The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone Cream 2.5% and Hydrocortisone Ointment 2.5% contain hydrocortisone. Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (Up)-. The structural formula of hydrocortisone is:

Each gram of the 2.5% Cream contains 25 mg of hydrocortisone in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Each gram of the 2.5% Ointment contains 25 mg of hydrocortisone in a base of white petrolatum and mineral oil.

Last updated on RxList: 3/18/2009

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Hydrocortisone Cream USP, 2.5%		Hydrocortisone Ointment USP, 2.5%
a white cream is available as follows:		a white ointment is available as follows:
NDC 0168-0080-31	30 g tubes	NDC 0168-0146-30	28.35 g (1 oz) tubes
NDC 0168-0080-16	453.6 g (1 Lb) jars	NDC 0168-0146-16	453.6 g (1 Lb) jars

Store at controlled room temperature 15° - 30°C (59° - 86°F).

E. Fougera & Co., A Division Of Altana Inc. Melville, New York 11747. R8/98

Last updated on RxList: 3/18/2009

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

No information provided.

Last updated on RxList: 3/18/2009

No information provided.

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

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.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Laboratory tests

The following tests may be helpful in evaluating HPA axis suppression:
Urinary free cortisol test; ACTH stimulation test.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy

Teratogenic Effects-Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Last updated on RxList: 3/18/2009

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Last updated on RxList: 3/18/2009

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Last updated on RxList: 3/18/2009

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
5. 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, as these garments may constitute occlusive dressings.

Last updated on RxList: 3/18/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HYDROCORTISONE - ORAL

(HYE-droe-KOR-ti-sone)

COMMON BRAND NAME(S): Cortef

WARNING: This medication is similar to certain natural substances made by your body (adrenal gland hormones). If you have been taking this medication for a long time, your body may not make enough natural hormones while you are under physical stress (e.g., due to infection, surgery, severe injury). Your dose may need to be adjusted. If you have stopped taking this drug within the past 12 months, you may need to start taking it again if your body is under physical stress. Consult your doctor for more details.

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any signs of infection (e.g., persistent sore throat/fever, coughing up yellow/green phlegm, pain during urination, muscle aches) that occur during treatment.

USES: Hydrocortisone is used to treat many conditions, such as joint problems, severe allergic reactions, certain skin or eye conditions, certain problems with the blood/hormones/immune system, a certain bowel problem (ulcerative colitis), swelling, and worsening multiple sclerosis.

Hydrocortisone is a glucocorticoid hormone. It decreases your body's natural defensive response and reduces symptoms such as redness and swelling.

HOW TO USE: Take this medication by mouth with food or milk, usually three or four times daily or as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to therapy. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well. Follow the dosing schedule carefully, and take this medication exactly as prescribed.

Cholestyramine and colestipol may decrease the absorption of this medication. If you are taking either of these drugs, separate them from this medication by at least 4 hours.

If you take this medication once daily, take it in the morning before 9. If you are taking this medication every other day or on some other schedule besides a daily one, it may help to mark your calendar with a reminder.

If you have been taking this medication for a long time, do not suddenly stop taking it without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased to reduce symptoms such as extreme tiredness, weakness, weight loss, or nausea. (See also Warning section.) Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Stomach upset, headache, dizziness, menstrual period changes (e.g., delayed/irregular/absent), trouble sleeping, increased sweating, acne, increased appetite, or unusual weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, bone/joint pain, fast/pounding/irregular heartbeat, unusual weight gain, swelling of the ankles/feet, puffy face, unusual hair growth, difficult breathing, mental/mood changes (e.g., depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat, frequent/painful urination, eye pain/discharge), vision changes, seizures, back pain, unusual skin growths.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain eye diseases (cataracts, glaucoma, herpes of the eye), certain heart problems (e.g., congestive heart failure), high blood pressure, severe liver disease (cirrhosis), kidney disease, underactive thyroid gland (hypothyroidism), diabetes, stomach/intestinal problems (e.g., diverticulitis, ulcer, ulcerative colitis), brittle bones (osteoporosis), current infections (e.g., tuberculosis, positive tuberculosis test, other herpes), bleeding problems, history of blood clots, certain mental/mood conditions (e.g., psychosis, anxiety, depression), low salts in the blood (e.g., low potassium or calcium).

This drug may make you dizzy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication or have taken it within the last 12 months.

Do not have immunizations, vaccinations or skin tests unless specifically directed by your doctor. Avoid contact with people who have recently received oral polio vaccine.

Avoid exposure to chickenpox or measles infection while taking this medication. If you are exposed to these infections, seek immediate medical attention.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this medication to decrease the risk of stomach/intestinal bleeding.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug for long periods of time in children. This medication may temporarily slow down a child's growth rate. Monitor your child's height and growth rate regularly. Consult your doctor for more details.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to the unborn baby. Discuss the risks and benefits of taking this medication with your doctor. Infants born to mothers who have been using this medication for an extended period of time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aldesleukin, large doses of aspirin and aspirin-like drugs (salicylates), nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), birth control pills, estrogen hormone replacement, blood thinners (e.g., warfarin), bupropion, drugs for diabetes, herbal products (e.g., licorice), isoniazid, mifepristone, natalizumab, drugs affecting liver enzymes that remove hydrocortisone from your body (such as ephedrine, erythromycin, azole antifungals including ketoconazole, barbiturates including phenobarbital, rifamycins including rifampin, certain anti-seizure medications including phenytoin), drugs that may cause potassium loss (e.g., amphotericin B, water pills such as hydrochlorothiazide or furosemide), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin).

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) which may increase the risk of stomach bleeding. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 mg per day), should be continued. Consult your doctor or pharmacist for more details.

This product may interfere with certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

If this medication is used for an extended time, laboratory and/or medical tests (e.g., blood sugar/mineral levels, blood counts, blood pressure, bone density tests, eye exams, height/weight measurements, X-rays) should be performed regularly to check for side effects. Consult your doctor for more details.

Lifestyle changes that may help reduce the risk of bone problems (osteoporosis) while taking this drug for an extended time include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Discuss with your doctor lifestyle changes that might benefit you.

If you take this medication for long-term treatment, wear or carry identification stating that you are using it.

MISSED DOSE: If you are taking this medication once daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. If you are taking this medication every other day, ask your doctor or pharmacist what you should do if you miss a dose.

STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture.

Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture.

Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised September 2008 Copyright(c) 2008 First DataBank, Inc.