LINDANE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Olta Pharmaceuticals Corporation

INN (International Name):

Lindane

Pharmaceutical form:

LOTION

Composition:

10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lindane Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who: - cannot tolerate other approved therapies, or - have failed treatment with other approved therapies. Lindane Lotion should be used in the context of an overall scabies management program that includes: - Microscopic evaluation of skin scrapings to confirm the diagnosis. - Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Lotion only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies. - Washing of all recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels in very hot water or dry-cleaned. Caregivers applying this product to patients should wear gloves less permeable to Lindane, such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more pe

Product summary:

Lindane Lotion USP, 1% is supplied in 1 fl oz (30 mL) (NDC#: 45068-101-01) and 2 fl oz (60 mL) (NDC#: 45068-101-02) bottles. SHAKE WELL BEFORE USING Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Patient Information leaflet

LINDANE- LINDANE LOTION
Olta Pharmaceuticals Corporation
----------
MEDICATION GUIDE
Lindane (LIHN-dane) Lotion USP, 1%
You must read and follow all instructions before using Lindane Lotion.
Read the information you get
every time you or a family member get Lindane Lotion. There may be new
information. This Medication
Guide does not take the place of talking with your doctor about your
medical condition or treatment. If
you have any questions about Lindane Lotion, ask your doctor or
pharmacist.
What is the most important information I should know about Lindane
Lotion?
Lindane Lotion is a poison if you do not use it the right way. Lindane
Lotion goes through your skin and
may affect your brain and nerves. Lindane Lotion can cause seizures,
also called convulsions, "fits" or
epilepsy.
•
Seizures and death can happen in people who use Lindane Lotion too
much or too often.
•
Seizures can happen in some people even if they use Lindane Lotion
exactly as directed.
If you or a family member has a seizure while using Lindane Lotion,
get emergency help right away.
•
Do not use Lindane Lotion unless:
•
You have scabies and were treated with another medicine that did not
work for you, or
•
You cannot use other safer medicines to treat your scabies.
•
Do not use Lindane Lotion more than 1 time to treat an attack of
scabies. Do not use Lindane
Lotion to treat a second attack of scabies that comes soon after the
first episode. Using it more
than 1 time can cause seizures and death. No one knows a safe time to
reuse Lindane Lotion. Even
if you still itch after using Lindane Lotion, do not use more or use
it again. Scabies (bugs) can
make your skin itch for a few weeks even after all of the bugs are
dead.
•
Do not use more Lindane Lotion than your doctor tells you.
•
Do not keep Lindane Lotion on your skin for more than 8 to 12 hours.
•
Do not put Lindane Lotion in your mouth because it is a poison if
taken by mouth. If you get
Lindane Lotion in your mouth or swallow Lindane Lotion, call your area
Poison Control

Summary of Product characteristics

LINDANE- LINDANE LOTION
OLTA PHARMACEUTICALS CORPORATION
----------
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, butylparaben, carrageenan,
cetyl alcohol, glyceryl
monostearate, methylparaben, perfume compound, purified water, stearic
acid and triethanolamine 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
6
6
6
Lindane Lotion USP, 1%, is an ectoparasiticide and ovicide effective
against _Sarcoptes scabiei_ (scabies).
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 applied to the