Lindane Product Advancements
Lindane Patient Education
Appropriate use of lindane medications by patients and caregivers is an important aspect of their safety and effectiveness. In 2003, the Food and Drug Administration (FDA), in collaboration with the U.S. manufacturer, addressed this issue with the creation of patient-friendly medication guides for both lindane lotion and lindane shampoo. These guides are now required by law to be dispensed by pharmacists with every new lindane prescription.1
Lindane medication guides are designed to enhance lindane safety: 2,3
- Written in plain English, the medication guides help physicians and pharmacists to educate patients and caregivers on potential risks, proper use, and contraindications
- The medication guides are integrated into the newer single-use packaging of lindane lotion and shampoo to ensure they are dispensed with each prescription
Lindane lotion and shampoo packaging ensures that the medication guide stays together with the bottle and is easily accessed by pharmacists, patients, and caregivers
Well-informed patients are less likely to misuse medications like lindane
| Lindane products | U.S.2–6 | Canada7 |
|---|---|---|
| Regulatory status | Prescription only | O.T.C.*, no prescription required |
| Patient-friendly medication guide | Packaged with each bottle and dispensed by pharmacist with each prescription—required by law | None |
* O.T.C.=over-the-counter medication
Critical information covered in Medication Guides for lindane lotion and shampoo:2,3
- What is lindane lotion/shampoo?
- Who should not use lindane lotion/shampoo?
-
How do I use lindane lotion/shampoo?
- Before you put it on
- When you put it on
- When you are supposed to wash it off
- After you wash it off
- What should I avoid while using lindane lotion/shampoo?
- What are the ingredients in lindane lotion/shampoo?
Please See Important Safety Information on Lindane
References:
- U.S. Food and Drug Administration (FDA). Public health advisory: Safety of topical lindane products for the treatment of scabies and lice. March 28, 2003. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110845.htm.
- Medication Guide Lindane Lotion USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM133687.pdf.
- Medication Guide Lindane Shampoo USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM133688.pdf.
- Lindane lotion, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/006309lotionlbl.pdf.
- Lindane shampoo, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/006309shampoolbl.pdf.
- U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER) Report to the Nation: 2003. Available at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/UCM078975.pdf.
- Lindane Canadian package insert: Lindane Shampoo and Lotion. Pharmascience, Inc., Montréal, Canada.