(See BOXED WARNINGS.)
Seizures and deaths have been reported following Lindane Lotion's use with
repeat or prolonged application, but also in rare cases following a single application
reportedly used according to directions. It is not known how soon after application
of a single dose of Lindane Lotion that a second dose of Lindane Lotion can
be safely applied.
There have been cases of adverse events reported for Lindane Lotion and Lindane
Shampoo in which a serious outcome (hospitalization, disability or death) has
occurred.4 In approximately 20% of the total reported cases, Lindane
Lotion and Shampoo were reported to have been used according to the labeled
directions. Of these cases, thirteen deaths were reported, many cases which
were remote from the time of actual Lindane use. Lindane toxicity, verified
by autopsy was the cause of one infant's death, was the cause of death reported
for an adult who ingested it orally in a successful suicide. The direct causes
of death for the other cases were attributed to reasons other than Lindane.
Most of these adverse events occurred with Lindane Lotion.
Infants, children, the elderly, and individuals with other skin conditions
and those who weigh < 110 lbs (50 kg) may be at greater risk of serious neurotoxicity.
(See Pediatric Use and Geriatric Use.) Animal studies have shown
increased susceptibility to neurologic adverse events in younger animals. Children
have a larger body surface area to volume ratio that may result in a proportionately
larger systemic exposure.
Careful consideration should be given before prescribing Lindane Lotion to
patients with conditions that may increase the risk of seizure, such as HIV
infection, history of head trauma or a prior seizure, CNS tumor, the presence
of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from
alcohol or sedatives, as well as concomitant use of medications known to lower
seizure threshold. (See PRECAUTIONS: DRUG INTERACTIONS.)
Patients should be instructed on proper use of Lindane Lotion, especially the
amount to apply, how long to leave the lotion on, and the need to avoid retreatment.
Patients should be informed that itching may occur, and even worsen, after the
successful killing of scabies. Repeat treatment is usually not necessary.
A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law.