Aristocort A

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:

• 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)

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:

• 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.

• If you have an allergy to triamcinolone or any other part of Aristocort A (triamcinolone cream and ointment).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Aristocort A with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Aristocort A as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Do not use tight-fitting diapers or plastic pants if treated part is in the diaper area. This may cause more drug to get into the body.
• Do not use to treat diaper rash.
• Do not put on cuts, scrapes, or damaged skin.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Aristocort A, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aristocort A. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Aristocort A.

Review Date: October 4, 2017

Applies to triamcinolone topical: mucous membrane paste, topical cream, topical kit, topical lotion, topical ointment, topical spray

General

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

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Local

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

Dermatologic

Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the skin and oral mucosa, secondary infection, atrophy of the skin and oral mucosa, striae, and miliaria[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Nervous system

Frequency not reported: Intracranial hypertension (including bulging fontanelles, headaches, bilateral papilledema)[Ref]

Some side effects of Aristocort A 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: Apply a thin film to affected areas two to four times a day
Lotion: Apply a thin film to affected areas three to four times a day
Spray: Three to four applications 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.

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

Data not available

Administration advice:
-This drug should not be used on the face, groin, or axillae, unless directed by a healthcare professional.
-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.
-Long term therapy in infants should be avoided as adrenal suppression may occur.
-Patients on long term therapy should not be given any live attenuated vaccines if there is a risk of immunosuppression.

Storage requirements:
-Avoid freezing
Lotion: Shake well before using
Spray: Avoid excessive heat; do not puncture or incinerate

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. It is for external use only. Contact with the eyes should be avoided.
-Patients should be advised not to use this medication for any condition other than for which it was prescribed.