Amcinonide Topical application

It is very important that you use amcinonide 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.

amcinonide 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.

amcinonide 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. amcinonide 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 amcinonide.
• Apply a thin layer of amcinonide to the affected area of the skin. Rub it in gently.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried.
• 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 amcinonide 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 amcinonide. 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 topical dosage forms (cream, lotion, and ointment):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two to three times per day.
    • Children—Apply to the affected area of the skin two to three times per day.

Missed Dose

If you miss a dose of amcinonide, 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.

Cream and ointment: Apply a thin film topically to affected area 2 to 3 times a day depending on severity of condition
Lotion: Apply topically and rub into the affected area completely twice a day

Comments:
-Occlusive dressings can be a therapeutic adjunct for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, occlusive dressings should be discontinued and antimicrobial therapy should be initiated.
-The affected area where the drug is applied should be protected from washing, clothing, rubbing until the lotion is dried.

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

Cream and ointment: Apply a thin film topically to affected area 2 to 3 times a day depending on severity of condition
Lotion: Apply topically and rub into the affected area completely twice a day

Comments:
-Occlusive dressings can be a therapeutic adjunct for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, occlusive dressings should be discontinued and antimicrobial therapy should be initiated.
-The affected area where the drug is applied should be protected from washing, clothing, rubbing until the lotion is dried.
-Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen.

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

Data not available

Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Consult WARNINGS section for additional precautions.

Administration advice:
-Contact with the eyes should be avoided.
-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:
-Store at room temperature; do not freeze.

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.

Summary of Use during Lactation

Amcinonide has not been studied during breastfeeding. Since only extensive application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short-term application of topical corticosteroids would pose a risk to the breastfed infant by passage into breastmilk. However, it would be prudent to use the least potent drug on the smallest area of skin possible. It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only the lower potency corticosteroids should be used on the nipple or areola where the infant could directly ingest the drugs from the skin. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[1] Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Topical application of a corticosteroid with relatively high mineralocorticoid activity (isofluprednone acetate) to the mother's nipples resulted in prolonged QT interval, cushingoid appearance, severe hypertension, decreased growth and electrolyte abnormalities in her 2-month-old breastfed infant. The mother had used the cream since birth for painful nipples.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Topical) Hydrocortisone, Topical

References

1. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38(3):317-25. PMID: 14623482

2. De Stefano B, Bongo IG, Borgna-Pignatti C et al. Factitious hypertension with mineralocorticoid excess in an infant. Helv Paediatr Acta. 1983;38:185-9. PMID: 6874387

Substance Name

Amcinonide

CAS Registry Number

51022-69-6

Drug Class

Corticosteroids, Topical

Glucocorticoids

Anti-Inflammatory Agents