MALATHION LOTION, 0.5%- malathion lotion, 0.5% lotion

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

MALATHION (UNII: U5N7SU872W) (MALATHION - UNII:U5N7SU872W)

Beschikbaar vanaf:

Karalex Pharma, LLC, Woodcliff Lake, NJ 07677

INN (Algemene Internationale Benaming):

MALATHION

Samenstelling:

MALATHION 5 mg in 1 mL

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Malathion Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. Malathion Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. Malathion Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle. The safety and effectiveness of Malathion Lotion in children less than 6 years of age has not been established via well-controlled trials.

Product samenvatting:

Malathion Lotion, USP 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 42043-150-23. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Flammable. Keep away from heat and open flame.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

MALATHION LOTION, 0.5%- MALATHION LOTION, 0.5% LOTION
KARALEX PHARMA, LLC, WOODCLIFF LAKE, NJ 07677
----------
MALATHION LOTION, USP 0.5%
RX ONLY
For topical use only. Not for oral or ophthalmic use.
DESCRIPTION
Malathion Lotion contains 0.005 g of malathion per mL in a vehicle of
isopropyl alcohol (78%),
terpineol, dipentene, and pine needle oil. The chemical name of
malathion is (±) -
[(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester.
Malathion has a molecular weight of
330.36, represented by C
H O PS , and has the following chemical structure:
CLINICAL PHARMACOLOGY
Malathion is an organophosphate agent which acts as a pediculicide by
inhibiting cholinesterase activity
in vivo. Inadvertent transdermal absorption of malathion has occurred
from its agricultural use. In such
cases, acute toxicity was manifested by excessive cholinergic
activity, i.e., increased sweating, salivary
and gastric secretion, gastrointestinal and uterine motility, and
bradycardia (see OVERDOSAGE).
Because the potential for transdermal absorption of malathion from
Malathion Lotion is not known at this
time, strict adherence to the dosing instructions regarding its use in
children, method of application,
duration of exposure, and frequency of application is required.
INDICATIONS AND USAGE
Malathion Lotion is indicated for patients infected with Pediculus
humanus capitis (head lice and their
ova) of the scalp hair.
CONTRAINDICATIONS
Malathion Lotion is contraindicated for neonates and infants because
their scalps are more permeable
and may have increased absorption of malathion. Malathion Lotion
should also not be used on
individuals known to be sensitive to malathion or any of the
ingredients in the vehicle.
WARNINGS
1. Malathion Lotion is FLAMMABLE. The lotion and wet hair should not
be exposed to open flames or
electric heat sources, including hair dryers and electric curlers. Do
not smoke while applying lotion
or while hair is wet. Allow hair to dry naturally and to remain
uncovered after application of
Malathion Lotio