Ala-Cort

Name: Ala-Cort

Manufacturer

  • Crown Laboratories

  • Del-Ray Dermatologicals

Ala-Cort Drug Class

Ala-Cort is part of the drug classes:

  • Corticosteroids acting locally

  • Corticosteroids for local oral treatment

  • Antiinflammatory Corticosteroids

  • Corticosteroids, weak group I

  • Corticosteroids, weak, other combinations

  • Corticosteroids/antiinfectives/mydriatics in combination

  • Glucocorticoids

What is the most important information I should know about Ala-Cort (hydrocortisone topical)?

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.

What should I discuss with my healthcare provider before using Ala-Cort (hydrocortisone topical)?

You should not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not use this medicine on a child without a doctor's advice. Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects.

How should I use Ala-Cort (hydrocortisone topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medicine on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover the treated skin area unless your doctor tells you to.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Call your doctor if your symptoms do not improve, or if they get worse while using hydrocortisone topical.

Store at room temperature away from moisture and heat.

What happens if I overdose?

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.

Ala-Cort (hydrocortisone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Stop using hydrocortisone topical and call your doctor if you have:

  • blurred vision, or seeing halos around lights;

  • uneven heartbeats;

  • sleep problems (insomnia);

  • weight gain, puffiness in your face; or

  • tired feeling.

Common side effects may include:

  • acne, skin redness, mild burning or itching;

  • changes in skin color; or

  • dryness or cracking of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before Using Ala-Cort

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.

Ala-Cort Side Effects

Along with its needed effects, a medicine 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:

Incidence not known
  • 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 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:

Incidence not known
  • 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For Healthcare Professionals

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

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