LINDANE shampoo

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:

SHAMPOO

Composition:

10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis ), crab lice (infestations of Pthirus pubis ), and their ova only in patients who - cannot tolerate other approved therapies, or - have failed treatment with other approved therapies. Lindane Shampoo should be used in the context of an overall lice management program that includes: - Visual inspection to ensure that the patient is currently infested with live lice (empty egg casings or "nits" can remain on hair shaft long after true infestation). - Manual removal of nits using a comb designed for this purpose and/or individual removal with tweezers followed by close examination of the hair and scalp. - Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Shampoo only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies. - All recently worn clothing, underwear, pajamas, used sheet

Product summary:

Lindane Shampoo USP, 1% is supplied in 1 fl oz (30 mL) (NDC#: 45068-100-01) and 2 fl oz (60 mL) (NDC#: 45068-100-02) bottles. SHAKE WELL BEFORE USING Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Patient Information leaflet

LINDANE- LINDANE SHAMPOO
Olta Pharmaceuticals Corporation
----------
MEDICATION GUIDE
Lindane (LIHN-dane) Shampoo USP, 1%
You must read and follow all instructions before using Lindane
Shampoo. Read the information you get
every time you or a family member get Lindane Shampoo. 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 Shampoo, ask your
doctor or pharmacist.
What is the most important information I should know about Lindane
Shampoo?
Lindane Shampoo is a poison if you do not use it the right way.
Lindane Shampoo goes through your skin
and can affect your brain and nerves. Lindane Shampoo can cause
seizures, also called convulsions, "fits"
or epilepsy.
•
Seizures and death can happen in people who use Lindane Shampoo too
much or too often.
•
Seizures can happen in some people even if they use Lindane Shampoo
exactly as directed.
If you or a family member has a seizure while using Lindane Shampoo,
get emergency help right away.
•
Do not use Lindane Shampoo unless
•
You have lice and another medicine did not work for you, or
•
You cannot use other, safer medicines to treat your lice
•
Do not use Lindane Shampoo more than 1 time to treat an attack of
lice. Do not use Lindane
Shampoo to treat a second attack that comes soon after the first
episode. No one knows a safe time
to reuse Lindane Shampoo. Even if you still itch even after using
Lindane Shampoo, do not use
more or use it again. Lice (bugs) can make you itch for some time even
after all of the bugs are
dead.
•
Do not use more Lindane Shampoo than your doctor tells you.
•
Do not keep Lindane Shampoo on your hair for more than 4 minutes.
•
Do not put Lindane Shampoo in your mouth because it is a poison if
taken by mouth. If you get
Lindane Shampoo in your mouth or swallow Lindane Shampoo, call your
area Poison Control
Center right away and get emergency help.
What is Lindane Shampoo?
Lindane Shampoo is a

Summary of Product characteristics

LINDANE- LINDANE SHAMPOO
OLTA PHARMACEUTICALS CORPORATION
----------
LINDANE SHAMPOO USP, 1%
RX ONLY
WARNINGS
Lindane Shampoo should only be used in patients who cannot tolerate or
have failed first-line
treatment with safer medications for the treatment of lice. (See
INDICATIONS AND USAGE.)
NEUROLOGIC TOXICITY
Seizures and deaths have been reported following Lindane Shampoo use
with repeat or prolonged
application, but also in rare cases following a single application
according to directions. Lindane
Shampoo should be used with caution in infants, children, the elderly,
and individuals with other
skin conditions, and those who weigh < 110 lbs (50 kg) as they may be
at risk of serious
neurotoxicity.
CONTRAINDICATIONS
Lindane Shampoo is contraindicated in premature infants and
individuals with known uncontrolled
seizure disorders.
PROPER USE
Instruct patients on proper use of Lindane Shampoo, the amount to
apply, how long to leave it on,
and avoiding retreatment. Inform patients that itching occurs after
the successful killing of lice and
is not necessarily an indication for retreatment with Lindane Shampoo.
(See DOSAGE AND
ADMINISTRATION.)
DESCRIPTION
Lindane Shampoo USP, 1%, is an ectoparasiticide and ovicide effective
against _Pediculosis humanis_
_capitis_ (head lice), _Pthirus pubis_ (crab lice), and their ova. In
addition to the active ingredient, lindane, it
contains acetone, citric acid, polysorbate 60, purified water and
triethanolamine lauryl sulfate to form a
shampoo base. The pH may be adjusted with citric acid and/or
triethanolamine. 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 exerts its parasiticidal action by being directly absorbed
into the parasites and their ova.
6
6
6
1
Feldmann and Maibach reported approximately 10% absorption of a
lindane acetone solution applied to
the forearm of human subjects and left in place for 24 hours. This
vehicle was different from the
approved product and t