderm Mild Ointment
• Cortoderm Regular Ointment
• Emo-Cort
• Emo-Cort Scalp Solution
• Hydrocortisone Cream
• Novo-Hydrocort
• Novo-Hydrocort Cream
• Prevex Hc
• Sarna Hc

Available Dosage Forms:

• Solution
• Cream
• Spray
• Lotion
• Ointment
• Pad
• Liquid
• Gel/Jelly
• Kit
• Foam
• Stick
• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Applies to hydrocortisone topical: topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

Other dosage forms:

• topical application cream, topical application lotion, topical application ointment, topical application solution
• topical application cream
• topical application cream, topical application ointment

Along with its needed effects, hydrocortisone topical (the active ingredient contained in Ala-Scalp HP) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydrocortisone topical:

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects of hydrocortisone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Applies to hydrocortisone topical: compounding powder, rectal cream with applicator, rectal foam, rectal ointment, rectal solution, rectal suppository, topical cream, topical gel, topical kit, topical lotion, topical ointment, topical pad, topical paste, topical solution, topical spray, topical stick

General

The most commonly reported side effects were burning, itching, irritation, dryness, and folliculitis.[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis[Ref]

Endocrine

Frequency not reported: HPA axis suppression, decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients[Ref]

Immunologic

Frequency not reported: Decreased resistance to infection, concomitant skin infections[Ref]

Ocular

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections[Ref]

Psychiatric

Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders[Ref]

Local

Frequency not reported: Burning, itching, irritation, dryness, folliculitis[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis[Ref]

Musculoskeletal

Frequency not reported: Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, anaphylaxis, angioedema[Ref]

Respiratory

Frequency not reported: Pulmonary edema

Dermatologic

Frequency not reported: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria, miliaria, telangiectasia[Ref]

Metabolic

Frequency not reported: Fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, negative nitrogen balance due to protein catabolism, increased appetite, weight gain[Ref]

Hepatic

Frequency not reported: Elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly[Ref]

Nervous system

Frequency not reported: Convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, neuritis, neuropathy, vertigo[Ref]

Other

Frequency not reported: Abnormal fat deposits, hiccups, increased or decreased motility and number of spermatozoa, malaise[Ref]

Some side effects of Ala-Scalp HP may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Administration advice:
-The treated area should not be bandaged, covered, or wrapped, as to be occlusive, unless directed by a healthcare provider.
-Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area.

Storage requirements:
-Excessive heat and freezing should be avoided.
-The aerosol container should not be stored at temperatures above 120F (48.8C).

Monitoring:
-Endocrine: HPA-axis suppression (Urinary free-cortisol test, ACTH-stimulation test)

Patient advice:
-Patients should report any signs of local adverse reactions, especially those that develop under occlusive dressings.
-This medication is to be used as directed by the physician.
-Patients should be advised not to use this medication for any condition other than for which it was prescribed.