LINDANE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lindane (UNII: 59NEE7PCAB) (Lindane - UNII:59NEE7PCAB)

Available from:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

Lindane

Composition:

Lindane 10 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINDANE- LINDANE LOTION
MORTON GROVE PHARMACEUTICALS, INC.
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LINDANE LOTION, USP 1%
RX ONLY
WARNINGS
Lindane Lotion should only be used in patients who cannot tolerate or
have failed first-line
treatment with safer medications for the treatment of scabies. (See
INDICATIONS AND
USAGE.)
NEUROLOGIC TOXICITY
Seizures and deaths have been reported following Lindane Lotion use
with repeat or prolonged
application, but also in rare cases following a single application
used according to directions.
Lindane Lotion should be used with caution for infants, children, the
elderly, and individuals with
other skin conditions (e.g., atopic dermatitis, psoriasis) and in
those who weigh < 110 lbs (50 kg)
as they may be at risk of serious neurotoxicity.
CONTRAINDICATIONS
Lindane Lotion is contraindicated in premature infants and individuals
with known uncontrolled
seizure disorders.
PROPER USE
Instruct patients on the proper use of Lindane Lotion, the amount to
apply, how long to leave it on,
and avoiding retreatment. Inform patients that itching occurs after
the successful killing of scabies
and is not necessarily an indication for retreatment with Lindane
Lotion. (See DOSAGE AND
ADMINISTRATION.)
DESCRIPTION
Lindane Lotion, USP 1%, is an ectoparasiticide and ovicide. In
addition to the active ingredient, lindane,
it contains 2-amino-2-methyl-1-propanol, carrageenan, cetyl alcohol,
cocoa butter, glyceryl
monostearate, methylparaben, propylene glycol, propylparaben, purified
water, stearic acid and
trolamine to form a lotion. The pH range is between 6.5 and 8.5.
Lindane is the gamma isomer of
1,2,3,4,5,6-hexachlorocyclohexane having the following structural
formula:
C H CL M.W. 290.83
CLINICAL PHARMACOLOGY
Lindane Lotion, USP 1%, is an ectoparasiticide and ovicide effective
against _Sarcoptes scabiei_ (scabies).
6
6
6
Lindane exerts its parasiticidal action by being directly absorbed
into the parasites and their ova.
Feldmann and Maibach reported approximately 10% systemic absorption of
a lindane acetone solution
when appli