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From: Morton
Grove Pharmaceuticals
Important
new information about Lindane Shampoo and Lindane Lotion, USP 1%
April 2004
Dear RxLink Pharmacist:
Have you been
receiving the most accurate information about Lindane Shampoo and Lotion?
Lindane
Shampoo (AT rated to Kwell Shampoo) and Lindane Lotion (AT rated to
Kwell Lotion) are both effective second-line therapies that are
prescribed by physicians when other medicines have been tried and
have failed. Both therapies are sold only under a physician's
prescription. Lindane Shampoo is an effective second-line therapy for
head lice, while Lindane Lotion is an effective therapy for treatment
of scabies.
While these
products are both useful and effective when needed, it is essential
that they are used only in accordance with the directions provided.
Seizures and fatalities have been reported following Lindane use with
repeated or prolonged application but also in rare cases following a
single application reportedly used according to directions. Also,
central nervous system stimulation as mild as dizziness has occurred.
We ask for your assistance to assure appropriate use. Morton Grove
Pharmaceuticals, in conjunction with the FDA, has taken the following
measures designed to help prevent improper use of these medications.
-Lindane
Shampoo and Lotion are now supplied in 2-oz bottles only. The 2-oz
bottle is a single application, which will help prevent patients from
using more than the recommended dosage in accordance with the
physician's prescription.
-A medication
guide containing full prescribing and usage information has been
attached to each carton of Lindane Shampoo and Lindane Lotion. This
guide gives the patient information and instructions needed to assure
optimum safety and effectiveness.
-Use special
care when prescribing to patients who may be especially prone to side
effects or adverse events, such as pregnant and nursing mothers, the
elderly, and children weighing less than 110 pounds.
-A complete
package insert has been built into the label.
Thank you for
your attention to this important matter. We are confident that these
practices will assist pharmacists, physicians, and patients in
assuring the proper use of Lindane Shampoo and Lotion.
Please refer
to the enclosed prescribing information for complete details.
P.S. For
further information about the appropriate use of Lindane products,
visit http://www.fda.gov/cder/drug/infopage/lindane/lindaneQA.htm |
