Dermtex HC

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

Hydrocortisone topical may also be used for other purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of hydrocortisone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

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

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.

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Dermtex-HC. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• With the lotion, shake it well before using.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  • For topical dosage form (cream):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Apply to the affected area of the skin two or three times per day.
  • For topical dosage form (lotion):
    • Adults—Apply to the affected area of the skin two to four times per day.
    • Children—Apply to the affected area of the skin two to four times per day.
  • For topical dosage form (ointment):
    • Adults—Apply to the affected area of the skin three or four times per day.
    • Children—Apply to the affected area of the skin three or four times per day.
  • For topical dosage form (solution):
    • Adults—Apply to the affected area of the skin three or four times per day.
    • Children—Apply to the affected area of the skin three or four times per day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 Dermtex HC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.