MALATHION lotion

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Malathion (UNII: U5N7SU872W) (Malathion - UNII:U5N7SU872W)

Tilgængelig fra:

Taro Pharmaceuticals U.S.A., Inc.

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Malathion Lotion USP, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5294-4. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Flammable. Keep away from heat and open flame.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MALATHION- MALATHION LOTION
TARO PHARMACEUTICALS U.S.A., INC.
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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.
10
19
6
2
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 lotion.
2. Malathion lotion sh