First Aid Advice: How to Treat BurnsThe introduction of hydrocortisone to the nonprescription market in was a revolutionary move by the FDA. How was hydrocortisone judged safe enough for consumer self-use? Hydrocortisone was first marketed as a prescription medication in According to the agency, two factors were critical in denying the petition. First, there was insufficient evidence that consumers could safely self-medicate with hydrocortisone. Second, the agency was concerned about percutaneous absorption. The experts concluded that hydro cortisone 0.
Minor burns - aftercare: MedlinePlus Medical Encyclopedia
The introduction of hydrocortisone to the nonprescription market in was a revolutionary move by the FDA. How was hydrocortisone judged safe enough for consumer self-use? Hydrocortisone was first marketed as a prescription medication in According to the agency, two factors were critical in denying the petition.
First, there was insufficient evidence that consumers could safely self-medicate with hydrocortisone. Second, the agency was concerned about percutaneous absorption. The experts concluded that hydro cortisone 0. Addressing a matter of paramount concern to the FDA in its negative decision, the panel concluded on the basis of current research that hydrocortisone did not cause hypothalamus-pituitary-adrenal HPA axis suppression in patients with chronic skin disease.
Whether or not hydrocortisone should be available on a nonprescription basis was debated by the American Academy of Dermatology in and Among their concerns have been masking the development of skin cancers or other serious conditions, thereby delaying their diagnosis, as well as such adverse reactions as atrophy, striae, and steroid-induced rosacea.
A paper in the Archives of Dermatology concluded that the earlier opposition had been unwarranted and that the switch was justified. Hydrocortisone carries numerous instructions and warnings that must be read carefully, thoroughly understood, and scrupulously followed to ensure safe use. The age of the patient is important for the pharmacist to ascertain. Hydrocortisone is not safe for any patient under the age of 2 years.
Patients aged 2 years or older are directed to apply the product to the affected area three to four times daily. Hydrocortisone is approved to self-treat a variety of dermatologic conditions. These include insect bites; allergic reactions e. The FDA does not allow hemorrhoid products to be labeled for those under the age of 12 years and advises that a physician should be consulted when treating external anal itching in this age-group.
Patients are instructed to halt use of nonprescription hydrocortisone and see a physician if the symptoms worsen, if they persist for more than 7 days, or if they clear up and recur again within a few days. Nonprescription hydrocortisone products should not be applied to the eyes or eyelids.
Patients who are pregnant or nursing should only use hydrocortisone on the advice of a physician. The labels of hydrocortisone products warn patients against use in diaper rash. Hydrocortisone is contraindicated if a female patient with genital itching also has a vaginal discharge. Hydrocortisone might provide symptomatic relief, giving the patient the idea that she is better, and delaying her visit to a physician for an antibiotic or antibacterial.
Burns should not be treated with hydrocortisone, as it is not known to be effective in burned skin. Hydrocortisone is inappropriate as sole therapy for fungal conditions, such as tinea pedis, tinea corporis, or tinea cruris. Hydrocortisone is not known to be effective or safe for treating such minor conditions as acne, dandruff, hair loss, warts, corns, calluses, or sunburn. The United States is one of the only countries without a widespread third class of medications that would require pharmacist counseling with the limited exceptions of pseudoephedrine, ephedrine, and Plan B.
Since professional intervention is not required in sales of nonprescription products, the label must contain every bit of information needed to ensure proper use by the self-medicating patient. The FDA assumes that patients using nonprescription products will read and heed all sections of the label, thoroughly understanding all of the information and acting exactly as the label directs.
This assumption underlies virtually every decision made by the FDA regarding nonprescription products, but it is especially critical in Rx-to-OTC switched products such as hydrocortisone. To verify or disprove this assumption, researchers must survey actual users of the products in question. A British study explored that issue for hydrocortisone products and the corticosteroid clobetasone clobetasone has been available as a nonprescription product in Britain since Several patients were treating multiple conditions.
This tabulation illustrates the value of pharmacist intervention in advising against use where nonprescription corticosteroids are inappropriate e. Ten percent applied the products to the face, in direct opposition to clear label directions not to do so. An interested pharmacist trained in recognition of minor dermatologic conditions might have been able to render a more reliable judgment of what type of condition was present in that large segment of shoppers.
Hydrocortisone is a nonprescription product that carries numerous critical instructions and warnings to help ensure that it is used safely and effectively. However, research in Britain confirmed that there are numerous instances when patients engage in incorrect use.
Pharmacists can be vitally important in ensuring that patients use powerful OTC pharmacologic agents only when appropriate and that they heed all warnings and precautions.
Nonprescription hydrocortisone has been on the market for 30 years. Hydrocortisone is useful for different types of dermatitis or skin inflammations caused by such allergens or irritants as soap, detergents, cosmetics, jewelry, and poison ivy, oak, or sumac. The skin affected with these problems may appear to have a rash, be broken out with blisters, be affected with raw areas, or have a dry, scaly appearance. Hydrocortisone can help stop itching of the skin and genital or anal areas, and it also helps relieve the discomfort from insect bites.
In addition, it is of some use in psoriasis or seborrheic dermatitis. The product should be applied three to four times daily. It is important to avoid incorrect usage of this product. If you are using it for hemorrhoids, do not attempt to place it into the rectum, whether using the fingers or any other type of applicator device.
For instance, you should never allow it to be used on anyone under the age of 2 years. It should not be used in or near the eyes. If the condition worsens or lasts longer than 7 days, you should stop use and consult a physician.
If the condition clears up but returns a few days later, hydrocortisone is not appropriate and a physician appointment is the best move. Pregnant patients and those who are breast-feeding should not use it unless advised to do so by their physician.
Which Type of Product Is Best? You will notice that hydrocortisone is available in several forms, such as creams, ointments, sprays, and lotions. The choice is personal, as all products are effective. Creams have a smooth feel that some patients prefer, whereas ointments cover the skin with a greasy or oily layer of active ingredient. Ointments are more resistant to water removal, such as when one later washes the hands. Lotions spread over the skin more smoothly than creams or ointments but are also subject to water removal.
Sprays allow the user to cover the area without rubbing a product on. This is an advantage when rubbing or touching the affected area causes itching or pain. If after reading the OTC hydrocortisone labels you are still confused about which product to select, please do not hesitate to ask the pharmacist for a recommendation.
The Path to Nonprescription Status Hydrocortisone was first marketed as a prescription medication in Physician Attitudes Whether or not hydrocortisone should be available on a nonprescription basis was debated by the American Academy of Dermatology in and Conclusion Hydrocortisone is a nonprescription product that carries numerous critical instructions and warnings to help ensure that it is used safely and effectively. Remember, if you have questions, Consult Your Pharmacist.
Accessed February 26, Recommendations regarding the safety and effectiveness of hydrocortisone. Advisory panel review of OTC topical analgesic, antirheumatic, otic, burn, and sunburn protection and treatment drug products. Concurrence with the recommendation of the topical analgesics panel.
Topical hydrocortisone from prescription to over-the-counter sale. FDA recognition that hydrocortisone is safe and effective as an OTC antipruritic active ingredient at concentrations up to 1. Cortaid Maximum Strength Cream. Use of nonprescription topical steroids: To comment on this article, contact rdavidson jobson.
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