What happens if I overdose Olux-E Emollient Foam?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include muscle weakness; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; drowsiness; flushing; rapid breathing; fruit-like breath odor); unusual weight gain, especially in the face; vision changes.
Proper storage of Olux-E Emollient Foam:
Store Olux-E Emollient Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not store above 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not refrigerate or freeze. Do not store in the bathroom. Keep Olux-E Emollient Foam out of the reach of children and away from pets.
Overdose of Olux-E Emollient Foam in details
Symptoms:
Topically applied Olux-E Emollient Foam may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur.
Treatment: In the event of overdose, Olux-E Emollient Foam should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated or as recommended by the national poisons center, where available.
What should I avoid while taking Olux-E Emollient Foam?
Olux-E Emollient Foam should not be used to treat any skin condition your doctor has not prescribed it for.
Avoid using Olux-E Emollient Foam to treat skin on your face, underarms, or groin area without your doctor's advice.
Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use Olux-E Emollient Foam on broken or infected skin. Also avoid using this medication in open wounds.
Olux-E Emollient Foam warnings
Effects on the Endocrine System
Olux-E Emollient Foam Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential for systemic absorption, use of topical corticosteroids, including Olux-E Emollient Foam Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of Olux-E Emollient Foam Cream on the HPA axis, subjects with plaque psoriasis applied Olux-E Emollient Foam Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days. Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on Olux-E Emollient Foam Cream. In another trial to evaluate the effects of Olux-E Emollient Foam Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied Olux-E Emollient Foam Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on Olux-E Emollient Foam Cream.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.
Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended.
Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.
Local Adverse Reactions with
Topical Corticosteroids
Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Olux-E Emollient Foam Cream. Some local adverse reactions may be irreversible.
Concomitant Skin Infections
Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Olux-E Emollient Foam Cream until the infection has been adequately treated.
Allergic Contact Dermatitis
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.
What should I discuss with my healthcare provider before taking Olux-E Emollient Foam?
Some medical conditions may interact with Olux-E Emollient Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have hardening of the skin or any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin
- if you have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test
- if you have recently had or are scheduled to receive a vaccination
- if you are taking other corticosteroids by mouth (eg, prednisone) or are using other products on your skin that contain corticosteroids (eg, hydrocortisone)
Some MEDICINES MAY INTERACT with Olux-E Emollient Foam. Because little, if any, of Olux-E Emollient Foam is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Olux-E Emollient Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Olux-E Emollient Foam precautions
Effects on the Endocrine System
Olux-E Emollient Foam Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential for systemic absorption, use of topical corticosteroids, including Olux-E Emollient Foam Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of Olux-E Emollient Foam Cream on the HPA axis, subjects with plaque psoriasis applied Olux-E Emollient Foam Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days. Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on Olux-E Emollient Foam Cream. In another trial to evaluate the effects of Olux-E Emollient Foam Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied Olux-E Emollient Foam Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on Olux-E Emollient Foam Cream.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.
Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended.
Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.
Local Adverse Reactions with
Topical Corticosteroids
Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Olux-E Emollient Foam Cream. Some local adverse reactions may be irreversible.
Concomitant Skin Infections
Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Olux-E Emollient Foam Cream until the infection has been adequately treated.
Allergic Contact Dermatitis
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.
What happens if I miss a dose of Olux-E Emollient Foam?
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.
References
- DrugBank. "Clobetasol". http://www.drugbank.ca/drugs/DB11750 (accessed September 17, 2018).
- MeSH. "Glucocorticoids". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
