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A synthetic corticosteroid.1 2 12 d
Advice to Patients
Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.c d (See Topical Administration under Dosage and Administration.)
Importance of not applying on the face, underarms, or groin unless directed by clinician.c d
Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.c d
Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.b c d
Importance of informing parents of children not to use in the treatment of diaper dermatitis and not to apply in the diaper area as diapers or plastic pants may constitute occlusive dressings.c d
Importance of discontinuing use when control is achieved; importance of contacting clinician if no improvement is seen in 2 weeks.c d
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.c d
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d
Importance of advising patients of other important precautionary information. (See Cautions.)
What do I need to tell my doctor BEFORE I take Aclovate?
- If you have an allergy to alclometasone or any other part of Aclovate (alclometasone).
- 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 medicine may interact with other drugs or health problems.
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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Topically applied Aclovate® Cream and Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
For Healthcare Professionals
Applies to alclometasone topical: topical cream, topical ointment
The most commonly reported side effects were itching, burning, erythema, dryness, irritation, and papular rashes.[Ref]
Frequency not reported: Cushings syndrome[Ref]
Common (1% to 10%): Papular rash
Frequency not reported: Folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, striae, miliaria, secondary infection, hypertrichosis, skin maceration, skin atrophy[Ref]
Common (1% to 10%): Itching, burning, erythema, dryness, irritation
Rare (less than 0.1%): Stinging[Ref]
Frequency not reported: Hyperglycemia[Ref]
Frequency not reported: Glucosuria[Ref]
Some side effects of Aclovate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Alclometasone Levels and Effects while Breastfeeding
Summary of Use during Lactation
Alclometasone has not been studied during breastfeeding. Since only extensive application of the most potent of these drugs 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 (e.g., hydrocortisone, triamcinolone) 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. Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.
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.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
(Topical) Hydrocortisone, Topical
1. Greenberger PA, Patterson R. The management of asthma during pregnancy and lactation. Clin Rev Allergy. 1987;5:317-24. PMID: 3319123
2. Ellsworth A. Pharmacotherapy of asthma while breastfeeding. J Hum Lact. 1994;10:39-41. PMID: 7619245
3. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg.htm
4. 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
5. 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
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